Author: AS Legal

Surrogacy Law In India

Surrogacy is a method in which a woman consents to carry a child and go through gestation for it. When the child is born, it is then given to the couple who sought it. The surrogate mother will not raise the child but only acts as a gestational carrier after being implanted with an embryo.

Regulation in India

India lacks appropriate regulatory measures for the surrogacy business or more popularly known as baby-making business. It is a was a thriving business of $2.3Billion/annum before passing of The Surrogacy Act.

In 2016, the Surrogacy Bill was introduced in the Parliament which was passed 2 years later, on 18th December 2018. The act prohibits the increase of commercial surrogacy in India. The legislation aims and provides children to only those couples who could not bear children.

Conditions

The acts provide that the person who is going to be a surrogate mother should be a close relative to the couple seeking a child. However, it does not define the who these ‘close relatives’ shall be. National Surrogacy Board has been established for the regulation and systematic governance of surrogacy practice in India.

The act requires the couple and the surrogate mother to have eligibility certificates to do so, which shall be released by competent authorities. The act puts the biggest limitations on foreigners and Non-Resident Indians (NRIs). They are no longer allowed to seek surrogacy in India. The decision was taken after many cases of abandonment of children, and child trafficking cases came to light.

The act does not cover the same-sex couples and hence, dampens the idea of equal rights to the LGBTQ+ community. The same applies to the people in relationships different from traditionally monogamous married ones, which means even single parents and live-in couples do not come under the purview of this act. The couple seeking surrogacy should be married for at least five years and mandatorily possess a competent registered doctor’s certificate, confirming their infertility.

Another limitation put by the act is that couples that already have children are not allowed to seek surrogacy in India. However, such couples can adopt children as per existing laws.

The act has often been criticised for to be a prohibition, more than a regulation. So in 2020 parliament of India approved the Assisted Reproductive Technology Bill for removing the prior law.

 

K.Kalaiselvi vs Chennai Port Trust (2013)

The Supreme Court in the landmark judgement of K.Kalaiselvi vs Chennai Port Trust (2013) has contended that “In some cases surrogacy is the only available option for parents who wish to have a child that is biologically related to them.”

The court has further defined surrogacy into four types.

l  Traditional surrogacy (also known as the Straight method): The surrogate is pregnant with her own biological child, but this child was conceived with the intention of relinquishing the child to be raised by others; by the biological father and possibly his spouse or partner, either male or female. The child may be conceived via home artificial insemination using fresh or frozen sperm or impregnated via IUI (intrauterine insemination), or ICI (intracervical insemination) which is performed at a fertility clinic.

l  Gestational surrogacy (also known as the Host method): The surrogate becomes pregnant via embryo transfer with a child of which she is not the biological mother. She may have made an arrangement to relinquish it to the biological mother or father to raise, or to a parent who is themselves unrelated to the child (e.g. because the child was conceived using egg donation, germ donation or is the result of a donated embryo.). The surrogate mother may be called the gestational carrier.

l  Altruistic surrogacy: Altruistic surrogacy is a situation where the surrogate receives no financial reward for her pregnancy or the relinquishment of the child (although usually all expenses related to the pregnancy and birth are paid by the intended parents such as medical expenses, maternity clothing, and other related expenses).

l  Commercial surrogacy: Commercial Surrogacy is a form of surrogacy in which a gestational carrier is paid to carry a child to maturity in her womb and is usually resorted to by well-off infertile couples who can afford the cost involved or people who save and borrow in order to complete their dream of being parents. This medical procedure is legal in several countries including in India where due to excellent medical infrastructure, high international demand and ready availability of poor surrogates it is reaching industry proportions. Commercial surrogacy is sometimes referred to by the emotionally charged and potentially offensive terms wombs for rent, outsourced pregnancies or baby farms.

 

National Health Insurance Schemes in India

National Health Insurance Schemes in India

The government of every nation is working towards providing adequate healthcare to its citizens. They take measures for the welfare of the people from time to time. It includes ensuring adapting infrastructure, spreading awareness about medical issues, and promoting health insurance facilities. The government of India also takes such measures and provides the Central Government Health Scheme offers.

   

 Central Government Health Scheme offers 

1. Ayushman Bharat Pradhan Mantri Jan Arogya Yojana: Ayushman Bharat Pradhan Mantri Jan Arogya Yojana is a universal health insurance scheme by Ministry of Health and Family Welfare, Government of India. It was launched to provide free access to healthcare for 40% of people in the country. The scheme offers health cover of Rs. 5 lack and aims to provide healthcare facilities to over ten crore families covering urban and rural poor.

 

2. Pradhan Mantri Suraksha Bima Yojana: Pradhan Mantri Suraksha Bima Yojana was launched in February 2015. It is an accident insurance scheme for people in the age group of Pradhan Mantri Suraksha Bima Yojana. The scheme provides annual cover of Rs. 2 lakh for Pradhan Mantri Suraksha Bima Yojana. The premium of the policy is automatically deducted from the policyholder’s bank account. It has an annual premium of Rs. 12 exclusives of taxes. 

 

3 Aam Aadmi Bima Yojana: Aam Aadmi Bima Yojana was launched on 2nd October 2007 rural landless household. It covers the individual from the age of 18 years to 59 years. The premium of Rs. 200/- per person is shared equally by the Central Government and the State Government. The head of the family or the one earning member in the family of such a household is covered under the scheme. It also includes giving scholarships to in the family of such a household is covered under the scheme. Upon the natural death, the family is compensated with Rs. 30,000 and if the death is caused by in the family of such a household is covered under the scheme. 

4. Central Government Health Scheme: Central Government Health Scheme (CGHS) was started in 1954, and provides comprehensive health care facilities for the Central Govt. employees and pensioners and their dependents. The person covered under this scheme is required to be residing in India. The medical facilities are provided through Wellness Centres (previously referred to as CGHS Dispensaries) /polyclinics under Allopathic, Ayurveda, Yoga, Unani, Sidha and Homeopathic systems of medicines.

 

5.  Employment State Insurance Scheme: Employment State Insurance Scheme is a multidimensional scheme which provides socio-economic protection to worker population and their dependents. This insurance scheme commences from day one socio-economic protection to worker population and their dependents. The workers are covered under this scheme and socio-economic protection to worker population and their dependents, including cash in physical distress such as sickness or even when the worker is permanently or temporarily disabled.

 

Besides, if any woman who has lost the capacity to earn or socio-economic protection to worker population and their dependants, they are entitled to a monthly pension under this scheme known as dependants benefits.

 

But this scheme does not apply to each and every worker of the company. It applies to only to all permanent members of factories with more than ten employees. The scheme is recently extended to various businesses such as shops, road and motor transport, restaurants, and newspaper entities that employ more than 20 people.

 

6. Janashree Bima Yojana: Janashree Bima Yojana was launched on 10th August 2000. The scheme replaced the Rural Group Life Insurance Scheme and Social Security Group Insurance Scheme. It covers individuals within the age group of 18 to 59 years. The scheme includes special features like Shiksha Sahyog Yojana and Women SHG Groups. Persons between 18 and 59 years and who are the members of the identified 45 occupational groups are eligible to be covered under the scheme.

 

7. Universal Health Insurance Scheme: Universal Health Insurance Scheme is implemented to help those families who live below the poverty line. The scheme covers the medical expenses of each and every member of the family. It provides reimbursement of medical expenses up to Rs.30,000/- towards hospitalization floated amongst the entire family. Rs.25,000/- is provided in case of death due to an accident of head of the family and compensation due to loss of earning of the earning member Rs.50/- per day up to a maximum of 15 days.

 

8. Rashtiya Swasthiya Bima Yojana: Rashtriya Swasthiya Bima Yojana was launched on 1st April 2008 by Ministry of Labour and Employment, Government of India to provide health insurance coverage for Below Poverty Line (BPL) families. People covered under this scheme gets hospitalization coverage up to Rs. 30,000/- for most of the diseases that require hospitalization. Coverage of this scheme extends to five family members, including the head of household, spouse, and up to three dependents. The registration fees to be paid by the beneficiaries is Rs. 30/- while Central and State Government pay the premium to the insurer selected by the State Government on the basis of competitive bidding.

 

The Street Vendors (Protection of Livelihood and Regulation of Street Vending) Act, 2014

The Street Vendors (Protection of Livelihood and Regulation of Street Vending) Act, 2014

 

A statistical data given by the Ministry of Housing and Urban Poverty Alleviation shows that there are more than 10 million of the street vendors in India. Alone Mumbai, Kolkata, Delhi, and Ahmedabad has more than 9 million of them. These street vendors are a significant part of India's informal economy. Most of the street vendors are the migrants from the rural areas who come to metropolitan cities for earning purpose. 

Due to the lack of capital, these vendors sell their products on the government places like railway stations, bus stands, and public streets. Being an unregulated practice, the street vendors has to face several problems like eviction threats by municipal authorities or extortion by police. In 2010's Commonwealth games many vendors were evicted due to security concerns. This lead to a massive outcry by NGO's and the vendors and the idea of protecting the rights of street vendors was born. The act was tabled in Parliament in 2012 and came into force in 2014.

  

The objective

The government of India enacted The Street Vendors (Protection of Livelihood and Regulation of Street Vending) Act, 2014 to legalise the street vendors' vending rights. This act was brought in accordance with Article 14 of the Constitution of India which states right to equality, and freedom to trade, profession, and business and enshrined under Article 19(1)(g) of the Constitution. The act regulates the street vendors and gives provisions for a regulatory body. The act lays responsibility on the government to recognise the rights of the street vendors and provide them with protection from any kind of extortion and infringement. 

The state governments have been empowered by the act to protect the rights of the street vendors. The act also gives provision for a "Town Vending Committee" constituted by the respective state government under section 22. There is also local authority which is a Municipal Corporation or a Municipal Council or a Nagar Panchayat. The local authority will work on the recommendation of the Town vending committee.

  

Town Vending Committee

The Town Vending Committee plays a vital role in recognising the rights of street vendors. It operates over the local authority and makes survey surveys, setting up that particular area's holding capacity. The committee also issues the vending license to carry out vending business.

  

Composition

The committee consists of a Chairman, and other members having their representation from the traffic police, the planning authority, medical officer, an association of market traders, an association of street traders, community interest organisation and other organisations deems suitable by the government. The Chief Election Commissioner or the Municipal Commissioner is the Chairman of the "town vending committee". 10 per cent members of the committee shall be from non-government organisations or community service-based organisations. In order to protect the rights of the street vendors, 40 per cent members shall be the from street vendors community, out of which one-third representative shall be women, and due prominence shall be given to the Scheduled caste and scheduled tribe people.

  

Power and functions of the committee

The "town vending committee" has to organise meetings from time to time concerning the framing of rules and regulations and discharging its functions. The local authority of that area will provide the office place for the committee. 

According to Section 3 of the act, the committee shall survey the area where the street vendors conduct their business, and such survey shall be done once in 5 years. The committee will determine the holding capacity of the street vendors, and it shall be two and a half per cent of the total population of the ward or locality. 

Further, section 4 says that the committee shall issue the "vending certificate" to the vendors who have completed the age of 14 years or such age as may be prescribed by the appropriate government.

No street vendor shall be evicted in case he is left from the survey done by the town committee and has not been certified. Section 5 provides that every street vendor shall give an undertaking to the Town Vending Committee prior to the issue of a certificate of vending under section 4, that— 

(a) he shall carry on the business of street vending himself or through any of his family member. 

(b) he has no other means of livelihood: 

(c) he shall not transfer in any manner whatsoever, including rent, the certificate of vending or the place specified therein to any other person.

  

Right of Street Vendors

Section 12 to Section 17 of the act provides provisions for the rights of Street Vendors. It is mentioned that every street vendor has to carry out the business as per the conditions mentioned in the certificate. Every street vendor has to abide by the rules and can relocate a new area for the practice of his street vending after the consultation with the town vending committee. The street vendor is liable to maintain public hygiene and cleanliness and civic amenities near the vending area and shall occupy the space within the time frame and vacate such space as the provided time frame ends. For the enjoyment of the rights and services, the vendor has to pay certain charges as provided by the local authority.

Orphan Drugs Legislation- comparison of Indian and global scenario

Orphan Drugs Legislation- comparison of Indian and global scenario

 

What are Orphan Drugs?

Drugs used to treat rare medical conditions are called Orphan Drugs like narcolepsy, multiple sclerosis, and fibrosis. These drugs derived the name as Orphan Drugs because pharmaceutical companies do not put enough efforts to research and develop medicines which are not profitable. The sale of medication would not recover the amount of money invested in developing these drugs.

The rare diseases which are treated by Orphan drugs can be referred to as Orphan Diseases. The government of a nation decides whether to grant a disease an Orphan disease and work for the development of a drug to treat it. 

It is only due to the government’s efforts of different nations; several breakthroughs have been achieved, which would not have been possible otherwise due to economic profit factors.

 

 

Law related to Orphan Drugs around the world

In 1980s Orphan Diseases in the USA gained attention for the first time. The case of a young boy with Tourette’s Syndrome was able to gain considerable attention to orphan disease patients’ condition. On January 28, 1983, the USA passed a set of laws devoted to orphan diseases and orphan drugs in the form of the Orphan Drugs Act (ODA). The key goal of the act was to support orphan disease development and research of orphan drugs. Following this, several other countries took inspiration and drafted their own laws as per requirements.

 

Legislation in the European Union

In 1990s European Union showed interest in the development of laws related to orphan diseases. And in the year 2000, the European Union enacted similar legislation, Regulation (EC) No 141/2000(Orphan Drug Regulation’ ODR’). The act has undergone only one amendment in 2009, which says that an orphan drugs will be stripped of its orphan status in 5 years if it is proved to be extraordinarily profitable to the pharmaceutical companies. 

The definition of Orphan Drugs used by the European Union is more comprehensive than the USA as it includes Tropical diseases generally found in the developing countries. Orphan Status is granted to a drug if it is invented to treat a disease which affects not more than 5 in 10,000 people in the European Community. Committee on Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) regulates the legislation related to orphan drugs and diseases.

 

Legislation in Japan

On October 1, 1993, Japan framed its own set of orphan drug regulations adopting a few unique provisions to encourage Research and Development of Orphan Drugs. 

The new rules say that the status of orphan drugs can be given only to those that meet the 2 requirements mentioned below:

(1) Number of patients The number of patients who may use the drug or medical device should be less than 50000 in Japan. 

(2) Medical needs The drugs or medical devices should be indicated for the treatment of serious diseases, including difficult-to-treat diseases. In addition, they must be drugs or medical devices for which there are high medical needs satisfying one of the following criteria.

 

Legislation in Singapore and Australia

Singapore in 1991 gave the definition to Orphan Drugs and had set up a legal framework which regulates the import of orphan drugs in Singapore. Australia adopted the orphan drug legislation in 1997 with the assistance of the FDA and USA. The legislative framework is mostly based on on the US model and legislations.

 

Legislation in India

Unfortunately, the knowledge of Orphan and treatment has not flowed into the Indian population’s consciousness. So far, there have been more than 450 rare diseases that have been found in India. According to the census of 2011, there were about 72,611,605 people in India affected by rare diseases. India has a very high population of people affected by rare diseases compared to the world average, and there is no initiative by the government. 

The large population suffering from orphan diseases in India poses a great opportunity for pharmaceutical companies to grow their businesses. However, the absence of legislation and the mindset of concerned authority deters the pharmaceutical industry from showing any interest.

 

HIV and AIDS (Prevention and Control) Act, 2017

HIV and AIDS (Prevention and Control) Act, 2017

 

HIV (human immunodeficiency virus) Is A Virus That Attacks Cells That Fight body infection. The virus makes a person more vulnerable to other infections and diseases. It is spread by certain bodily fluids, most commonly during unprotected sex or through sharing injection drug equipment.

If the virus is left untreated, it can lead to the disease AIDS (acquired immunodeficiency syndrome). Treatment of AIDS/HIV is very important; otherwise, life expectancy can be a maximum of 11 years after being infected.

To safeguard the rights of the infected people and control the spread of the spread of the virus, the Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome (Prevention and Control) Act, 2017 was passed on 20th April 2017 by the Parliament. The act’s main objective is to prevent discrimination against the infected people and spread awareness regarding the illness and its spread.

   

Objective and Scope of the Act

The objectives and scope of the act are as follows:

1. To stop the myths revolving around HIV or AIDS.

2. To prevent discrimination involving HIV or AIDS.

3. To punish people who spread myths and discrimination against HIV and AIDS infected people.

4. To provide equal rights and opportunities to the infected people.

 

 

Key Provisions

1. The act prohibits the discrimination towards the infected people. This prevents the spread of HIV/AIDS.

2. Without the concerned person’s permission, no research, test or treatment can be conducted.

3. The infected person who is below 18 years has a right to reside in a shared household.

4. The act prohibits publication and advocacy of hate against any infected person.

5. To look after and resolve the complaints and necessities regarding HIV and AIDS, there should be an ombudsman in every state.

6. Person spreads hatred against any infected person would be punished with minimum 3 months to a maximum of 3 months of two years imprisonment with a fine which may extend up to one lakh.

7. Antiretroviral Therapy (ART) is a legal right of every infected person.

8. Every infected person will be treated free of cost under the ‘test and treat’ policy.

 

 

Benefits of Act

1. The act has empowered the infected person to disclose discrimination in housing, property rights, health care, public services, education, public office keeping and insurance.

