On 25th October 2021, the Indian Department of Pharmaceuticals (DoP) issued a draft policy document to catalyse R&D and innovation in the Pharma and Med-Tech sector in India. There is the scope to provide feedback on the draft by 6 November 2021 at the latest.
The specific objectives of the policy are:
- To simplify regulatory processes to enable rapid drug discovery and development and innovation in medical devices;
- To explore mechanisms to incentivise private sector investment in research and evaluate various funding mechanisms – Budgetary support, Venture capital, CSR funding etc. and fiscal incentives to support innovation;
- To identify mechanisms to strengthen the R&D ecosystem through increased collaboration between Industry and Academia
- To enable integration of the existing policies and programs of various departments/ agencies/ institutes in order to develop mechanisms to dovetail research as per requirement of the Industry.
To achieve these objectives, three main focus areas are envisaged. They are:
- To create a regulatory environment that facilitates innovation and research in product development, expanding the traditional regulatory objectives of safety and quality.
- To incentivise private and public investment in Innovation through a mix of fiscal and non-fiscal measures, thereby matching risks with remunerative financing options.
- To build an enabling ecosystem designed to support innovation and cross sectoral research as a strong institutional foundation for sustainable growth in the sector.
Of the measures under these three focus areas to meet the policy objectives, the following are contemplated in order to create a regulatory environment in favour of Innovation:
Process optimisation
Regulators will be mandated to work together to reduce process overlapping and establish timelines for requisite approvals.
A Common Specific Procedure Pathway (CSPP) would be provided for each class of product. This would include checklists, prescribed timelines, parallel processing, joint inspections, automatic/deemed approvals, and sharing of data across regulators, with aim of reducing the time taken for regulatory approvals for innovative products by at least 50% within the next two years.
Technology based platform
Creation of a single end to end digital portal is proposed, which would be used by different departments/ regulators. The Portal:
- to be hosted by CDSCO will offer a single interface between Innovator and Regulator.
- 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.
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.
Regulatory Capacity
The policy proposes to strengthen the existing institutional capacity of the regulatory bodies (CDSCO) by setting up of 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, AI/ML based innovations, Sensors, etc.
The National Pharmaceutical Pricing authority (NPPA) will be supported to develop greater expertise in pricing of new innovative products, while pursuing affordability as an overall objective.
The policy 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 capacity building of regulators will enable them to introduce benchmarked best practices, stay ahead of the curve and add value to the expansion of the Pharma- Medtech sectors through Innovation.
Legislation
A review of the multiple legislations impacting research and development in Pharmaceuticals and medical devices will be undertaken with a view to remove inconsistencies, and redundancies. Some examples of the measures sought are:
- Enable joint inspection by CDSCO and State FDA (which should be conducted only once), in parallel, in case of vaccines and biologics for a particular class of product, for marketing authorisation
- 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.
The proposed changes are quite far reaching in breadth and ambition and if delivered fully, have the potential to be a game changer for India in its quest to create an ecosystem for innovation in the sector, in order for the country to become a leader in drug discovery and innovative medical devices through the creation and promotion of an entrepreneurial environment.
Allowing less two weeks for feedback on such an important document seems like a missed opportunity.
Source: Dept of Pharmaceuticals Website