12 Firms in Race to Build CDSCO's Digital Drug Regulatory System

According to a recent media report by The Hindu BusinessLine, Raghuvanshi said the platform could be rolled out within the next month. It is intended to combine simpler regulatory processes with AI and data analytics to improve oversight and make compliance easier for industry and other stakeholders.

“This is a very big and ambitious project for the regulatory system," Raghuvanshi added.

The system would help CDSCO identify matters that need regulatory intervention while reducing unnecessary intervention elsewhere. Raghuvanshi said more than 99 per cent of the country’s regulatory processes are already fully digital, and the new platform would extend that shift. CDSCO has also formed a committee of AI experts to advise on the evaluation, approval and regulation of AI-based healthcare products.

CDSCO is seeking to establish an internal scientific cadre. Raghuvanshi said 1,500 additional posts have been agreed to in principle, but the proposal remains under consideration for approval. Recruitment would start after it is cleared.

The new staff would strengthen reviews of new drug applications, audits and inspections, while helping address gaps in the current Subject Expert Committee system. His aim, he said, is for CDSCO’s internal specialists to handle more than 90–95 per cent of the work now done through those committees.

Raghuvanshi said reforms concerning the Review Committee on Genetic Manipulation, a longstanding industry request, were progressing and that a solution was expected soon. Guidance on similar biologics was also anticipated.

In clinical research, CDSCO is considering whether to permit first-in-human studies in India for products developed abroad. Raghuvanshi said the number of global clinical trials conducted in India had risen from roughly 120–130 and could reach about 160 this year. He linked the growth to greater confidence among multinational companies in India’s capacity to conduct trials to global standards.

Prior permission has also been removed for most research activities, apart from certain critical areas, Raghuvanshi said.

Researchers can submit the required information through a digital platform before starting eligible work. Nearly half of India’s bioequivalence studies, particularly those undertaken for overseas clients, no longer need advance permission.

Raghuvanshi told The Hindu Business Line that this would give contract research organisations and their clients greater certainty when planning and conducting studies.