REGULATE, REGULATE AND REGULATE

June 7, 2023

The Delhi High Court has recently directed the Central government to report the outcome of consultations and deliberations with the stakeholders related to the five-year-old draft notification for inclusion of rules to regulate online sale of drugs in six weeks, and inform the Court the final stand by the government on the matter. Earlier on December 12, 2018, the court had issued an interim order in favour of the chemists and druggists organisations which had complained that the current activities of e-pharmacies are against the existing drug regulations of the country. In its interim order, the court had injuncted the e-pharmacies from online sale of medicines without licence and directed the drug regulator to ensure that the same is prohibited forthwith until further orders. But, complaints were pouring in from different quarters that the online sale of medicines was going on uninterrupted in the country. In view of the rising complaints, the Drugs Controller General of India (DCGI) on February 8 this year issued show cause notices to online pharmacies for allegedly stocking and selling drugs in contravention of the provisions of the Drugs and Cosmetics Act, 1940 and Rules thereunder, once again bringing back the long pending issue of lack of regulations on e-pharmacies under the existing drug regulations in the country. More recently, the All India Organization of Chemists and Druggists (AIOCD) has sent a letter to the Cabinet Secretary, urging him to intervene and ban online pharmacies on the grounds that they are violating norms and putting people's lives at risk. The seriousness of the issue can be gauged from the fact that the online sale of medicines included drugs under Schedule H, H1, and X which are only allowed to be sold by the retailers under a valid prescription of a registered medical practitioner and supplied under the supervision of a registered pharmacist. 

The government has itself to blame for this kind of chaotic situation in the pharmacy market in the country as the Union Health Ministry has been sitting on the draft policy on online pharmacy which it had released on August 28, 2018. Utter confusion prevails in the country's pharmaceutical market at present as the country currently 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. The D&C Act does not distinguish between conventional and online sale of drugs. As per Section 18(c) of D&C Act, 1940 to be read with Rule 65, only a licensed retailer is entitled for the sale of drugs and that too on the basis of prescription of a doctor only. But, 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. 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 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.  But unfortunately, the issue is still entangled in the bureaucratic circles of the Union Health Ministry. Certainly, much water has flowed under the bridge since the release of the draft policy in 2018, the government should now come out  with the ‘Final Rules on e-pharmacy’.

PHARMABIZ.com