In the recent past, a lot of controversies have come to light with regards to e-pharmacies, the most significant one being whether e-pharmacies are legal in India or not. Other controversies include the use of ‘cyber physicians’ on some sites, the selling of medication without a doctor’s prescriptions on others. Some e-pharmacies are legitimate and also beneficial to consumers whereas others often engage in questionable practices.There is a lot of ambiguity surrounding the question of the legal status of e-pharmacies in India. The food and drugs administrations (FDAs) of various states have filed legal complaints against online pharmacies, one illustration of this being the FIR filed by the Maharashtra FDA against the online seller Snapdeal for selling prescription drugs on the internet along with over-the-counter (OTC) drugs.
The basic argument about the legality and viability of the online pharmacies has been regarding the sale of prescription drugs. Many e-pharmacies have adopted a method where the consumers are required to upload a virtual copy of their prescriptions or an e-prescription. This virtual prescription is then verified by the online pharmacy and accordingly the medicines are provided to the customers. Such a prescription can be used only once to purchase the prescribed medicines and cannot be re-used.
The law regarding e-pharmacies is filled with ambiguities, and therefore has been interpreted in the following manner and divided into three categories:
- In this zone fall the medicines which can only be sold by a registered pharmacy having a pharmacist on its payroll.
- The orders of sale can only be taken from regions where the retail license is valid and registered. For example, if the license for retail is valid only in Karnataka, then orders shall only be entertained for Karnataka.
- Every state has a state drug department that grants licenses for the sale of medical drugs only in that particular state.
- There is ambiguity with regards to sale of medicines between different states, because there exists no provision for an inter-state license for sale of medical drugs.
- There is also some ambiguity in relation to the collection of money before the delivery of medicines. This puts in question the legality of the payment through credit/debit card option given on the websites, where one can make the payment before the delivery of the medicines ordered.
- sale of prescription drugs without a prescription from a doctor is prohibited.
- Sale of drugs at a price higher than the price given as the maximum retail price (MRP) is an offence.
The validity and legality of e-prescriptions fall into a grey area of the law and therefore, acceptance of these prescriptions by e-pharmacies for supplying drugs against such prescriptions has been under the scanner.
Section 4 of the Information Technology(IT) Act deals with “Legal recognition of electronic records”and Section 5 of the IT Act provides for “Legal recognition of electronic signature”. Section 5 also gives the three prerequisites for legal recognition as that there should be a law that requires information, matter or document should signed by a person, in place of such signature, an electronic signature is affixed and such an electronic signature should be affixed in a manner prescribed by the central government. Rule 65 of The Drugs and Cosmetic Rules, 1945 give that “a prescription should be in writing and signed by the person giving it with his usual signature and be dated by him”.This reading of sections 4 and 5 of the IT Act along with Rule 65 of the Drugs and Cosmetics Rules satisfy the legality and validity of an e-prescription, a prescription written and signed electronically.
The position of law on the legality of e-prescriptions has been settled by the recently enacted Pharmacy Practice Regulations, 2015. Section 2(j)(3) of the Regulations give the definition of a prescription as a “written and electronic direction from a Registered Medical Practitioner or other properly licenses practitioners to a pharmacist to compound and dispense a specific type and quality of preparation or prefabricated drug to a patient”.This definition makes clear that e-prescriptions are valid and legally recognizable.
Therefore, it can be concluded that doctors can prescribe medication to their parents through an electronic prescription as well, but the issue remains whether or not the present Indian laws allow for these e-prescriptions to be used for buying medicines online as well or only for buying from a physical pharmacy.
In India, the sale of prescription drugs is regulated by laws formulated under “the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules, 1945, and Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954”. All these Acts are pre-colonial and therefore could not have anticipated the online selling of pharmaceutical products through e-pharmacies. Hence, these laws are silent on the issue of e-pharmacies and do not have any laws to regulate online selling of prescription drugs. Since the Indian laws are silent on the functioning and regulating of online pharmacies, many online pharmacy websites have taken the regulations given under the Drugs and Cosmetics Act for running physical pharmacies as being applicable to online pharmacies as well, constructing them to be legal per se.
In July 2015, the health ministry of India ordered the constitution of a subcommittee to look into the issue of online pharmacies. The Committee has been constituted under the headship of the Food and Drug Administration (FDA) Commissioner of Maharashtra,HarshadeepKamble. The issue before the subcommittee was the examination of the online sale practices carried out by developed countries and how they have impacted public health in these countries and whether their implementation is possible in India. The committee has invited comments and inputs from various stakeholders such as public companies, trade bodies amongst others. The sub-committee has not submitted its report yet.
On October 29, 2015, the Bombay High Court declared that the online sale of medicines given under schedule H of DCA without a prescription or a cash memo is illegal and asked the Maharashtra government to take the steps necessary to prevent unauthorised and illegal selling of scheduled drugs on the internet. This was a consequence of a PIL seeking a ban on e-pharmacies selling prescription drugs without prescriptions or cash memos.
The guidelines on regulation of e-pharmacies proposed by FICCI should be put in force to ensure consumer safety while carrying out transactions of pharmaceutical products online. Implementation of these guidelines will also create responsibilities on the part of the e-pharmacies to make sure that they do not sell illegal or counterfeit pharmaceutical products and provide the consumers with all the necessary information for buying medicines online. The VIPPS accreditation program introduced by the NABP in the US can be incorporated in India as well to make e-pharmacies safe for Indian consumers. The concept of designing a secure app for purchasing medicines online will also contribute to increasing the ease of access of the consumers to medical supplies.