State Licensing Authorities cannot approve unapproved Fixed Dose Combinations falling under the definition of "New Drugs."

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 the approvals granted for Fixed Dose Combination (FDC) drugs falling under the "New Drug" category.

The respondent authority asserted that State Licensing Authorities had been granting licenses for FDCs without central evaluation of safety and efficacy, leading to the market presence of unapproved and potentially hazardous drugs.

Following show-cause notices issued under this advisory, some manufacturers voluntarily surrendered their licenses.

1. Whether the impugned communication dated 11.04.2025, directing a review and potential revocation of licenses for FDCs categorized as "New Drugs," warrants judicial interference.

2. Whether the state-level approval of FDCs without adherence to the centralized scrutiny under the New Drugs and Clinical Trials Rules, 2019 is legally sustainable.

The Court applied the regulatory framework of 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 FDCs of two or more previously approved drugs 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 marketing authorization for a new drug occur without the central authority's permission.

The Court reasoned that the NDCT Rules establish a centralized regulatory scheme to ensure patient safety through the evaluation of scientific validity and efficacy before any "new drug" reaches the market.

The Court observed that the practice of State Licensing Authorities granting approvals for FDCs bypassed these mandatory statutory requirements.

Since the impugned communication was issued in the interest of public health and merely directed state authorities to verify if licenses complied with the NDCT Rules, it did not constitute an arbitrary exercise of power.

The Court noted that the petitioners failed to demonstrate that they possessed valid permissions from the central Drug Controller to market the drugs in question.

The Court held that unapproved FDCs pose a risk to public health and must be regulated strictly under the 2019 Rules and all pending applications were also disposed of.