Regulatory issues in the biotechnology industry will be simplified along with speeding up of approvals to enable the industry to become more competitive in the global sphere.
“Concerns relating to delays in approval and procedural delays will be addressed to create an industry-friendly environment in the sector,” Dr Viswa Mohan Katoch, secretary to the Government of India for health research, said at the Bangalore India-Bio event here.
He also said there were a lot of streamlining being done in the biotechnology regulations.
Earlier, industry leaders expressed their concern for the inordinate delays faced by them in securing approvals. “There are many unnecessary regulatory approvals that need to be received from the government which adds to the delays,” Dr Rashmi H Barbhaiya, CEO and MD of Advinus Therapeutics Ltd, said.
He also said that multiple regulatory authorities should be replaced with a single-window approval authority.
Referring to this matter, Kiran Mazumdar-Shaw, CMD of Biocon, said that delays in securing approvals hamper competitiveness of Indian biotechnology companies in the global sphere. Other industry experts also echoed similar sentiments concerning this issue.
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“Due to the inordinate delay in getting regulatory approvals, there are fewer fund houses ready to put in their money into the biotechnology sector,” Nitin Deshmukh, chief executive officer of Kotak Private Equity Group, said.
He also said that regulatory uncertainties should be addressed to create more financial linkage in this sector.
CM denies banning clinical trials
Karnataka chief minister, B S Yeddyuruppa has denied reports suggesting ban on clinical trials in the state due to lack of regulatory guidelines.
Earlier, medical education minister S A Ramdas had said the government would impose temporary ban on clinical drug trials as the trend of treating patients like guinea pigs was increasingly alarming due to lack of requisite guidelines.
“I want to put the record straight. There are no plans to ban clinical trials, but only relates to clinical trials relating to some medical specifications, Yeddyurappa said here.
Karnataka is estimated to conduct 1,500 clinical trials in the state out of which around 70 per cent is conducted in Bangalore alone.
“We welcome the statement from CM regarding clinical trials as these are pretty much necessary for any drug innovation,” Kiran Mazumdar-Shaw said.