01Facts
The petitioners, several pharmaceutical companies and firms, challenged an order dated 11.04.2025 issued by the Central Drugs Standard Control Organisation (CDSCO), FDC Division
¶ 1The impugned communication requested State and Union Territory Drug Controllers to review approvals for Fixed Dose Combination (FDC) drugs categorized as "New Drugs"
¶ 2The respondent authorities contended that various State Licensing Authorities had granted manufacturing and sale licenses for these FDCs without following the mandatory centralized evaluation of safety and efficacy, potentially posing risks to public health
¶ 5Some manufacturers had already voluntarily surrendered their licenses following show-cause notices
¶ 702Issues
i.1. Whether the impugned communication dated 11.04.2025, directing a review and possible revocation of licenses for certain FDCs, warrants judicial interference under Article 226
¶ 6, 9ii.2. Whether FDCs consisting of previously approved drugs, when combined for the first time, require centralized approval as "New Drugs" under the prevailing regulatory framework
¶ 303Law Applied
The Court primarily applied the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules), framed under Sections 12(1) and 33 of the Drugs and Cosmetics Act, 1940
¶ 3Specifically, Rule 2(1)(w)(iii) defines a "new drug" to include a fixed-dose combination of two or more drugs, even if approved separately, when proposed to be combined for the first time
¶ 3Rule 3 designates the Drug Controller General of India (DCGI) as the central licensing authority, and Rule 19 mandates that no clinical trial or marketing authorization proceed without the respondent's permission
¶ 4Provisions in the judgment · 2 · Linked ones open on LawLens
Drugs and Cosmetics Act, 1940 Section 12Section 33
04Reasoning
The Court observed that the regulatory scheme establishes a centralized scrutiny mechanism to ensure safety, scientific validity, and ethical considerations before a drug reaches the market
¶ 4The Court found that the impugned order was a "sensitization" measure issued in the interest of patient safety and public welfare
¶ 2, 8The Court noted that the petitioners failed to demonstrate that they possessed valid permissions from the central respondent-authority to market the drugs in question
¶ 9Because the State Licensing Authorities had bypassed the statutory requirements of the NDCT Rules, the FDCs lacked the necessary scientific validation for safety and efficacy
¶ 5, 7Therefore, the Court reasoned that the directive to State authorities to review and potentially revoke unapproved licenses was a valid exercise of regulatory oversight
¶ 605Holding
The Court held that the impugned communication was a lawful advisory requiring authorities to examine licenses and take appropriate action, including revocation where warranted, in accordance with the NDCT Rules, 2019
¶ 6The Court dismissed the writ petitions, holding that there was no justification to interfere with the impugned order. All pending applications were disposed of accordingly
¶ 10Original Court PDF
Cafoli Lifecare Pvt. Ltd. & Ors.vsUnion Of India & Anr.
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