Maharashtra FDA Approaches DCGI For Regulating Illegal Online Pharmacies Operating In India

Maharashtra FDA Approaches DCGI For Regulating Illegal Online Pharmacies Operating In IndiaIllegal online pharmacies in India have become life threatening nuisance but Indian government has still not deemed it appropriate to tackle this problem. The truth is that online pharmacies in India are operating in an unregulated manner. This is despite the fact that we have well established laws for opening an online pharmacy store in India. Even the Ayurvedic and Nutraceuticals e-businesses are required to comply with Indian laws to operate legally.

Health, food and medicine related legal compliances in India have become really stringent. A good compilation of food, health, cosmetics, drugs, medicines and nutraceutical laws, rules and regulations in India has been provided by Perry4Law for the larger benefit of all healthcare stakeholders.

As on date, the online pharmacies, including Ayurvedic e-commerce websites, in India are not at all complying with the legal requirements pertaining to their operation in India. Rather they are actively violating the laws of India in this regard. Illegal and unregulated online sale of prescribed medicines in India is still happening despite the threat of the Directorate of Drugs Control of India to punish such illegal pharmacies. Similarly, Ayurvedic preparations and products are openly sold in active violation of Indian laws and regulations.

The online sale of prescribed drugs and medicines in India is a very controversial area. Most of the online pharmacy stores in India and Ayurvedic products websites are unable to comply with the requirements of Indian laws. There are many techno legal requirements pertaining to privacy, data protection (PDF), encryption, cyber law due diligence (PDF), Internet intermediary obligations, cloud computing, etc that are required to be complied with by online pharmacy stores and Ayurvedic products websites operating in India.

Mobile health related laws and regulations in India have added another dimension to these complicated legal norms. If a medical device is also sold by these online pharmacies that intend to serve a health/medical purpose, the mobile health and telemedicine related legal issues would also arise.

The regulatory and legislative measures to check online pharmacies trading in banned drugs in India are also in pipeline. The digital communication channels for drugs and healthcare products in India are also subject to numerous regulatory compliances. All these issues require implementation of techno legal measures on the part of Indian government.

In one such step, the Maharashtra Food and Drug Administration (FDA) has approached the Drugs Controller General of India (DCGI) to device an action plan for curbing the illegal online sale of medicine.  Stating it as a nationwide phenomenon, an FDA official maintains that they are in constant touch with DCGI to plug the loophole in terms of enforcement of the drugs act before it culminates into an alarming situation.  FDA officials say this is a huge racket as foreign buyers can obtain prescription drugs including addictive anti-depressants, anti-hypertensives and those containing sildenafil citrate (a key component in drugs for erectile dysfunction also used to treat pulmonary arterial hypertension) easily and beat stringent rules in their local markets. A senior FDA official has informed that FDA has till date seized drugs worth over Rs. 2 crore from various parts of the city over the last one month and are still on the lookout for more companies involved the illegal sale of prescription drugs.

Online purchase of medicines is a clandestine activity and as Maharashtra FDA Commissioner pinpoints, “It is an unorganised trade and forms a miniscule part of the total Rs. 80,000 crore export business potential accounted from India. We are still investigating the matter and more such companies might face action for illegal sale of drugs without a license and prescription in contravention to Section 18 C and 18 (a) (6) and may attract penalties under Section 27 (b) and (d) ranging from 3 years imprisonment or fine upto Rs. 10, 000 or 5 years imprisonment or fine above Rs. one lakh.

It is only natural that more such legal actions would be taken against illegal online pharmacies websites in the near future. It would be a prudent exercise to comply with the techno legal requirements in this regard by the online pharmacies and Ayurvedic products websites as soon as possible.