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Source: The post on India’s pharmaceutical industry has been created on the article “India’s drug detox: Digital update, regulator upgrade” published in “Indian Express” on 20th November 2023.
UPSC Syllabus Topic: GS Paper 2 Governance– Government policies and interventions for development in various sectors and issues arising out of their design and implementation.
News: The article discusses issues with India’s pharmaceutical industry, highlighting problems with substandard drugs and regulatory challenges. It mentions recent government efforts to improve drug tracking and regulation, including a new portal to monitor drug production and distribution.
About Indian Pharmaceuticals industry
Global Standing: India ranks 3rd worldwide in terms of production volume and 14th by value.
Generic Medicines: India is the world’s largest provider of generic medicines, accounting for a 20% share in global supply by volume. The industry offers around 60,000 generic brands across 60 therapeutic categories.
Vaccine Manufacturing: India leads in vaccine manufacturing, contributing 60% of the world’s vaccines.
Foreign Direct Investment (FDI): a) Greenfield Pharmaceuticals- 100% FDI is permitted under the automatic route. b) Brownfield Pharmaceuticals- Also allows 100% FDI, with 74% under the automatic route and the remaining through government approval.
Market Size and Growth: The current value of the industry is $50 billion, projected to grow to $65 billion by 2024 and $120 billion by 2030.
Exports: India is a significant exporter, serving over 200 countries. It supplies over 50% of Africa’s generics, about 40% of the generic demand in the US, and 25% of all medicines in the UK. There was a 103% growth in the industry from 2014 to 2022, rising from $11.6 billion to $24.6 billion.
Potential: The Indian Economic Survey 2021 foresaw the pharmaceutical industry in India reaching between USD 120-130 billion by 2030. Additionally, sectors related to the pharmaceutical industry, such as biopharmaceuticals, bio-services, bio-agriculture, bio-industry, and bioinformatics, are projected to reach $150 billion by 2025, a significant increase from the $70 billion recorded in 2020.
What are the issues with India’s pharmaceutical industry?
What are the government initiatives to improve this situation?
Adherence to WHO Standards: The Indian government directed medicine manufacturers to follow World Health Organization standards, aiming to improve drug quality.
Monitoring Portal for the Pharmaceutical Industry: The Indian government is launching a monitoring portal to oversee the pharmaceutical industry, aimed at tracking the entire drug-making process and ensuring transparency. This portal mandates manufacturers and distributors to submit detailed information on raw materials and invoices. It also lists drugs identified as substandard, thereby safeguarding against their distribution.
National Policy on Research and Development and Innovation in Pharma-MedTech Sector: It focuses on fostering academia-industry collaboration to establish India as a leader in drug discovery and medical device innovation.
Scheme for Promotion of Research and Innovation in Pharma MedTech Sector (PRIP): the PRIP scheme, with a budget of Rs. 5000 crores, intends to propel the sector towards innovation-driven growth. It includes setting up Centers of Excellence and emphasizing research areas like New Chemical Entities, enhancing India’s global competitiveness in pharmaceuticals.
For information on drug regulatory system in India read here
What should be done?
Enhance Regulatory Enforcement: Strengthen the enforcement of existing regulations and standards set by bodies like the WHO and US FDA to ensure drug quality.
Improve Transparency: Implement the proposed portal fully for tracking drug-making processes, raw material sourcing, and distribution, thereby increasing supply chain transparency.
Increase Trust in Generics: Address the distrust among physicians towards unbranded drugs through better quality assurance and education.
Enhance Monitoring Systems: Adopt and implement the Mashelkar committee’s recommendations, such as the appropriate ratio of drug inspectors to production and retail units for more effective monitoring.
For more information read here
Question for practice:
Discuss the key issues faced by India’s pharmaceutical industry and the government initiatives aimed at addressing these issues.
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