PHARMA SECTOR IN INDIA (Syllabus: GS Paper 3 – Sci and Tech)

Context: India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has withdrawn powers delegated to State licensing authorities to issue NOCs (no objection certificates) for manufacture of unapproved, banned or new drugs for export purposes.

Pharma Sector in India

• Global Ranking: India ranks third worldwide as a producer of drugs and pharmaceuticals by volume, a testament to its significant role in the global pharmaceutical market.
• Dominance in Vaccine Supply: Supplying 62% of the global demand for vaccines, India stands as a crucial player in global vaccination efforts, underscoring its pivotal role in public health.
• Vaccine Suppliers: India emerges as a leading supplier of key vaccines such as DPT (diphtheria, pertussis, and tetanus), BCG (Bacillus Calmette-Guérin), and measles vaccines, contributing significantly to global immunization programs.
• WHO Vaccine Sourcing: At least 70% of the World Health Organization's vaccines, as per the essential immunization schedule, are sourced from India, highlighting the country's indispensable contribution to global healthcare initiatives.
• Dominance in Generic Medicines: The country is the largest provider of generic medicines worldwide, commanding a 20% share in global supply by volume. 
• Global Export Hub: India exports pharmaceuticals to over 200 countries worldwide. It meets over 50% of Africa's requirement for generics, nearly 40% of the generic demand in the US, and approximately 25% of all medicine needs in the UK.

Impact on India's Position in the Generic Medicine Market

• Status: India's pivotal role in the international generic medicine market implies that any policy change directly affects manufacturers and importers.
• Licensing Authority: Industry insiders highlight the significance of centralizing the licensing authority. This move aims to streamline regulatory processes and ensure efficient market entry for generic drugs.
• Landmark Changes Expected: The sector anticipates landmark changes as numerous drugs go off-patent, paving the way for the entry of generic products into the market.