2. The exclusion of an infected person from segregation is prohibited. Every infected person has the right to live in a shared household and use non-discriminatory facilities. 

3. The act reads: “No person shall, by the expression, either spoken or written, print, spread, promote or convey the feelings of hatred against any protected persons or community of protected persons by signs or visible representations or otherwise.”

4. No infected person may undergo medical care, medical procedures, or research without informed consent under the law. 

 

 

Penalties under the Act

The Penalties for a person who violates the act are mentioned below:

1. Person spreading hate or discrimination against an infected person would be punished with a term of not less than three months imprisonment to a maximum imprisonment of two years with fine which may extend to one lakh rupees or both.

2. If a person violated the orders of ombudsman he has to pay a fine of up to ten thousand and if he fails to pay the fine then he has to pay a fine of five thousand every day till he pays the fine.

3. If a person discloses an infected person’s HIV status without his or her permission or without a court order or violates the ombudsman’s order and without testamentary guardianship then he can be penalized with a fine that can stretch up to one lakh rupees.

4. No person shall subject any other person or persons to any detriment on the ground that such person or persons have taken any of the following actions, namely: — 

(a) made a complaint under this act. 

(b) brought proceedings under this act against any person. 

(c) furnished any information or produced any document to a person exercising or performing any power or function under this act; or 

(d) appeared as a witness in a proceeding under this act

Trademark Infringement and Remedies in India

Trademark Infringement and Remedies in India

 

A Trademark makes out a company stand out and gives it a more noteworthy status. The law administrating and protecting Trademark in India is the Trademarks Act, 1999. Section 2 of the act defines Trademark as a mark capable of being represented graphically and capable of distinguishing one person's goods or services from those of others and may include the shape of goods, their packaging and combination of colors. 

 

Legal Framework

In India, Trademarks are secured through explicit resolutions like The Trademarks Act, 1999 and auxiliary resolutions like the Companies Act 1956, and the Customs Act, 1962.

The Trademark Act and other enactments recommend the method to be followed before the Trademarks Registry. The common procedural matters are dealt with in the Code of Civil Procedure 1908, while the accounts of customs records, the Intellectual Property Rights (Imported Goods) Enforcement Rules 2007 apply. Where the matter of Trademark is utilized in an organization name, the Companies Act applies and the criminal authorization cases are brought under the Indian Penal Code 1860.

 

Unregistered Trademarks

Section 27 of the Trademarks act lays the provision of no action for infringement of unregistered Trademark. —

1. No person shall be entitled to institute any proceeding to prevent or to recover damages for, the infringement of an unregistered trademark.

2. Nothing in this Act shall be deemed to affect rights of action against any person for passing off goods or services as the goods of another person or as services provided by another person or the remedies in respect thereof.

The offended party has to prove that:

A. The trademarks in dispute are comparable, and the respondent is misleadingly making its products look like those of the offended party. 

B. And there will undoubtedly be disarray in the psyches of purchasers. The test is to determine whether an individual of normal insight and of defective memory would be confused.

 

Registered Trademark

Section 29 and Section 30 of the Trademarks Act gives provisions for the encroachment activity. Unlike going off, in an encroachment activity, there is not really any weight on the offended party since qualification is as of now settled through enrollment.

 

The registration process for Trademark 

indistinguishable imprints or marks can be registered in an online Trademark registry. The enlisted center examines the imprint or design and may convey to the candidate any issues with it through a merged assessment report. 

Opposition can be recorded within four months of the imprint being distributed in the Trademark Journal. Anyone may oppose or question an enlistment on the grounds of disarray, weakening, clarity or conceivable trickiness.

If the imprint or design is not opposed by anyone, it continues to enrollment. And if any person is aggrieved by an order or decision of the Registrar under this act, or the rules made thereunder may prefer an appeal to the Appellate Board within three months from the date on which the order or decision sought to be appealed against is communicated to such person preferring the appeal.

 

Rectification/cancellation

Once the Trademark is granted, it can be dropped or cancelled in the light of the fact that it was wrongly allowed. A registered trademark can be drooped on the ground that of consistent non-use for a long time and three months from the date of award of enrollment.

 

Remedies

Unlike the U.S. where Trademark encroachment is covered under the Lanham Act, 1946 and doesn't cover criminal cures, Indian law considers criminal cures. Trademarks infringing law are culpable with detainment for a half year to three years and a fine between INR 50000-200000. The act further gives provision for detainment for a long time and additional penalty. 

The legality of e-Pharmacies in India

The legality of e-Pharmacies in India


e-Pharmacies has built a large customer base in India, providing quality drugs. But time again, various questions arise about the functioning and the legality of e-Pharmacies in India in the context of delivering prescription drugs online.

The legality of these drugs have often been questioned as to the Drugs and Cosmetics Act, 1940 only give provisions regarding pharmacies to be set up in brick and mortar, hence creating a vacuum for regulating the online sale of drugs.

The food and drugs administrations of various states have filed the food and drugs administrations of various states that were put under scanner by Maharashtra FDA for selling prescription drugs online alongside over-the-counter (OTC) drugs. This shall be further explained below:

 

Prescription and Over-the-counter (OTC) drugs


Prescription Drugs: These drugs are prescribed by a doctor to consume only one individual and cannot be bought without a valid prescription. These drugs can only be sold by a Registered Medical Practitioner.

Over-the-counter (OTC) Drugs: These are the types of drugs which do not require any prescription from doctors and can be sold by any grocery store or retail store.

 

How can prescription drugs be bought online?

Many e-pharmacies have opted the method of uploading a virtual copy of prescriptions which is then verified by the e-Pharmacy website. The virtual prescription can only be used once to buy the prescribed drug and hence cannot be re-used.

The law regulating online pharmacies has several ambiguities, and hence it has been interpreted and divided in the following three categories:


Green Zone: The drugs can be sold by a registered pharmacy having a registered pharmacist on a payroll.

Grey Zone: Every state for selling drugs and medicines has a drug department that grants licenses. However, there is an ambiguity for shipping drugs and medicines to other states since there is no provision for an interstate license for selling pharmaceuticals. There is also ambiguity regarding the payment of money before delivery of medicine, raising the card payment option's legality on the website, where one can pay prior to delivering the medicines.

Red Zone: Selling Prescription drugs online without prescription is prohibited. Further selling drugs at a higher price than the maximum selling price (MRP) is a crime.

Most e-pharmacies adopts the procedures under the Green Zone, yet these zones are the mere interpretation of law and government does not mandate the setting up of e-Pharmacies.

 


Are e-prescriptions valid?


The legality e-prescription has been a grey area of the law.

Section 4 of the Information Technology (IT) act provides for "Legal Recognition of electronic records and Section 5 further provides for "Legal Recognition of electronic signature".

Rule 65 of the 'The drugs and cosmetic rules, 1945' mentions that a prescription shall be in writing and signed by the person giving it with his usual signature and be dated by him.

Section 4 and Section 5 of the Information Technology Act read with Rule 65 of the Drugs and cosmetic Rule, 1945 satisfy the legality of a prescription written and signed electronically. Therefore, the scanned copy of a prescription should be valid and enforceable in the eyes of the law.

 

The Pharmacy Practise Regulations of 2015 defines "Prescription" as a written or electronic direction from a Registered Medical Practitioner or other properly licensed practitioners. Hence, a doctor can prescribe medicines via an electronic prescription as well. 

 

Drugs and Cosmetics Act, 1940 and e-Pharmacies

The Drugs and Cosmetic Act is silent on various aspects which hinders the Pharmaceutical industry's growth in India. It is a pre-colonial act which is completely silent about the functioning of e-Pharmacies, and it's licensing.

The legislation needs to be amended and lay down the provisions and guidelines for setting up an e-Pharmacy for selling all kinds of scheduled drugs.

Tobacco Control Policies in India

Tobacco Control Policies in India


Tobacco consumption is a major health issue in the world. China is the largest consumer of tobacco, followed by India. In India, nearly 25% consume tobacco in some form in urban areas and 38% in rural areas. 

According to WHO, a hundred million premature deaths have taken place due to tobacco in the 20th century. And this figure will rise up to one billion in the 21st century. Some of the immediate harmful effects of consuming tobacco on our health care: 

l  Coronary vessels of the heart get affected. 

l  Cardiovascular diseases like stroke.

l  It also causes high cholesterol and blood pressure.

l  Respiratory diseases like chronic bronchitis, emphysema, Asthma, and Tuberculosis. 

l  The decreased supply of blood to the heart. 

Tobacco control legislation in India

The Government of India has framed tobacco control policies to control the consumption in the country. 

Cigarettes (Regulation of Production, Supply, and Distribution) Act, 1975


l  The act makes it mandatory to display health warnings on the cartons, packets, and even tobacco products advertisements.

l  The act also restricts the trade and commerce in, and production, supply and distribution of, cigarettes and matters connected therewith or incidental thereto.

l  Penalties can be imposed on the seizure of tobacco if and when the provisions were breached. 

l  The Central Government is empowered to intervene in developing, monitoring, and marketing of the tobacco industry.

However, the act does not cover non-cigarette tobacco products like gutka, cigars, beedis, and cheroots despite strict regulations.

Memorandum issued by the Cabinet Secretariat in 1990

The Cabinet Secretariat took a major decision in the year 1990, which banned tobacco smoking in domestic flights, health care centres, educational institutions, trains, and buses. However, this was an administrative order of the central government, and it lacked clear instructions for its enforcement, and hence it was mostly ineffective.


Prevention of Food Adulteration (Amendment) Act, 1990

This act makes it mandatory to give statutory warnings concerning harmful health effects for eating pan masala and chewing tobacco.


Cinematograph (Amendment) Act, 1952

The amendment in the act banned scenes from the cinema where the actors smoked and thereby endorsed and promoted tobacco consumption in any form.


Drugs and Cosmetics (Amendment) Act, 1940

The amendment in the act abolished the use of toothpaste and powders that contained tobacco.


Committee on subordinate legislation, November 1995

The 22nd report Framed under the Cigarettes (Regulation of Production, Supply and Distribution) Act, 1975 pertaining to Committee on Subordinate Legislation made recommendations to the health ministry. It suggested protecting non-smokers from second-hand smoke or passive smokers. The report advocated stronger laws for electronic media while also spreading awareness regarding tobacco smoking's health hazards. 


The Cable Television Networks (Amendment) Act, 2000

The act abolished any tobacco products' use or consumption in the advertisement on any cable television, state-owned publications, and electronic media.

The Cigarettes and other tobacco products (Prohibition of Advertisement and Regulation of Trade and Commerce Production, Supply and Distribution) Act, 2003 

This act is currently the prevalent law in India. Major provisions are: 

l  Smoking in public places is banned.

l  This act bans advertisements of tobacco products.

l  Ban on sale on Tobacco products to minors below 18 years of age.

l  The packaging of all Tobacco products should mandatorily show pictorial health warnings on smoking.

l  Tobacco products cannot be sold within the area of 100 yards of any educational institution.

l  It is compulsory to test the tar and nicotine content of any tobacco product.

 

National Food Security Act, 2013

National Food Security Act, 2013

The Constitution of India does not recognise the right to food as a fundamental right under Article. But it can be covered under the ambit of right to live with human dignity. Article 47 also imposes a duty upon states to raise the level of nutrition and standard of living and improve public health. Food security was previously dealt with under the Public Distribution System (PDS) and the Targeted Public Distribution System (TPDS). National Food Security Act, 2013 (NFSA) brought a drastic change in Food Distribution and Security schemes and protocols. After the enactment of the new Act, 67% of the population was entitled to receive highly subsidised foodgrains.

 

Salient Feature of the Act

Various new features of the Act has been discussed below:

1. Targeted Public Distribution System: Under this system, the households identified by the government as 'Priority Households' are entitled to 5 kg of foodgrains per person per month at subsidised prices. For targeting these types of households, Antodyan Anna Yojna was launched by the government in December 2000. Now this scheme comes under NFSA and households identified are entitled to thirty-five kilograms of food grains per person per month at prices ranging from Rs. 3 – Rs. 1 per kg. Children between the age group of 6 months to 6 years, including children suffering from malnutrition, will be provided with free meals by the local 'Anganwadi'. Children between 6 years to 14 years will be provided with mid-day meals in government schools or government-aided schools. Pregnant women and lactating mothers will also be provided free meals and maternity benefits of Rs. 6000.

2. Identification of Eligible Households: The task of identifying eligible households are done by the respective states/UTs. The states/UTs can frame their own criteria or use Socie Economic and Caste Census data. People living in tribal areas or hilly areas are paid special attention.

3. Commission: The Act establishes a State Food Commission with the objective of monitoring and evaluating the implementation of the Act and advising the state government. The commission consists of of a chairperson, five other members and a member secretary. The commission is also tasked with preparing an annual report for presenting before the legislature and Act as the appellate authority for District Grievance Redressal Officers. 

4. Grievance Redressal: The Act provides two-tier grievance redressal mechanism: the State Commissions and District Grievance Redressal Officers (DRGO). The DRGO are appointed by the State Government, and the State Commission is the appellate authority for every complaint filed before DRGO.

5. Transparency and Accountability: Section 27 of NFSA provides that all TDPS records should be placed in the public domain. Section 28 further provides that local authorities authorised by the state government should conduct periodic social audits on the functioning of fair price shops, TPDS and other welfare schemes and take necessary actions in such manner as may be prescribed by the state government.

6. Penalties: Section 33 of the Act provides that any public servant or authority found guilty, by the State Commission at the time of deciding any complaint or appeal, of failing to provide the relief recommended by the District Grievance Redressal Officer, without reasonable cause, or wilfully ignoring such recommendation, shall be liable to a penalty not exceeding five thousand rupees.

7. Compensation: Section 8 of the Act provides that in case of non-supply of the entitled quantities of foodgrains or meals to entitled persons, such persons shall be entitled to receive such food security allowance from the concerned State Government to be paid to each person, within such time and manner as may be prescribed by the Central Government.

8. Reforms in Targeted Public Distribution System: Section 12 of the Act provides that the Central Government shall endeavour to progressively undertake necessary reforms in the Targeted Public Distribution System in consonance with the role envisaged for them in this Act. 

The reforms shall, inter alia, include— 

(a) doorstep delivery of foodgrains to the Targeted Public Distribution System outlets; 

(b) application of information and communication technology tools including end-to-end computerisation in order to ensure transparent recording of transactions at all levels, and to prevent diversion; 

(c) leveraging "aadhaar" for unique identification, with biometric information of entitled beneficiaries for proper targeting of benefits under this Act; 

(d) full transparency of records; 

(e) preference to public institutions or public bodies such as Panchayats, selfhelp groups, co-operatives, in-licensing of fair price shops and management of fair price shops by women or their collectives; 

(f) diversification of commodities distributed under the Public Distribution System over a period of time; 

(g) support to local public distribution models and grains banks; 

(h) introducing schemes, such as cash transfer, food coupons, or other schemes, to the targeted beneficiaries in order to ensure their foodgrain entitlements specified in Chapter II, in such area and manner as may be prescribed by the Central Government.

9. Obligation of the Central Government: The central government shall provide for ensuring the regular supply of foodgrains to persons belonging to eligible households, allocate from the central pool the required quantity of foodgrains to the State Governments under the Targeted Public Distribution System. 

10. Obligation of the State Government: The State Government shall be responsible for implementation and monitoring of the schemes of various Ministries and Departments of the Central Government in accordance with guidelines issued by the Central Government for each scheme, and their own schemes, for ensuring food security to the targeted beneficiaries in their State.

 

Amendments and New Bill

The National Food Security (Amendment) Bill, 2018 has been introduced in Lok Sabha to amend the National Food Security Act, 2013. The Proposed Changes are enumerated below:

l  The definition of 'Food Security' given under Section 2(6) should be changed and include an exception condition of war in which the supply of food to the entitled persons will not be possible.

l  The definition of 'Meal' given under Section 2(9) is to be modified and include s fresh hot cooked food made from locally procured material and does not include pre-cooked meals or take-home ration;".

l  Changes in Section 3 have to be made to entitle any person the option to take food grains of their choice rather as specified by the state government. 

l  Changes under Section 8 has to be made to substitute the words "entitled quantities of foodgrains or meals" with the words "entitled quantities of foodgrains of the recipient's choice or meals".

l  Clause (h) of subsection (2) of Section 12 shall be omitted.

l  The words, "flood, drought, fire, cyclone or earthquake" under section 44 shall be omitted the proviso given under section 44 should also be omitted.

Biotechnology Law In India

Biotechnology Laws in India

Biotechnology is the science of modifying DNA present in a plant or animal to get desired results and enhance its functions. Making bread using yeast, production of wine or beer by fermentation, etc. are some of the examples of using biotechnology using the biological structure of different organisms. But today biotechnology has taken greater meaning, and we all are affected by it. By using this technology scientist can create vaccines, many diseases that were thought to be incurable now have medicines to control or eradicate it. Biotechnology has proven to be a boon for humankind and helped us in every sector, such as in the fuel sector and also in agriculture. 

Biotechnology Laws in India

The main agency that governs and work in this industry is Department of Biotechnology that made under the Ministry of Science and Technology. Another agency, named Genetic Engineering and Approval Committee made under the Ministry of Environment and Forest, also works in the same field. Both the organizations have worked and framed different laws in India for the development and governance of Biotechnology. 

