The former Drug Controller General of India (DCGI), Dr M Venkateswarlu (61), passed away on Sunday night at Mumbai, Maharashtra, succumbing to a massive heart attack.

Dr Venkateswarlu, who has been ailing with kidney failure for past several months, is acclaimed as the renovator of the Indian pharmaceutical regulatory set up. He was the brain behind various paradigm shifting decisions in his tenure in the Central Drug Standard Control Organisation (CDSCO) as Joint Director and the DCGI.

The revision of age old Schedule M norms to update drug manufacturing standards on par with the global Good Manufacturing Practices (GMPs), Schedule Y norms to bring in quality of clinical trial practices up to the standards of the Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) elsewhere has been initiated in his one and a half year stint as DCGI.

Dr Venkateswarlu took charge as the DCGI on August 2006 and continued in the post till his retirement on January 2008. The tenure includes a six months extension of his services as DCGI considering the importance of the tasks pursued by him in the period. However, his action on strict implementation of revised Schedule M and quick actions on the fixed drug combinations (FDCs) sold in the country without the approval of DCGI has invited a lot of debate in the pharma industry.

"His untimely demise is a heavy loss for the Indian pharmaceutical industry and the regulatory authority," said R P Meena, director general of Drugs Control Administration, Andhra Pradesh. The All India Drug Control Officers Confederation (AIDCOC) has marked their condolence to the family of the deceased. "We are shocked with the untimely demise of Dr Venkateswarlu, who has been an active member of confederation right from its formation in 1995," said Ravi Udayabhaskar, secretary general, AIDCOC.

Dr Venkateswarlu had always extended support to the pharma industry with his expertise in regulatory and research knowledge, said an industry source. He had also actively supported and worked behind various industry related forums and has emphasised that the actions of the industry should benefit the general public, added the source.

Dr Venkateswarlu's body has been taken to Hyderabad, where he hails from.