Hyderabad: The biotechnology department (DBT) plans to create regulatory sandboxes for India’s pharmaceutical sector to fast-track approvals and accelerate drug development, said Managing Director of Biotechnology Industry Research Assistance Council Jitendra Kumar on the sidelines of the Bio Asia event in Hyderabad.
Akin to regulatory sandboxes that currently operate in the banking and insurance sectors, the introduction of a pharma-sector sandbox will allow innovations such as drugs, digital health solutions, and medical devices to make a faster entry into the market after tests validate them.
A sandbox framework is a limited form of regulatory waiver or flexibility, enabling firms to conduct tests with reduced regulatory requirements. It cuts the friction between regulators and firms and bureaucratic delays.
Western drug regulators, the European Medicines Agency (EMA) and the US Food and Drug Administration (USFDA), have already facilitated such a regulatory set-up in their countries and regions to foster innovation in the health sector. While these agencies do not formally term their mechanisms “regulatory sandboxes”, they have introduced innovation task forces, pilot programmes, and accelerated approval pathways that function similarly to support emerging technologies, including AI-driven healthcare solutions.
The government intends to “reduce regulatory uncertainty and ensure regulatory insight is not a barrier but a catalyst for innovation”, Jitendra Kumar said. “We want to facilitate early interactions between innovators and the CDSCO, so that right from the approval of the drug application stage, we can quicken the process.”
The Central Drugs Standard Control Organisation (CDSCO) is responsible for the approval of drugs, the conduct of clinical trials, the laying down of the standards for drugs, and controlling the quality of imported medicines.Big pharma companies and private drug manufacturers at the Bio Asia conclave agreed that a handshake between CDSCO and innovators would fasten clinical trials’ approval in India.
Long delays in approvals of clinical trials significantly add to drug costs, and industry and health policy analyses have noted that complex approval systems have contributed to India’s share of global clinical trials declining over the past decade.
Earlier industry estimates had placed India’s share at around five percent, which the industry says fell to below one percent in recent years.
Regulators in the US, EU, and Brazil have aligned several of their standards through global frameworks, such as the International Council for Harmonisation (ICH), aimed at improving efficiency while maintaining patient safety.
Vice President of Drug Development at BMS, Natarajan Kalyanaraman, said that a change in India’s pharmaceutical regulatory pathway could shorten the time to market a drug and increase its probability of success.
“Indian pharma has the talent, the capital, and the academic rigour to bring out new molecules. There is also an openness in doing medical research in India. However, for all these pieces to come together, the regulatory framework is crucial,” he said.
Industry inputs for the regulatory sandbox have been collated, and BIRAC is awaiting clearance from the DBT and the Ministry of Science and Technology.
BIRAC was set up by the Department of Biotechnology (DBT), Government of India, as an interface to strengthen and empower the emerging pharma and biotech firms, helping them undertake strategic research and innovation, in line with India’s healthcare needs.
(Edited by Madhurita Goswami)
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