The Biotechnology industry in India is governed by the following enactments depending upon their relevance/applicability on case to case basis:

1. Environment Protection Act, 1986

2. EXIM Policy

3. Foreign Exchange Management Act, 1999

4. Laws pertaining to Intellectual Property Rights

5. Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro-Organisms/Genetically Engineered Organisms or Cells, 1989 notified by Ministry of Environment & Forests December 5, 1989, under Environment and Protection Act, 1986.

6. Revised Recombinant DNA Safety Guidelines

7. National Seed Policy, 2002

8. Guidelines for Research in Transgenic Plants & Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts, 1998

9. Seeds Act, 1966

10. Drugs & Cosmetic Act 1940 along with Drugs and Cosmetic Rules

11. The Plants, Fruits and Seeds [Regulation of import in India] Order 1989 issued under the Destructive Insects and Pests Act, 1914.

12. Guidelines for Generating Preclinical and Clinical Data for rDNA Therapeutics, 1999

13. Drug Policy, 2002.

14. Biological Diversity Act

Several other committees have been established to regulate the activities involving handling, manufacturing, storage, testing, and releasing genetically modified materials in India. Most of these committees' members are from the scientific community of the Department of Biotechnology and Ministry Environment and Forest. 

The most important committees are:

· The Institutional Biosafety Committees (IBSC), responsible for the local implementation of guidelines,

· Review Committee on Genetic Manipulations (RCGM) accountable for issuing permits;

· GEAC accountable for monitoring the large scale and commercial use of transgenic materials.

Research and Development

To carry out the research and development in the field of recombinant DNA, the company has to submit the rDNA research proposal to IBSC constituted by it. The proposal should contain the prescribed particulars viz., rationale, molecular biology of genetically modified organisms, containment facility, risk management.

The IBSC will make an application to RCGM for permission of experiments (up to 20 liters of capacity).RCGM upon giving its approval shall also intimate its decision to State Biotechnology Coordination Committee (SBCC) and Drug Controller General of India (DCGI).

Manufacture

The manufacture of new rDNA drug involves the following steps:

1. Production of Test Batch 

An application has to be made to the DCGI seeking permission to manufacture trial batches of the drug. After obtaining the permission, five of such batches has to manufactured that are characterized as physicochemical, biological and contaminants.

2. Animal Trials 

The preclinical studies begin with the animal trials to define the physiological, toxicological and efficacious potential of rDNA product. An application must be made to the Institutional Animal Ethics Committee (IAEC) seeking permission to conduct animal trials. After getting permission, the proposal is submitted to RCGM for animal study.

3. Human Trials 

The human trials are conducted in the following three phases:

Phase I: It involves preliminary evaluation of the safety of the drug in healthy volunteers.

Phase II: It involves an initial efficacy trial on a small number of patients.

Phase III: It involves assessment of safety and efficacy of large scale multicentric trials on patients.

Biosafety Regulations

Potential Risks are involved with the use of genetically modified organisms in both agriculture and healthcare to human health and the environment. International attempts are made for biosafety under the Convention on Biological Diversity (CBD). The Cartagena Protocol on Biosafety was negotiated and adopted under the aegis of CBD on January 29, 2000. The protocol protects the biological diversity from the potential risks. India is a party to the CBD and a signatory to Cartagena Protocol on Biosafety and has also decided to ratify the same. Presently, India has rDNA Safety Guidelines, 1990, which were revised in 1994. 

How to Obtain a patent for pharmaceutical products in India

How To Obtain A Patent For Pharmaceutical Products In India

India ranks third in Asia pacific and the top 12 destinations for biotechnology worldwide. With the evolution of pharmaceutical technology in India, it has become an utmost concern for Indian Patent Office that the uniformity and consistency of examination and grant of patents be maintained. 


What is Patent?

The Patent Act, 1970 govern patents in India. A patent is an intellectual property which grants the inventor or the patentee the exclusive right to exploit the invention economically for a limited period of 20 years from the date of filing the patent application within India, in exchange of full disclosure of his invention. The purpose of granting a patent right is to incentive inventors towards developing new technology and making scientific progress. 


Patent Protection in India

A pharmaceutical invention requires significant time and resources. Thus, the protection of these inventions and their patents could not be more critical. However, to apply for a patent under the Patent Act, 1970, an invention must qualify the following criteria:

l  Patentable subject matter: The invention should not fall under section 3 which defines “what are not invenetions” and section 4 of Patent Act, 1970 which says “Inventions relating to atomic energy not patentable.”

l  Novelty of the invention: the invention should not be have been published in India or anywhere else in the world before the date of filing the patent application.

l  Non-obviousness/Inventive step – the invention cannot be obvious and should have a significant leap of scientific progress.

l   Industrial Application: the invention should have some practical utility and industrial application that can be applied in real life; it cannot be an abstract theory.

According to article 27(1) of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement, patents should be granted for inventions in any field of technology without discrimination. The third amendment of the Patents Act, 1970 bring biotechnological and pharmaceutical inventions under the purview of patentable subject matter in India. 

 

Types of Patent Application

Various types of patents are filed under patent law depending on various parameters like the statute governing it, the jurisdiction etc. These are various types of patent applications that can be filed by an inventor:

l  an ordinary patent application under the Patents Act, 1970, 

l  a divisional application is filed in case many many inventions disclosed in the main application, 

l  a Patent of Addition is filed in the post the filing of the main application of patent, in case of improvement or modification in the invention, 

l a Convention Application, which is filed for a patent in a convention country within 12 months from the date of the basic application

l  a National Phase Application under the Patent Cooperation Treaty (PCT), that allows a national or resident of a PCT country (like India) to enjoy the benefit of patent holdings in all or any of the PCT countries. 



Obtaining a Patent in India


1. Patent Search: The first step while filing for a patent application is to search by the inventor to confirm that the same invention has not been made previously. This step is essential and helps the inventor to avoid wastage of time and resources. This would also help the inventor in drafting the application in such a way that it highlights the unique features of his invention compared to similar inventions that have already been published or patented. A patent search may be conducted at the patent office or online by the website of the Patent Office. A similar search for patents should also be conducted on an international database like Google Patents to ensure that a similar invention has not been published or patented in a different country. 


2. Choosing Appropriate Patent Office- There are four patent offices in India located at New Delhi, Mumbai, Kolkata and Chennai, respectively. The territorial jurisdiction of the patent offices are as follows-

l  New Delhi Branch – Delhi, Haryana, Jammu and Kashmir, Himachal Pradesh, Punjab, Uttar Pradesh, Rajasthan, Uttaranchal and Chandigarh;

l  Mumbai Branch – Maharashtra, Madhya Pradesh, Gujarat, Nagar Haveli and Daman and Diu and Dadra;

l  Chennai Branch – Tamil Nadu, Kerala, Karnataka Andhra Pradesh, Lakshadweep and Pondicherry;

l  Kolkata Branch – the rest of India. 


3. Drafting the Patent Application- A patent application has to be filed with various declarations and forms as described below:

1. Application for Patent (Form 1)

2. Proof of right to file the application from the inventor (Form 30)

3. Provisional or Complete specification (Form 2)

4. Statement and undertaking within 6 months of application (Form 3) (in case of filing abroad in addition to filing in India)

5. Declaration as to inventorship (Form 4/5)

6. Power of authority (Form 26) (in case of filing through a patent agent)

7. Priority document within 18 months of application (in case of Convention or PCT applications)


4. Provisional or Complete Specification- A patent is granted to whoever files a patent application first. Hence, an inventor may file a provincial application for the patent before the completion of the invention. It does not require to disclose minute details of the invention and only needs to give a reasonably skilled person in the relevant industry a basic idea of the functionality of the invention. In this case, the complete specification is required to file within 12 months from the date of filing of the first application, thus giving him time to obtain funding based on a potential patent.


5. Publication of the Application: After filling the application, it is published in the journal of the Patent Office for public inspection within 18 months of filing. The details of the application, including the date of application, application number, name and address of the applicant and the abstract of the invention for which the patent is sought are published.


6. Pre-Grant Opposition: Any person under  Section 11A of the Patents Act, 1970 can file an opposition within 6 months from the date of publication of the application on any of the grounds provided under Section 25(1) of the Patents Act. 


7. Filing Request for Examination of Application: Post-publication of the patent application the inventor is required to file a request for examination (to initiate the examination of the application by the patent examiner), within 48 months of applying Form 18.First Examination Report- The patent application is examined and scrutinised by a patent examiner under the patent office to ensure that there are no grounds for objection to the granting of the patent. The examiner then prepares a First Examination Report within a maximum period of 3 months. Following this, the report has to be disposed off by the Controller within one month of receipt of such report from the examiner and a Statement of Objections has to be issued within one month of disposal of the report. 


8. Grant of Patent Certificate- Once the requirement issued by the Patent Office has been met and the deficiencies have been rectified, the details of the patent are recorded in the Register of Patents and the same is published in the Official Journal of the Patent Office and a patent certificate in the prescribed format is issued to the applicant. 

Digital Information Security in Healthcare Act (DISHA) 2018 Explained

Digital Information Security in Healthcare Act (DISHA) 2018

In today’s digital era, paperwork has become minimal. Every data is now stored in digital form due to its own benefits. This applies to the medical data of patients and their sensitive information too. But with the digitisation of data and storage has its own security concerns. Data breach and need for security of digital patient data have been a critical issue in India.

Previously the collection, storage and handling of sensitive data in electronic form were governed by the Information Technology Rules 2011 i.e. Data Protection Rules which are prescribed in the Information Technology Act 2000. These rules lay down selective information to be sensitive data and information. These rules in the medical perspective include information of a patient relating to physical, mental, physiological conditions as well as all medical history and records. In 2016, the government of India tried to enable the Electronic Health Record Standards of India. But these standards have many flaws and was not accepted by the industries. Hence, in 2018 Digital Information Security in Healthcare Act, 2018 (DISHA) was formulated as a first attempt to bring measures for information security of patients of the country and to secure the right to privacy of those seeking medical assistance. 


Objective

The main objective of the act is to provide privacy, security, standardisation, and confidentiality for health-related data. The act regulates the generation, collection, storage, transmission, and access to the digital health data associated. It led to the establishment of the National Digital Health Authority and Health Information Exchanges. It collects and records all health-related information relating to physical and mental health, donation of any body part or any bodily substance, and health services provided to the person, information collected while providing health services, information of testing or examination of a body part or bodily substance, and details of any clinical establishment accessed by the person. DISHA created regulators to give effect to the provisions- National Electronic Health Authority at the central level, and State Electronic Health Authorities at state levels. 



Key Provisions


Rights of the Data Subject, Ownership and Consent- The act provides provisions by which the data is completely owned y the individual to whom the data is concerned. It gives various rights that the owner of data may exercise with respect to his records, such as:

1. Right to access his or her own digital health records and alter if there is any inaccurate digital health data;

2. The right to confidentiality, privacy, and security of his/her records;

3. In case of breach of his or her personal and sensitive health data right of seeking damage or compensation;

4. The right to require the owner’s permission for each instance of use or transmission of his digital health records; and

5. The owner of the data has the right to refuse or give consent for the generation, collection, storage, transmission, access, or disclosure of his personal digital health data.


The Collection and Processing of Digital Health Data-The act provide that any digital data of a patient stored or transmitted by medical establishments may be accessed on a “need to know basis” by a specific person for a lawful purpose. While other entities can only access the data with the owner’s consent and written permission each time.


Adjudication- Under DISHA adjudication bodies has been established both on the central and state level. Any dispute arising within the state will be heard by the state adjudicatory bodies and appeals from orders of these state adjudicatory authorities will be heard by the central level adjudicatory authority. Any offence of criminal nature is to be tried before a court that should not be inferior to that of a session court, and complaints regarding these offences may be made by the union government or the state government, or National Electronic Health Authority or State Electronic Health Authorities or by an affected person. 


Data Breach Notification- A data breach can be a simple or serious breach of data. The former is defined to mean the collection and otherwise handling of the digital health data – 

l  in contravention of the DISHA guidelines,

l  That results in the destruction, delete or alteration of the digital data, or

l  In a manner that violates the rights of the owner as prescribed in the act and the breach of the digital health data gives rise to one of the rights of the owner to claim compensation from the person or entity who has breached the data.


A serious breach of digital health data is –

l  Any breach of the data that is done intentionally, fraudulently, dishonestly, and negligently;

l  A breach carried out for the purpose of commercial use or commercial gain;

l  A repeated breach of digital health data by an establishment, entity, or Health Information Exchange; or

l  A breach that relates to data that is not de-identified or anonymised;

 

Confidentiality of Medical Information

Medical confidentiality is a concept of doctors maintaining the secrecy of all the information received by a patient during treatment.

Patients on a daily basis, share sensitive and secret personal information to health care provider such as doctors, physicians etc. Therefore, it is the topmost priority of health care provider to maintain privacy and confidentiality. 

The medical information given to the health care provider shall not be divulged to others unless the patient provides his or her consent to do so or required by the law. 

Though it is very rare to keep the medical information of a patient completely undisclosed as a very breach of confidentiality occurs when the medical records are passed by the doctors to others and refer it as one of their case studies. If the information is published publicly, the identity of the patient is never disclosed, and if it appears in any way, then the patient has the right to sue.

 

Laws governing the Confidentiality of Medical Information

According to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, it has been stated in chapter 2 (2.2) that Patience and delicacy should characterize the physician. Confidences concerning individual or domestic life entrusted by patients to a physician and defects in the disposition or character of patients observed during medical attendance should never be revealed unless their revelation is required by the laws of the State. Sometimes, however, a physician must determine whether his duty to society requires him to employ knowledge, obtained through confidence as a physician, to protect a healthy person against a communicable disease to which he is about to be exposed. In such an instance, the physician should act as he would wish another to act toward one of his own family in like circumstances.

Furthermore, Chapter 7 (7.14) state that The registered medical practitioner shall not disclose the secrets of a patient that have been learned in the exercise of his / her profession except – 


i) in a court of law under orders of the Presiding Judge; 

ii) in circumstances where there is a serious and identified risk to a specific person and / or community; and 

iii) notifiable diseases.



Chapter 8 gives the provision for the consequences of the violation. Regulation 8.2 explains that if any complaint is made concerning professional misconduct can be brought before the appropriate Medical Council for Disciplinary action. Upon receipt of any complaint of professional misconduct, the appropriate Medical Council would hold an inquiry and give the opportunity to the registered medical practitioner to be heard in person or by a pleader. If the medical practitioner is found to be guilty of committing professional misconduct, the appropriate Medical Council may award such punishment as deemed necessary or may direct the removal altogether or for a specified period, from the register of the name of the delinquent registered practitioner. Deletion from the Register shall be widely publicized in the local press as well as in the publications of different Medical Associations/ Societies/Bodies.

And under chapter 8- (8.5), if the decision is pending on the complaint registered against him, then the appropriate Council may restrict the physician from performing the procedure or practice which is under research/scrutiny.

Mental Health Act 2017 | Mental Health Act in India

Mental Healthcare Act, 2017

Mental Health is a crucial part of the overall health of a person. There has been a significant increase in mental illness in India. While there are many reasons for it, but the most important is the lack of awareness about the importance of psychologists and therapies. According to a survey conducted by the Indian Council of Medical Research (ICMR), 7.5% of the total population of India is hit by mental illness.1 And the recent pandemic and lockdown has caused rapid growth in mental issues due to fear of Job Loss, Anxiety & Domestic Violence, Panic Attacks, raising the number to 20%.2 

A recent survey conducted by a British foundation, Mental Health Research UK, claimed that 42.5% of the employees in India’s corporate sector is struggling with depression or an anxiety disorder.

The Mental Healthcare Act (MHCA) passed by the Government in 2017 is appreciated for addressing the need of millions of Indians wanting help. The act abolishes the existing Mental Healthcare Act, 1987 which was highly criticised for not acknowledging rights of a mentally ill person and contained many other drawbacks like the limited definition of “mental illness to “mental disorder” or no attention to WHO guidelines.

 

Mental Illness: Definition

The term “mental illness” is defined by Section 2(s) of Mental Healthcare Act, 2017 as a substantial disorder of thinking, mood, perception, orientation, or memory that grossly impairs judgment, behavior, capacity to recognize reality, or ability to meet the ordinary demands of life, mental conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition of arrested or incomplete development of mind of a person, especially characterized by sub normality of intelligence.

The MHCA, 2017 provides an elaborative definition of “mental illness” which was lacked by the previous act 1987.

Major Provisions



Rights of Person with Mental Illness


l  Every person has the right to get mental health care from mental health services run or financed by the appropriate Government.  


l  Every person with a mental illness shall have a right to live with dignity.


l  There shall be no discrimination on any basis including gender, sex, sexual orientation, religion, culture, caste, social or political beliefs, class, or disability against mentally ill people.


l  A person with mental illness shall have the right to confidentiality in respect of his mental health, mental healthcare, treatment and physical healthcare.


l  No photograph or any other information relating to a person with mental illness undergoing treatment at a mental health establishment shall be released to the media without the consent of the person with mental illness.


l  Right of choosing the person who would be answerable for making decisions with the view to the treatment, his admission into a hospital, etc.


l  Persons with mental illness living below the poverty line whether or not in possession of a below poverty line card, or who are destitute or homeless shall be entitled to mental health treatment and services free of any charge and at no financial cost at all mental health establishments run or funded by the appropriate Government and at other mental health establishments designated by it.


l  The person with mental illness shall have the right to make an advance directive that states who his/her nominated representative should be and how he/she wants to be treated for the illness. The advance directive should be certified by a medical practitioner or registered with the Mental Health Board.



