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.