Branded Medicines: Patented, innovative drugs with high cost due to exclusivity.
Branded Generics (87% share): Off-patent drugs sold under brand names at higher prices than true generics.
Problem: Patients face higher costs without receiving innovation benefits—called the 'worst of both worlds.'
3. Weaknesses in India’s Pharmaceutical Regulation
Delayed Safeguards: Good Manufacturing Practices (GMP), inspections, and pharmacy vigilance were adopted late.
Fragmented Policy: Reforms came through piecemeal notifications, not holistic laws.
Institutional Fragmentation:
- CDSCO (Central Drugs Standard Control Organization): Approves new drugs, imports, trials.
- State Drug Regulatory Authorities (SDRAs): Handle licensing, monitoring, prosecutions.
- DTAB, DCC, CDL: Advisory, coordination, and testing roles.
Issue: Centre–State division leads to duplication, weak enforcement, and gaps in accountability.
4. Key Challenges in Drug Quality & Regulation
Enforcement Weakness: Overlapping jurisdictions, weak penalties, and poor monitoring.
State-Level Constraints: Lack of labs, inspectors, and technical training; inadequate resources reduce the ability to check spurious/substandard drugs.
Dependence on Imports: APIs largely sourced from China and Taiwan, creating supply chain and quality risks.
Financial Constraints: Regulators depend on delayed government funds, affecting efficiency.
Lack of Transparency: No centralized database of manufacturers, unclear timelines, poor record-keeping.
Pharmacy vigilance Gaps: Limited reporting of adverse drug reactions (ADR), weak communication of outcomes.
Data Integrity Issues: Several Indian firms flagged for unreliable research and testing practices.
5. Consumer Behavior & Trust Deficit
Most patients prefer branded generics despite the availability of cheaper true generics.
Reasons: Aggressive marketing by pharmaceutical companies and lack of government-led awareness campaigns.
Result: Erosion of trust in both domestic consumers and international markets.
6. Regulatory Measures Taken
Strengthening of States’ Drug Regulatory System (SSDRS) – support for labs and regulators.
2008 Amendment to DCA – stricter penalties for spurious drugs, some offences made non-bailable.
Mandatory Inspections before granting manufacturing licenses (Rules, 1945).
Schedule M Revision – adoption of WHO-GMP standards.
Pharmaceuticals Technology Up gradation Assistance Scheme (PTUAS) – financial support for small units (turnover < ₹500 crore).
Special Courts – fast-track cases under the Drugs and Cosmetics Act.
7. New Frontiers in Drug Sales
Online Pharmacies: Studies show unsafe practices (delivery without prescription).
Retail Chains: Evidence of better quality control and small reduction in prices; potential if strictly regulated.
8. Way Forward
Strengthened Regulation: More funding for inspections, licensing, and testing.
Financial Autonomy: Regulators should generate and manage their own revenue.
Digital Reforms: Centralized drug database, real-time pharmacy vigilance through digital reporting, better record-keeping and transparency.
Consumer Awareness: Sustained campaigns to promote trust in generics.
Uniform National Standards: Greater centralization of regulatory powers in CDSCO, better coordination with SDRAs.
Capacity Building: Training drug inspectors, upgrading labs, and ensuring adequate staff at both Centre and state level.
9. Conclusion
India’s pharmaceutical industry is a pillar of global healthcare, but its reputation is at risk due to regulatory lapses, over-reliance on branded generics, and weak consumer trust.
To sustain its role as the 'Pharmacy of the World', India must:
- Shift from reactive to proactive regulation.
- Strengthen Centre–State cooperation.
- Improve consumer awareness about true generics.
- Invest in digital monitoring and robust inspections.
Success in these reforms will secure India’s global reputation, safeguard domestic public health, and support its economic future.
