Regulator bans 35 combination drugs over safety issues

New Delhi: India's drug regulator has ordered companies to stop manufacture and sale of 35 fixed dose combinations (FDCs), saying they compromise "patient safety" and "may lead to adverse reactions."

The Drug Controller General of India (DCGI) has also asked state and union territory drug controllers to review their approval process for combination drugs and ensure strict compliance of legal provisions, health ministry insiders told ET.

The move comes amid increasing worries over FDCs flooding the market without being tested for safety and effectiveness over the past two years, they said.


FDCs-medicines that combine two or more drugs into a single dosage-are commonly used for pain relief, fever, hypertension, heart attack and stroke.

Some of the extensively prescribed FDCs in the banned list include dapagliflozin + glimepiride + metformin for diabetes, cilnidipine + metoprolol succinate for hypertension, and dextromethorphan hydrobromide + phenylephrine hydrochloride used to treat cough and nasal congestion.

"It has come to the notice of this directorate that certain fixed dose combination (FDC) drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy as per the provision of NDCT Rules 2019 under the Drugs & Cosmetics Act 1940. This poses a serious risk to public health and safety," DCGI Rajeev Singh Raghuvanshi said in a letter to state drug controllers.

ET has seen a copy of the letter.

According to the DCGI, approving such FDCs without scientific validation compromises patient safety and may lead to adverse drug reactions, drug interactions, and other health hazards.

He has instructed state drug regulators to make sure that the 35 identified FDCs are not manufactured and sold in the country. "Also, conduct an investigation and take necessary action as per the provision of NDCT Rules 2019 under the Drugs & Cosmetics Act 1940 and the same shall be intimated to this office," the letter said.

Earlier, the drug regulator had sent show-cause notices to the manufacturers of these FDCs, who replied that they have not violated any rules as they possessed licences granted by state licensing authorities (SLAs).

Permission from the office of DCGI is required for granting licences to FDCs falling under definition of 'new drugs'. However, it was observed that SLAs were granting licences without due approval from DCGI.