Taking a sterner view about the fixed dose combination (FDC) issue, the drug authorities have asked the manufacturers to prove the safety and efficacy of the FDCs approved before October 1, 2012 and made it clear that those FDCs approved by the State licencing authorities from October without the permission of the DCGI will be considered for ban.

Fixing October 1 as the cut-of-date on the vexed issue of FDCs which is still sub-judice, the Drugs Controller General of India (DCGI) has directed the State drug controllers to ask the concerned manufacturers to prove the safety and efficacy within 18 months, failing which such FDCs will be considered for being prohibited for manufacture and marketing in the country.

“As regards the new FDCs, if any, licenced by the state licensing authorities after October 1, 2012 without approval of DCGI, the same will be considered for being prohibited for manufacturing and marketing in the country,” DCGI Dr G N Singh said in a directive.

The grant of manufacturing licenses for sale of FDCs which fall under the definition of the term 'new drug' in the country without due approval from the DCGI had been raised several times before. The Parliamentary Standing Committee, in its report on the functioning of the CDSCO, had pointed out that some state authorities were issuing licences for a very large number of FDCs without prior approval of the DCGI. This has resulted in the availability of many FDCs in the market which have not been tested for efficacy and safety. This can put patients at risk, according to the panel.

“The Ministry of Health and Family Welfare (MoHFW) had issued repeated statutory directions under Section 33P to the State Governments to instruct their respective drug licensing authorities to refrain from granting license for manufacture of new drugs and FDCs covered under the definition of new drug without due approval of the DCGI,” the notice said.

The last such direction was issued on October 1, 2012, wherein the State Governments were directed to instruct their respective licensing authorities to abide by the provisions prescribed under the Drugs and Cosmetics (D&C) Rules for grant of manufacturing licences for drugs falling under the definition of new drug and not to grant licences for manufacture for sale or for distribution or for export of such new drugs except in accordance with the procedures laid down under the rules, i.e., without prior approval of the DCGI, according to the directive.

“Earlier in 2007, direction was issued to the state drug controllers to withdraw 294 FDCs which were licensed without approval of DCGI. However, the manufacturers association got stay order from the Madras High Court. The matter is still sub-judice. Action in respect of the aforesaid 294 FDCs will be taken after the outcome of the court case in the Madras High Court,” it said.