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A potential made-in-India blockbuster diabetes drug got stuck with the national regulator's procedures during trials and lost a vital global lead of 18 months: This is not a lone case but something that domestic drug discovery companies apparently are regularly wringing their hands over.
Chiefs of pharma biotech companies on Wednesday cried foul over what they called a stifling regulatory system that spoils their hard labour in the labs. They said urgent reforms were needed in the system that allows research into and clears new drugs from the country.
A leading voice in the industry who was here on the first day of the eleventh annual Bangalore India Bio was Dr Rashmi Barbhaiya, CEO and co-promoter of Advinus Therapeutics, a Tata-sponsored discovery company.
No level field
“The regulatory environment is suffocating the industry and putting India at a disadvantage. In a highly competitive sector, there is no level playing field for domestic industry with other countries,” Dr Barbhaiya said at a session on regulatory issues faced by the biotechnology industry.
His company's novel diabetes drug (presumably a diabetes drug molecule codenamed GKM-001 which Advinus is developing) lost time due to procedural delays over early toxicological studies at the Drug Controllerate General of India, the former Ranbaxy R&D head, said.
“A consulting firm in Boston (estimated) that the base line sales figure (of such a drug) in 2020 could be $4 billion. We wasted 18 months of precious time” over getting clearances in time, he said.
A new drug application required 30-40 studies and curtailed exploratory research. But for these delays, “something (a novel drug) would have surfaced out of India in these 50 years,” he remarked.
Other speakers also berated the Indian regulatory system as complex, longer than in other countries and requiring extra reports and separate clearances for related studies.
Dr Barbhaiya suggested certain administrative and policy changes to smoothen drug R&D in the country: Phase-I studies should be cleared within three months; investigative new drug (IND) committees should meet every month and the government should allow phase-I trial of drug molecules from a foreign company to be conducted in India.
Ms Kiran Mazumdar-Shaw, CMD of Biocon Ltd, said India was losing its competitive and intellectual property edge due to the delay. Lead time was important for getting patents for original drug research, she said.
“IND approvals came so late that we had to destroy the products and make them afresh.”
The industry should form a task force to address the issues, she added.
From the other side, Dr V.M. Katoch, Secretary, Department of Health Research, and DG, Indian Council of Medical Research, said the sluggish system was changing; the procedures were worse for stem cell and nanotechnology research.
In a tele address, Dr M.K. Bhan, Secretary, Department of Biotechnology, said the Bill to have a separate regulator for the biotech industry was ready to go before the next session of Parliament.
Mr Apurva Shah, Group MD, Veeda Clinical Research, said the government should walk the talk “if you want a novel Indian drug by 2020.”
Foreign companies got clearances far more easily than Indian ones, said Ms Smita Singhania, Vice-President and Head, Regulatory Affairs at MabPharma, a Cipla joint venture.
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