Nearly eight months after the parliamentary standing committee on health observed that many drugs in India are being sold without having undergone clinical trials to check for their safety, the Drug Controller-General of India (DCGI) on Tuesday directed that all new fixed dose combinations (FDCs) licensed after October 2012 without the approval of DCGI will be prohibited for manufacturing and marketing in the country.
Also, for the FDCs falling under the definition of “new drug” licensed by state licensing authorities before October 2012 without the permission of DCGI will have to prove safety and efficacy of such FDCs within a period of 18 months, failing which the drug will be considered prohibited for manufacturing and marketing in the country.
The issue was raised earlier by the parliamentary committee report which observed that some of the state licensing authorities had issued manufacturing licences for a very huge number of FDCs without prior clearance from the drug controller office. “This has resulted in the availability of many FDCs in the market which have not been tested for efficacy and safety that can put patients at risk,” said the recent letter by the DCGI to all state drug controllers.
Earlier too in October 2012, the Union health ministry had issued statutory directions to the state government to instruct their drug licensing authorities to refrain from granting licenses for manufacture of new drugs and FDCs covered under the definition of the term “new drug” without due approval of the DCGI.
“The drug licensing authorities were instructed to abide by the provisions prescribed under the Drugs and Cosmetics Rules for grant of manufacturing licenses for drugs falling under the definition of the term ‘new drug’ and not to grant licenses for manufacture for sale or distribution or for export of such new drugs,” added the letter.
The DCGI has, therefore, directed the state drug controllers to ask the manufacturers in their states to prove the safety and efficacy of the FDCs within a period of 18 months, failing which they will be prohibited from manufacturing their drugs in the country.