APEX drugs regulatory body CDSCO has directed drug Controllers of all States and UnionTerritories to stop manufacture, sale and distribution of unapproved 35 fixed-dose combination drugs that include painkillers, nutrition supplements and anti-diabetics. They have also been asked to review their approvalprocess for such fixed dose combination drugs (FDC) and ensure strict compliance of the provisions of the Drugs and Cosmetics Act 1940 and rules. FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs)in afixedratio.

 

The regulatorissued thedirections after it found that certain FDC drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy, posinga serious risk topublichealth and safety. In a communication sentonApril11,DrugsController Generalof India (DCGI)DrRajeev Raghuvanshi referred to the letterissuedbyhisofficeon January 2013whereconcernswereraised regarding the grant of manufacturing licenses for sale of FDC drugs that fall under the definitionofa“NewDrug”in thecountry without due approval fromDCGI. The same concern hasbeenraised from time to timeandmultiplelettershavebeenissuedto the respective state licensingauthorities that granted permission formanufacturing andmarketing of unapproved FDCs.

 

Themost recent such letter wasissued in February this year. “It has come to the notice of this directorate that certain FDCdrugs have been licensed formanufacture, sale, and distribution without prior evaluation of safetyand efficacyasper theprovisionofNDCTRules 2019underthe Drugs and Cosmetics Act 1940. This poses a serious risk topublichealth and safety,”theletter stated. The approval of such unapproved FDCs compromisespatient safety and may lead to adverse drug reactions, druginteractions, and other healthhazardsdue to theabsenceofscientific validation, the letterunderlined. Upon issuance of show cause notices to the manufacturers, they have stated that these licenses were granted bythe respective drug licensingauthorities and have not violated any rules, it said.