State Licensing Authorities cannot approve unapproved Fixed Dose Combinations without Central Licensing Authority clearance under NDCT Rules.

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 requested State and Union Territory Drug Controllers to review approvals for Fixed Dose Combination (FDC) drugs that qualify as "New Drugs".

The respondent authorities contended that various State Licensing Authorities had been granting licenses for FDCs without evaluating safety and efficacy as required by central regulations, leading to the presence of unapproved and potentially hazardous drugs in the market.

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

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.

Rule 2(1)(w)(iii) defines a fixed-dose combination of two or more previously approved drugs, combined for the first time, as a "new drug".

Under Rule 3 and Rule 19, the Drug Controller General of India is designated as the central licensing authority, mandating centralized scrutiny and permission before clinical trials or market authorization can proceed.

The Court reasoned that the NDCT Rules establish a mandatory centralized regulatory framework to ensure patient safety and scientific validity.

It observed that the petitioners failed to demonstrate that they possessed valid permissions from the central respondent-authority to sell the drugs in question.

The Court found that the impugned order was an "advisory" meant to sensitize authorities to the risk of unapproved FDCs, which may cause adverse drug reactions due to a lack of scientific validation.

Since the communication merely directed State authorities to ensure compliance with existing statutory requirements (the NDCT Rules) and to take action only "where warranted," the Court found no procedural or legal infirmity in the executive action.

The Court upheld the respondent’s authority to direct State Licensing Authorities to review and revoke licenses of FDCs that fall under the category of "new drugs" if they were granted without adhering to the safety and efficacy evaluations mandated by the NDCT Rules, 2019.

All pending applications were disposed of accordingly.