Mental Health Authority


The act provides for the government to set up the Central Mental Health Authority at national-level and State Mental Health Authority in each State.

Every mental health practitioner and mental health institute has to mandatorily register with this Authority.



Mental Health Treatment


The act also specifies the process and procedure for admission, treatment and discharge of mentally-ill individuals.

A medical practitioner or a mental health professional shall not be held liable for any unforeseen outcomes on following a valid advance directive.



Decriminalisation of suicide


 As provided in Section 115;

(1) Notwithstanding anything contained in section 309 of the Indian Penal Code any person who attempts to commit suicide shall be presumed, unless proved otherwise, to have severe stress and shall not be tried and punished under the said Code.

(2) The appropriate Government shall have a duty to provide care, treatment and rehabilitation to a person, having severe stress and who attempted to commit suicide, to reduce the risk of recurrence of attempt to commit suicide.

This is a big step which annulled Section 309 IPC which stated that ‘Any person attempting to perform suicide shall be punished with simple imprisonment which may prolong to one year.’

 

References

1) Birla, Neerja. “Mental Health in India: 7.5% of Country Affected; Less than 4,000 Experts Available.” The Economic Times, Economic Times, 10 Oct. 2019, economictimes.indiatimes.com/magazines/panache/mental-health-in-india-7-5-of-country-affected-less-than-4000-experts-available/articleshow/71500130.cms?from=mkj

2) Loival, Manogya. “20% Increase in Patients with Mental Illness since Coronavirus Outbreak: Survey.” India Today, 31 Mar. 2020, www.indiatoday.in/India/story/20-per-cent-increase-in-patients-with-mental-illness-since-coronavirus-outbreak-survey-1661584-2020-03-31. 

Liability of Health Care Provider in Constitution of India

Liability of Health Care Provider in Constitution of India


The Constitution of India does not guarantee any special rights to the consumer or patient. However, Hon’ble Supreme Court, in various judgements has viewed that the right to life as enshrined in Article 21 of the Constitution of India includes the right to health and medical treatment to a sick person. The right of a patient is derivative, and it arises from the obligation of the health care provider.

Enforcement of Rights through Remedies


When a person feels that his life and personal liberty is endangered, he can resort to the Supreme Court or High courts for the enforcement of rights so infringed by state action. When the state fails to protect or preserve the life or liberty of the person, the courts are empowered to grant compensatory relief to such an aggrieved person.

Right to move to the Supreme Court or High Court


Article 32 of the Indian Constitution enshrine the provision to seek redressal for the violation of fundamental rights. Any person may move to the Supreme Court or High Court who is unable to access the law due to their illiteracy or social or economic condition. Supreme Court has the power to issue directions or orders or writs, including writs in nature if habeas corpus, mandamus, prohibition, quo-warrants, and certiorari, whichever may be appropriate, for the enforcement any of the rights. Similarly, a person can move to the High Court by appropriate proceedings for the enforcement of the rights conferred and guaranteed under the Constitution and other laws.

Right to life and Health Care


The right to health and access to medical treatment has been included under the purview of Article 21. The principle of the right to life enshrined in Article 21 enlarges its scope to encompass human personality with invigorated health enables him to earn his livelihood, with dignity and equality.2 Lack of health deprives a person of his livelihood.3

Right to Health Care: Judicial View


In Vincent Pani Kurlnagara vs. Union of India4, the question before the Court was that public health is incorporated only in the Directive Principles and it is not enforceable before the Court of law. The Supreme Court observed: “maintenance and improvement of public health have to rank high as these are indispensable to the very existence of the community and on the betterment of these depends on the building of the society which the Constitution makers envisaged. Attending to public health in our opinion, therefore, is of high priority – perhaps the ones at the top for the have not and weaker sections of society, the right to health and medical care is a part of the right to life”.

Furthermore, the Supreme Court in Paschima Banga Khet Mazdoor Samity & Others vs. State of West Bengal & Another5 has held that Article 21 imposes an obligation on the state to safeguard the right to life of every person. The hospitals run by the government are duty-bound to extend medical assistance for preserving human life. Failure on the part of a government hospital to provide timely medical treatment to a person in need of such treatment is against his right to life guaranteed under Art. 21.

 

Compensation

The Supreme Court in AS Mittal vs. the State of UP6 while dealing with a PIL on Negligence by doctors in providing services at an eye camp observed that the intention of the camp was noble, but it was a medical catastrophe for the patients. The Court awarded compensation on humanitarian grounds to the affected patients.

In Kusum Sharma vs. Batra Hospital and Medical Research Centre7, it has been observed interalia as follows:-


“Negligence is the breach of a duty exercised by omission to do something which a reasonable man, guided by those considerations which ordinarily regulate the conduct of human affairs, would do, or doing something which a prudent and reasonable man would not do. Negligence is an essential ingredient of the offense. The Negligence to be established by the prosecution must be culpable or gross and not the Negligence merely based upon an error of judgment. A medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field.”

 

References:

1: Sharma MK, “Right to Health and Medical Care as a Fundamental Right” AIR 2005, Journal, p.255.

2: Consumer Education and Research Centre vs. Union of India, AIR 1995 SC 922.

3: Bharath Kumar K. Palicha vs. the State of Kerala, AIR 1997 Ker. 291.

4: Vincent Pani Kurlnagara vs. Union of India, AIR 1987 SC 990.

5: Paschima Banga Khet Mazdoor Samity & Others vs. State of West Bengal & Another, 1996 4 SCC 37.

6: AS Mittal vs. State of UP, AIR 1989 SC 1571.

Common Factors Affecting The Quality of Food

Common factors affecting the quality of Food


The importance of quality of food cannot be overlooked. Archaeological and historical pieces of evidence show the decline and disappearance of human groups, tribes, and even civilizations. Even today, the majority of the human population suffers from starvation or does not have access to good quality food.

There are many factors that affect the quality and life of our food:

Farming Factors: Food treated with pesticides and antibiotics, as in the case of with a lot of conventionally grown produce and animal products, might get a longer shelf life but are not good for your health at all. Some chemical used as pesticides and antibiotics has shown severe side effects like cancer or infertility in both men and women. Exposure to pesticides is dangerous, especially for children and pregnant women. That is why people are opting for organically grown food which is pesticide and antibiotic-free.

Storage: The amount of time your food is stored before you consume it, and the conditions in which it was stored dramatically affects the quality. The nutritional value of food is greatly affected by the time of storage. The longer the time of storage, the lesser the nutritional value. The temperature in storage also affects food quality. According to the Food and Agriculture organization, foods deteriorate quickly when they are stored in hot, humid conditions.

Processing and handling: Fresh-cut fruits and vegetables are now common in the supermarket because they offer convenience to consumers. However, these fresh-cut fruits and vegetables deteriorate much faster than intact food. The nutritional value also decreases due to the minimal form of processing. On the other hand, packaged food is heavily processed and enhanced with artificial flavoring or color, human-made fats, and other unhealthy additions that reduce their nutritional quality and value.

Cooking: The way you prepare your food affects its quality. A a study published in “Journal of Zhejiang University Science B” in August 2009 showed how different methods of cooking and preparation of broccoli affected its nutritional value. Steaming was the only method that did not affect the nutritional value of broccoli.


Water Scarcity in India

Water Scarcity in India


Water is the essence of life. It is needed to ensure food security, take up industrial production, and protect the environment. Since ancient times Indian culture has encouraged water preservation and environment conservation through spiritual teachings and sacred texts.

Today, India is facing several challenges such as the growth of population, scarcity of drinking water, deceptive monsoon rains, etc. To counter these challenges and promote sustainable development, the Indian legal system provides four significant sources of law related to water pollution:


1. Comprehensive legislation which regulates prevention, preservation and abate of water pollution, i.e., Water (Prevention and Control of Pollution) Act, 1974

2. Environment Protection Act, 1986 also covers water-related issues.

3. Public nuisance action against polluters

4. Public interest litigations under the aegis of Article 32 and 226 of the Indian Constitution 


In State of Orissa v. Government of India Katju, J. opined that the right to get water is a part of life guaranteed by Article 21 of the Constitution. Water is a gift of nature. Human hand cannot be permitted to convert this bounty into a curse and oppression. Right to live guaranteed in any civilized society implies the right to food, water, decent environment, education, medical care and shelter. These are basic human rights known to any civilized society.

 


Water Crisis in India


Man has exploited water more than any other resource on this planet. Most of the water on this planet is stored in oceans and ice caps which unusable. The water demand is fulfilled by rainwater, groundwater, rivers and lakes. Most of these resources in India is getting highly polluted or scarce due to high usage. Though the government and several NGOs have taken several steps, but the quality of water resources seems to be far from satisfactory. The river Ganga which is considered most important and spiritual river of India is a toxic dump of highly polluting industries and municipal corporations. As per 42nd amendment in the Indian Constitution Article 51A (g) confers a duty on the citizens to protect and conserve natural resources. But lack of knowledge and coordination between various governing bodies and proper operation and maintenance of treatment plants has led to the scarcity of water.


India is going through the worst water crisis in history. According to Niti Aayog, more than 600 million people are facing acute water shortage. With 70% of water contaminated, India 120 out of 122 countries in the water quality index.


The report of Niti Aayog says that “By 2030, the country’s water demand is projected to be twice the available supply, implying severe water scarcity for hundreds of millions of people and an eventual ~6% loss in the country’s GDP”. The report added that the total availability of water is still “lower than this projected demand, at 1,137 BCM”. “Thus, there is an imminent need to deepen our understanding of our water resources and usage and put in place interventions that make our water use efficient and sustainable”. 40% of the total population will not have access to drinking water by 2030.

Water Borne Diseases

Water-Borne Diseases


Water-Borne diseases is a concerning and growing issue worldwide. These diseases are caused due to pathogenic micro-organisms that transmitted through water. According to the World Health Organisation causes 1.5 million human deaths each year and estimates 3.6% of the total DALY (disability-adjusted life year) global burden of disease. The WHO estimates 58% of this burden or 842,000 deaths per year is due to lack of safe drinking water supply, sanitation and hygiene.

Common Water Borne Diseases


1. Typhoid: Typhoid is a fever caused by Salmonella Typhi, usually caused due to food washed with contaminated water. Some of its symptoms include prolonged headache, high fever, loss of appetite, nausea, constipation, joint pain and in most cases, diarrhoea. Once the virus of typhoid enters your bloodstream, it multiplies quickly leading to high fever. According to WHO, more than 161 000 die because of typhoid.

2. Cholera: Cholera is an acute diarrhoeal infection caused by water contaminated with the bacterium Vibrio cholera. In its severest form, cholera may lead to dehydration, watery diarrhoea including death in a few hours, according to WHO each year  21 000 to 143 000 die worldwide due to cholera.

3. Hepatitis A: Hepatitis A is a liver disease caused by water contaminated with hepatitis A virus (HAV). The common symptoms of the disease are nausea, severe abdominal pain, fatigue and low-grade fever. It also causes jaundice, yellow skin, dark urine and severe vomiting. WHO estimates that hepatitis A caused approximately 7 134 deaths in 2016 (accounting for 0.5% of the mortality due to viral hepatitis).

4. Dysentery: Dysentery is caused by Shigella species (bacillary dysentery) or Entamoeba histolytica (amoebic dysentery). It causes bloody diarrhoea, i.e. any diarrhoeal episode in which the loose or watery stools contain visible red blood. Dysentery causes inflammation in your intestine that can lead to severe abdominal pain, diarrhoea and high fever.

5. Trachoma: Trachoma is a disease caused by a bacteria called Chlamydia trachomatis. The inner layer of your eyelids get rough and causes severe pain, cornea or in worse cases even blindness. It is estimated that trachoma and trichiasis cause up to US$ 8 billion annually due to lost productivity from blindness and visual impairment. 


6. Arsenicosis: Drinking water contaminant with arsenic over a long period leads to arsenic poisoning or Arsenicosis. It causes drowsiness, severe headaches, confused state of mind, severe diarrhoea. A person having Arsenicosis will have muscle cramps, excess saliva, bloody urine, severe hair loss, excessive sweating and vomiting. 


7. Shigella: The person having shigella will suffer from bloody stools and severe diarrhoea. It is caused by a bacteria called shigella and spread when a person does not wash their hands after changing a child’s diaper, or it can also be passed through contaminated food. 


8. Malaria: Malaria is one of the significant causes of death in India. It is caused by a parasite that is transmitted to people through the bites of infected female Anopheles mosquitoes. According to WHO, in 2018, there were an estimated 228 million cases of malaria worldwide. The estimated number of malaria deaths stood at 405 000 in 2018.

9. Lead poisoning: The water contaminated with lead can lead to lead poisoning. It can cause organ damage, high blood pressure and kidney-related problems. 


10. Polio: Polio or Poliomyelitis or infant paralysis highly infectious viral disease that primarily affects children under five years of age. This disease affects a person’s spinal cord, thereby causing muscle weakness and in extreme cases, paralysis. However, India has gained control over this disease, and it is now a rarely occurring phenomenon.  

Monosodium Glutamate – A Hidden Poison In Our Food

Monosodium glutamate - A hidden poison in our food



Monosodium glutamate or MSG is a flavor enhancer that is commonly used in Chinese food. It comes from the combination of an amino acid called glutamic acid and sodium. Monosodium glutamate can be found in traditional dishes like Japanese broth by isolating glutamic acid in seaweed. MSG naturally occurs in food like tomatoes and cheeses but the MSG we use is quite harmful. Just like natural sugar found in fruit isn’t harmful- only when it is messed with in a lab is it a threat to our health. 


Some common symptoms that are seen due to MSG toxicity include headaches, flushing, sweating, facial pressure or tightness, numbness, tingling or burning, heart palpitations, intense thirst, chest pain, nausea, and weakness. 


Today fast food restaurants load their food with MSG. It looks like salt so makes sure you don’t accidentally add it in everything.


Results from studies conducted on both animals and humans have shown that even the lowest amount of MSG has toxic effects. It has the potential to disrupt neurons and might have adverse effects on behavior. Studies on animals have further revealed that neonatal MSG consumption sets a precedent for the development of obesity later on. The adverse effect of MSG caused insulin resistance and reduced glucose tolerance in rodents which raises concern about the obesity in humans too.


The same study has further revealed that MSG causes disrupted energy balance by increasing the palatability of food and disturbing the leptin-mediated hypothalamus signaling cascade, potentially leading to obesity. It also decreases the liver transaminases indicating hepatic damage.


Both studies on animals and humans show that MSG affects the reproductive system too. Administration of MSG at a dose of 2 mg/g during various perinatal periods leads to an increased number of pachytene stage cells among the primary spermatocytes compared to controls in spermatogenesis.

Energy Drinks and Adverse Effects | Energy Drink Side Effects

Energy Drinks and Adverse Effects

Energy drinks are a booming industry in India. Youngsters are opting energy drinks to boost up their stamina to provide instant energy. But does these cans and bottles of energy drinks really help?

Energy drinks are non-alcoholic beverages containing stimulants like caffeine, herbal extracts (guarana, ginseng, yerba mate, Ginkgo Biloba), glucuronolactone, taurine, inositol, L-carnitine and B-vitamins. Naturally caffeinated drinks like coffee, cocoa, tea etc. are not regarded as energy drinks. Energy drinks should also not be confused with sports drinks that contain carbohydrates, minerals, electrolytes, and flavouring agents. These are intended to replenish water and electrolyte in the body.

Energy drinks were introduced to the world by ‘Dr. Enuf’ in the US in 1949. More than 300 variants of energy drinks are available in the US market alone. India, China, and Brazil are considered as the growing markets. Red Bull came to India in 2003 and dominated the market.



Adverse effects:


Too much caffeine: The high amount of caffeine and sugar will let you feel fresh and energised. But too much of caffeine can cause jitters, a fast heartbeat, and trouble sleeping.’

Further, though the sugar gives a burst of energy watch out for the phenomenon called ‘sugar crash’, the energy provided by sugar wears off quickly, and you feel exhausted all over again. Moreover, the quinine that used to give the energy drinks the fizz is always bad for bones.


Addiction: Caffeine can be addictive, whether it is tea, coffee, or energy drinks. If someone is consuming energy drinks regularly than the person might get headaches, becomes cranky or feel tired of not getting energy drinks. As these drinks taste sweet, children are also attracted to them. These drinks cause electrolyte abnormalities in children, and parents should strictly prohibit it.


Dehydration and weakness: People take energy drinks for instant energy, that is why they end up taking it during workout hours and while playing sports. When energy drinks are taken without any other liquid, it may lead to dehydration. High levels of caffeine in these drinks prevent the kidney from retaining the fluids, thereby dehydrating your body.

Moreover, never mix energy drinks with alcohol because having them together may limit your body’s ability to realise how much alcohol you drank, as it will give you the feeling that you are not impaired. It will also give bad dehydration. You will urinate more often due to the combined effect of the alcohol and the caffeine in the energy drink.

