India bans manufacture and sale of 35 painkillers, nutrition supplements, anti-diabetics drugs

Drugs

India's apex drugs regulatory body, Central Drugs Standard Control Organisation (CDSCO), has directed drug controllers of all states and union territories to stop the manufacturing, sale and distribution of unapproved 35 fixed-dose combination drugs, including painkillers, nutrition supplements and anti-diabetics medicines.

The state drug controllers have also been asked to review their approval process for such fixed dose combination (FDC) drugs, and ensure strict compliance with the provisions of the Drugs and Cosmetics Act, 1940. Notably, FDC drugs consist of a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.

The ban was issued after the regulator found that some FDC drugs were licensed for manufacture, sale and distribution without prior safety checks, posing serious threat to public safety and health.

"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," Drugs Controller General of India (DCGI) Rajeev Raghuvanshi said in a letter to the drug controllers.

After show-cause notices were issued to the manufacturers of such drugs, they said that they received licenses from the respective authorities and no rules were violated. Raghuvanshi's letter further noted that this has led to the partial enforcement of rules under the Drugs and Cosmetics Act 1940 across 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 of the provisions of the act and rules," the letter said.

The letter listed out the 35 unapproved FDCs which were earlier licensed by state drug controllers for manufacture, sale, and distribution without evaluation of safety and efficacy by Central Drugs Standard Organisation (CDSCO).

(With inputs from PTI).