New Delhi: There is an urgent need for building the right kind of capacity and increase the allocation of funds to meet the anticipated demand for clinical trials in India, a top official from the ministry of science and technology said at an ASSOCHAM event held at New Delhi today.

“The clinical trials industry in India is grappling with serious issues of capacity building as there is a dearth of skilled human resources in the sector and there is a need for a road map to train and churn out qualified clinical researchers,” said Dr. M.K. Bhan, secretary, Department of Biotechnology, Ministry of Science and Technology while addressing a symposium on clinical trials organized by the Associated Chambers of Commerce and Industry of India (ASSOCHAM).

“Today we have a large number of qualified scientists, pharmaceutical and medical graduates but the number of trained clinical research professionals is few which has created a demand-supply gap of professionals in the industry,” said Dr Bhan.

Funding is another significant area which requires significant attention for the clinical research to thrive in India, said the secretary. “The government should come out with a comprehensive plan to increase the budgetary allocation for clinical research and clinical trials in India,” said Dr. Bhan while releasing an ASSOCHAM-APHETA study titled, ‘Global Clinical Trials: Challenges & Solutions.’

"India still lacks a comprehensive list of guidelines for approval of biosimilar drugs markets," said Dr Bhan.

"There is a tremendous opportunity to market drugs in Asia due to availability of a fast growing market, research frequency and time saving due to huge population, high disease incidence and increasing life expectancy that allow us to develop knowledge and capability through alliances and partnerships but challenges like unavailability of ready sites for clinical trials and difficulties in importing drug samples do remain. "Besides, we have ample of amount to invest but there are lack methods on how to use the funds," added Dr Bhan.

Condemning the prolonged process of granting permission to conduct clinical trials in the Dental Council of India (DCI), Dr. Jagdish Prasad, Director General of Health Services said, “It is shocking and surprising to learn that in India the DCI takes seven to eight months period to give permission for conducting clinical trials while in the United States the whole procedure takes barely a month’s time.”

“I will look into this myself and will assure that from today onwards the permission to conduct the clinical trials be granted within two months to whosoever applies to the DCI for the same,” said the senior official of the ministry of health and family welfare while addressing the ASSOCHAM conference.

“Dearth of manpower and lack of proper place are the biggest hurdles being faced by the government vis-à-vis growth of clinical trials industry in India,” said the DGHS. “This calls for an open-discussion between the government and the researcher as to where should the clinical trial be carried out.”

Quoting the ASSOCHAM-APHETA study, Dr. Prasad said, “Though there is a huge scope for companies operating in the domains of pharma and bio-technology for conducting clinical trials of their products, India would require about 50,000 clinical research professionals to absorb this growth potential.”

The DGHS also called for a collective contribution from private sector, manufacturers, sponsors, scientists and physicians and stressed for giving a freehand to the researchers and create jobs for future growth of clinical research in India. “We welcome suggestions and recommendations from industry bodies and all the stakeholders in the sector and we will implement the same to revamp the whole process to ensure growth of the sector.”

Amid others who spoke during the ASSOCHAM symposium included: Dr. B.K. Rao, chairman, ASSOCHAM committee on Hospitals & Healthcare; Dr. Rashmi Shirali, senior advisor, APHETA.