Indian Pharma Needs Precision Surgery and Strong Recovery Pill (IE)
Introduction
India,
the “Pharmacy of the World”, is a leading global supplier of affordable generic
medicines. Yet, recurring quality concerns, regulatory weaknesses, and heavy
API import dependence have exposed deep structural gaps. Strengthening
regulation, quality systems, and innovation is now essential to sustain global
trust and ensure resilient, safe healthcare delivery.
Indian Pharma Requires
Structural Reforms ("Surgery")
1. Weak Drug Quality Regulation
I.
Repeated incidents of contaminated medicines have damaged India's
reputation.
II.
Fragmented coordination between the Central Drugs Standard Control
Organisation (CDSCO) and State Drug Controllers.
III.
Shortage of trained inspectors and inadequate manufacturing audits.
IV.
Weak post-market surveillance.
Example
WHO linked contaminated Indian
cough syrups to deaths of over 120 children in Africa and Central Asia?
2. Inadequate Regulatory Capacity
I.
Slow inspections and licensing.
II.
Outdated laboratory infrastructure.
III.
Uneven enforcement across states.
IV.
Regulatory gaps encourage substandard manufacturing.
3. Overdependence on Imported APIs
I.
Nearly 65% of Active Pharmaceutical Ingredients (APIs) continue
to be imported, largely from China.
II.
Supply-chain disruptions affect medicine availability and prices.
III.
Impact
Strategic
vulnerability during pandemics and geopolitical tensions.
4. Innovation Deficit
I.
Heavy reliance on generic medicines.
II.
Low investment in New Chemical Entities (NCEs), biologics and AI-driven
drug discovery.
III.
Private R&D spending remains significantly below global innovators.
5. Supply Chain and Distribution Loopholes
I.
Illegal sale of medicines.
II.
Online platforms with weak compliance.
III.
Leakage of physician samples.
IV.
Poor traceability of drug movement.
6. Erosion of Global Credibility
I.
Import alerts and warning letters from international regulators.
II.
Quality concerns affect exports despite India's manufacturing scale.
Why a Strong Recovery Pill
is Equally Necessary?
1. Strengthen Regulatory Governance
I.
Modernise CDSCO with adequate manpower and technology.
II.
Harmonise standards with WHO, USFDA and EMA.
III.
Risk-based inspections and digital monitoring.
2. Build a Quality-by-Design
Ecosystem
I.
Mandatory GMP compliance.
II.
AI-enabled manufacturing audits.
III.
Barcode-based drug traceability.
IV.
Strong pharmacovigilance.
3. Achieve API Self-Reliance
I.
Expand PLI Scheme for bulk drugs.
II.
Develop Bulk Drug Parks.
III.
Encourage domestic fermentation technology.
4. Shift from Generics to Innovation
I.
Increase R&D investment.
II.
Promote biosimilars, biologics and precision medicine.
III.
Faster approval pathways for innovative drugs.
IV.
Industry-academia collaboration.
5. Digital Transformation
I.
End-to-end digital supply chain.
II.
Blockchain-based drug authentication.
III.
AI-assisted quality inspections.
IV.
National medicine tracking platform.
6. Strengthen Global Competitiveness
I.
Diversify export markets.
II.
Align with global regulatory standards.
III.
Enhance India's role in global health security.
Government Initiatives
Supporting Recovery
·
Production Linked Incentive (PLI) Scheme for Pharmaceuticals.
·
PLI Scheme for Bulk Drugs (APIs).
·
Bulk Drug Parks Scheme.
·
Revised Schedule M for Good Manufacturing Practices.
·
Promotion of pharmaceutical research through PRIP (Promotion of
Research and Innovation in Pharma-MedTech).
·
Digitalisation through the SUGAM Portal and regulatory reforms.
Challenges in Implementing Reforms
·
Federal coordination issues between Centre and States.
·
High compliance costs for MSME manufacturers.
·
Skilled manpower shortages.
·
Balancing affordable medicines with strict regulation.
·
Limited investment in frontier pharmaceutical research.
Way Forward: From "Pharmacy of The World"
To "Innovation Pharmacy of The World"
·
Reform drug regulation through an autonomous, technology-enabled CDSCO.
·
Develop indigenous API and biotechnology ecosystems.
·
Increase public-private investment in pharmaceutical R&D.
·
Strengthen quality assurance across the value chain.
·
Build global trust through transparent and science-based regulation.
·
Integrate AI, genomics and digital manufacturing into pharmaceutical
production.
Conclusion
India’s
pharmaceutical sector stands at a crossroads between scale and sustainability.
While it remains a key supplier of affordable medicines, structural gaps
threaten its global credibility. A balanced push for regulatory reform, API
self-reliance, and innovation-led growth is essential to make Indian pharma a
trusted global hub of safe and high-quality medicines, aligned with Viksit
Bharat 2047.
SOURCE : https://www.newindianexpress.com/editorial/2026/Jun/22/indian-pharma-needs-a-surgery-and-strong-recovery-pill