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BRING SANITY IN PHARMA MARKET

Ramesh Shankar
Wednesday, June 16, 2021, 08:00 Hrs  [IST]

Recently, the Karnataka High Court has quashed the criminal petition filed by the Karnataka state drug authorities against Snapdeal, the New Delhi-based e-commerce company, for selling Schedule H drug Suhagra-100 (sildenafil citrate) tablets manufactured by Cipla at Baddi without having a valid license under Drugs & Cosmetics Act, 1940. After detailed deliberations, the court held Snapdeal not liable for punishment under D&C Act and quashed the petition. During the hearing, the court noted that Snapdeal had put in robust systems to inform all the stakeholders on its online marketplace platform of their responsibilities and obligations under applicable law. The court noted further that therefore Snapdeal had discharged its role as an intermediary. The court also noted that Snapdeal had exercised due diligence in accordance with Section 79(2)(c) of the Information Technology Act 2000 read with IT Rules, 2011 in ensuring that the sellers who register on its website conduct themselves in accordance with the applicable laws. The court held that being intermediary U/s 2(w) of IT Act, 2000 is not liable for any action for making use of its facilities. Further, it also noted along with other reasons that neither Snapdeal nor its Directors can be held responsible for the offence under U/s 18(c) of the D&C Act, punishable U/s 27(b)(ii) and they cannot be prosecuted. Though the court dismissed the petition against Snapdeal, it brought to the fore the issue of absence of a new set of rules for e-pharmacy in the country.

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. While the nation’s e-pharmacy market is brimming with activity with the entry of billionaires like Jeff Bezos and Mukesh Ambani in the fledgling sector, 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. 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. In the present circumstances of Covid-19 pandemic, when the people have been asked by the government as well as the medical fraternity to remain indoors, the relevance of e-pharmacy is much more significant.  It is 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 more than six years. 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 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 Union Health 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. 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 market.

 

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