DCGI asks drug manufacturers to get clearance before Aug 30

With hardly any drug maker coming forth to prove safety and efficacy of 'new drugs' introduced in India without proper approval, the country's apex drug regulator has asked all such manufacturers to apply before it by August 30 or face prohibition of the drug.

The deadline comes after makers of fixed dose combinations (FDCs), who got approvals from state licencing authorities without prior clearance of the Drug Controller, failed to apply for proving the safety and efficacy of the drugs.

The Drug Controller General of India had in January this year asked all makers of FDCs, who got manufacturing licences from states without DCGI's proper approval, to prove the efficacy and safety of such drugs within a period of 18 months, failing which such FDCs would be considered prohibited for manufacture and marketing in the country.

"So far, hardly any such manufacturers have approached the Central Drugs Standard Control Organisation (CDSCO) to prove the safety of such FDCs," the drug controller said.

The DCGI said in view of this, it has decided that applications for such FDCs should be submitted to it latest by August 30 so that they can be processed in a timely manner.

Such applications will be examined by expert committees set up by the regulator and then cleared by the DCGI.

The DCGI pointed out that the Parliamentary Standing Committee of the Ministry of Health and Family Welfare in its 59th report on functioning of CDSCO has also observed that some state licencing authorities have issued manufacturing licences for a very large number of FDCs without prior clearance from CDSCO.

"This has resulted in availability of many FDCs in the market which have not been tested for efficacy and safety. This can put patients at risk," the DCGI said.

Incidentally, the drug controller had earlier directed the state drug controllers to withdraw 294 FDCs which got licences without approval of DCGI, but the manufacturers got a stay order from the Madras High Court. The DCGI said action will be initiated against such drug makers after the outcome of the Madras High Court ruling.