Vision Group on Biotechnology led by Kiran Mazumdar Shaw has proposed to the government of India to set up a Task Force to reform the current regulatory system. The biotech industry which has been putting up with long waits to get clearances at various stages of drug development is pressing for a speedy and fast-track approvals.
“We need a Task Force on similar lines that was created under the chairmanship of Dr RA Mashelakr which spearheaded many decisions on a fast track for pre-clinical development”, she said.
Voicing concerns on the regulatory systems in the country, Dr Rashmi H Barbhaiya, CEO and managing director, Advinus Therapeutics Ltd. said, “ India's regulatory environment is suffocating with inordinate delays putting the country at a disadvantage. There is a total mismatch of regulations in the country which was putting the country’s biotech and pharma industry at a significant competitive disadvantage.
A simple approval for a Investigational New Drug Application for a single dose takes nearly 26 months and the entire approval for human trials is expected only after 12-16 months, he added.
Chairing the session at a round table discussion on regulatory issues and the need to create an environment to foster innovation in the Indian biotechnology industry, Dr Barbhaiya said that while his company was working on the development of an indigenous diabetic drug for Type II condition, the wait for clearances was a serious impediment to progress of research efforts in the company. “We wasted 18 months of patent life and Advinus is not the only company facing these impediments. There are scores of biotech enterprises which have been victims to tardy regulatory consents”, he said.
Dr Barbhaiya stated that extra money and time invested to get the clearances was hurting the companies. At this juncture when Indian biotech companies were known for their research upscale efforts, government needed to bring in administrative changes that could make a difference. There was need to introduce Phase I trials in the country and allow a once a moth meeting with the IND committee besides permit import of animals though a single committee clearance.
Shaw said, “serious concerns are there and we as an industry need to introspect on losing competitive edge. The regulatory delays have caused grave set backs. Product is destroyed as research is capital intensive and expensive. Postponements of Regulatory decisions was eating into the Intellectual Property pipeline”.
From a regulator's perspective Dr. KK Tripathi, adviser/scientist ‘G’ and member secretary RCGM, department of biotechnology and Ministry of Science and Technology said that duty of the regulator was to facilitate the industry rather than create impediments. Around 100 applicants were received and all of them were cleared at RCGM.
We have written an obituary on the funding opportunities in the drug development area. Biotech which was a sunrise industry in 2000, still continues to be at the same level in 2011. Regularity hindrances was the only cause of this and this has led the venture capital and private equity players to keep away from the biotech sector, stated Nitin Deshmukh, CEO, Kotak Private Equity Group.
On a positive note, Dr VM Katoch, secretary to the government of India, department of health research and DG, ICMR said that every effort would be made to speed up and streamline the regulatory process.