India’s Epharmacy Rules: What’s The Holdup, Patna High Court Asks

As the epharmacy players continue to service despite unclear regulatory procedures, the Patna High Court has taken a strict cognizance of the delay and sought response from the Ministry of Health and Family Welfare on the same.

In a hearing on July 31, the Patna High Court bench of Justice Jyoti Saran And Justice Partha Sarthy noted that the changes in the Drugs and Cosmetics Rules, 1945 framed under the Drugs and Cosmetics Act, 1940 had been introduced in August last year. The amendments and objections was to be disposed of within 45 days, however, this hasn’t yet been done.

The court also said that the ministry has shown no inclination of attaching finality to such rules. Rajesh Kumar Verma, the assistant solicitor general had informed the court that the matter is yet pending for consideration before the Ministry.

The court then directed the secretary, Ministry of Health and Family Welfare to inform the court as to why the draft rules remains in the draft situation and what is the impediment in giving it a final shape.

The next hearing has been scheduled for August 19. Notified in September 2018, the draft epharmacy rules note that those selling drugs and cosmetics online, have to obtain licences in the manner prescribed, within a period of two months from the date of notification.

The delay has caused further agony for the epharmacy industry as in October 2018 the Madras High Court announced a ban on the online sale of medicines. The same was followed by the Delhi High Court and by the last hearing in January 2019, the ban on epharmacies was stayed till a decision is announced in the matter.

Earlier in February, the Delhi High Court was upset with the Centre “on playing delaying tactics” with draft epharmacy rules. At the time, the delay was attributed to the impending general elections which completed in May 2019.

Further, the Delhi High Court has asked the Central government to submit a status report on the epharmacy rules, at the earliest.

After the second round of ramping by the courts, how much more delay can the Ministry of Health afford for notifying rules will be seen.

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