Irked by the poor response to his earlier directive to submit safety and efficacy data of FDC drugs approved by the state drug controllers before October 1, 2012 without his office's approval, the Drugs Controller General of India (DCGI) has issued a new directive, asking the manufacturers of such FDC drugs to submit the application for such FDCs before August 30 this year.

Earlier in January this year, the DCGI had directed the State drug controllers to ask the concerned manufacturers to prove the safety and efficacy of such FDCs within 18 months, failing which such FDCs will be considered for being prohibited for manufacture and marketing in the country.

So far hardly any such manufacturers have approached the CDSCO to prove the safety and efficacy of such FDCs, forcing the DCGI to revise the deadline given to the manufacturers in this regard.

As per the new DCGI directive, the manufacturers while submitting their  applications should apply in Form 44 along with requisite treasury challan and supporting documents supporting the safety and efficacy of the FDC. The applications will be examined in consultation with Expert committee. If considered necessary, the applicants will be asked to  present their case before the committee. In case of requirements of clinical trial, protocol etc. should be submitted by the firm for approval by DCGI. In case of multiple applications for the same FDC, all such applicants will have option to conduct one such study (wherever necessary) sponsored by the firm, if required.

The issue of 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 at several forums in the country for the last some years. The Parliamentary Standing Committee, in its 59th report on the functioning of the CDSCO, had also pointed out that some state drug authorities were issuing licenses for a very large number of FDCs without prior approval of the DCGI. The report had pointed that this practice has resulted in the availability of many FDCs in the market which have not been tested for efficacy and safety, putting the patients at risk.

“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,” the DCGI said.