India seeks feedback on creating regulatory framework

India has proposed regulatory reforms intended to encourage R&D and innovation in the pharma and medtech industries. The proposals are part of a broader plan to make India a leader in drug discovery and innovative medical devices by establishing an entrepreneurial environment in the country.

In working toward the goal, the Department of Pharmaceuticals (DoP) is proposing to simplify India’s regulatory processes to enable rapid drug discovery and innovation in medical devices. As DoP sees it, the Indian framework needs to expand beyond “the traditional regulatory objectives of safety and quality” by starting to “differentiate in favor of innovation.”

DoP has identified barriers to the realization of its objective. First, the department has determined that the presence of “multiple agencies with different mandates and expertise that an Innovator firm has to navigate” means new products and innovations that “fall outside the existing standards” may lack “clear processes.” DoP said India’s modified Clinical Trial Rules and the Medical Device Rules address some, but not all, of the gaps.

Second, DoP said the regulatory capacity within the government needs to keep pace with advances in science and technology, thereby enabling authorities to rely less on “ad-hoc external inputs.” The lack of internal expertise in emerging areas “contributes to long timelines for grant of approval to innovative products,” DoP said.

Faced with the challenges, DoP is proposing to create a Common Specific Procedure Pathway (CSPP) for each class of product. The pathway would include “checklists, prescribed timelines, parallel processing, joint inspections, automatic/deemed approvals, and sharing of data across regulators.” CSPP forms part of the department’s plans to make regulators work together, reduce overlaps and thereby cut the time taken for approvals of innovative products by at least 50% in the next two years.

DoP is also proposing to create a digital portal, hosted by India’s Central Drugs Standard Control Organization (CDSCO), which will serve as a single interface between innovators and all the agencies involved in overseeing the development and approval of their products. The portal will automate the transfer of data between departments and use “artificial intelligence-backed dossier review and deficiency identification … to enhance efficiency and reduce human interface.” The ultimate goal of the portal is to bring transparency, timeliness and predictability to regulatory processes and outcomes.

Other aspects of the proposal cover regulatory capacity and legislation. DoP wants to strengthen CDSCO with “project management roles to provide dedicated support to the industry Innovators.” That side of the strategy includes the addition of expertise in biopharmaceuticals and “high end medical devices.” DoP also wants India’s National Pharmaceutical Pricing Authority to add expertise “in pricing of new innovative products, while pursuing affordability as an overall objective.”

Finally, DoP is proposing to review the legislation covering biopharma and medtech R&D. The plan is to remove inconsistencies and redundancies, for example by exempting some products from India’s Biological Diversity Act and by enabling CDSCO and state regulators to conduct joint inspections. RAPS