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The All India Organisation of Chemists and Druggists (AIOCD), representing over 12 lakh licensed brick-and-mortar pharmacies spread across the country, has recently written to Prime Minister Narendra Modi to take immediate and decisive action against the operations of illegal e-pharmacies across the country. The AIOCD’s demand comes close on the heels of an appeal by the Tamil Nadu Chemists and Druggists Association (TNCDA) to the President of the United States Donald Trump for a global mandate to end the online sale of medicines. The TNCDA’s request was in the background of the ‘Operation Meltdown’, a massive US Drug Enforcement Administration (DEA) crackdown that shuttered over 200 illegal online pharmacy domains tied to a transnational criminal organization based in India. In the letter to the Prime Minister, the AIOCD highlighted that the recent US action serves as a stark warning that illegal e-pharmacies are a serious criminal and public health hazard rather than a mere trade issue. The organization emphasized that if such large-scale criminal misuse can occur in a country like the United States with the stringent laws, the magnitude of danger in India is deeply alarming. AIOCD further argued that the current regulatory vacuum allows the e-pharmacy platforms to operate in complete violation of the spirit of the Drugs and Cosmetics Act. The AIOCD has now demanded immediate withdrawal of government notifications GSR 220(E) and GSR 817(E) which were originally issued as temporary or emergency measures. Now, these notifications are being blatantly exploited by illegal e-pharmacy operators to justify unregulated activities. They claim these loopholes facilitate the circulation of spurious, sub-standard, and misbranded drugs, as well as the violation of essential cold-chain requirements for critical medicines.
It is a fact that the AIOCD has been up in arms against the online sales of drugs in the country, alleging that it is a threat to public health. The national trade body has been demanding to the government to come out with a set of rules to govern the e-pharmacies in the country. The fact is that utter confusion prevails in the pharmaceutical market at present as the country presently does not have a regulatory mechanism for online sale of drugs and the laws governing the brick-and-mortar pharmacy business are applicable to the e-pharmacies as well. It is quite strange that the Union Health Ministry has been deliberating over this important issue for the last more than a decade. As the country's pharmaceutical trade started gradually moving from offline to online on the turn of the last decade, the issue caught the attention of the regulators and the Ministry in July 2015 constituted an expert committee, under the chairmanship of the then Maharashtra FDA Commissioner Dr Harshdeep Kamble, to assess the feasibility of online pharmacy in the country. After prolonged deliberations, the Ministry on August 28, 2018 came out with an extensive set of draft regulations to amend D&C Rules by incorporating separate part for the regulation of online pharmacies in the country. Ever since, the issue is entangled in the bureaucratic circles of the ministry. There can be no two opinions about the fact that as the potential of the e-pharmacy sector is gradually but steadily unfolding in the country in the wake of people’s preference for doorstep delivery of medicines, the nation’s pharmacy market is brimming with activity with the entry of several big entities in the fledgling sector. And quite predictably, the cut-throat competition among the peers has brought in its wake several unethical trade practices. There is no doubt about the scope for e-commerce in the pharmaceutical sector, if properly regulated. The government should now shed its cavalier attitude on this serious health issue and should come out with final set of rules to end the unethical trade practices.
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