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On a petition filed by Delhi-based South Chemists and Distributors Association (SCDA) against the Central government for not taking action on e-pharmacies, the Delhi High Court has recently asked the Union Health Ministry to frame a policy on online sale of drugs within four months. The court has given a warning to the government that this would be the last and final opportunity for the government to come out with a final policy on e-pharmacy. The court’s ultimatum is quite understandable as it comes in the backdrop of the fact that the Health Ministry has literally been dilly-dallying on the issue ever since it released the draft notification for online sale of drugs way back in 2018. A new set of final rules for e-pharmacy is of much significance today as in the absence of clear-cut provisions in the D&C Act regarding the sale of drugs through e-pharmacies, utter confusion prevails in the country's pharmaceutical market at present. As the country's pharmaceutical trade started gradually moving from offline to online on the turn of last decade, the issue caught the attention of the regulators and the Union Health Ministry in July 2015 had 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 in August, 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. The government has wasted a lot of time. It should immediately give final touches to a policy which will go a long way in bringing the much needed sanity in the country’s pharmaceutical trade.
Given the complex nature of the issue, the government’s predicament is understandable. While the country’s brick and mortar pharmacy traders are up in arms against online sale of drugs, the e-pharmacy players have long been clamouring for a set of rules on online sale of drugs. The D&C Act does not distinguish between conventional and online sale of drugs and the unfolding situation has resulted in the verbal duel between the offline and online pharmacy associations. It is true that the relevance of e-pharmacy is much more significant today ever since the Covid-19 pandemic, when the people have been asked by the government as well as the medical fraternity to remain indoors. It was under this background, experts in the field have been making a clarion call to the government to come out with the ‘Final Rules on e-pharmacy’, on which the government has been working for the last several years. No doubt, the subject of online sale of drug is one of complex in nature and any modification in the manner of sale of drugs will have far reaching consequences and will involve changes in many other Acts and Rules and Regulations apart from D&C Act, 1940; Pharmacy Act, 1948; Pharmacy Practice Regulations, 2015; Indian Medical Act, 1956; Code of Ethics Regulations, 2002, and Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954. As the existing laws are vague on the issue, there are rampant sale of prescription drugs by the e-pharmacies in contravention to the prevailing laws. In the context of the rising incidence of multi-drug resistant bacteria, which is a serious public health issue worldwide, there is a larger public interest in regulating the online sale of drugs. Easy access to critical medicines like antibiotics through online pharmacies is a serious issue and there is definitely a need to have stringent and specific provisions for ensuring the effective monitoring and supervision of online pharmacies.
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