Stories
India's Drug Panel Rejects Public Disclosure of Batch Test Reports, Citing Authenticity Concerns
- •India's top drug advisory panel, the Drugs Consultative Committee (DCC), declined a proposal for a public digital platform for drug quality reports.
- •The proposal aimed to mandate drugmakers to upload batch test reports or certificates of analysis to a public portal.
- •The DCC's main objection was that mere uploading by manufacturers would not guarantee authenticity or quality without effective verification and regulatory oversight.
- •The committee emphasized that tougher regulatory work, including risk-based inspections, effective audits, independent sampling, and firm enforcement, would improve drug quality more effectively.
- •While rejecting the current proposal, the expert panel suggested that any future digital disclosure mechanism should be part of a broader verifiable regulatory system, not a substitute for inspections and testing.
Key Questions Answered
The Drugs Consultative Committee declined the proposal because mere document uploading by manufacturers does not prove authenticity or ensure drug quality without effective verification and regulatory oversight. The panel emphasized that risk-based inspections, audits, and enforcement actions contribute more directly to drug quality improvements.
Under the Drugs and Cosmetics Act and revised Schedule M Good Manufacturing Practice rules, manufacturers must test each batch, keep records, and produce certificates of analysis for inspectors upon request. Quality is primarily monitored through risk-based inspections, independent sampling, and regulatory audits rather than public databases.
Industry officials noted that publishing certificates of analysis without a clear verification mechanism could confuse patients, expose commercially sensitive information, and increase compliance burdens. They argued that any future disclosure platform must be carefully designed with the industry to include clear rules on verification and public data interpretation.
