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DoP releases draft policy to catalyse R&D and innovation in pharma-MedTech sector

The Department of Pharmaceuticals (DoP) has come out with a draft policy to catalyse research and development (R&D) and innovation in pharmaceutical and medical devices sectors in India.

The draft policy aims to encourage R&D in Pharma-MedTech sector, and promoting innovation for India to become a leader in drug discovery and innovative medical devices through incubating an entrepreneurial environment. The department has invited comments from the stakeholders by November 6, 2021.

The policy has a ten-year perspective, and will be implemented through an Action Plan defining roles, responsibilities, activities, targets and timelines. The Action Plan will be broken down to five year and annual activities for ease of implementation. A High-level Task Force will be set up in the DoP to guide and review the implementation of the policy.

The policy focuses on simplifying regulatory processes to enable rapid drug discovery and development and innovation in medical devices; exploring mechanisms to incentivise private sector investment in research and evaluate various funding mechanisms including budgetary support, venture capital, CSR funding etc., and fiscal incentives to support innovation; and strengthening the R&D ecosystem through increased collaboration between industry and academia in order to develop mechanisms to dovetail research as per requirement of the industry.

On the regulatory front, which is currently geared towards assuring safety and efficacy and not differentiate in favour of innovation, the policy contemplates to create a regulatory bias in favour of innovation and original research by mandating all regulators (as there are several regulators and agencies involved in the approval processes) to work together to reduce process overlapping and establish timelines for requisite approvals.

A Common Specific Procedure Pathway (CSPP) will be provided for each class of product, including checklists, prescribed timelines, parallel processing, joint inspections, automatic and deemed approvals and sharing of data across regulators. The aim is to bring down the time taken for regulator approvals for innovative products by at least 50 per cent within the next two years.

It also proposes to create a single end-to-end digital portal as a single window to be hosted by Central Drugs Standard Control Organisation (CDSCO) as an interface between innovator and regulator. Artificial Intelligence and natural language processing will be used to automate dossier review and document management workflows.

The capacity of CDSCO will be strengthened by setting up project management roles to provide dedicated support to the industry innovators, including building in-house expertise in bio pharmaceuticals and high end medical devices, specialisation to be created or in-sources to handle oversight of regulatory functions in respect of new biological entities and new chemical entities, biological, imaging medical technologies, new materials, tele-diagnostics, AI, machine learning based innovations, sensors etc. 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 government would undertake a review of the multiple legislation’s impacting R&D in pharma and medical devices sectors with a view to remove inconsistencies and redundancies. This could include measures such as exemption of products that are cultured and cultivated artificially under controlled conditions and not impacting natural resources from the Biological Diversity Act, review Drug Price Control Order 2013 to enable differential pricing for innovation with therapeutic benefits, among others.

Institutional bodies need to be empowered for approving pre-clinical protocols, making Institutional Animal Ethics Committee (IAEC) to be on par with Institutional Biosafety Committee (IBSC) to permit regulatory approvals for pre-clinical activities. It also proposes to enable joint inspection by CDSCO and State drug authority, to be conducted only once, in parallel, in case of vaccines and biological for a particular class of product, for marketing authorisation.

It also proposes to review the legislation enabling regulation of all medical devices in a phased manner with a lead time of 12 months to manufacture each category of medical devices. It also advises measures to create dedicated licensing provisions for Ayurveda, Siddha and Unani drugs and explore providing Ayurveda WHO licensing authority to have the power to issue WHO GMP certificate.

The second focus area of the policy, on funding of innovation and incentivising investment, the DoP kept the provisions open for stakeholder’s consultations before adding to the draft.

Regarding the third focus area in the policy, which is enabling an ecosystem for innovation, the policy proposes to strengthen industry-academia linkages by strengthening academic infrastructure and integrating it into a coherent framework for building skilled manpower for the industry. Modernisation and strengthening of curriculum with future ready technology like AI, Biologics, continuous flow technology and others, institutionalising industry representation in NIPERs and providing varying degree of financial and managerial involvement, integrating pharma education at graduate, post graduate and doctoral levels under NIPERS and enhancing expertise in biopharma education, attract Global educational Institutions of eminence to create centres in India, purposeful investments n few priority institutes to build Centres of Excellence on med-tech innovation and R&D,  

The draft policy also proposes collaboration across research and educational institutions and sectors, setting up of an Inter-Departmental Research Council on Pharma, creation of a dedicated innovation hub etc.

The Action Plan will list activities in four categories namely Policy decisions, Program execution, Collaboration and Communications. The Policy Action Plan will cover a five-year period with annual plans with attendant financing framework. A monitoring and evaluation framework will also be designed with rational target setting, resource optimisation and portal based reporting mechanism. An Industry led Advisory Committee will also be set up for continuous feedback on the implementation and monitoring. Independent evaluation would be carried out at prescribed periodicity against the defined outcomes, it added.

The draft policy aims to encourage R&D in Pharma-MedTech sector, and promoting innovation for India to become a leader in drug discovery and innovative medical devices through incubating an entrepreneurial environment. The department has invited comments from the stakeholders by November 6, 2021.

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