India’s quest for global footprint in drug discoveries is bound to fail if there is no emphasis on adhering to international Good Laboratory Practices (GLP), warned G.J. Samathanam, Director of Research and former Advisor and Head, Technology Development & Transfer Division of DST, Government of India.
He was participating in a session on Discovery and Development of Novel Drugs, Make in India — Challenges and Avenues at the Indian Science Congress here on Tuesday.
Though India is a world leader in the manufacture of generic drugs and accounted for more than 10 per cent of the global output, it would remain a non-entity without a single novel drug of its own without adhering to GLP.
His warning comes in the wake of recent setbacks to the credibility of Indian pharmaceutical companies due to allegations of non-compliance of standards.
He said more than 80 per cent of the R&D funding in pharmaceuticals goes to government laboratories and they must adopt GLP.
Calling for creating a mission mode on novel drug discovery, Dr. Samathanam said there should be a time frame to bring out a novel drug in the market, without which the Make in India initiative was bound to remain grounded in the pharmaceutical sector. Fast tracking regulatory considerations and adopting a model for non-interference for what he called “routine entities like auditing” was imperative if the novel drug discovery was to be success, he added.
