E-Pharmacy Norms: Centre Gets 6Weeks to Inform HC

LI Network

Published on: 29 May 2023 at 12:31 IST

The Delhi High Court has given the Indian government a period of six weeks to provide an update on the progress of consultations and discussions with stakeholders regarding the proposed regulations for e-pharmacies.

The court was addressing petitions that called for a ban on the “illegal” online sale of drugs and challenged the draft rules introduced by the Ministry of Health and Family Welfare to amend the Drugs and Cosmetics Rules.

Chief Justice Satish Chandra Sharma and Justice Subramonium Prasad, presiding over the bench, clarified that the ongoing cases would not hinder the Central government from taking action against individuals who violate the court’s interim order issued on December 12, 2018. The interim order had imposed a stay on the sale of drugs without a license by online pharmacies.

Upon reviewing the latest status report submitted by the Indian government, the court observed that the draft notification from August 2018 had not been finalized and was still undergoing consultations and deliberations. The court granted the Union of India six weeks to provide information on the outcome of these consultations and deliberations, as well as the final stance of the government on the matter. The next hearing is scheduled for August 28, 2023. The court reiterated that the ongoing cases would not impede the government from taking action against individuals who violate the interim order issued on December 12, 2018.

The Ministry of Health and Family Welfare had issued a draft amendment to the Rules, 1945, to regulate the online sale of drugs through a notification on August 28, 2018. The ministry had sought objections and suggestions from stakeholders to be considered by the Central government. Based on the received comments and suggestions, the draft rules will be finalized and published in the official Gazette, according to the ministry’s status report.

The report stated that the petitioners had submitted representations to the authorities, which are currently under consideration. Considering the significant concerns raised by various stakeholders regarding the draft notification, the report emphasized the need for further deliberations to take into account their views.

The report also mentioned that the authorities have received numerous representations from various stakeholders, the majority of which have opposed the draft rules on online sale of drugs. It indicated that the draft notification is currently pending consultations and deliberations, and the Central Drugs Standard Control Organisation (CDSCO) is planning to conduct fresh stakeholder consultations with relevant associations or affected parties.

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