Regulator proposes drug testing in govt labs before export
New Delhi, May 20
The Central Drugs Standard Control Organisation (CDSCO) has proposed testing of medicines in government labs before exports so as to rule out quality issues. The Ministry of Health is learnt to be actively considering the proposal, which comes on the back of several instances involving quality of Indian drugs abroad.
Former Indian Council of Medical Research (ICMR) chief NK Ganguly has been at the forefront of the demand for government certification of export consignments. “The government must insist that any export material, even if licensed by the State Drug Controller, should be examined and approved by the CDSCO. Currently, not all such consignments go to the national regulator for approval. The CDSCO should further approve only those drugs that have been certified by government-approved labs,” says Ganguly.
The regulator has now further proposed that the exporter produce the certificate of analysis issued by government labs in respect of batches to be exported and such a certificate should be deemed mandatory for export permission by the Directorate General of Foreign Trade.
The proposal is to test drugs for standards specified in the Indian Pharmacopoeia Commission at accredited central drug labs at Kolkata, Chandigarh, Chennai, Hyderabad, Mumbai, Guwahati and all labs accredited by the National Accreditation Board for Testing and Calibration Laboratories.
The move comes at a time when Indian drugs have been caught in massive controversies abroad. Last October, the WHO issued a global alert in respect of cold and cough syrups exported by Haryana-based Maiden Pharma and linked these medicines to deaths of over 66 Gambian children, a charge India denied.
