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.