   

BIO-MEDICAL WASTE MANAGEMENT RULES, 2016

BIO-MEDICAL WASTE MANAGEMENT RULES, 2016

Biomedical waste comprises the human and animal anatomical waste, treatment equipment like needles used, and other articles used medical organisations in treatment and research. Total biomedical waste generates in India is 484 TPD from 1,68,869 healthcare facilities (HCF), out of which 447 TPD is treated.

Proper and Scientific disposal of Biomedical waste is necessary to minimise the adverse effect on health workers and the environment. The waste generated is estimated to be 1-2 kg per bed per day in a hospital and 600 gm per day per bed in a clinic. Improper disposal of waste increases the risk of infection and develop resistant microorganisms.

The Ministry of Environment and, Forest and Climate Change, notified new Biomedical Waste Management rules, 2016 on March 28th publish a new set of rules, 'Biomedical Waste Management Rules, 2016'.

What is Biomedical Waste?

According to section 3(f) of Biomedical Waste Management Rules, 2016 "bio-medical waste" means any waste, which is generated during the diagnosis, treatment or immunisation of human beings or animals or research activities pertaining thereto or in the production or testing of biological or in health camps, including the categories mentioned in Schedule I appended to these rules.

Biomedical waste can be divided into four categories:


1. Yellow: In this category, eight types of waste are categorised- Human anatomical waste, animal anatomical waste, soiled waste, expired or discarded waste, chemical waste, chemical liquid waste(separate collection system leading to effluent treatment system), discarded linen, mattresses, beddings contaminated with blood or body fluid, and microbiology, biotechnology, and other clinical laboratory waste.

2. Red: It includes contaminated waste (recyclable) generated from disposable items such as tubing, bottles, intravenous tubes and sets, catheters, urine bags, syringes (without needles and fixed needle syringes) and vacutainers with their needles cut) and gloves.

3. White(Translucent): It includes waste sharps including metals (includes used, contaminated and discarded metal sharps)

4. Blue: It includes broken or contaminated or discarded glass and metallic body implants.

Objective

The main objective of the new rules is based on three R, namely, reduce, recycle, and reuse. The aim is to delimit the waste, recover or reuse it as much as possible, and avoid disposing of it.

It is explicitly mentioned in these rules that these guidelines do not apply on radioactive wastes, hazardous chemicals, solid wastes covered, the lead-acid batteries, hazardous wastes covered, hazardous microorganisms, genetically engineered microorganisms and cells covered under other rules. The primary purpose of the rules is raining to workers, health checkups, immunisation, and occupation safety of the workers.

Salient Features:

Some of the salient features of the rules are as follows:

1. Now, the waste generated from vaccination camps, blood donation camps, and surgical camps are included.

2. Duties of both occupier, i.e. the person having administrative control and operator, i.e. the person who controls the medical facilities of collection, reception, transportation, treatment, and disposal of biomedical wastes, are unambiguously specified under these rules.

3. Maintenance of biomedical waste registers daily and monthly. The operator or the occupier has to update the register on the website and also the maintenance of all the records for operation of hydroclaving/incineration/autoclaving for five years.

4. The waste has been classified into four categories, and instead of 10 and the method, i.e. segregation, packaging, transportation, and storage of biomedical wastes has been improved.

5. There should be a common biomedical waste treatment facility and on-site treatment or disposal facility within 75 kilometres. State government should provide land for the establishment of a common biomedical waste treatment facility and disposal facility.

6. There should be pretreatment of the laboratory, microbiological waste, and blood bags on-site before disposal either at Common biomedical waste treatment facility or on-site.

7. The Ministry of Environment, Forest, and Climate change will monitor the implementation of rules yearly. 

 

Right to Health in Constitution of India

Right to Health in Constitution of India

Health is an essential feature for the development of a nation. In India right to health care and protection has been provided since early times of Independence. India has ratified various international conventions promising to secure health care right of individuals in society. The Constitution of India does not recognize the right to health as a fundamental right. However, Article 21 of the Constitution of India guarantees a fundamental right to life & personal liberty. The expression’ life in this article means a life with human dignity & not mere survival or animal existence. Article 21 should be read with Articles 38, 42, 43, & 47 to understand the obligation of the state. It has a much broader meaning which includes the right to livelihood, better standard of life, hygienic condition in workplace & leisure.

Definition of Health:

According to World HEALTH organization, health is a state of complete physical, mental and social wellbeing and not merely the absence of disease.

The definition clearly indicated that condition of life should incorporate physical, mental & social well being & must be devoid of disease & infirmity.

Right to Health and Preamble of Indian Constitution

The Preamble of Indian Constitution adopts a socialistic pattern of society which strives to provide for the welfare state. The concept of democratic socialism aims to improve the condition of health care of the people.

DIRECTIVE PRINCIPLE OF STATE POLICY AND HEALTH

Part IV of the Constitution of India which has DPSP imposed duties on states. The Provisions of DPSP directly or indirectly are related to public health. Articles 38 impose liability on the state that “state secures a social order for the promotion of the welfare of the people”. However, without public health, we cannot achieve it—article 39(e) related to workers to protect their health. Article 41 imposes a duty for public assistance which include health care assistance. Article 42 imposes a duty on the state to protect the health of infant & mother by maternity benefit. Article 47 imposes a duty on the state to raise the level of nutrition & the standard of living of its people as a primary responsibility.


Panchayat, Municipality and Health:

Not only the state but the Panchayat and Municipalities are also liable to improve e and protect public health. “The legislature of a state may endow the panchayats with necessary power and authority in relation to matters listed in the eleventh schedule.” 4 The entries in this schedule having direct relevance to health are as follows;

l   Safe water for drinking

l   Health and sanitation including hospitals, primary health centres & dispensaries

l   Family welfare

l   Women and child development

l   Social welfare including the welfare of the disabled and mentally retarded

l   Water supply for domestic industrial and commercial purpose

l   Public health, sanitation conservancy and solid waste management

l   Regulation of slaughterhouses and tanneries.

 

FUNDAMENTAL RIGHT AND HEALTH

Directive principles are only aims and goals of the state, and no person can claim for non- fulfilling these directions. Article 21 says “no person shall be deprived of his life or personal liberty except according to the procedure established by law”. In numerous judgements honourable Supreme Court has held that right to health & medical care is a fundamental right covered by Article 21. Further, Article 23 is indirectly related to health. Article 23(1) prohibits traffic in human beings as it is known that trafficking of women and children leads to prostitution, which in turn is to a significant factor in the spread of AIDS. Article 24 is related to child labour; it says “no child below the age of 14 years shall be employed to work in any factory or mine or engaged in any other hazardous employment. Thus Article 24 directs the relevance of child health.

 

Drugs Export Policy and Procedure in India

Drugs Export Policy and Procedure in India

 

Indian pharmaceutical and drugs industry is the third-largest in the world in terms of volume and thirteenth largest in term of value. India mostly manufactures generic drugs which constitute 70 per cent of the market, and 20 per cent is covered by counter medicines and nine per cent by patent drugs.

Procedure to export medicines from India

IEC Number (Importer Exporter Code Number): Every importer and exporter of drugs in India has to register at Director General of Foreign Trade Department. To apply for IEC Number, an application has to be submitted to Director General of Foreign trade's Regional Authority office. The exporter can also apply for online registration portal by visiting http://dgft.gov.in/.

The application will be scrutinized by Regional Authority of DGFT online, and a digitally signed e-IEC is issued and/or emailed to applicant within two working days if all the mandatory documents and formalities are completed. In case of rejection, a letter or email with the reason for rejection would be sent to the applicant.

Documents required:

· Premises ownership proof or rent agreement or lease proof

· Partnership deed or company association documents

· Bank Certificate or Cancelled cheque having printed details of firm/company and account number

· Or as asked by DGFT department

 

WHO: GMP certified Plant

Most of the countries allow pharmaceutical import from plants that are WHO: GMP approved only. Few countries like the USA have their own authority certification requirements for importing any drugs. To export to the USA you have to be approved by USFDA. 

 

Distributor/Agent or Registered Office in Importing Country:

Most of the micro manufacturers appoint import agent and distributor in importing country because of the expenses in marketing and sales team to handle marketing and promotion. This is the best option for the exporters who don't want to set-up their arrangement. The distributor will look at marketing and promotion, registration of product and other legal formalities in importing country.

 

Dossiers:

A Dossier is very important in the registration process in importing country and permission/approval from DCGI for export. It contains complete information about the origin, nature, chemical properties and other particulars of a drug.

 

The format of the dossier may vary in each country as per their rules and regulations. So an in-depth study of the dossier as per country laws and regulation is necessary before registration.

 

Permission from DCGI:

Before exporting any drug from India, an approval/permission/NOC, i.e. COPP from DCGI is required. The Approval/Permission/NOC is one time for each product and valid for one calendar year but subject to renew further.

Indian Customs has started SWIFT (Single Window Interface for Facilitating Trade) under which exporter can acquire the required permission from different regulatory authorities like Animal quarantine, Plant Quarantine, Drug Controller, etc. online without approaching these agencies separately.

 

Custom Clearance: For Custom Clearance, the exporter has first to generate shipping bill through custom online Software system electronically. After the shipping bill is generated, the product will be inspected by the customs officials. The official will also check the necessary documents and other particulars and submit an examination report to higher custom officials for approval.

After all the necessary documents and inspection 'Let Export Order' will be issued. The 'Let Export Order' is the proof of completion of the export customs procedure and three shipping bill will be printed. One for the exporter, one for exchange control copy for submission in Reserve Bank of India through Exporter's Bank and one for shipping carrier for the imported country destination. 

Drugs Import Policy and Procedure in India | Import of Pharmaceuticals

Drugs Import Policy and Procedure in India


India is the third-largest manufacturer in the field of Pharmaceutical industry. This industry is governed by the Ministry of Health & Family Welfare and Ministry of Chemical & Fertilizers. Although India produces many drugs itself but a large portion is imported mainly from the European Union, followed by North America and Asia.

Drugs Export and import is regulated by the Central Drugs Standard Control Organisation (CDSCO), through 11 Port offices located in different parts of the country. CDSCO regulates the drug import and export of drugs in India by the following rules and Acts.

1. Drugs and Cosmetics Act, 1940 and Rules, 1945. 

2. Pharmacy Act, 1948. 

3. Drugs and Magic Remedies Act, 1954. 

4. Medicinal and Toilet Preparation Act, 1956. 

5. Narcotic and Psychotropic Substances Act, 1985.

6. The Drugs (Prices Control) order, 1995.

 

The bulk drug (Active Pharmaceutical Ingredients) and finished formulations are regulated under the Drugs and Cosmetics Act, 1940 and Rules, 1945. The application for registration and import has to be made to the Drugs Controller General at CDSCO.

 

Guidelines for permission to import or manufacture of new drugs for sale or to undertake clinical trials

No Drug is allowed to be imported in India without the sanction of the licensing authority in writing. All drugs that are not recognized as safe for the use by experts or are not consumed to a large extent are known as new drugs.

Permission for importing new drugs may be acquired from the licensing authority after furnishing the necessary documentary evidence of the drug's standards of quality. The application for importing new drugs should be accompanied as specified in schedule Y.

 

l  Form 44 -Application for grant of permission to import or manufacture a new drug or to undertake Clinical trail 

 

l  Form 12 -Application for license to import drugs for examination, test, or analysis 

 

l   Form 11 -License to import drugs for examination, test, or analysis (1yr validity) 

 

l  Form 4 -Issue of import certificate (6 months validity) 

 

l  Form 1 -Application for the issue of import certificate for import of narcotic drugs and psychotropic substances (6-month validity) 

   

Application for Permission: An application is made in FORM 44 accompanied with the following data-

· Chemical and pharmaceutical information

· Animal Pharmacology data

· Animal toxicology data

· Human Clinical Pharmacology data

· Regulatory status in other countries

· Prescribing information

· Complete testing protocol for quality testing

Clinical Trial: Concerning new drug, clinical trial means the study of such new drug in human subjects to generate data for discovering or verifying its, 

· clinical or; 

· pharmacological, including pharmacodynamics.

· adverse effects.


Stages of Drug importation


Phase 1

1. Application for the issue of a Registration Certificate shall be made in form 40 by the manufacturer or authorized agent to the licensing authority.

2. A power of attorney shall document the authorization by a manufacturer to his agent. Such power of attorney shall be executed and authenticated either in India before a First Class Magistrate, or in the country of origin before such an equivalent authority. 

3. (i) A fee of one thousand and five hundred US dollars 2[or its equivalent in Indian rupees] shall be paid along with the application in Form 40 as registration fee for his premises meant for manufacturing of drugs intended for import into and use in India.

4. (ii) A fee of one thousand US dollars 2[or its equivalent in Indian rupees] shall be paid along with the application in Form 40 for the registration of a single drug meant for import into and use in India and an additional fee at the rate of one thousand US dollars for each additional drug: Provided that in the case of any subsequent application for registration of additional drugs by the same manufacturer, the fee for accompanying shall be one thousand US dollars 2[or its equivalent in Indian rupees] for each drug.

5. The applicant shall be liable for the payment of a fee of five thousand US dollars for expenditure as may be required for inspection or visit of the manufacturing premises or drugs, by the licensing authority or by any other persons to whom powers have been delegated in this behalf by the licensing authority under rule 22.

6. The applicant shall be liable for the payment of testing fee directly to a testing laboratory approved by the Central Government in India or abroad, as may be required for examination, tests and analysis of the drug.

7. A fee of three hundred US dollars shall be paid for a duplicate copy of the Registration Certificate if the original is defaced, damaged.

8. No Registration Certificate shall be required under these rules in respect of an inactive bulk substance to be used for a drug formulation, with or without Pharmacopoeia conformity.

Phase 2:

1. An application for an import License shall be made to the licensing authority in Form 8 for drugs excluding Schedule X, and in Form 8-A for Schedule X drugs; either by the manufacturer or by the manufacturer's agent in India who is having the wholesale license for sale or distribution of drugs and shall be accompanied by a License fee of one thousand rupees for a single drug and one hundred rupees for each additional drug and by an undertaking in Form 9 duly signed by or on behalf of the manufacturer.

2. Any application for import licence in Form 8 or 8-A, which shall be accompanied by a copy of Registration Certificate issued in Form 41 under Rule 27-A; in the case of emergencies the issue of Import License by the central government in Form 10 or 10-A without the issuance of Registration Certificate under Rule 27-A, for reasons to be recorded in writing.

3. A fee of two hundred and fifty rupees shall be paid for a duplicate copy of the licence if the original is defaced, damaged or lost. 

Food Export Policies and Regulations in India

Food Export Policies and Regulations in India

Directorate General of Foreign Trade regulates food Export in India under the Ministry of commerce. Exporters have to comply with the provisions of the Foreign Trade (Development and Regulation) Act, 1992, and terms conditions of any License/certificate/ permission/Authorization as well as the provisions of any other law for the time being in force.

 

Application for Grant of Export License

The application for grant of export license n in respect of items mentioned in Schedule 2 of ITC (HS) has to be made in the ‘Aayaat Niryaat Form’, to the Director-General of Foreign Trade. The Foreign Trade Facilitation Committee scrutinizes the application on the merits s for the issue of export.

 

Profile of Exporter

Each exporter has to file exporter profile once with the Regional Authority in Part 1 of ‘Aayaat Niryaat Form’.The Regional Authority enter the information furnished in Part 1 of ‘Aayaat Niryaat Form’ in their database. 

 

Application for IEC Number

An application for Import-Export Code has to be made by the Registered/Head Office of the applicant to the Regional Authority under whose jurisdiction, the Registered office falls in the ‘Aayaat Niryaat Form.

 

Other Authorities

1) Commodities Board- There are five y Commodity Boards under the Department of Commerce. These Boards regulates the production, development and export of tea, coffee, rubber, spices and tobacco.

A) Tea Board: A license under the provision of Tea (Distribution & Export) Control Order 1957 is necessary to export the tea from India.

B) Spice Board: Certificate of Registration as Export of Spices issued by the Board is also mandatory in addition to IE Code No. Spices Board issues Certificates of Registration for export of spices under Section 11 of the Spices Board Act.

C) Rubber Board: The Rubber Board is a statutory organization constituted under Section (4) of the Rubber Act, 1947. The activities of the Board are exercised through nine departments viz. Rubber Production, Research, Processing & Product Development, Training, License & Excise Duty, Statistics and Planning, Market Promotion, Finance & Accounts and Administration. 

D) Coffee Board: The Coffee Board is a statutory organization constituted under Section (4) of the Coffee Act, 1942. The Board is mainly focusing its activities in the areas of research, extension, development, market intelligence, external & internal promotion and welfare measures. 

E) Tobacco Board: The Tobacco Board was constituted as a statutory body on 1st January 1976 under Section (4) of the Tobacco Board Act, 1975. the primary function of the Board is the export promotion of all varieties of tobacco and its allied products, and its functions extend to production, distribution (for domestic consumption and exports) and regulation of Flue-Cured Virginia (FCV) tobacco.

 

2) Export Inspection council: To ensure the sound development of export trade of India through Quality Control and Inspection and for matters connected thereof the Government of India under Section 3 of the Export (Quality Control and Inspection) Act, 1963 (22 of 1963)set up The Export Inspection Council (EIC).

