Delhi HC Upholds Ban on Unapproved FDC Drugs, Backs DCGI Action

New Delhi: The Delhi High Court has cleared the path for cancelling licences related to the manufacture, sale, marketing, and distribution of fixed-dose combination (FDC) drugs that lack approval based on safety and efficacy data.

According to a recent media report in The Indian Express, the court affirmed a 2025 directive issued by India’s central drug regulator prohibiting the sale of such unapproved FDC medicines.

In its order dated April 21, the court observed, “unapproved FDCs compromise patient safety and may lead to adverse drug reactions and cause other health hazards due to the absence of scientific validation”.

FDC drugs refer to formulations that combine two or more active pharmaceutical ingredients—substances in medicines responsible for therapeutic effects- into a single dosage form such as a tablet, capsule, or injection.

While FDCs can simplify treatment by reducing the number of pills a patient needs to take daily, they may also result in unnecessary drug exposure if a component is not required for a particular patient.

The government has periodically reviewed such combination drugs. In August 2024, as many as 156 FDCs were banned after being classified as “irrational” and lacking therapeutic value.

Previously, when pharmaceutical companies challenged actions by the Drug Controller General of India against unapproved FDCs, the court had often granted interim protection, directing authorities not to take coercive action until final decisions were made.

However, the April 21 ruling marked a shift, as the court dismissed the petitions without extending such interim relief.

Several generic drug manufacturers, including Ajanta Pharma, Maxford Healthcare, Rica Enterprises, and Dolphin Life Sciences, had approached the High Court in 2025 seeking to quash the regulator’s communication regarding licensing of unapproved FDCs by state authorities.

Earlier, on April 11, 2025, the DCGI had instructed drug regulators across states and Union Territories to ensure that unapproved FDCs are not sold, marketed, or distributed.

The central authority also directed state drug controllers to investigate such cases and initiate action under the New Drugs and Clinical Trials (NDCT) Rules, 2019, along with the Drugs and Cosmetics Act, 1940.

In his April 21 order, Justice Purushaindra Kaurav stated, “There does not seem to be any valid permission being granted by the respondent (DCGI) authorizing the petitioners (pharma companies) to sell in the market the drugs in question.”

The regulator’s communication had identified 35 unapproved FDCs, including several used in diabetes management—such as combinations of metformin hydrochloride with voglibose and glimepiride with metformin—as well as combinations used for infections (antibiotics and antifungals), female infertility, hypertension, multivitamins, and antacids.

The Centre informed the High Court that approvals for all new drugs intended for human use are centrally regulated and require clinical trial evaluation. Under the NDCT Rules, even if individual drugs are previously approved, their first-time combination qualifies as a “new drug”.

Such “new drugs” must undergo central scrutiny before clinical trials or market approval. The NDCT framework designates the DCGI as the licensing authority, and no clinical trial can proceed without its approval and clearance from an ethics committee. Licences for manufacturing and sale are granted only after a thorough assessment of safety and efficacy.

However, the regulator pointed out that “a practice has been developed” where state authorities have issued licences for FDCs without complying with statutory requirements.

The Indian Express reports that the DCGI warned that such approvals, granted without proper evaluation under NDCT provisions, have led to the circulation of unapproved FDCs in the market, posing significant risks to patient safety and public health.