Delhi HC Grants 2 Months as ‘Final Opportunity’ to Frame Online Medicine Policy

The extension was permitted on the grounds that the issue was "complex" and any modification in the manner of the sale of drugs would have far-reaching consequences.

Following the Center’s plea, the Delhi High Court (HC) has granted an eight-week extension to frame a policy on the online sale of medicines.

The extension was permitted on the grounds that the issue was "complex" and any modification in the manner of the sale of drugs would have far-reaching consequences.

The HC bench comprising Acting Chief Justice Manmohan and Justice Manmeet PS Arora made clear that "if the draft policy is not prepared before the next date of hearing, this court will have no other option but to proceed ahead with the matter".

Timeline of Events

The roots of this matter trace back to August 28, 2018, when the Ministry of Health and Family Welfare issued a draft notification concerning the online sale of drugs.

The Union Ministry of Health and Family Welfare introduced draft rules to amend the Drugs and Cosmetics Rules, intending to regulate the online sale of drugs.

However, these rules encountered opposition and were criticized for being rushed without adequate regulations.

In response to this, a Public Interest Litigation (PIL) was filed in the Delhi HC challenging the online sale of medicines.

The PIL asserts that the "illegal" online sale of medicines could lead to a "drug epidemic," drug abuse, and the misuse of habit-forming and addictive drugs.

Additionally, the PIL underscored the absence of proper mechanisms to control online medicine sales, highlighting the significant risks to people's health and lives, thus impinging on their right to a safe and healthy life under Article 21 of the Constitution.

Subsequently, the Delhi HC took cognizance of the matter. On December 12, 2018, the high court stayed the sale of drugs without a license by online pharmacies while hearing the PIL.

The petition also sought contempt action against the central government for allegedly failing to act against the defaulting e-pharmacies.

Previously, some e-pharmacies had informed the HC that they do not require a license for the online sale of drugs and prescription medicines, as they merely deliver medications, similar to the food delivery app Swiggy.

Owing to the PIL, the HC sought responses from the Center, the Delhi government, the Central Drugs Standard Control Organisation (CDSCO), and the Pharmacy Council of India to the petition.

The HC also granted the Union Ministry of Health and Family Welfare four months as a final opportunity to formulate a comprehensive policy on the online sale of medicines.

It emphasized that if the draft policy was not prepared before the next hearing, the court would proceed with the matter.

However, progress in formulating a comprehensive policy has been sluggish, prompting the Ministry to request additional time.

During the recent hearing, the ministry's joint secretary was present in court in pursuance of its order from November of last year, during which the bench noted that more than five years had passed, and the Union of India had ample time to frame the policy.

What’s Causing the Delay?

The Ministry has cited the complexity associated with modifying the drug sale process, which would entail amendments to various Acts and Rules/Regulations.

These encompass 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.

In response to the Ministry's request for an extension, the division bench granted a final opportunity, imposing a strict deadline of eight weeks for the formulation of the policy.

However, the court explicitly stated that failure to present the draft policy by the next hearing date would leave them with no alternative but to proceed with the matter.