Pharma Firms Can Now Pay Fines for Minor Violations, Avoid Trials
India
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News18•05-01-2026, 16:34
Pharma Firms Can Now Pay Fines for Minor Violations, Avoid Trials
- •New rules allow pharmaceutical companies to settle minor regulatory violations by paying fines instead of facing court trials.
- •The "compounding of offences" process is introduced via the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, under the Jan Vishwas Act.
- •CDSCO, under the Ministry of Health, has issued guidance; the Additional Director General of Health Services acts as the compounding authority.
- •Only minor technical or paperwork errors, not posing public health risks, are eligible; serious violations still incur criminal penalties.
- •Industry experts welcome the move, citing benefits like quicker self-correction, reduced court burden, and improved ease of doing business.
Why It Matters: New rules enable pharma companies to resolve minor violations with fines, streamlining justice and business.
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