The Delhi High Court’s Deadline: For Online Drug Sales

A noteworthy opposition came from the AIOCD, urging the drug regulator to discard the 2018 draft rules on online drug sales.

The Health Master

March 7, 2024

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Last Updated on March 18, 2024 by The Health Master

Online Drug Sales

The Delhi High Court, in a recent development, has issued a stern ultimatum to the Union Ministry of Health and Family Welfare. The court has directed the ministry to formulate a policy regarding the online drug sales within the next four months.

This comes as the last and final opportunity for the ministry, as emphasized by a division bench led by Acting Chief Justice Manmohan and Justice Manmeet Pritam Singh Arora.

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The Long-drawn Draft Notification

The genesis of this directive lies in the ministry’s plea for an extension, citing the intricate nature of the subject.

The draft notification for online drug sales was initially issued on August 28, 2018, and the ministry argues that the complexity of the matter requires thorough consideration.

It highlights the potential repercussions, stating that any modification in the sale of drugs would trigger changes in multiple Acts and Rules/Regulations, including but not limited to the:

Drugs and Cosmetics Act, 1940;
Pharmacy Act, 1948;
Pharmacy Practice Regulations, 2015;
Indian Medical Act, 1956;
Code of Ethics Regulations, 2002, and
Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954.

Download online pharmacy draft notification

A Final Opportunity

Considering the ministry’s plea, the division bench has granted a final four-month extension, emphasizing that this is the last chance to frame the policy.

The court’s order, dated March 4, 2024, explicitly warns that failure to prepare the draft policy by the next hearing date will leave the court with no choice but to proceed with the matter.

The upcoming hearing is scheduled for July 8, 2024.

Ministry’s Ongoing Struggle

This isn’t the first instance of the ministry seeking an extension for policy formulation.

The High Court had previously issued an ultimatum in November 2023, giving the Centre eight weeks to frame the policy.

The court argued that five years had already elapsed since the publication of the draft notification, providing ample time for the ministry to address the matter.

Ultimatum and Personal Accountability

In the November 2023 hearing, the court had directed the Joint Secretary responsible for the policy to be personally present if the policy wasn’t framed within the stipulated eight weeks.

True to this directive, the Joint Secretary was present during the March 4, 2024, hearing.

Stakeholder Meetings and Appeals

To comprehend the intricacies of the issue, the drug regulator held meetings with various stakeholders, including representatives from the:

All India Organisation of Chemists and Druggists (AIOCD),
Pharmacy Council of India (PCI), and
e-pharmacy firms such as Tata 1mg, Pharmeasy, Netmed, Flipkart, and Practo in August 2023.

Opposition from Pharma Traders

A noteworthy opposition came from the AIOCD, urging the drug regulator to discard the 2018 draft rules on online drug sales.

The majority of stakeholders, including trade unions, civil societies, and chemists and druggists associations, opposed the draft rules, further complicating the regulatory landscape.

Regulator’s Communication and Action

The Central Drugs Standard Control Organisation (CDSCO) informed the court that it received various representations against the draft rules.

Following the court’s order in 2018, the CDSCO communicated with State and Union Territory drug regulators to ensure the prohibition of online drug sales without a license.

The Drug Controller General of India (DCGI) also issued show-cause notices to nearly 20 e-pharmacies in 2023.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.