Online pharmacies are poised to big growth in Asia and India is number one choice in this regard. There is no dearth of entrepreneurship in India and there are plenty of online pharmacy and healthcare entrepreneurs in India. As on date most of these entrepreneurs are stressing upon business growth and development rather than upon regulatory compliances. This is more so when we have no dedicated laws for online pharmacies, telemedicine, e-health, m-health, privacy protection, data protection (pdf), cloud computing, etc. Healthcare cyber security is another area of concern that most of the healthcare service providers in India are currently ignoring.
Nevertheless, telemedicine and online pharmacies businesses in India must comply with existing techno legal laws of India. But this is not happening as on date and many e-commerce portals have been facing heat of law enforcement agencies of India. For instance, Maharashtra’s FDA has already ordered filing of FIRs against Snapdeal, its CEO Kunal Bahl, directors and distributors for online sale of prescription drugs. Similarly the Indian government has just clarified about the Foreign Direct Investment (FDI) in e-commerce sector of India so that foreign exchange related violations can be better tackled. The Delhi High Court has already ordered the government to investigate 21 e-commerce websites for possible violations of foreign direct investment (FDI) laws. But as on date the techno legal compliances for e-commerce industry in India are not complied with by a dominant majority of e-commerce businesses.
Online sale and purchase of prescribed drugs and medicines in India is still a neglected area as far as regulations are concerned. Till May 2016 we have no dedicated online pharmacies laws in India and telemedicine laws in India. As a result illegal and unregulated online sales of prescribed medicines in India have increased a lot. This fact also came to the knowledge of Indian government and now online pharmacies websites of India are under regulatory scanner and punishment may follow. 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.
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. The Directorate General of Foreign Trade (DGFT) has recently amended the procedure for implementation of the Track and Trace system for export of pharmaceutical and drug consignments from India.
Individuals and companies selling pharmaceutical products through website are also required to comply with various laws. These include laws related to medicines and pharmacy profession and cyber law of India. Surprisingly most of the online pharmacies stores and websites in India are not aware about the cyber law due diligence requirements and Internet intermediary liabilities. As a result they are violating the provisions of Information Technology Act, 2000.
In the absence of clear cut policies and guidance, e-health in India is facing legal roadblocks. Till now we do not have any dedicated e-health laws and regulations in India. The legal enablement of e-health in India is urgently required. In United States, the Health Insurance Portability And Accountability Act Of 1996 (pdf) and Health Information Technology for Economic and Clinical Health Act (HITECH Act), etc are some of the laws that take care of medico legal and techno legal issues of e-health and telemedicine. Laws like these are missing in India.
There is also a gross deficiency of data protection and privacy laws in India. Thus, private data and health records can be leaked by these online pharmacies with little grievance redressal and compensation mechanism. It is high time for Indian government to regulate illegal and unethical online pharmacies operating in India.