"Regulatory changes for clinical trials needed"

India needs regulatory changes as far as clinical trials are concerned for an effective mechanism, former secretary of the Department of Biotechnology, M K Bhan, said here today.

He said that emerging countries like India, China and Brazil should have more contribution in terms of clinical research and drug discovery. There are weaknesses in the regulatory framework with respect to clinical trials in India. It is not only in the regulatory system, even clinical science as a discipline has not been introduced in medical colleges, Bhan told reporters on the sidelines  of 'BioAsia-2013' a three-day annual event on the biotechnology industry.

There is another problem. Various medical colleges in the country have programmes for training in medicine, but we do not have good investigators for public health. This also includes good quality human resources, he said. He said that posts such as Drug Controller General of India should be elevated and given equal importance like the post of SEBI chairman.

There is a leadership issue also. We can not leave him at lower level, he said. USA-India Chamber of Commerce president Karun Rishi said that outsourcing from USA pharma companies to India companies for clinical research and drug discovery has slowed down in the recent past for various reasons. He said Indian companies are capable of handling research work, provided there is good support from the Indian government.

Regulatory changes for clinical trials needed:

India needs regulatory changes for an effective mechanism for clinical trials, former secretary of the Department of Biotechnology, M K Bhan, said here today. He said that emerging countries like India, China and Brazil should have more contribution in terms of clinical research and drug discovery. 

There are weaknesses in the regulatory framework with respect to clinical trials in India. It is not only in the regulatory system, even clinical science as a discipline has not been introduced in medical colleges, Bhan told reporters on the sidelines  of 'BioAsia-2013' a three-day annual event on the biotechnology industry. There is another problem. Various medical colleges in the country have programmes for training in medicine, but we do not have good investigators for public health. 

This also includes good quality human resources, he said. He said that posts such as Drug Controller General of India should be elevated and given equal importance like the post of SEBI chairman. There is a leadership issue also. We can not leave him at lower level, he said. USA-India Chamber of Commerce president Karun Rishi said that outsourcing from USA pharma companies to India companies for clinical research and drug discovery has slowed down in the recent past for various reasons. He said Indian companies are capable of handling research work, provided there is good support from the Indian government. 

PTI