The Madras High Court has directed the Union of India, the Ministry of Health and Family Welfare and others to expedite and finalize draft rules and policies for online drug sales/trade.

The Division Bench of Justice SM Subramaniam and Justice C Kumarappan directed,“The respondents 2 and 4 namely, the Union of India, Department of Health and Family Welfare, Nirman Bhavan, New Delhi and Central Drugs Standard Control Organisation, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, New Delhi are directed to expedite and finalize the policy and notify the same as directed by the Delhi High Court in its order dated 04.03.2024.”

Advocate Arjun Suresh appeared for the Appellant while Senior Advocates Vijay Narayan and M.S. Krishnan appeared for the Respondents.

The Appellant challenged the order passed by single bench of the High Court which observed that it is necessary for the Central Government to notify the Rules at the earliest in the interest of the public and the online drug trade. The direction was issued to the Union of India, Department of Health and Family Welfare and Central Drug Standard, Control Organization, Directorate General of Health Services to notify the proposed Drugs and Cosmetics Amendment Rules, 2018 in the Gazette at the earliest.

Thereafter, the stakeholders namely, persons doing trade in online pharmacies have to obtain respective licenses in the manner prescribed in the Rules to be notified. The draft rules framed by the Central Government are yet to be notified. Thus, online traders were bound to not proceed with their business in online pharmacy. Since online trading of Drugs and Cosmetics was prohibited by the writ court, the writ appeals came to be instituted.

The Delhi High Court, vide an order dated May 4, 2024, had given the last and final opportunity to the Ministry of Health and Family Welfare to frame police for the online sale of drugs within four months. “It is 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.”, the Delhi High Court has held.

The Court said that as the Delhi High Court already seized the matter and the Government of India is in the process of finalizing a new policy and to avoid inconsistency in dealing with the issues, which are all identical, they were inclined to dispose of the matter.

Moreover, the Court noted that the policy to be framed may have far-reaching consequences and the Government of India has to consider various issues raised between the drug companies, stakeholders and the public in general.

The Court also directed, “Till such time the policy is framed by the Government of India or the Delhi High Court finally dispose of the matter, the status quo prevailing as on today shall continue. However, subject to the condition that the online sale of drugs must be made only through or by the licensed Druggists and Chemists. In the event of any violation, the Authorities competent are bound to initiate appropriate action against the individual offenders in the manner known to law.”

Accordingly, the Court disposed of the Appeal.

Cause Title: Practo Technologies Pvt. Ltd. v. Tamil Nadu Chemists and Druggists Association and Ors. (Neutral Citation: 2024:MHC:2491)

Appearances:

Appellant: Advocate Arjun Suresh

Respondents: Senior Advocates Vijay Narayan, M.S. Krishnan, Advocates S.K. Chandrakumar, N Ramesh, K. Tippu Sulthan, Thriyambak Kannan, Naveenkumar Murthi, Ankur Khandelwal and S Varsha.

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