The EIC is responsible for the enforcement of quality standards, and compulsory pre-shipment inspection of the various commodities meant for export and notified under the Export (Quality Control & Inspection) Act, 1963.

 

3) Marine Products Export Development Authority (MPEDA): The MPEDA is a statutory body, set up under Section 4 of MPEDA Act, 1972. It is responsible for the development of the marine products industry with particular reference to exports.

 

4) Agricultural and Processed Food Products Exports Development Authority (APEDA): The APEDA is a statutory body set up by an Act of Parliament of 1986. It is entrusted with the tasks of agricultural exports, including the export of processed foods in value-added form.

 

5) Directorate of Plant Protection: Directorate of Plant Protection Quarantine & Storage was established in the year 1946 on the recommendation of Woodhead Commission. It checks/verifies pesticide residue certificates for grapes exported to the European Union before issuance of PSC to the exporters. 

 

Custom clearance procedure

 

1) The arrival of Goods at Port: After goods arrive at the port, the documents have to submit to the Custom House for further procedure. The documents include a packing list, invoice, letter of credit, certificate of origin and other relevant documents. The checklist of documents is uploaded to ICEGATE.

 

2) Processing of Shipping Bill: After the submission of the required document, the customs officer scrutinizes and verifies them according to the physical quantity of goods received. He generates the shipping bill for export of goods from India and gives a copy to the dock appraiser.

 

3) Examination of the Goods: The dock appraiser after examining the goods according to the examination order generates a ‘Let Export’ order. In case of discrepancy, the goods are sent back to the export department. Otherwise, goods are forwarded to the preventive superintendent and loaded to the assigned vessel.

 

4) Loading of Goods: The clearing and forwarding agent deliver the ‘Let export’ marked bill to the steamer agent. The goods are then loaded in the supervision of the preventive officer, and he gives ‘Shipped on Board’ endorsement on the shipping bill. Besides, the commanding officer of the ship issues ‘Mate receipt’ confirming the export of goods.

 

5) Export General Manifest: All the shipping lines/agents need to furnish the Export General Manifests, Shipping Bill wise, to the Customs electronically within seven days from the date of sailing of the vessel.

Food Import policy and regulations in India

Food Import policy and regulations in India


Every food importer in India has to comply with the provisions of the Foreign Trade (Development and Regulation) Act, 1992. Moreover, the provisions of Foreign Trade Policy and terms and conditions of any License/certificate/permission/Authorization and provisions of any other law for the time being in force.

Foreign Trade (Development and Regulation) Act, 1992


FTDR was promulgated for the development and regulation of foreign trade and matters connected therewith or incidental thereto. The FTDR elaborates the following:- 

1. Power of Central Government to make Orders and Announce Export and Import Policy: Section 3,4,5, and 6 of the act provides that the Central Government may make provisions for the development and regulation of foreign trade by facilitating imports and increasing exports.

2. Importer-Exporter Code Number: Section 7-9 of the act provides that an importer has to get an importer-exporter Code Number granted by the Director-General or the officer authorized by the Director-General.

3. Search, Seizure, Penalty and Confiscation: Section 10 of the act provides that the Central Government may authorize any person to exercise such powers with respect to entering such premises and searching, inspecting and seizing of such goods, documents, things and conveyances, subject to such requirements and conditions, as may be prescribed.

 

Import Procedure

1) Filling of application: Every application for an Import/Export license/certificate/Authorisation/ permission should be completed as required under the relevant provisions of the Policy/Procedures. An incomplete application is liable to be rejected, giving a specific reason for rejection. However, in the manual application, the applicant may furnish a soft copy of the application in MS word format.

2) Documentation: Importer has to furnish an import declaration in the prescribed Bill of Entry format. The declaration should disclose the value of the imported goods. In addition, any import licenses and phytosanitary certificates (in case of agricultural commodities), along with documentation such as sales invoices and freight and insurance certificates may also be furnished.

3) Profile importer/ Exporter: Every importer or exporter has to file importer/exporter profile once with the Regional Authority in Part 1 of ‘Aayaat Niryaat Form’.

4) Application for Grant of IEC Number: The application for Importer-Exporter Code shall be made by the Registered/Head Office of the applicant to the Regional Authority under whose jurisdiction, the Registered office in the‘Aayaat Niryaat Form’ falls.

 

Customs Clearance Procedure for Food items:


1. Bill of Entry (BOE) is filed at the Customs ICE GATE (https://icegate.gov.in) on Single Window Interface for Facilitating Trade (SWIFT). SWIFT is working on Risk-based sampling system, called as Risk Management System(RMS).

2. Risk Management System (RMS) scrutinizes the application and if the sampling is required; the BOE is referred to FSSAI on online Food Import Clearance System (FICS).

3. CHA/Importer needs to be registered on FICS (www.ics.fssai.gov.in). 

4. FSSAI accepts the BOE and may ask for further details from CHA/Importer, if necessary. 

5. If all the relevant information is provided, Authorized Officer (A.O) fixes an appointment for the inspection of the consignment (only two opportunities are provided to the CHA/Importer to confirm the appointment).

 

6. On inspection, if everything is found satisfactory, including labelling and packaging requirements of the consignments, the samples are drawn (2 nos). If not, the Authorized Officer rejects the consignment and issues NonConforming Report.

 

7. Samples are then sent to FSSAI Notified Food Laboratory, If the sample is found conforming then No Objection Certificate (NOC) is generated and if not conforming, then Non-Conforming Report (NCR) is generated, rejecting the clearance of food consignment.

 

8. If the importer is not agreed with the finding of the laboratory report, he may apply for retesting at the referral laboratory. The outcome of the test result will determine the fate of consignment. He may present the review application to the Review Officer (Director, Imports) along with the required documents at the FSSAI Headquarter.

 

9. The order passed by the Review Officer can be challenged before the CEO, FSSAI whose decision thereon will be final.

 

10. For more details, please go through the FSS Act 2006 and regulations made thereunder. They are available on the website, i.e. www.fssai.gov.in.

 

Organ Transplantation laws in India

Organ Transplantation laws in India

 

Organs transplant has proven to be a boon for us. This miracle of medical science and technology has saved countless lives. The number of patients needing a transplant outnumbers the donors available, making the government step in and make laws to stop illegal activities involving the commercialisation of organ transplantation. 

Laws Governing Organ Transplantation in India

Organ Transplantation has a shorter history as compared to other developed nations. The first kidney transplant was done in May 1965 at the King Edward Memorial Hospital at Bombay. Transplantation activities increased in the 80s and 90s. However, a new trend of kidney trade started in the 80s. Foreigners from all over the world started to flock to India for transplantation from a paid donor. 

The government of India enforced the Transplantation of Human Organs Act (THOA) in 1994. Subsequently, in 1995 the Transplantation of Human Organs Rules came in force. The Act made commercialisation of organs a punishable offence. It also legalised the concept of brain dead in India, allowing deceased donation by obtaining organs from brain stem dead person.

 

What is Brain Dead?

Brain Dead is a state where all brain activities have stopped and cannot be reversed. Even if the heart is working due to ventilator, the patient can be safely pronounced to be dead in such a situation.

According to the Transplantation of Human Organs Act “brain-stem death” means the stage at which all functions of the brain stem have permanently and irreversibly ceased and is so certified by Medical experts.

 

Regulation of Cadaver Donation

Section 3-8 of the Act regulates the Cadaver Donation. According to section 3, any person can, before his or her death, in writing authorise in the presence of two witnesses the removal of any organ of his body after his death. In a case where a person did not make such authorisation, the person who is lawfully in possession of the dead body can authorise the removal of any organ of the deceased person. Provided, unless he has reason to believe that any near relative of the deceased person has an objection to the same.

 

Regulation of Living Donation

Section 9 of the Act provides provisions for living donation. The Act provides a separate procedure of living donation by near relatives and living donation by an unrelated donor. 

Section 2(i) defines near relatives as son, daughter, father, mother, brother or sister, grandfather, grandmother, grandson, or granddaughter. The near relative has to fill an application form and submit it to the competent authority (i.e., the head of the hospital or the committee constituted by the hospital, called Hospital Authorisation Committee). The committee then interviews the donor, recipient and their relatives. The whole interview is to be video recorded. If satisfied, it gets approval for transplantation.

In case of an unrelated donor, an application form has to be submitted to the Hospital Authorization Committee. After scrutinising the application and interviewing the donor, the recipient, and their relatives, the Hospital Authorization Committee will forward the application to the State Authorization Committee, which will again scrutinise the application. Then interview the donor, the recipient, and their relatives. The interview on both levels has to be video recorded.

 

Regulation of “Hospitals”

Section 10 and Section 14 provides that unless registered no hospital or Human Organ Retrieval Centre can commence any activity relating to removal, storage, or transplantation of any human organ or tissue.

For registration, the hospital has to be in a position such as specialised services, possess such skilled workforce and equipment, and maintain such standards as may be prescribed from time to time. Furthermore, to register as a Human Organ Retrieval Centre under the Act, the hospital shall have Intensive Care Unit facilities along with infrastructure, equipments and manpower as required to diagnose and maintain the brain-stem dead person.

 

Regulation of Medical Practitioners

According to Section 3(4) of the Act, organ removal can only be done by a registered medical practitioner. Registration is not required for a medical practitioner, but the transplantation has to be conducted in a registered hospital. Section 2(n) of the Act defines a “registered medical practitioner” to mean a medical practitioner who possesses any recognised medical qualification as defined in clause (h) of Section 2 of the Indian Medical Council Act, 1956 (5) and who is enrolled on a State Medical Register as defined in clause (k) of that section. 

 

Punishment

According to Section 18 of the Act, a person is to be punished with imprisonment for a term which may extend to 10 years and with fine which may extend to Rs. 20 lakhs if he is involved in the removal of any human organs without authority. Suppose the person convicted is a medical practitioner. In that case, his name shall be reported by the Appropriate Authority to the respective State Medical Council for taking necessary action.

According to section 19, if a person does commercial dealing of human organs, he will be punished with imprisonment for a term which shall be not less than five years but which may extend to 10 years and shall be liable to fine which shall not be less than Rs. 20 lakhs but may extend to Rs. 1 crore.

According to Section 20 of the Act, any person who contravenes any other provision of the Act can be punished with imprisonment for a term which may extend to 5 years or with fine which may extend to Rs. 20 lakhs.

Food Adulteration in India: Penalties, Complaint and Remedies

Food Adulteration in India: Penalties, Complaint and Remedies

Food adulteration is a concerning issue in India. It not only brings down the nutritional value but also adds harmful chemicals and acids in our food. Due to the low literacy rate in some areas, people are not aware of such things, and they consume these harmful chemicals and acids unknowingly. From food poisoning to death, these adulterated food items, including medicines, vegetables, paste, creams, products of famous brands and so on are a growing issue.

Penalties imposed under the Food Safety and Standards Act, 2006

Under Food Safety and Standards Act, 2006, following penalties are imposed upon the people who commit food adulteration. Section 50,51,52,53,54,55,56,57,58,59 states the penalties:

1. Any person who sells to the purchaser’s prejudice any substance which is not according to how the consumer actually demanded or is not according to the provisions demanded shall be liable to the penalty not exceeding five lakh rupees.

2. Any person who whether by himself or by any other person on his behalf manufactures for sale or stores or sells or distributes or imports any food item for human consumption which is of lower quality or sub-standard, shall be liable to a penalty which may extend to five lakh rupees.

3. Any person who whether by himself or by any other person on his behalf manufactures for the sale or stores or distributes or imports any food item for human consumption which is misbranded, i.e. the food item which is in not accordance with the statutory requirements of the act, or brands the food in a misleading way, shall be liable to a penalty which may extend to three lakh rupees.

4. Any person who publishes or is a party to a publication of an advertisement which falsely represents the quality of the food or gives a false guarantee of the food shall be liable to a penalty which may extend to ten lakh rupees.

5. Any person who whether by himself or by any other person on his behalf manufactures for the sale or stores or distributes or imports any food item for human consumption which contains any matter which is decayed or extraneous, shall be liable to a penalty which may extend to one lakh rupees.

6. Any person whether by himself or by any other person manufactures a food article to sell it to the consumer, under unhygienic or unsanitary conditions, shall be liable to a penalty which may extend to one lakh rupees.

7. If any person distributes an adulterant which is not injurious to health, the fine may be one lakh rupees, and if that adulterant is injurious to health, the fine may exceed to ten lakh rupees.

8. Whoever contravenes to any of the provisions of the act, shall be liable to pay the penalty which may extend to two lakh rupees.

9. Any person whether by himself or any other person manufactures a food article with the knowledge of selling it to the consumer sells unsafe food which can injure the person or lead to the death of the person shall be liable to pay the fine which may exceed to ten lakh rupees and maybe imprisonment for not less than seven years.

Complaint

Whenever a person comes to know or is a victim of any case of food adulteration, he or she can file a complaint at;

Tier 1: manufacturer/ shopkeeper

Tier 2: Local Health Authority of India or district commissioner of the food safety Authority of the state/ union territory

Tier 3: Consumer Forum

Consumer forums are on three levels: District, State and National. District Consumer forum has the original jurisdiction, and appellate jurisdiction lies with state and national consumer forums.

Consumers can also contact to FSSAI( The Food Safety and Standards Authority of India) which is a statutory body to supervise the rules and regulations. FSSAI also launched a digital platform called the ‘Food Safety Voice’ where consumers can register their complaints and food safety issues.

Remedies available to the consumers

Section 65 Food Safety and Standards Act, 2006 lays down the provisions of compensation in case of injury or death of a consumer:

Any person who by himself or any other person manufactures a food article which may be injurious to the consumer or his death shall be made liable to pay the victim a fine which may be exceeded to

i) not less than five lakh rupees in case of death;

ii) not exceeding three lakh rupees in case of grievous injury;

iii) not exceeding one lakh rupees in all other cases of injury.

Provided that the compensation need to be paid at the earliest before six months and in case of death, an interim relief should be sent to the victim’s family within a period of thirty days.

What is FSSAI License and Types

What is FSSAI License and Types


To ensure food safety and standard in India, food manufacturers and sellers need to have a Food License. Food Safety and Standard Authority of India (FSSAI) regulates and check for the quality standard of food manufacture, storage and handling practices and business dealing in food mandatorily need to have FSSAI registration and license. It is 14 digit license or registration number, which is printed on all food packages; even restaurants must have FSSAI registration and license number.

The licence is valid for minimum 1 and maximum of 5 years and failing to obtain a license can bring legal consequences and damage goodwill of the business.

 

Types of Licenses: -


Food Licenses are acquired based on their turnover, scale of business and the type of activity. All businesses have to either apply for simple registration or a license (central or state).


FSSAI Basic Registration: This is required for businesses and startups with annual turnover below Rs. 12 Lakhs. The registration is also mandatory for temporary stallholder and small-scale businesses and cottage industries. The registration can be further upgraded to state license if the turnover increases or changes are made in the business for which state or central food license is required.


FSSAI State License: The license required by the business whose annual turnover is between Rs. 12 lakhs to 20 crores. Food businesses like mid-size manufacturers, transporters, retailers etc. needs state FSSAI license. This license can be further upgraded to a central license if the turnover of business increases or changes are made in the business central food license is required.


FSSAI Central License: This license is mandatory for large businesses with an annual turnover of over 20 crores. Big food businesses like large manufacturers, importers, food business operators in Central Government Agencies etc. need to obtain Central FSSAI registration. 


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Medical Negligence in india | What is Medical Negligence

Medical Negligence: Meaning

 

Legal meaning of Medical Negligence is slightly different from then from its general sense. In layman’s understanding, medical negligence simply means carelessness, but in the legal definition, medical negligence is more than mere carelessness. It is a failure of a person to perform a certain act which he was expected to do in the course of his duty. 

In recent years we all have seen or heard cases of doctors declaring alive baby as dead, leaving medical instruments in patients body or prescribing wrong medicines, etc., all these examples of medical negligence.

  

Medical Negligence in Indian Hospitals

Hospital liability arises in medical negligence either directly or vicariously. A hospital’s direct liability arose when the hospital itself was deficient in providing a suitable environment and care to a patient. And Vicarious liability arises when an employee has acted negligently, and the hospital is indirectly responsible for the it’s employee fault. The rule of vicarious liability in medical negligence is applied to the hospital because it is the employer and the medical practitioner are its employees. In India, the rule of vicarious liability states that employer is liable for the negligence done by the employee.

  

When does medical negligence arise?

The liability of a doctor does not simply arise because the patient has suffered an injury. The liability arises when the injury suffered is due to the direct negligent of a doctor or medical practitioner. So not every injury sustained by a patient falls under the purview of medical negligence. For an act to be medical negligence in India, there has to be a direct relationship between a patient’s injury and the negligent act of the medical practitioner. Moreover, for the negligent act of doctor or other medical practitioners, vicarious liability of hospital arises automatically.

 

Remedies available against Medical Negligence

In cases of medical negligence, the victim or the family members have the option of two types of legal remedies.

Firstly, a criminal complaint can be filed against the medical practitioner or the hospital. The Indian Penal Code prescribed negligence as a crime under Section 52, 80, 81, 88, 91, 92 304A, 337 and 338. Section 304A deals with the crime of causing a person’s death due to negligence or rash acts.

