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.
