New Guidelines for Compounding Minor Drug Violations

The Central Drugs Standard Control Organization (CDSCO) has implemented new guidelines to compound minor drug violations, operationalizing a legal change initiated in 2023.

Background

• The guidelines stem from the Jan Vishwas (Amendment of Provisions) Act which focuses on decriminalizing and rationalizing offenses for ease of living and business.
• Previously, minor non-compliance under the Drugs and Cosmetics Act, 1940 led to criminal prosecution.

Key Changes

• Compounding allows firms to settle minor offenses by reporting them and paying a fine instead of facing litigation.
• The scope of Section 32B was broadened to include offenses like making or distributing drugs not covered by Section 27(a-c) of the Act.
• Compounding provides "immunity from prosecution" for the specific case, subject to conditions.

Potential Benefits

• Prevents unnecessary criminalization for record-keeping and disclosure offenses.
• Enables enforcement to focus on more severe violations.

Concerns and Pitfalls

• Risk of the guidelines becoming a ‘pay and pass’ scheme if not implemented transparently.
• Lack of public reporting on compounding orders may erode public faith in legal proceedings and the regulator.
• No provisions for consumer groups or whistle-blowers to participate before granting immunity.
• Broad interpretation of compoundable errors could lead to inconsistent application and reduced compliance.
• Need for linking compounding with corrective actions, follow-up inspections, and public actions like product recalls to ensure long-term risk reduction.