Drug norms need sunlight, not silence

Published Date: 17-01-2026 | 12:48 am

The Central Drugs Standard Control Organisation (CDSCO)’s new standard operating procedure, released in January 2026, finally gives shape to a long-pending idea: allowing “compounding” of minor offences under drug law. The enabling rules came into force in April 2025, but only now has compounding become a working tool. Applicants may seek it before or after prosecution, provided they cooperate fully and disclose all facts. Immunity is conditional — and rightly so.

This is a practical step forward. Regulators must focus their energies on the biggest threats: spurious, adulterated, misbranded, or unsafe drugs. Criminalising clerical errors or labelling slips wastes capacity. But compounding must not become a backdoor escape. The Jan Vishwas Act expanded the list of compoundable offences. With that wider scope comes greater discretion. That discretion must be exercised transparently.

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The CDSCO should publish a redacted, searchable register of all compounding decisions. It should include the type of offence, product category, licence holder, amount compounded, corrective action taken, and whether the offence was a first. Riskier cases must be tied to real-world remedies — corrective action plans, follow-up inspections, and public alerts or recalls where needed.

Penalties should be scaled. Bigger firms and bigger risks should attract higher fines. Repeat violators should face escalating sanctions. A limited window for consumer representatives to submit comments in high-risk cases would also enhance accountability.

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Above all, the system must not rely on private file notes. It must show its workings. Done right, compounding can reduce judicial burden, promote self-correction, and improve safety. Done opaquely, it will only shift the problem out of view. The test of regulatory reform is not how much is permitted — but how clearly the public can see what is being done, and why.

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