Context
The Union Minister of State for Commerce and Industry, has suggested that the country’s pharmaceutical sector will touch the 130 billion US dollar mark by 2030.
About Pharmaceutical Sector of India
- The pharmaceutical industry in India is currently worth $50 Bn.
- Major segments of industry include generic drugs, OTC drugs, bulk drugs, vaccines, contract studies & production, biosimilars and biologics.
- The Pharmaceutical industry in India is the third largest in the world in phrases of extent and 14th largest in terms of value.
- The Pharma sector currently contributes to around 1.72% of the country’s GDP.
- India is the 3rd largest producer of API accounting for an 8% share of the Global API Industry.
Achievements of Pharmaceutical Sector of India
- India debts for 60% of global vaccine manufacturing, contributing as much as 70% of the WHO demand for Diphtheria, Tetanus and Pertussis (DPT) and Bacillus Calmette–Guérin (BCG) vaccines, and 90% of the WHO demand for the measles vaccine.
- India elements over 50% of Africa’s requirement for generics, ~40% of generic demand within the US and ~25% of all medication in the UK.
- The cumulative FDI equity influx in the Drugs and Pharmaceuticals industry is US$ 22.52 billion in the course of the period 2000-2024, nearly 3.4% of the entire inflow acquired across sectors.
- The nation is the largest provider of regularly occurring drugs globally, occupying a 20% share in global supply through extent, and is the leading vaccine producer globally.
- India is referred to as the “pharmacy of the sector” due to the low fee and high first-rate of its drug treatments.
Challenges for Pharmaceutical Sector of India
- Intellectual Property (IP) Protection: India’s patent laws, specifically regarding compulsory licensing and Section 3(d) of the Indian Patent Act, have caused frequent disputes with multinational agencies.
- Dependence on Imports: APIs and Key Starting Materials (KSMs) import dependence exposes the industry to vulnerabilities associated with supply chain disruptions and rate fluctuations.
- Skilled Human Resource: Indian pharmaceutical industry requires a fairly skilled personnel to power research and development, control operations, and ensure quality control.
- Failing the quality tests: The country’s pharma industry has largely been in denial over quality-related concerns expressed by national and international observers.
- According to a Central Drugs Standard Control Organization (CDSCO) survey in 2014-2016, about 5 percent of Indian tablets, several of them synthetic by big pharma businesses, failed the fine check.
Government projects
- The Production Linked Incentive (PLI) scheme for prescription drugs is being carried out with a total outlay of the Rs. 15,000 crore (US$ 2.04 billion) spanning from 2020-21 to 2028-29, to reinforce India’s production ability, raise funding, and diversify product services in the sector.
- Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP): exceptional widely wide-spread medicines are made available at less expensive charges to at some point of committed outlets referred to as Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJK).
- Strengthening of Pharmaceutical Industry (SPI): The scheme is carried out for the duration from FY 21-22 to FY 25-26.
- It aims to offer help to existing Pharma clusters and MSMEs throughout the country to improve their productivity, quality and sustainability to bolster the prevailing infrastructure centers in the Pharma MSME clusters.
- Scheme for Promotion of Bulk Drug Parks: The aim is to offer world class commonplace infrastructure centers to units located in the parks so as to assist in appreciably bringing down the manufacturing cost of bulk drugs and thereby make India self-reliant.
- 100% Foreign Direct Investment (FDI) in the pharmaceutical sector is allowed under the automated direction for greenfield pharmaceuticals.
- 100% FDI within the pharmaceutical sector is permitted in brownfield prescription drugs; in which 74% is allowed under the automated route and thereafter via the authorities approval course.
Way Ahead
- The pharmaceutical industry in India is a huge part of the state’s foreign trade and offers rewarding capability for buyers.
- Speedy creation of popular capsules into the market has remained in recognition and is anticipated to advantage the Indian pharmaceutical industry.
- In addition, the thrust on rural health programmes, lifesaving drugs and preventive vaccines also augurs properly for the pharmaceutical organizations.
Source: News on AIR