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P A Francis
Wednesday, October 4, 2017, 08:00 Hrs  [IST]

The US Food & Drug Administration last week took action against more than 500 websites illegally selling dangerous and unapproved versions of prescription drugs including antibiotics, opioids, injectable epinephrine products to American consumers. The action is part of a major global operation that the US FDA participated to target illegal drugs marketed online. The US FDA also issued warning letters to the operators of most of the websites engaged in this illegal trade and worked with internet registrations. This initiative was part of Operation Pangea X, a global cooperative effort led by Interpoldisclaimer icon, to combat unlawful sale and distribution of illegal and substandard medical products through internet. The goal of Operation Pangea X is to identify the makers and distributors of illegal prescription drugs and to remove these products from the supply chain. In 2015, another international crackdown on illegal internet trade in medicines had yielded £51.6 million worth of products from 115 different countries. And from UK alone, £15.8 million worth of unlicensed medicines and 15,000 devices were seized as part of Operation Pangea X. That time also the US FDA took action against 1050 websites, including some from India, for illegally selling unapproved prescription medicines and devices.
India has been accused of selling some of the lifestyle drugs through some of its illegal websites to the US and European markets in the recent past. Tracking and taking action against selling fake and substandard medicines by illegal websites has been a challenge faced by the Indian authorities for some years now. In India, such illegal operators are causing a major threat to the patient community as there is no law framed to regulate internet sale of medicines. A policy to regulate online trade of pharmaceutical products is yet to be formulated in India although drug control authorities have been working on that from 2014. Drugs Controller General of India appointed a committee under Harshdeep Kamble, former commissioner of Maharashtra FDA, to explore the possibility of allowing online trade in pharmaceuticals and laying down specific rules. The committee submitted its recommendations in 2015 but no decision has been taken by the DCGI yet. Its recommendations and drafts are still being debated by various stakeholders. Absence of a regulatory framework has encouraged several big and small players into this new trade in the country during the last four years. Internet sales of medicines indeed led to a steady increase in sales of several medicines online benefiting some of the well known e-commerce companies. A serious issue in the online trade of medicines is the safety of drugs delivered to the patients. In the purchase of medicines online, there is no role for pharmacist to advise the patients about the dosage and side effects. The biggest challenge for drug authorities from new trading platform is the routing of spurious and fake medicines by the unscrupulous traders into online. The recent actions by US FDA and European authorities against several websites selling unapproved drugs point to this stark reality. Therefore, systematic and regular monitoring of websites and internet sales of medicines should be the cornerstone of the policy on internet trade in medicines.


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pradeep Awasthi Oct 5, 2017 8:25 AM
The new cocept of purchasing goods through on line order has progressively evolved from household commodities to OTC brands and now un approved prescription products by the different online distribution chain network in India as well as overseas countries.This on line purchase of some unapproved rxion products which are substandard quality and marketed without license had started to create a dangerous threat to the patient community,Which is the most recent finding of USFDA,who had traced so many illegal sites and online internet marketers who had been already involved in online supply of many drugs to European countries as well as UK since 2015.Therefore in 2015 only USFDA took a powerful action by seizing this only network of marketing this fake medicines and their devices not only in India but also in overseas countries.

In Continuity of same Operations against un approved prescriptions of online products in India,Now DCGI had taken a step head for appointing speci
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