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.
Strengthening regulatory capabilities
The draft policy proposes to strengthen the existing institutional capacity of the CDSCO by setting up project management roles to provide dedicated support to the industry innovators.
The strengthening of the regulator’s capabilities would include building in-house expertise in biopharmaceuticals and high end medical devices.
“Specialisation will have to be created or in-sourced to handle oversight of regulatory functions in respect of New Biological Entities and New Chemical Entities, Biologics, Imaging medical technologies, New Materials, tele-diagnostics, artificial intelligence/machine learning based innovations, sensors, etc.
The draft says NPPA will be supported to develop greater expertise in pricing of new innovative products, while pursuing affordability as an overall objective.
The policy also advocates collaboration with relevant international regulatory agencies to enhance expertise of Indian regulators for approval of new drugs and medical devices and ensure a globally harmonized regulatory system; existing MoUs available with CDSCO will be reactivated and expanded for this purpose.
The draft also proposes a review of the multiple legislations impacting research and development in pharmaceuticals and medical devices to remove inconsistencies, and redundancies.
It promises to review legislation enabling regulation of all medical devices in a phased manner with lead time of 12 months to manufacture for each category of medical device – Class A, B, C & D, and create dedicated licensing provisions for Ayurveda, Siddha & Unani (ASU) drugs.
The draft also talks about exploring providing Ayurveda WHO licensing authority to have the power to issue WHO GMP certificate.