Government Bans 35 Fixed-Dose Combination Drugs from Manufacture and Sale

Government Bans 35 Fixed-Dose Combination Drugs: The apex drugs regulatory body, CDSCO (Central Drugs Standard Control Organization), sent a letter to all State and Union Territory drug controllers directing them to stop the manufacture, sale and distribution of 35 unapproved fixed-dose combination drugs, including painkillers, nutritional supplements and anti-diabetics.

State licensing authorities are also instructed to review their approval process for fixed-dose combination drugs (FDCs) to ensure strict compliance with the provisions of the Drugs and Cosmetics Act of 1940 and the associated rules.

FDC drugs combine two or more active pharmaceutical ingredients (API) in a fixed ratio.

Also Read: Haryana YouTuber’s Wife and Lover Murdered Husband: Bhiwani Police Uncover Shocking Details

The direction was given based on finding that some FDC-drugs were licenced for manufacture, sale, and distribution without adequate evaluation of safety and efficacy, which posed a definite hazard to public health and safety.

In a communication sent by Drug Controller General of India (DCGI) Dr. Rajeev Raghuvanshi on April 11, he stated that "in January 2013," he referenced a letter from his office regarding "concerns regarding the grant of manufacturing licenses for sale" of FDC drugs that fall under the definition of a "NewDrug" in the country, without prior approval from DCGI.

Similar concerns have been raised from time to time and several letters have been sent to the respective state licensing authorities concerned, which granted permission for the manufacturing and marketing of a number of unapproved FDCs. The most recent letter was in February of this year.

"It has come to the notice of this directorate that certain 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 and Cosmetics Act 1940. This poses a serious risk to public health and safety," the letter stated.

Such approval of unapproved FDCs, it stressed, compromises patient safety and may lead to adverse drug reactions, drug interactions, and other health hazards.

Also Read: IPL Breakaway Cricketer Told to ‘Leave Delhi’; Family Responds: ‘Why Should He Run?’

It says in the letter that the manufacturers, after issuance of show-cause notices, have stated the licences have been granted by respective drug licensing authorities and have been well within the law. That surely does not render the stated unapproved drugs safe.

The letter said it had resulted in a patchy enforcement of the NDCT Rules, 2019, as enumerated in Drugs and Cosmetics Act, 1940, in the country.

"In view of the above, all state and union territory drug controllers are requested to review their approval process for such FDCs and ensure strict compliance with the provisions of the act and rules," the letter said.

It also cited 35 unapproved FDCs that were previously licenced for manufacture, sale, and distribution by state/UT drug controllers without being evaluated for safety and efficacy by the CDSCO and were then cancelled either by the Drug Licensing Authorities (SLAs) or voluntarily surrendered by manufacturers following the issuance of show-cause notices for reference.

Also Read: Kunal Kamra Row: Bombay High Court Reserves Order, Stays Arrest