State Authorities must review and revoke FDC licenses granted without central safety and efficacy evaluations.

The petitioners, several pharmaceutical companies and firms, challenged an order/communication dated 11.04.2025 issued by the Directorate General of Health Services, Central Drugs Standard Control Organisation (FDC Division).

The impugned communication directed State and Union Territory Drug Controllers to review the approval process for Fixed Dose Combination (FDC) drugs classified as "New Drugs".

The respondent authorities issued this advisory due to concerns that State Licensing Authorities were granting licenses for FDCs without evaluating safety and efficacy as required under central regulations.

Some manufacturers had already voluntarily surrendered licenses following show-cause notices issued pursuant to this review.

The court 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.

Rule 2(1)(w)(iii) defines a "new drug" to include fixed-dose combinations of two or more drugs, approved separately, but being combined for the first time.

Under Rule 3, the Drug Controller General of India (DCGI) is designated as the central licensing authority, and Rule 19 mandates that no clinical trial or drug manufacture/marketing authorization for a "new drug" can proceed without the DCGI's express permission.

The Court observed that the regulatory framework establishes a centralized scrutiny system to ensure patient safety and scientific validity before a "new drug" enters the market.

The Court reasoned that the impugned communication was merely an advisory for State authorities to ensure compliance with the NDCT Rules and to revoke licenses where scientific validation of safety and efficacy was absent.

Since the petitioners failed to demonstrate that they possessed valid permissions from the Central Licensing Authority for the drugs in question, the court found no legal ground to set aside a measure intended to protect public welfare.

The Court dismissed the writ petitions, holding that there was no justification to interfere with the impugned advisory and all pending applications were also disposed of.