PRIP Scheme: Promotion of Research and Innovation in Pharma

Table of Contents

The Department of Pharmaceutical under the Ministry of Chemicals and Fertilisers has launched the PRIP Scheme. The scheme focuses on certain priority areas that will help India’s pharma industry to strengthen its global position by developing of research infrastructure and launching new commercially viable products.

Objectives of PRIP Scheme

Transform the Indian Pharma MedTech sector from cost-based to innovation-based growth by:

Strengthening research infrastructure
Promote industry-academia linkage for R&D in priority areas
Inculcate culture of quality research
Nurture the pool of our scientists
Sustained global competitive advantage of India’s pharmaceutical sector
Contribute to quality employment generation.

Funding: The scheme is a central sector scheme with a financial outlay of Rs 5,000 crore over a 5 year period from 2023-24 to 2027-28.

Salient Features of the PRIP Scheme

The PRIP Scheme will have two components:

Component A: Setting up of Centres of Excellence (CoEs) at the National Institute of Pharmaceutical Education & Research (NIPER).
- This component aims to establish CoEs in 7 existing NIPERs at a tentative cost of Rs 700 crores over a period of 5 years.
- These CoEs will help in:
  - Building specific research capacities in the identified priority areas in time time-bound program.
  - Tapping industry-academia linkage.
  - Strengthen research infrastructure in Pharm-MedTech sectors
  - Access to advanced facilities for research
  - Nurturing talent pool in the pharma research sector.

NIPER	Specialisation of CoE to be established
NIPER Mohali	Anti-Viral and Anti-Bacterial Drug Discovery & Development
NIPER Ahmedabad	Medical Devices
NIPER Hyderabad	Bulk Drugs
NIPER Kolkata	Flow chemistry and continuous manufacturing
NIPER Raebareli	Novel drug delivery system
NIPER Guwahati	Phyto-pharmaceuticals
NIPER Hajipur	Biological therapeutics

Component B: Promotion of Research in the Pharma Medtech Sector
- Category B I: Nine established pharma companies will be selected under this category who are willing to carry out R&D in six priority areas with academic collaboration in Government institutes of national importance.
  - Companies can avail of facilities such as labs, equipment, and support staff at the national institutes.
  - Companies provide training to select several students/scientists of the institutes.
  - Investments made by companies on the projects at the institutes are to be supported with financial support at 35% of the total cost or 125 crores whichever is less on a milestone basis (From TRL 1 to TRL 9) over 5 years under the benefit sharing principle.
- Category B II:
  - Aims to expedite market launch and commercialization of products/ technologies in priority areas having high commercial potential or societal impact by providing financial assistance.
  - Funding would be provided to 30 research projects in 6 priority areas which are at TRL 5 to reach TRL 9 by providing 35% of the cost or Rs 100 crores whichever is less over a period of 5 years on the principle of benefit sharing.
  - Funding will be released on an installment basis upon reaching the desired milestone:

S. No.	TRL Level	% of funding
1	5 to 6	30
2	6 to 7	30
3	7 to 9	40

Benefit Sharing under Category B I & II

Funding disbursed for projects will be recovered through benefit sharing through royalty or equity routes:

10% royalty on net sale of product/technology till the patent is effective.
Equity (not less than 100% of the support provided by the Department of Pharmaceuticals (DoP).

Category B III: Funding of up to Rs 1 cr/project would be provided over 5 years to about 125 research projects in 6 priority areas to help Indian start-ups and MSMEs reach TRL 4 having potential or which have made sufficient headway in the research in the selected priority area.
- Beneficiaries will be required to pay 5% royalty on net sales of products/technology developed through DoP support till the time such royalty payment becomes equivalent to the assistance provided by DoP.

PRIP Scheme: Six Priority Areas

(i) New Chemical Entity (ii) New biological entity (iii) Phyto-pharmaceuticals (natural product).

Complex generics & Biosimilars

Precision medicine (Targeted Innovative Therapeutics)

Based on genes or proteins to prevent, diagnose or treat a disease.

Stem cell therapy

Biomarkers

Medical devices:

Orphan Drugs: Medicinal products for diagnosis, prevention, or treatment of rare diseases or disorders. Currently, there are about 450 rare diseases in India (in tertiary care hospitals).

Drug Development for Anti-Microbial Resistance

About National Institutes of Pharmaceutical Education & Research (NIPER)

Department of Pharmaceuticals under the Ministry of Chemicals and Fertilisers has established seven NIPERs as institutes of National Importance.
Central Government established NIPERs under the ‘The National Institute of Pharmaceutical Education & Research Act, 1998.’
List of 7 NIPERs are: NIPER Mohali, NIPER Ahmedabad, NIPER Hyderabad, NIPER Kolkata, NIPER Raebareli, NIPER Guwahati, NIPER Hajipur

Objectives of NIPERs:

Imparting post-graduate and doctorate education
Conducting high-end R&D in various specializations in pharmaceutics

NIPERs have been giving higher importance to R&D which is evident from the following steps:

Deciding on a Common Research Program
Launch of NIPER Research Portal
Enhanced importance to industry academia linkage.
Amendment to NIPER Act, allowing the establishment of Centres of Excellence for drug discovery and development of medical devices.