State Licensing Authorities cannot approve manufacture of FDCs falling under "New Drug" category without DCGI approval.

The petitioners, several pharmaceutical companies and firms, challenged an order 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 approvals granted to Fixed Dose Combination (FDC) drugs that qualify as "New Drugs".

The regulatory authority observed that several State Licensing Authorities had granted manufacturing and sale licenses for FDCs without following the centralized approval process, potentially compromising patient safety and public health.

New Drugs and Clinical Trials Rules (NDCT Rules), 2019, 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, previously approved separately, when combined for the first time.

Rule 3 designates the Drug Controller General of India as the central licensing authority, and Rule 19 mandates that no clinical trial or market authorization be initiated without centralized permission.

The framework is further supported by the Good Clinical Practice Guidelines regarding safety and efficacy assessments.

The court reasoned that the regulatory framework mandates centralized scrutiny by the respondent-authority for any drug falling under the definition of a "new drug" to ensure scientific validation, safety, and efficacy.

The court noted that State Licensing Authorities had bypassed these statutory requirements, leading to the distribution of unapproved FDCs which pose significant health hazards and adverse drug reactions.

The court found that the impugned order was a necessary "sensitization" of authorities in the interest of public welfare.

Since the petitioners failed to demonstrate that they held valid permissions from the Central Drug Controller for the drugs in question, there was no legal basis to set aside the advisory.

The court held that the FDC division acted within its rights to request State authorities to review and revoke licenses where manufacturers failed to adhere to the NDCT Rules, 2019.

The final holding affirms that patient safety and public health considerations outweigh the commercial interests of the petitioners in cases where statutory approval processes for "new drugs" are bypassed.