Pharmaceutical Market and Initiatives in India (FY 2023-24)

The entire pharmaceutical market in India is reportedly estimated to be around USD 50 billion for FY 2023-24 with domestic consumption being USD 23.5 billion and exports USD 26.5 billion. It ranks third in volume and fourteenth in value among the countries. 

The Indian pharma basket consists of generic drugs, vaccines, biosimilar products, biologics, etc. In order to strengthen the research and innovation capabilities, the Department of Pharmaceuticals has established the seven National Institutoes of Pharmaceutical Education & Research (NIPERs) and has also introduced the “ National Policy on Research & Development and Innovation in Pharma-MedTech” in 2023. It is still referred to as an investment friendly policy, has good regulation policy and seeks to turn India into a country of drug discovery. There was also the Rs. 5000 crore Public Research and Innovations in Maharashtra (PRIP) Scheme that was intended to improve on research facilities as well as to promote innovation. Furthermore, amendments have been made to the intellectual property laws in order to strengthen the hand of start-ups risks and MSMES with policies such as the Start-Ups Intellectual Property Protection (SIPP) scheme, etc

Market Overview

• India's pharmaceutical market is worth USD 50 billion for FY 2023-24, consisting of USD 23.5 billion for domestic consumption and USD 26.5 billion for exports.

• India is the third-largest pharmaceutical market globally by volume and the 14th-largest in terms of production value.

• The pharmaceutical segment consists of many products such as generic drugs, bulk drugs, OTC drugs, vaccines, biosimilars, and biologics.

Jobs and output in pharmaceuticals

The total turnover of pharmaceuticals, medicinal, and botanical products was Rs. 4,56,246 crores in FY 2022-23 (constant prices). In 2022-23, the industry had 9,25,811 people.

R&D and Innovation Focus

• The Department of Pharmaceuticals has set up seven National Institutes of Pharmaceuticals Education & Research (NIPERs) for postgraduate and doctoral studies along with research in any higher pharmaceutical areas. There is National Policy on Research & Development and Innovation in Pharma-MedTech Sector that has been established and is aimed at fostering pharmaceuticals innovation and R & D.

Key Policy Goals (2023)

• Fostering the innovativeness of the jurisdiction’s regulatory framework.

• Aid the growth and creativity through both non-fiscal and fiscal measures.

• Strengthening Cross-industry collaborative research and sustainable development in the pharmaceuticals industry.

Promotion of Research and Innovation in Pharmaceutical (PRIP) Scheme

• The PRIP Scheme has been allocated a budget of 5000 crores rupees from 2023-24 to the biennium 2027-28, with a goal of assisting the pharmaceutical industry in shifting from a cost-based to an innovation-based basis.

• The scheme has two components to it:

  • Component A: Expand the research facilities through new Centres of Excellence at the NIPERs.

  • Component B: Financing Companies and Academic R&D projects in selective interest areas to advance R&D in Pharma-Messaging Innovations.

Clinical Trials and Drug Development:

• The introduction of new Drugs and the clinical trial regulations of 2019 changed the drug clinical trial and registration procedures and requirements relevant to them, so the principles of rapid approval for drugs and orphan indications now apply.

• Provision on duration period of up to 90 days has been provided for CTA approvals and new drugs registration with a. The provisions for fast approval have also been made.

Intellectual Property Initiatives

• Although no enhanced policy was undertaken for the IP regime of the pharmaceutical industry, India has made some strides toward globalization of its Intellectual Property.

Conclusion

India's pharmaceutical market is poised for significant growth, reaching USD 50 billion in FY 2023-24. The government's focus on R&D, innovation, and intellectual property protection is strengthening the industry. The PRIP Scheme and National Policy on Pharma-MedTech will further boost research and drug development. These efforts will enable India to expand its global market share and drive economic growth in the sector.