Directives to Review and Revoke Licenses for New FDC Drugs Without Central Licensing Authority Approval are Valid.

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

The impugned communication requested State and Union Territory Drug Controllers to review approvals for Fixed Dose Combination (FDC) drugs categorized as "New Drugs"

The 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

Some manufacturers had already voluntarily surrendered their licenses following show-cause notices

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

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

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

Specifically, 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

Rule 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

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

The Court found that the impugned order was a "sensitization" measure issued in the interest of patient safety and public welfare

The Court noted that the petitioners failed to demonstrate that they possessed valid permissions from the central respondent-authority to market the drugs in question

Because the State Licensing Authorities had bypassed the statutory requirements of the NDCT Rules, the FDCs lacked the necessary scientific validation for safety and efficacy

Therefore, the Court reasoned that the directive to State authorities to review and potentially revoke unapproved licenses was a valid exercise of regulatory oversight

The Court dismissed the writ petitions, holding that there was no justification to interfere with the impugned order. All pending applications were disposed of accordingly