Court validates Central Government's prohibition on specific drug formulations, emphasizing precautionary measures and expert evaluations.
In a significant judgment, the Delhi High Court has upheld the Central Government's decision to prohibit the manufacture, sale, and distribution of certain Fixed Dose Combinations (FDCs), citing public health concerns. The judgment, delivered by a Division Bench comprising Justices Anil Kshetarpal and Harish Vaidyanathan Shankar, overturned a previous ruling by a single judge that had set aside the government's ban on these drug formulations.
The appeals, filed by the Union of India and the All India Drug Action Network, challenged the earlier decision that questioned the sufficiency of the expert committee's recommendations and the government's regulatory process under Section 26A of the Drugs and Cosmetics Act, 1940. The banned FDCs included combinations of diabetes management drugs Glimepiride, Pioglitazone, and Metformin, which were deemed by experts to potentially involve health risks due to lack of safety data and possible medication errors.
The court emphasized that the Central Government's decision was based on expert evaluations and aligned with public health priorities. The judgment highlighted the precautionary nature of Section 26A, which does not require proof of actual harm but considers the likelihood of risk to human health as a sufficient trigger for regulatory action.
The court noted that the expert committee, constituted following a directive from the Supreme Court, included specialists from various medical and scientific disciplines. The committee had conducted extensive deliberations and co-opted additional experts to ensure a robust evaluation of the FDCs in question.
While addressing the earlier judgment's concerns regarding the sufficiency of the committee's report, the division bench clarified that judicial review does not extend to substituting the court's opinion for that of specialized authorities on matters of scientific assessment. The court reiterated that the statutory framework under Section 26A empowers the Central Government to take precautionary measures in public interest, based on expert advice.
This ruling underscores the judiciary's recognition of the importance of expert evaluations in drug regulation and the need to prioritize public health considerations. The decision reaffirms the government's authority to regulate pharmaceuticals to prevent potential risks to human health, even in the absence of conclusive evidence of harm.
Bottom Line:
Drugs and Cosmetics Act, 1940 - Section 26A - Prohibition of Fixed Dose Combinations (FDCs) - Notifications issued by Central Government prohibiting certain FDCs upheld - Judicial review does not extend to substituting Court's opinion for expert assessment - Central Government's satisfaction based on expert evaluation and public health considerations given primacy.
Statutory provision(s): Drugs and Cosmetics Act, 1940 - Section 26A
All India Drug Action Network v. Lupin Ltd. (Delhi)(DB) : Law Finder Doc Id # 2837956
