Court Dismisses Petition Challenging Review of Approval Process for New Drugs, Citing Patient Safety Concerns
In a significant ruling, the Delhi High Court has dismissed petitions challenging an advisory issued by the Directorate General of Health Services concerning the approval process for Fixed Dose Combination (FDC) drugs categorized as "new drugs." The advisory, which calls for a thorough review by State and Union Territory Drug Controllers, aims to ensure patient safety and uphold public welfare by addressing premature drug approvals.
The case, Maxford Healthcare v. Union of India, was heard by Justice Purushaindra Kumar Kaurav. Maxford Healthcare and other petitioners, who are engaged in pharmaceutical research and development, sought to set aside the advisory issued on April 11, 2025. The directive requires drug controllers to reassess the approval process for FDCs to ensure compliance with statutory safety and efficacy requirements as per the New Drugs and Clinical Trials Rules, 2019.
The judgment emphasized the need for centralized regulatory scrutiny before clinical testing or market authorization of new drugs. Under Rule 2(1)(w)(iii) of the NDCT Rules, any fixed dose combination of drugs approved separately but combined for the first time falls under the definition of a "new drug," requiring rigorous evaluation.
The petitioners argued against the advisory, claiming it was unwarranted interference. However, the court noted that licenses for manufacturing and selling FDCs had been granted without adhering to the NDCT Rules, resulting in unapproved FDCs posing risks to public health. The court highlighted that some manufacturers voluntarily surrendered their licenses following the advisory's issuance, recognizing the potential hazards of unvalidated drugs.
Justice Kaurav concluded that the advisory was a necessary measure to address gaps in the approval process, ensuring drug safety and efficacy. The court found no valid grounds for the petitioners' challenge and upheld the advisory's directive to review and, if necessary, revoke licenses for non-compliant FDCs.
The judgment reinforces the regulatory framework's role in safeguarding public health and emphasizes the importance of adhering to established guidelines for drug approval.
Bottom line:-
Fixed Dose Combination (FDC) drugs - Regulatory framework under the New Drugs and Clinical Trials Rules, 2019 - State Licensing Authorities directed to review approvals for FDCs categorized as "new drugs" to ensure compliance with statutory safety and efficacy requirements.
Statutory provision(s): Drugs and Cosmetics Act, 1940, New Drugs and Clinical Trials Rules, 2019, Rule 2(1)(w)(iii), Rule 19
Maxford Healthcare v. Union of India, (Delhi) : Law Finder Doc id # 2892057
