Delhi HC Asks Union Ministry to Frame Online Drug Selling Policy within 4 Months

The genesis of this issue dates back to August 28, 2018, when the Ministry issued a draft notification regarding the online sale of drugs.

In a recent development, the Delhi High Court has issued a stern warning to the Union Ministry of Health and Family Welfare, urging them to formulate a policy for the online sale of drugs within the next four months.

The court emphasized that this would be the Ministry's last chance to address the long-pending issue.

The directive was issued by a division bench led by Acting Chief Justice Manmohan and Justice Manmeet Pritam Singh Arora, responding to the Ministry's request for a four-month extension due to the complex nature of the matter.

Reflecting on Past Moves

The genesis of this issue dates back to August 28, 2018, when the Ministry issued a draft notification regarding the online sale of drugs. However, progress in framing a comprehensive policy has been slow, prompting the Ministry to seek additional time.

The Ministry argued that the intricacies involved in modifying the drug sale process would have far-reaching consequences, necessitating amendments to various Acts and Rules/Regulations.

These include 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 plea for an extension, the division bench granted a final opportunity, setting a strict deadline of four months for the formulation of the policy.

However, the court made it clear that failure to present the draft policy by the next hearing date would leave them with no alternative but to proceed with the matter. The next hearing is scheduled for July 8, 2024.

Challenges Encountered

The Ministry acknowledged the complexity of the matter, asserting that modifications to the sale of drugs online would necessitate changes across multiple Acts and Rules/Regulations, impacting the operations and enforcement by stakeholders.

The bench, while sympathetic to the challenges posed by such modifications, insisted on prompt action considering the protracted timeline since the draft notification's issuance.

The court's order stems from a petition filed by Dr Zaheer Ahmed, along with the Delhi-based South Chemists and Distributors Association (SCDA) and others. The petition raises concerns about the Central Government's inaction regarding e-pharmacies.

In previous hearings, the court had already expressed dissatisfaction with the delay, giving an ultimatum in November 2023 to frame the policy within eight weeks.

Involvement of Stakeholders

The court had previously directed the Joint Secretary responsible for the policy to be present at the hearing if the policy was not framed within the stipulated eight weeks. In the March 4, 2024 hearing, the Joint Secretary complied with this directive.

The Central Drugs Standard Control Organisation (CDSCO) also conducted meetings with key stakeholders, including the All India Organisation of Chemists and Druggists (AIOCD), Pharmacy Council of India (PCI) president Montu Kumar Patel, and representatives from major e-pharmacy firms such as Tata 1mg, PharmEasy, Netmeds, Flipkart, and Practo in August 2023.

AIOCD, representing pharma traders on a national level, urged the drug regulator to discard the 2018 draft rules on online pharmacy sales and take immediate action against e-pharmacies.

Further, the CDSCO informed the court that it had received numerous representations, views, and objections from various quarters, including non-government organizations, civil societies, trade unions, and chemists and druggists associations. Most of these representations opposed the draft rules for the online sale of drugs.

In response to the Delhi High Court's order in December 2018, which prohibited e-pharmacies from selling medicines online without a license, the CDSCO communicated the directive to State and Union Territory drug regulators in May and November 2019 and again in February 2023. In 2023, the Drug Controller General of India (DCGI) issued show-cause notices to nearly 20 e-pharmacies per this directive.

The court's stark warning acknowledges the urgency of the matter, given the five-year delay since issuing the draft notification in 2018. The outcome of the next hearing on July 8, 2024, is expected to have a significant impact on the future trajectory of online drug sales in the country.