Laws For Opening Of Online Pharmacy Store In India

Laws For Opening Of Online Pharmacy Store In IndiaOnline pharmacy is a complicated and legally risky field. This is so because the online pharmacy stores must comply with the legal issues in e-commerce in India besides complying with laws pertaining to online pharmacies in India. Perry4Law has already mentioned the legal risks of online medicine sales in India. We have also discussed the legal requirements to open online pharmacies in India. The Ayurvedic e-commerce legal issues in India are also evolving.

Online sale of prescribed drugs and medicines in India is a very controversial area. Most of the online pharmacy stores in India 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 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 conflict of laws in Indian cyberspace has also complicated the scene. Many times foreign online pharmacy websites target Indian citizens and supply even prohibited and banned drugs to Indian citizens. Most of these stores are located outside India and it becomes difficult to regulate their activities. 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.

Indian government is considering the proposal that Internet telephony and VOIP service providers must establish servers in India. The Ministry of Home Affairs, India and Intelligence Bureau (IB) are already exploring this possibility. We at Perry4Law believe that all Subsidiary/Joint Ventures Companies in India, especially those dealing in Information Technology and Online Environment, must mandatorily establish a server in India. Otherwise, such Companies and their Websites should not be allowed to operate in India. Similarly, online pharmacy store websites whose servers are located in foreign jurisdictions and that are violating Indian laws must be blocked in India on the lines of multi level marketing (MLM) websites.

Online sales of prescribed medicines in India are by and large unregulated and open for abuses. The illegal and unregulated online sales of prescribed medicines in India are flourishing like a plague. In fact, the fast growing and uncontrollable number of online pharmacies, mostly based abroad, has posed a serious challenge to State drug control authorities. They are simply not in a position to regulate the affairs of these online pharmacies that are openly violating the laws of India.

Now concerned over the risks involved in purchasing medicines, especially Schedule H drugs, from online pharmacies, authorities are working on ways to curb online pharmacies of India. While buying drugs without prescriptions is in itself a dangerous trend, online pharmacies present a greater risk, say doctors and pharmacists.

The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, have clear guidelines on the sale of Schedule H and Schedule X drugs. These can be sold only on prescription and there are specific rules, including for labelling. Even bar-coding of primary level packaging of export consignment of pharmaceuticals and drugs have been prescribed by India.

It is not the case that regulatory authorities of India are not aware of this dangerous trend. In fact, an official at the Directorate of Drugs Control has said that they have taken some steps and are working to curb online pharmacies. They are holding deliberations with the drugs consultative committee and very soon the illegal online pharmacies operating in India may be civilly and criminally prosecuted in India.

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