Secondly, a consumer complaint can be filed for medical negligence under the Consumer Protection Act, 1986. The complaint can be filed in the appropriate consumer forum. The consumer forums in India are divided into three tiers: 

 

l  District Forum: Cases with a total value up to Rs. 25 lakh are filed.

l  State Consumer Redressal Forum: Cases with the value above Rs. 25 lakh and below Rs. 1 crore are filed here.

l  National Commission: Cases with a total value of Rs. 1 crore and above are filed here.

 
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Health risks of Pesticide Residue in our food

We have been using pesticides to increase agriculture productivity. They have become very crucial in developing nations where the main task is securing relief from hunger. However, the continuous and uncontrolled use of chemical pesticides has resulted in contamination of the environment. They also get causes long-term effects on human health.

 

Pesticide residue in our food: -


Even after washing and cleaning our food grains, vegetables and fruits, pesticides may remain. They are used before and after harvest to protect the grains from damage or loss. Storage of food grains often requires intensive use of chemical pesticides like organophosphates, carbamate, synthetic pyrethroids and insect growth regulators. The most used and consumed pesticide in India includes sulphur, endosulfan, mancozeb, phorate, methyl parathion, monocrotophos, cypermethrin, isoproturon, chlorpyrifos, malathion, carbendazim, butachlor, quinalphos, copper oxychloride, and dichlorvos.


In India Food Safety and Standards Authority of India sets the maximum residue limits for pesticides in crops, foods, vegetables and fruits. 


A study done from a few samples of grapes shows insecticide residues like acephate, methamidophos, chlorpyriphos, monocrotophos and quinalphos. Another study on soft drinks available in the Indian market shows that pesticide residues 24 times higher than the Bureau of Indian Standards (BIS) norms.


Adverse effects of Pesticide residue on health: -


Most of the pesticide kills insects and other organisms by disrupting the nervous system. There are many assumptions that these chemicals can have a significant negative impact on human health as well. Though these chemicals can be washed off or do not have long durability, many of the pesticide residues that are attached tend to be lipophilic and can bio-accumulate in the body.


Many pesticides like organophosphate or organochlorine may disrupt the nervous system, paralysis or may cause death by binding to the enzyme acetylcholinesterase. They may cause other side effects like diarrhoea, diaphoresis or lacrimation.


Studies have revealed that increase of insecticides in blood level may lead to reduced fertility, early and late pregnancy loss, spontaneous abortion, and premature birth, genetic alterations in sperm, reduced sperm count.


Preventive measures: - 


There many different strategies which can be adopted to minimise pesticide and health problems. One of the methods used to reduce the use of pesticide is organic farming. There are studies and evidence which shows that organic food has consumption can reduce exposure to pesticide residues in food. Organic food has a much higher level of antioxidants and lower pesticide residue than non-organic food.


Another method is the use of bio-pesticide, which are biodegradable so no risk of pesticide residue. Natural Pesticides like neem tree are beneficial for the prevention of pesticide residues. 

Adverse effects of artificial food colouring on children

We are now consuming food dyes as never before. The statistics are not surprising when you consider all your food products from breakfast to ice creams are using more and more food colours. While naturals food dyes are available like Annatto, manufacturers choose synthetic food colourings which are quite dangerous for children. 


Food dyes like Blue 1 and 2, Citrus Red 2, Green 3, Red 3 and 40, Yellow 5 and 6 contains compounds like benzidine and 4-aminobiphenyl, that research has linked with cancer.

 

There are other problems associated with synthetic food colouring in children like allergies, hyperactivity, learning impairment, irritability and aggressiveness. According to a report by US-based Center for Science in the Public Interest (CSPI), Food Dyes: A Rainbow of Risks, artificial food colouring likely are carcinogenic, cause hypersensitivity reactions and behavioural problems, or are inadequately tested.

 

Further researches have found that children who consumed conventional synthetic dyes displayed hyperactive behaviour within an hour of consumption. (These children had not been diagnosed with ADD or ADHD.) 

 

“We see reactions in sensitive individuals that include core ADHD symptoms, like difficulty sitting in a chair and interrupting conversations,” says David Schab, M.D., M.P.H., assistant clinical professor of psychiatry at Columbia University. Even so, says Schab, this isn’t the most significant issue to get rid of synthetic food dyes. “Foods with dyes are often riddled with other nutritional problems, like excess calories and fat,” says Schab, who points out that childhood obesity is a far greater public health concern.

 

A survey was done in North Kerala by the Food Safety Department, which revealed that the use of synthetic colours in sugar-based confections is posing a severe health risk in children. Out of 14 samples collected by the authorities, 97 per cent contained permitted colours while three per cent contained a combination of permitted and non-permitted colours.

 

Furthermore, the analysis shows that 82 per cent of the samples exceeded the prescribed limit of 100 ppm (parts per million) for permitted colours.

Studies on animals have revealed that Brilliant blue can cause renal failure, asthma or liver damage while Tartrazine is responsible for Attention Deficit Hyperactivity Disorder, and sunset yellow causes adrenal tumour and hypersensitivity.

 

According to Chief Nutritionist Priya Bharma from Sri Balaji Action Medical Institute, “Artificial colouring helps to make food more captivating but at the cost of health, causing everything from hyperactivity and allergic reactions to cancer. Artificial colours are high in calories and less in nutrients and are mostly found in processed junk foods. For example, a royal blue dye found in candy, ice cream, cereal and snacks. Focus on eating whole and unprocessed food like dairy products, unflavored nuts, unpolished cereals, fruits and vegetables etc.”

Oxytocin: A Poison in our milk

Oxytocin: A Poison in our milk

 

Oxytocin is a hormone released by the anterior pituitary gland, both in animals and human beings. It travels through the blood in the body to the site of action from the site of release. This hormone is crucial for milking. It causes contraction of alveoli muscle cells surrounding the milk-producing cells.

 

Harmful effects of Oxytocin 

Dairy farmers have been using Oxytocin in animals to get more milk. But they are unaware of the detrimental effects on animals. Even after the ban by the government, the hormonal injections are easily available in the black market. The use of Oxytocin causes the uterus of cattle to contract, which causes immense pain. 

The government of India banned Oxytocin under Section 12 of the Prevention of Cruelty to Act, 1960. It prohibits the “introducing (of) any substance into the female organ of a milch animal with the object of drawing off from the animal any secretion of milk.”

 

Not only this drug causes immense pain and infertility, but also it reduces the lifespan of the animal. 

 

It causes harmful effects to humans also who consume milk obtained from animals subjected to Oxytocin injection-

 


Hormonal Imbalance- Medical experts suggest that consuming Oxytocin drugged dairy products can cause hormonal imbalance in humans. Boys may suffer to Gynecomastia (breast enlargement). And in girls, the age of menarche has drastically decreased from 16 to 10 years of age.

Children are highly vulnerable to this drug. It causes hearing imbalance and weak eyesight. Common symptoms after consuming excessive Oxytocin are exhaustion and loss of energy. The use of such milk may cause abortion to pregnant women and babies might born with deformities and low immunity levels.

Haemorrhage- The use of milk subjected to Oxytocin increases the risk of haemorrhage in mothers after giving birth. It critically affects the growth of hormones in young girls as they attain early puberty. Some women may be hypersensitive to Oxytocin, and it can impede breastfeeding. 

A brief history and evolution of pharmaceutical laws in India

A brief history and evolution of pharmaceutical laws in India


The history of medical science is as old as humans itself, at the beginning the mankind learned from the basic instincts, from the observation of birds and animals. They used cold water, leaves, dirt etc. for soothing. Slowly these methods developed and became the roots of modern medication and pharmacy.

In ancient India also, people practised a very developed medical system. The earliest information on about medicine and medical science is available from Vedic period with four Vedas along with their Brahmanas, Aranyakas, and Upanishads.

Later, the medical observations from the Vedic period laid the foundation for a more rational and methodical system known as Ayurveda.

Nevertheless, this system of medicine declined when Muslim invaded India, and with them, the Arabic or the Unani-Tibbi system flourished. However, until now, there were no scientific methods of standardisation of drugs.

The medical system in India saw another turn with British rule. The allopathic system became prominent, and initially, all drugs were imported from Europe. Later some drugs began to be manufactured in this country.

The Britishers at first imposed some laws having a direct or indirect bearing on drugs but they were insufficient-


l   1878 Opium Act- The manufacturing, cultivation, export-import and sale of opium were dealt with this act.

l   1889 Indian Merchandise Act- Misbranding of goods in general

l   1894 Indian Tariff Act- Imposing customs duty on goods including foods, drugs, chemicals and medicines imported into India or exported therefrom.

l   1898 Sea Customs Act -Goods with ‘false trade description’ were prevented from importing under this act.

l   1919 Poisons Act Regulated the import, possession and sale of poisons.

l  Indian Penal Code - Some sections deal with adulteration as a punishable offence.

 

Dawn of Pharmaceutical Profession and laws in India


On 11th August 1930 government of India appointed a committee under the chairmanship of Late Col. R.N. Chopra. The purpose of the committee was to see problems of Pharmacy in India and recommend the measures.


The committee published its report in 1931. According to it, there was no recognised profession of Pharmacy in India. Only a few compounders were filling the gap.


After that, Prof. M.L. Schroff initiated university level pharmaceutical education at Banaras Hindu University. In 1935 the United Province Pharmaceutical Association was established which later became Indian Pharmaceutical Association.


The government of India brought ‘Import on Drugs Bill’ in 1937; however, it was later withdrawn. In 1940 the government brought ‘Drugs Bill’ which was later adopted as Drugs and cosmetics act 1940. This act aimed to regulate import, manufacture, sale and distribution of drugs in India.


Next year under this act, the Drugs Technical Advisory Board was constituted, and Central Drugs Laboratory was established in Calcutta. In 1945 the government established Drugs rule under Drugs act 1940.


In 1945 the government brought pharmacy bill to standardise the pharmacy education in India, and in 1948, the Pharmacy Act was adopted.


In 1948 Indian Pharmaceutical Committee was established under the chairmanship of Dr B.N. Ghosh.


In 1949 Pharmacy Council of India was established under the Pharmacy Act.


The Drugs and Magic Remedies (Objectionable Advertisement) Act was brought in 1954. The object of this act was to control the advertisement regarding drugs. The act prohibits the advertising of drugs claiming to have magical qualities.

The Narcotic Drugs and Psychotropic Substances Act was enacted in 1985 to protect society from the danger of addictive drugs.  It controls and regulates the operations relating to Narcotic Drugs and Psychotropic Substances.

Food Security challenges India faced during the lockdown

Food is the basic necessity of all human beings. For India, even in best times, it has been the key priority. In the time like COVID-19, the need to ensure food safety has been a major challenge. 

The World Bank data shows that more than 176 million people are living in extreme poverty. The data also reveals that poor households are more vulnerable to the risk of COVID-19. Nevertheless, at the same time, these people face food insecurity. 

On the other hand, 2019 Multidimensional Poverty Index (MPI) data can also be referred to, which shows the number of poor in India is more than 369 million. The number is quite staggering and poses a great challenge, even in a non-emergency situation. And in a situation like COVID-19, this challenge becomes even serious when a number of livelihoods lost for a daily wage and self-employed worker. 

Food Security System in India and Challenges


With a number of over 0.55 million Fair Price Shops, Public Distribution System ensures the regular supply of food grains and other essential commodities.

 

At the beginning of March 2020, India has a stock of 77 million tonnes (mt) of rice and wheat and 2.25 mt of pulses in public storage. This three times more than what Food corporation of India mandates. 

Finance Minister Nirmala Sitaraman on 26 March announced a relief package of 1.76 lakh crore rupees under Pradhan Mantri Garib Kalyan Yojna. It includes provisions for:

 

l   80 crore poor people to get 1 kg of rice and 5 kg free for three months.

l   Jan Dhan Account holders to get Rs 500 per month for the next three months.

l   MNREGA wage increased to Rs 202 from Rs 182.

l   A sum of Rs 1,000 for 3 crore poor widows, senior citizens and disabled.

l   Building and Construction Workers Welfare Fund to be used by state governments to provide relief to construction workers.

With all these measures by the central government, state governments too announced their own Schemes. However, a big hurdle was lack of updation in the Public Distribution System and lack of documentation. Another issue was the ration card, which is neither divided nor portable across locations. Government’s new One Nation, One Ration Card policy is still a work in progress.

Even if a household gets wheat, then local millers who convert it into flour were not working. Rice was the only option available.

Furthermore, inter-state coordination has negatively affected food distribution. Agriculture is a state subject matter, and programs vary from state to state. 


Transportation, storage and distribution of large volumes of food became a problem leading to spoilage and contamination. Many warehouses were closed due to local law enforcement. There has been an issue of transportation too. Local administration is prohibiting the movement of trucks, and there is a scarcity of labourers as well.

Major Food Safety Laws in India

Major Food Safety Laws in India

India has covered a long distance from a starving nation of 1947 to one of the biggest producers of food. The nation is aspiring to be the food factory of the world. On the other hand, there are number of laws and regulations containing harsh, redundant & obsolete provisions formulated to make sure the safety and standards of food for the consumers. Some of the significant food safety and standard laws in operating in India are as under:

1. The Prevention of Food Adulteration Act, 1954 (Ministry of Health and Family Welfare)

This is the main act governing the food sector in India, which lays down provision for the protection from adulteration/contamination of food. This act regulates the use of chemicals, flavours, pesticides and other additives in food. Implementing agencies for the enforcement of the provisions of this Act and the Rules made thereunder is the respective State Government/U.T. Administration.

2.  Agriculture Produce (Grading & Marketing) Act, 1937 (Ministry of Agriculture)

Commonly known as AGMARK this act lays down specifications for various agricultural commodities. Currently, it covers quality guidelines for 222 different commodities. It provides a confirmation mark for agricultural items which guarantees that they conform to a set of standards affirmed by the Directorate of Marketing and Inspection.

3. Laws being operated by Bureau of Indian Standards (BIS) (Ministry of Food & Consumer Affairs)

BIS is the largest body which lays down standards for various food items. Though these standards are voluntary, but in some cases, it has been made mandatory. For example, cattle feed manufactured and sold in the State of Punjab has to mandatory meet the quality standards laid down by the BIS under Section 3 of the Essential Commodities Act, 1955.

4. The Essential Commodities Act, 1955

This act ensures the delivery of commodities, the supply of which if hoarded or black marketed would affect the normal life of the people. 

The Government of India uses it to regulate the production, supply and distribution of essential commodities. Moreover, to make them available to the consumers at fair prices, the government can also fix the maximum retail price (MRP).

Many quality control orders have also been issued under the act. Some of them are as follows:

a) Fruit Products Order, 1995 (Ministry of Food Processing Industries)- The order lays down provisions regulating sanitary and hygienic conditions in the manufacturing of fruit, vegetable products. It mandates to obtain a license for all manufacturers of fruit, vegetable products. It also lays down the maximum limit of preservatives, additives and contaminant in fruit and vegetable products. 

b) Meat Food Products Order, 1973 (Ministry of Food Processing Industries)- The order lays down the provisions for sanitary and hygienic conditions for the production of wholesome meat food products. All manufacturers of meat food products are licensed, but it excludes manufacturers who prepare products for consumption on the spot like a restaurant.

c) Milk & Milk Products Order,1992 (MMPO)- This order ensures the quality and increased supply of liquid milk to the consumers. It regulates the production, supply and distribution of milk and milk products in the whole country. The order also ensures sanitary requirements for dairies, machinery and premises.

d) The Vegetable Oil Products (Regulation) Order, 1998 (Ministry of Food and Consumer Affairs)- The Vegetable Oil Products (Regulation) Order, 1998 replaces the earlier orders, i.e. the Vegetable Oil Products (Control) Order, 1947 and the Vegetable Oil Products (Standards of quality) Order, 1975. This order has reduced the overlapping of earlier orders, i.e. the Vegetable Oil Products (Control) Order, 1947 and the Vegetable Oil Products (Standards of quality) Order, 1975. Now The Directorate of Vanaspati, Vegetable Oils and Fats is the prime authority for the implementation of standards vegetable oil product mainly at the manufacturing stage. 

e) The Edible Oils Packaging (Regulation) Order, 1998 (Ministry of Food and Consumer Affairs)- This order was promulgated after dropsy incident which took approx 60 lives illness of more than 3000 due to consumption of adulterated mustard oil. Now packers of edible oil have to be registered under this order. 

The order ensures the sale of edible oil to the standards of quality as provided in the Prevention of Food Adulteration Act, 1954. Selling of edible oil without packaging and the labelling requirements on the pack is prohibited. It also provides provisions for quality testing facilities and the sanitary and hygiene requirements for the premises.

In addition to above orders central and respective state governments has issued several other orders under Section 3 of the Essential Commodities Act, 1955.

Food Safety Infrastructure India Lacks

Food Safety & Standard Act-2006 and Rules thereunder;

A Half-Baked Cake   

Respected Sir,

That top issues are:-

i.          Lack of Testing Facilities / Infrastructures,

ii.        Less Industry Representation and

iii.       Lack of Transparency.

iv.        Standard of food Article (appendix)are of 1955.

v.         Commissioner of FDA of only Maharashtra State is  taking keen interest in implementing the Act.

