DCGI to design vaccine specific regulatory policy
Hyderabad: Soon the country will get a new policy specifically for vaccines as the Drugs Controller General of India, S. Eswara Reddy has announced his plans to this effect. DCGI plans to come out with vaccine-specific regulatory policy along with a manual for regulatory requirements for commercialization of new drug and on how to conduct clinical trials in India.
DCGI said that since pneumococcal is one of the major priority vaccines, they would first come out a policy to facilitate introducing the 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.
The symposium was attended by delegates from scientific research and academic and industry both from India and abroad and Manuel Elkin Patarroyo, the malaria vaccine scientist from Columbia, was the keynote speaker at the symposium.
Stating that they were also in process of making new regulations for conducting clinical trials and new drugs DCGI told IANS, “We will fix timelines. 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.”
DCGI 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.
At the symposium, Reddy underlined the need to communicate to media the facts about the deaths due to clinical trials and 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.
Director of PC2 Scientific Services, Dr. Dasari V Ravi Kumar said that Hyderabad is producing about 33 percent of global vaccines dosages and 35 percent to the pharmaceutical products in the country.