Recently launched pharma PLI projects

Context

The Union government has recently inaugurated 27 greenfield bulk drug park projects and 13 greenfield manufacturing plants for medical devices.

Key highlights

• • These 40 greenfield initiatives have been inaugurated under the PLI schemes for production of bulk drugs and medical devices.
    • A bulk drug, also known as an active pharmaceutical ingredient (API), is the chemical substance responsible for the healing consequences of a pharmaceutical product i.e., it is the primary ingredient in a medication that produces the intended medical effect.

• Highlighted importance of PLI scheme in Pharma

• • • The PLI scheme’s fulfillment has decreased India’s dependence on imports for drug treatments, API and medical devices.
    • Instead of uploading goods well worth Rs 75,000 crore, the country will now be exporting drugs and products worth Rs 75,000 crore.
    • The branch of pharmaceuticals is enforcing three PLI schemes — prescribed drugs, bulk drugs and medical devices.
    • For the PLI scheme for prescription drugs, the government has accepted 55 applicants with an incentive outlay of Rs 15,000 crore.
    • As many as 138 products from 26 PLI applicants have been accredited for greenfield production of medical devices with an outlay of Rs 3,420 crore.
    • The bulk drugs PLI consists of manufacturing forty one bulk drugs with a total outlay of Rs 6,940 crore.

• Revival of drug manufacturing

• • For example Penicillin G, which India had stopped making for the last 30 years after huge-scale dumping brought about plants shutting down.
  • Penicillin G will now be made in the country, with the plant anticipated to be operational in June 2024.

The pharmaceutical industry in India: Notable achievements

• The Indian pharmaceutical industry, frequently referred to as ‘the pharmacy of the arena’, contributes immensely to global public health and promotes regularly occurring healthcare access.
• India ranks 3rd worldwide for production by volume and 14th by value.
• India is the most important provider of regularly occurring drugs globally, occupying a 20% proportion in international supply by volume.
  • The pharmaceutical enterprise in India offers 60,000 familiar manufacturers across 60 therapeutic categories.
• It is the leading vaccine producer globally with 60% of the sector’s vaccines coming from India.

Industry situation

• Foreign Direct Investment (FDI)

• • • 100% FDI inside the Pharmaceutical area is allowed under the automatic route for greenfield pharmaceuticals.
    • 100% FDI within the pharmaceutical sector is permitted in brownfield prescribed drugs; wherein 74% is allowed under the automatic route and thereafter through the government approval direction.

• Market Size

• • • The pharmaceutical industry in India is worth $50 bn in 2022-23 and exports accounting for 50% of the production.
    • It is anticipated to reach $65 bn by 2024 and to $130 bn by 2030.

• Export

• • India is a main exporter of Pharmaceuticals, with over 200+ countries served through Indian pharma exports.
  • India supplies over 50% of Africa’s requirement for generics, ~40% of established demand inside the US and ~25% of all medicine inside the UK.
  • For the length 2021-22, export of drugs and pharma products stood at $24.6 bn compared to $24.44 bn as of 2020-21.
  • The Indian pharma enterprise witnessed an exponential increase of 103% at some point of 2014-22 from $11.6 bn to $24.6 bn.

Support extended by the government

PLI scheme

• PLI for Pharmaceuticals:

• • • The scheme was released with an outlay of INR 15,000 Cr till FY 2027-28.
    • The goal is to reinforce India’s manufacturing abilities by increasing funding and production in the zone and contributing to product diversification to high-price items.

• PLI for Promoting Domestic Manufacturing of Medical Devices

• • • The scheme, with an outlay of INR 3420 Cr until FY 2027-28, is being provided for the introduction of not unusual trying out and laboratory centers/centres in four Medical Device Parks.

• Vision Pharma 2047

• • • Make India an international leader in the manufacturing of low-priced, modern & first-class pharmaceuticals & medical devices for the goal of Vasudhaiva Kutumbakam
    • Vishwaguru in innovation & Research for handing over health care merchandise to future generations in a sustainable way, introducing natural products
    • Medical Devices to be a fundamental part of international delivery chains for raw substances, additives, spare elements, assemblies/subassemblies, and many others.
    • Digitisation and technology upgradation in the transport of services & merchandise below Jan Aushadhi Pariyojana

• National Pharmaceutical Policy (2023)

• • • The policy is being drafted to function as a complete framework to address the demanding situations confronted by way of Indian Pharmaceutical industries.
    • The draft coverage encompasses 5 key pillars:
    • Fostering Global Pharmaceutical Leadership, Promoting Self-Reliance, Advancing Health Equity and accessibility, Enhancing Regulatory Efficiency in the Indian Pharmaceutical Sector and Attracting investments.

• Scheme for Strengthening of Pharmaceuticals Industry (2022)

• • • The scheme, released with a total economic outlay of INR 500 Cr until FY 2025-26 to:
      • toughen the present pharmaceutical clusters’ potential with the aid of developing not unusual centers;
      • facilitate MSMEs of a validated track file to meet regulatory requirements; and
      • facilitate growth and improvement of Pharmaceutical and Medical Devices Sectors.

• Scheme for Promotion of Bulk Drug Parks (2020)

• • The scheme boosts domestic production of diagnosed KSMs, Drug Intermediates and APIs by attracting big investments in the sector.
  • Financial help, as much as INR one thousand Cr, may be provided for the introduction of common infrastructure facilities in 3 Bulk Drug Parks decided on in Gujarat, Himachal Pradesh, and Andhra Pradesh.

Source: PIB

UPSC Mains Practice Question

Q.Discuss the challenges and opportunities pertaining to India’s pharmaceutical industry. How PLI scheme helps boost pharmaceutical industry.(250 words)

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