The Karnataka Pharma Retailers & Distributors Organization (KPRDO) has recently expressed concern over the partnership between Swiggy Instamart and PharmEasy for a rapid drug delivery model in Karnataka. Instamart is the grocery service arm of the online food ordering and delivery company Swiggy, and PharmEasy is an online drug delivery platform which offers a variety of products and services throughout the country. According to the reported partnership, the two entities will join hands to deliver medicines ordered online, within 10 minutes through dark stores. KPRDO has now demanded to the drug authorities to immediately crackdown on Swiggy Instamart’s 10-minute Medicine Delivery Campaign, as the move is against the standards set under Indian law and may lead to serious health and safety issues to the people. It has urged the drug regulators to take immediate action to control a possible menace in the drug distribution system in the state as the ultra-fast delivery model being launched by the online companies may lead to circulation of expired and counterfeit drugs in the market as this rapid delivery system cannot follow the required legal and quality standards. It argues that this partnership will endanger the health of common citizens besides ignoring important standards like proper prescription checking and patient identification. KPRDO further argues that this collaboration will further violate the existing drug rules in the country. There are strict rules for drug distribution, storing and delivery, which ensure patients’ safety. But this delivery via dark stores within 10 minutes will cause the collapse of all the drug laws in the country. More importantly, the trade body has cautioned the drug authorities that at a time when the country is taking steps to address antimicrobial resistance through a number of initiatives, this ultra-fast delivery model will undermine the efforts of the government to tackle the AMR menace.
Obviously, this new development has once again triggered the need for a new set of rules to govern the e-pharmacies in the country. The Union Health Ministry appears to be totally indifferent in finalising a set of separate rules for e-pharmacy to regulate online sale of drugs in the country. A new set of 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 D&C Act does not distinguish between conventional and online sale of drugs, the laws governing the brick-and-mortar pharmacy business are applicable to the e-pharmacies as well. 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 Union Health Ministry in July 2015 had constituted an expert committee, under the chairmanship of 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. It is appalling, to say the least, to note that even after more than 10 years since the ministry constituted an expert committee on the issue, it is yet to give final shape to the rules. Of course, the issue raised by KPRDO is a critical regulatory and public health concern as medicines cannot be treated as routine consumer goods. Instead its dispensing requires compliance with prescription, storage handling compliance, and record-keeping requirements. Of course, much water has flowed under the bridge since it released the draft rules. Now, the government should shed its cavalier attitude and come out with the final rules on online drug delivery. |