Context:
The Central Drugs Standard Control Organisation (CDSCO) has issued new guidelines enabling compounding of minor drug-related offences, following amendments introduced through the Jan Vishwas (Amendment of Provisions) Act, 2023. The move aims to promote ease of doing business while maintaining regulatory oversight.
Key Highlights:
Legal & Policy Basis
- Amendment to Section 32B of the Drugs and Cosmetics Act, 1940.
• Expansion of list of compoundable offences.
• Linked to broader decriminalisation reforms under the Jan Vishwas Act.
Scope of Compoundable Offences
- Manufacturing for sale/distribution in breach of the Act (excluding serious offences under Section 27(a–c)).
• Stocking or exhibiting non-spurious and non-adulterated drugs in violation of procedural norms.
• Covers a wide spectrum — from documentation lapses to compliance failures.
Mechanism
- Firms can settle offences by paying prescribed fines.
• Provides “immunity from prosecution” for that specific case.
• Compounding is discretionary and subject to regulatory approval.
Concerns Raised
- Risk of becoming a “pay and pass” regime if transparency is lacking.
• No mandatory public disclosure of compounding orders.
• Limited scope for consumer groups or whistle-blowers to intervene.
• Weak linkage with corrective compliance mechanisms.
Relevant Prelims Points:
- Drugs and Cosmetics Act, 1940 – Regulates manufacture, sale, and distribution of drugs and cosmetics in India.
• Section 27(a–c) – Deals with severe penalties for adulterated or spurious drugs.
• Compounding of offences – Settlement of offences by payment of fine, avoiding criminal prosecution.
• Jan Vishwas Act, 2023 – Decriminalises minor offences across multiple laws to improve business climate.
• Role of CDSCO – National regulatory authority for pharmaceuticals and medical devices.
Relevant Mains Points:
- Reflects shift from criminalisation to compliance-based regulation.
• Balances regulatory enforcement with economic efficiency.
• Raises governance concerns regarding:
– Transparency
– Accountability
– Consumer protection - Effective regulation requires coupling compounding with:
– Corrective actions
– Follow-up inspections
– Public alerts and recalls - Illustrates broader debate: Ease of Doing Business vs Public Health Safeguards.
Way Forward
- Ensure mandatory disclosure of compounding decisions.
• Integrate compounding with risk-based inspections.
• Establish grievance redress mechanisms for stakeholders.
• Strengthen pharmacovigilance and quality audits.
UPSC Relevance:
- GS 2 – Governance, Regulatory Reforms
• GS 3 – Economy (Business Reforms, Pharmaceutical Sector)
• Prelims – Drugs and Cosmetics Act, Jan Vishwas Act