The Drugs Controller General of India plans to come out with vaccine specific regulatory policy and a manual for regulatory requirements for commercialization of new drug and on how to conduct clinical trials in India, it was announced on Saturday.
S. Eswara Reddy, Drugs Controller General of India, Central Drugs Standard Control Organisation said that since pneumococcal is one of the major priority vaccines, they would first come out a policy to facilitate introducing indigenously-produced vaccine.
Speaking at a symposium on 'research and development of vaccines: issues, challenges and opportunities' organized by PC2 Scientific Services, a strategic and technical consulting company in association with Federation of Asian Biotech Associations (FABA) and CR RAO AIMSCS at University of Hyderabad, he listed out the steps being taken by his organisation to promote innovation through transparent system and regulatory changes.
Reddy said they were also in process of making new regulations for conducting clinical trials and new drugs. "We will fix time lines. 30 days will be maximum timeline for giving response to their applications. If response is not received within 30 days, the application will be deemed approved," he said.
He also proposed to conduct symposiums across India and invite research institutions to know their regulatory challenges. The regulator will reach out to research and innovation centres by disseminating information about the regulatory requirements for commercialization of their products.
Reddy underlined the need to communicate to media the facts about the deaths due to clinical trials. He told the gathering that media gives a wrong projection about the number of deaths.
He said media reports that during last 7-8 years, 25,000 patients died during clinical trials in India while the fact is that only 5 percent of these deaths are actually due to clinical trials. "For example, during clinical trials related to cancer, patients who are already in terminal stage die. The death of such patients is not due to clinical trials," he said...(continue reading)