Govt bans manufacture, sale of 35 fixed-dose combination drugs

Apex drugs regulatory body CDSCO has directed controllers of all states and Union territories to stop the manufacture sale and distribution of unapproved 35 fixeddose combination drugs that include painkillers nutrition supplements and antidiabetics reported news agency PTIThey have also been asked to review their approval process for such fixed dose combination drugs FDC and ensure strict compliance with the provisions of the Drugs and Cosmetics Act 1940 and rulesFDC drugs are those which contain a combination of two or more active pharmaceutical ingredients APIs in a fixed ratioThe regulator issued the directions after it found that certain FDC drugs have been licensed for manufacture sale and distribution without prior evaluation of safety and efficacy posing a serious risk to public health and safetyIn a communication sent on April 11 Drugs Controller General of India DCGI Dr Rajeev Raghuvanshi referred to the letter issued by his office in January 2013 where concerns were raised regarding the grant of manufacturing licenses for the sale of FDC drugs that fall under the definition of a New Drug in the country without due approval from DCGI reported PTIThe same concern has been raised from time to time and multiple letters have been issued to the respective state licensing authorities that granted permission for manufacturing and marketing of unapproved FDCs The most recent such letter was issued in February this yearIt 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 reported PTIThe 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 underlinedUpon issuance of show cause notices to the manufacturers they have stated that these licenses were granted by the respective drug licensing authorities and have not violated any rules it saidThis has resulted in a lack of uniform enforcement of the provision of NDCT Rules 2019 under the Drugs and Cosmetics Act 1940 across the country the letter pointed outIn 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 reported PTIThe letter also listed out 35 unapproved FDCs which were earlier licensed by stateUT drug controllers for manufacture sale and distribution without evaluation of safety and efficacy by Central Drugs Standard Organisation CDSCO and later on cancelled by Drug Licensing Authorities SLAs or voluntarily surrendered by manufacturers following the issuance of show cause notices for referenceWith inputs from PTIatOptionskeyd0ddb8ef8f1a62a8cdd22fac27fc5ea7formatiframeheight90width728params