1.         The Act is prepared in the year 2006, its Rules were finalised in the year 2011. Now the only State of Maharashtra is implementing in said Act and Rules in very harsh manner. That the Act is new but the Standard (Appendix) same are as of PFA Rules, 1955. The Act as has been enforced is a death blow to Indian food industry and many of the clauses are not appropriate to the prevailing trade situation and are ambiguous. Unless changes are effected in the Act.

2.       The stringent standards and Conditions prescribed in the Food Safety and Standards Act and Rules is adversely affecting small manufacturers and traders of food products. That many villages in the country were yet to have easy access to potable. That implementing the stringent standards and conditions existing Food Business Operator in rural as well urban areas losing out to multinationals.

3.       Need for awareness- That adequate levels of awareness should be created and each and every food business operators should be educated to raise their business to the standards expected by the Food Standards and Safety Authority. For an initial period of three years, no prosecution should be initiated for contravening the norms of registration, licensing, and hygiene standards.

4.         That till date admittedly not a single laboratory in State of Maharashtra is NABL and notified by FSSAI, as per the Provisions of Section 43. That the FDA having knowledge regarding the same, inspite of this, the Officers of FDA  are drawing the sample/seizing the food articles and on the basis of the alleged Reports issued by Food Analyst, thousands of proceedings are filed against Food Business Operator and recovering the penalty/fine. Admittedly not single case is tenable on the basis of the Report issued by Food Analyst.

5.         That the agencies that enforce it-primarily the FDA  is holding small farms, traders, Cottage Industries, Kutir Udyog, Sall Scale Industry etc. to the same standard as big factories,  farms and new coming food processing industries. That as per the new Food Safety and Standard Act cores of rupees is required to build the infrastructure. Now the question arises “Why should small traders, Farms, Cottage Industries, Kutir Udyog etc. have to follow the same rules as the companies that are washing half the nation’s spinach in the same sink?” FSSAI under the garb of the Food Safety and Standard Act and Rules frame thereunder  aims to decouple the push for food safety from the possibility that food safety regulations might trample small farms, small traders, Farms, Cottage Industries, Kutir Udyog etc..

7.         Whatever numbers are chosen to define “local” and “small,” what’s most important, from the perspective of small traders, farms, Cottage Industries and Kutir Udyog, Small Scale Industries etc. are that some form of distinction, however imperfect, between big and small, local and non-local, be factored in.

8.         That while there can be no controversial opinions in punishing severely those found guilty of adulteration, at the same time, the honest traders should not be punished. The FSS Act 2006 imposes fine over 100 times when compared to the old PFA Act. Such a hike is unheard of anywhere in the world. There is a clear difference between deficiency to follow an act and committing willful offences. The law should give opportunity to set right the deficiency as well as to correct the mistakes. The maximum penalty should be Rs 25,000 instead of proposed Rs 10 lakhs. There are a number of such anomalies.

9.         That on the one hand Govt. itself having no infrastructure, well equipped notified and NABL laboratories to analysis the food articles at every district level. In Maharashtra only 3-4 labs are in working condition but not a single lab is NABL and are not notified by FSSI. So also none laboratory is having sufficient equipments/instruments and expert analyst. This is the situation in Maharashtra what about the Nation.

10.       There is an urgent need to upgrade the current infrastructure and to create more to meet the needs of the growing sector,” that quality assurance labs should be upgraded with all scientific instruments for the proper testing of raw and finished products.

11.       That the new act has several clauses which are not practically possible to implement in Indian context. That due to arbitrary and high handed act and role of Officer of FDA Maharashtra in implementation of Act and Rules in the present form, it shall lead to the closure of numbers  Food Processing Industries of Maharashtra and they may shift to nearby State and will force unemployment millions of people.

12.       That prior enforcement of Food Safety Act and it Rules the Central Govt. ought to have consider climate variability, Traditional farming, exposed to the vagaries of nature, cannot cope with this task. The government has still not realised the gravity of the climate phenomenon. To be able to face challenges posed by the weather, agriculture will require something like the Marshall Plan on a war footing.

13.       The grains shall not be exported to the other countries as we are using Pesticide, D.D.T. The countries who are trying to enter Indian Market shall prohibit the Indian food article etc. on the said grounds. That on the one side Central Govt. is granting subsidy in millions of Rupees to Pesticide, Fertilizer, insecticide industries.  That FSS Act strictly prohibits use of raw material having pesticide, toxic etc.

14.       In near future we have to eat only processed food articles, vegetable, fruits its which is stored in the cold storage.

15.       The processing industry which is likely to be entering in the Indian Market do not want court cases, they are ready to compensate monetary if their goods found adulterated. For them fine of Rs.5 Lac or Ten lac is not material.

16.       Condition regarding sending of 2nd sample part along with 1st Part – immediately is totally incorrect and stringent. unwanted monetary burden on the vendor

17.       If there is variance in both the Report – who shall bear the expenses for sending the third sample part to Referral Laboratory  

18.       Procedure regarding licensing and its documentations is stringent, Licence fees is also excess

19.       Condition of renewal of licence before 60 days (before 31st Dec.) is incorrect—penalty of Rs. 100/- per day is harsh.

20.       Condition of audit to vendor whose turnover is more than 12 lac at the hand of private auditors appointed by

21.       If anyone is preparing/repacking/ manufacturing number of food articles, whether he has to take licence separately for each and every food article.

22.       If the act is not wilful on the part of Vendor, why such harsh punishment

23.       If food article – grains – pulses etc. affect it quality or loss its original quality due to natural causes- then who shall be held responsible and what is the fine and punishment for the same.

24.       Condition regarding business without licence – 5 lac fine and six month imprisonment is too harsh.

25.       Now again question arises Whether all the test of each and every food articles are carried out at each and every district place within the stipulated period of 14 days. That when infrastructure is not available with Govt. how Govt. can give the guarantee of safety and Standard Food to a consumer .

26.       In the current agricultural marketing system, there is little that can be salvaged. The vicious cycle of CACP, APMC, FCI and PDS needs to be replaced by a simple system where the futures commodity markets are the default channels. Even if agricultural marketing is cleaned up, can the Indian farmer produce enough food, fuel and fibre to meet the aggregate demand?

27.       That the Act is of 2006 but till date no efforts had been taken by the authority of FSSAI or its scientific body to prepare the fresh standard of the food article as per climatic condition, geographical back ground of each any every State till date and taking coercive steps against Food Business operators.

28.                   This appears highly unlikely in a situation of climate variability traditional farming, exposed to the vagaries of nature, cannot cope with this task. The government has still not realised the gravity of the climate phenomenon. To be able to face challenges posed by the weather, FSSAI requires something like the Marshall Plan on a war footing. 

The Cost Of Water We Don’t Know

WATER

1. It is submitted that, WATER which is one of the basic necessities for human existence. Several debates, discussions, deliberations, seminars across the world is being held or conducted on this vital subject since it has effects on the very existence of the human race. Water is considered a purifier in most religions.


2. Water is a chemical substance with the chemical formula H2O. Water covers 70.9% of the Earth's surface, and is vital for all known forms of life. On Earth, 96.5% of the planet's water is found in oceans, 1.7% in groundwater, 1.7% in Glaciers and the ice caps of Antarctica and Greenland, a small fraction in other large water bodies, and 0.001% in the air as vapor, clouds (formed of solid and liquid water particles suspended in air), and precipitation. Only 2.5% of the Earth's water is fresh-water, and 98.8% of that water is in ice and groundwater. Less than 0.3% of all freshwater is in rivers, lakes, and the atmosphere, and an even smaller amount of the Earth's freshwater (0.003%) is contained within biological bodies and manufactured products.


3. Safe drinking water is essential to humans and other life forms. Access to safe drinking water has improved over the last decades in almost every part of the world, but approximately one billion people still lack access to safe water. However, some observers have estimated that by 2025 A.D. more than half of the world population will be facing water-based vulnerability. A recent report by World Health Organisation (November 2009) suggests that by 2030, in some developing regions of the world, water demand will exceed supply by 50% and thereby water plays an important role in the world economy.


4. This natural resource is becoming scarcer in certain places, and its availability is a major social and economic concern. Currently, about a billion people around the world routinely drink unhealthy water. Most countries accepted the goal of halving by 2015 the number of people worldwide who do not have access to safe water. Even if this difficult goal is met, it will still leave more than an estimated half a billion people without access to safe drinking water. The World Health Organization estimates that safe water could prevent 1.4 million child deaths from diarrhea each year. Water, however, is not a finite resource, but rather 30 re-circulated as potable water in precipitation in quantities many degrees of magnitude higher than human consumption. Therefore, it is the relatively small quantity of water in reserve in the earth (about 1% of our drinking water supply, which is replenished in aquifers around every 1 to 10 years), that is a non- renewable resource, and it is, rather, the distribution of potable and irrigation water which is scarce, rather than the actual amount of it that exists on the earth.


5. Water being an integral part of living creatures is an inseparable part of human beings. On the one hand, the population of the country is increasing in manifold numbers and on the other hand, the water resources to cater to the needs of these populace is dwindling day-by-day and thus a balancing act is required to be maintained.


6. Your kind attention is drawn to the provisions Food Safety Standards Act, 2011, provided under section 2.1.2(5), which gives clear interpretation that any water which is produced only for consumption purpose and transported in sealed containers from the place of production. However, our members only process the water so that the impurities therein are removed so that the said water can be safely used for any sort of industrial and such other personal purpose. Even the water so produced by us is never claimed or recommended by us for drinking purposes. It is important to be noted here that there are hundreds of us of water and mainly they are used for other purposes and the local authorities are unable to meet the need of the community for purified water and particularly during the season of summer. The “Jalseva” given by our members do not attract the provisions of said section or definition of food as is provided under section 3(j) of the said Act. “Jalseva” is a service provided to the community at par with the water supplied by any Municipal, Gram Panchayat or any water supply autonomous authority and it cannot be differentiated only for the sake of taking harsh action against the members. Hence, it is a clear position of law which cannot be denied by any sane person that any activity of production which is not specified or recommended for human consumption, and which do not fall in either of the definition or schedule, do not fall within the ambit of the said Act of 2006 or any other law for the time being in-force and therefore, the process of manufacturing or any of the allied activity undertaken and carried out by our members do not fall within the jurisdiction of your department and in turn, any of the officials sub-ordinate to your kind authority nor even any of the members, whose activity do not fall within the ambit of the said Act, can be asked for production or applying for any such licence under the said Act.


7. It is important to be pointed out that there is a department known as Pollution Control Department and your attention is drawn to the Circulars issued by the said Department. As per the said department and such other departments, it is specifically reported that the water so supplied through the public distribution system contains hazardous impurities/TDS and even at certain places, even the same cannot be used even for washing utensils or cloths. Our services are mainly for providing water which is purified and free from such impurities so available in the water of public distribution system which is used mainly for other uses and very small part thereof is used for drinking purposes. Wherever, there is a shortfall in the supply of pure water through the public distribution system, our Jalseva members make pure water available for being used for other purposes to the needy people. Though we never recommend or prescribe for use of our water for drinking purpose, as to wherefrom your officials are drawing conclusion that we are producing water only for “drinking purpose” or designating it as “food” is a riddle for the members of the association.


8. Inpsite of this, if your kind authority is of the opinion that there the product manufactured/produced by us is a “Food” or is only meant for “drinking” purposes, for which, a licence/registration is needed to be procured by our members, in this eventuality, we request your kind authority to convey us in writing as to from which source or evidence this conclusion has been drawn by your kind authority.


9. It is further submitted that following the uneven distribution of rainfall in 2011 and 2012 the state is facing severe water scarcity in western Maharashtra, Marathwada and Northen parts of Maharashtra and Vidharbha. In many towns and villages, due to shortage of funds, drinking-water-supply schemes for drinking water are lying incomplete in several towns and villages. It is admitted fact that in number of District of Maharashtra State peoples are not getting potable drinking water and same is the situation about the cattle’s. That due to shortfall of rain in various region of Maharashtra the farmer are in troubles. That the State Govt. of Maharashtra has received Rs.574 crore from the Centre as a part of  Rs. 1207 crore drought-relief package declared in early March of 2013. And the amount will be utilized for supplying drinking water to affected area of Maharashtra. That over all in India due drought situation in various State Centre has allocates Rs.29,000 crore to disaster hit state.

Milk Or Poison

Milk Or Poison

ARE WE DRINKING MILK OR TOXIC POISON?

Food Adulteration

 

Food adulteration is the act of intentionally debasing the quality of food offered for sale either by the admixture or substitution of inferior substances or by the removal of some valuable ingredient. Food is declared adulterated if:

 

1) a substance is added which depreciates or injuriously affects it

2) cheaper or inferior substances are substituted wholly or in part

3) any valuable or necessary constituent has been wholly or in part abstracted

4) it is an imitation.

5) it is coloured or otherwise treated, to improve its appearance or if it contains any added substance injurious to health.

 

Throughout life, not a day goes by when we don't taste the ubiquitous milk in some form or another. We are convinced that it is a 'complete food' that takes care of all our nutritional needs. Yet, is it really so? Is milk and other milk products really all that healthy?

"Milk!" The very word is comforting. "How about a nice cup of hot milk?" The last time you heard that question; it was from someone who cared for you. In fact, the entire matter of food, especially milk, is surrounded with a great deal of emotional and cultural conditioning. More so in India because we revere Lord Krishna who was a cowherd in his childhood.

"I grew up with the ayurvedic wisdom that milk and milk products are essential, not only as nutrients but also because they have medicinal value,". For instance, eye infections could be cured with human milk. When fatigued, there was nothing like a glass of fresh hot milk.

Milk is our very first food. In infancy, it is a link of love with our mother, and our only way to survival. As we grow up, mother's milk is replaced by cow's, buffalo's, or even goat's milk. We Indians are a nation of milk drinkers. Nearly all of us—infants, children, adults and the aged—drink milk. We consume several hundred gallons a year, and add to that milk products, such as cheese, butter, curd, khoya and sweets. So, can there be anything wrong with milk?

We constantly hear messages that assure us: "Milk is good for you." Our dietitians insist: "You've got to have milk, or where will you get your calcium from?" Nutritionists have also been harping for years that dairy products are an 'essential food group'. "And why not?". Milk is nutritious and affordable. It remains drinkable for a long time, if refrigerated. Its nutritional value remains unchanged." "This is not the milk from plastic bags nor is it homogenized in any way. I get it directly from the dairy farmers."

What's the scare all about? "If cows or other milch cattle are injected with antibiotics or thirst-promoting chemicals to increase their milk produce, or they are fed on greens grown with artificial fertilizers and pesticides, obviously we are consuming these poisons with the milk," "Milk preservation techniques play their own role and in the end, what we get is a harmful white liquid."

Just think, that the milk which is deliver at your door steps early in the morning by the milkman or purchased by you from the milk-booth or dairy is pure? Daily glass of milk is healthy, think again. Milk is considered as good for health, your doctor will agree so also your grandma.

For many, milk is nutritious and energetic, in short a wholesome diet in itself. A matter of purity, it’s time for rethinking for the matter of purity of milk. Milk is being adulterated with harmful substances such as Caustic Soda, Detergent, Urea, Refined soya been Oil etc.. That on this issue one TV channel earlier flash the news, inspite of this our government machinery failed to restrict the manufacturer of Synthetic Milk.

Now in Maharashtra the farmer/dairyman, milkman are injecting Oxytocin drug for getting the instant and excess milk. That the milkman instead of offering “quality cattle feed comprising mineral and vitamin mix, to enhance the producing capacity of milk,: injecting the “Oxytocin” drug to the animals in the morning as well as in the evening. In fact the injecting of the Oxytocin for quick release of milk from udder is wrong practice; the hormone is harmful to human being too.

 In fact Oxytocin is a natural hormone that causes the uterus to contract. Oxytocin is used to induce labor, strengthen labor contractions during childbirth, control bleeding after childbirth, or to induce an abortion. Oxytocin (ox-i-TOE-sin) is a hormone used to help start or continue labor and to control bleeding after delivery. It is also sometimes used to help milk secretion in breast-feeding.

That testing of the Oxytocin in milk is difficult; once injected into cattle the hormone breaks down in the body in a couple of minutes, but remains its harmful effect. That from the many research, it is noticed, that if the Oxytocin injected cattle’s milk is analise in the lab, it brings about changes in the milk and it may not show up, the other minerals, fats and proteins in the milk changed. Moreover, it’s not just animals alone who pay a price for the hormone injection. People drinking the same milk are also at risk.

According to the Animal Welfare Board. A substantial part of the Oxytocin could be seeping into milk. And children are most susceptible to its effect. It is known to impair both hearing and eyesight and result in loss of energy and exhaustion. Unfortunately people who consume this milk do not know that the milk has Oxytocin; there can be problem like neo natal jaundice, eyesight, gastric problems. It can also lead to puberty.

The prevention of Cruelty to Animals Act 1960 has made the indiscriminate use of Oxytocin a punishable offence. The Act says” if anyone injects a milk animal with any substance to improve lactation which is injurious to the health of animals, he shall be filed Rs.1,000 or jailed for up to two years or both. The animal shall also be confiscated by the government.

That preparing the synthetic milk or use of Oxytocin as stated above is serious business of corruption. That on one side on television and in media the government machinery is advertising that drink a full glass of milk. That every time before drinking a cup of milk everyone  might have to think twice.