19/11/2015
What are the legal requirements for selling a prescription medicine online in India?
Mohammed Abubakr, Founder & CEO of BookMEDS.com
Mohammed is a Most Viewed Writer in Pharmacy.
I am founder & CEO on a online pharmacy named We are angel funded and have spent significant effort & cost solving this problem.
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There is lot of material on internet regarding legality of online pharmacies in India. Most of this material is written by amateurs who do not have much understanding of Indian Law. Also, ‘online pharmacy’ is a very generic word that can be interpreted in many ways. Prior to founding BookMEDS, we consulted several lawyers including lawyers who have experience at Supreme Court regarding the same. We wanted to identify clear-cuts rules as per Indian laws and regulations.
Following are the key points highlighted by our lawyers:
· Laws for Pharmacies in India are derived from Drug and Cosmetics Act 1940, Drugs and Cosmetic Rules 1945, Pharmacy Act 1948 and Indian Medical Act 1956. Apart from this, there are few high court judgments that have provided further insights and interpretation of the laws.
· Indian Laws related to pharmacies were written prior to arrival computers, let alone internet.
· India doesn’t have any concrete laws defined for Ecommerce Companies. The only laws related to internet in India are defined under Information Technology Act, 2000. As per several media a report, Indian Government is currently drafting new set of laws for Ecommerce companies.
· After analyzing the various laws, our lawyers have come up with the following ‘zones’ for online pharmacies in India. Below, GREEN ZONE refers to activities that are legal under Indian Laws, GREY ZONE refers to activities that are uncertain under current legal system and RED ZONE refers to activities that are illegal. An online pharmacy must operate under GREEN ZONE.
Green Zone:
Following items are allowed as per Indian Laws:
· Medicines can be sold only by a registered pharmacy that has retail license. The pharmacy should have a registered pharmacist on payroll.
· It is mandatory for the customer to have a prescription for the medicines he/she is ordering. Over the Counter products can be sold without prescription.
· Orders can be taken from the customer either over the phone or internet only from the areas where the pharmacy retail license applies. For example, if the pharmacy has license is issued by Telangana State Government, orders can be taken over phone or internet only in Telangana State.
· All the medicines that go out for delivery has to be verified and certified by the registered pharmacist.
Grey Zone:
· Rules related to shipping medicines from one state of India to another aren’t clear. Every state has a Drug Department that grants license for certain medicines to be sold within a state. There is a possibility that, certain medicines valid in one state might not have license in another. Hence, there is ambiguity regarding shipping of medicines from one state to another.
· There is ambiguity in the Indian law whether a pharmacy is allowed to take money prior to delivery of medicines. Certain provisions of the law mandate, money to be collected from the customer only after medicines are physically handed over to the customer.
Red Zone:
· Exporting medicines outside of India directly to the customers (patients) is highly regulated. There is no provision in the Indian law to recognize the prescription written by the foreign doctor. (Note: India is one of the largest exporter of medicines but these exports happen to authorized agencies with the approval from the Drug departments of respective countries)
· Selling Schedule H and Schedule X medicines to customer without prescription is a crime. Proper customer record including name of the patient, doctor and address needs to be maintained for every Schedule H and Schedule X medicines sold by the pharmacy.
· Selling medicines to minors (under age 18).
· Selling banned drugs/medicines i.e. selling any medicine that is not approved by the State’s Drug Department.
· Selling medicines at cost higher than MRP unless customer is upfront told about delivery or service charges.
Based on the above analysis, we decided to operate BookMEDS in the green zone, which has legal basis as per Indian Laws. We will soon be releasing a white paper on future of pharmacies in India, especially online pharmacies.
