Apex regulatory body bans 35 fixed-dose combination drugs
Apex drugs regulatory body Central Drugs Standard Control Organisation (CDSCO) has directed drug controllers of all states and Union Territories to stop manufacture, sale and distribution of unapproved 35 fixed-dose combination (FDC) drugs that include painkillers, nutrition supplements and anti-diabetics.
FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. CDSCO said that these drugs pose a serious risk to public health and safety.
The drug regulatory body said that multiple letters have been issued to the state licensing authorities that granted permission for manufacturing and marketing of unapproved FDCs. The most recent such letter was issued in February.
“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.
The approval of such unapproved FDCs compromises patient safety and may lead to adverse drug reactions, drug interactions and other health hazards due to the absence of scientific validation, the letter underlined.
Upon issuance of show-cause notices to the manufacturers, they have stated that these licences were granted by the respective drug licensing authorities and have not violated any rules, it said.
“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.
