Proposal to cut approval time for innovative products by 50%

A draft policy document prepared by the Department of Pharmaceuticals under Ministry of Chemicals & Fertilisers has proposed to cut down the time taken for regulatory approvals for innovative products by at least 50% within the next two years.

The document dated October 25 says it wants to achieve this by nudging all regulators to work together to reduce process overlapping and establish timelines for requisite approvals.

Typically it takes about 18-24 months for approval of an innovative product.

The draft also talks about laying down a Common Specific Procedure Pathway (CSPP) for each class of product, on the lines of USFDA. The CSPP would include checklists, prescribed timelines, parallel processing, joint inspections, automatic approvals, and sharing of data across regulators.

In addition, the DoP has proposed a single-window digital portal hosted by CDSCO. The portal would offer a single interface between innovator and regulator.

It will function through an interconnected system with automated transfer of data across departments and agencies and enable upload of all documents on the integrated portal.

DoP said the portal will advance features like artificial intelligence-backed dossier review and deficiency identification using natural language processing (NLP) and automated document management workflows will be deployed to enhance efficiency and reduce human interface.

"The technology-based single point of interaction shall aim to bring transparency, timeliness and predictability in processes and outcomes around regulation," the draft document said.