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India Considers Public Platform for Drug Batch-Test Reports
India’s drug regulator is considering a website or digital platform for medicine test reports.
The reports would show whether individual batches of medicines passed quality checks.
People could use the information to learn more about medicines being sold.
The idea was discussed after five women died in Kota after receiving spurious oxytocin injections.
Currently, the public mainly sees monthly notices about medicines that fail quality standards.
The proposal may require changes to India’s drug laws.
An industry representative said publishing every report may be too difficult because there are many medicine batches and pharmacies.
He said authorities should first improve warnings and recalls for unsafe medicines.
The plan is still being considered and has not been presented as a final policy.
India’s drug regulator is considering a digital platform for public access to batch-level medicine quality-test reports.
The proposal followed a Rajasthan regulator’s representation after five women died in May following spurious oxytocin injections in Kota.
The plan would expand beyond monthly alerts identifying medicines classified as not of standard quality.
A proposed legal change could add digital disclosure requirements to the Drugs and Cosmetics Act, 1940, and its rules.
Industry representatives questioned the practicality of publishing every test report and urged stronger recalls and immediate safety alerts.
- Who
- India’s drug regulator, the Rajasthan drug regulator, pharmaceutical manufacturers, and industry representatives.
- What
- A proposal to create a digital platform publishing batch-level quality-test reports for medicines.
- Where
- India, following an incident in Kota, Rajasthan.
- When
- The proposal was discussed in the second week of September, after a related incident in May.
- Why
- To improve transparency and allow the public to access information about medicine quality; industry representatives also called for more actionable recalls and alerts.
Transparency and Public Access
Practicality and Actionable Enforcement
Publishing test reports
Transparency and Public Access
The Rajasthan drug controller said manufacturers’ pre-marketing quality-test reports should be made public so people can access information about the medicines they use.
Practicality and Actionable Enforcement
Uday Bhaskar, former director general of Pharmexcil, said universal digital disclosure may be impractical and may not provide meaningful value to consumers.
Regulatory priority
Transparency and Public Access
The proposed platform would expand transparency beyond the current system of publishing monthly not-of-standard-quality alerts.
Practicality and Actionable Enforcement
Bhaskar said authorities should prioritize immediate communication of critical safety information to retailers, wholesalers, and consumers, supported by an effective recall mechanism.
Key facts
- Proposal
- A digital platform for public access to manufacturers’ medicine quality-test reports.
- Regulatory body
- The Central Drugs Standard Control Organisation and the Drugs Controller General of India are involved in considering the proposal.
- Triggering incident
- Five women died in May after being administered spurious oxytocin injections at a Kota hospital, according to the report.
- Current system
- Authorities publish monthly alerts for medicines classified as not of standard quality.
- Possible legal change
- The proposal calls for suitable provisions in the Drugs and Cosmetics Act, 1940, and its rules.
- Industry scale
- India has more than 3,000 drug companies and 10,500 manufacturing facilities supplying domestic and global markets.
- Industry concern
- An industry representative said universal disclosure would be impractical given the number of batches and more than 800,000 retail chemists.
Quotes
Uday Bhaskar
Former director general of Pharmexcil, an industry export body
“Instead of these unfeasible plans, authorities should start by focusing on 'not of standard quality' products. Rather than merely uploading them to a website, that critical information must be communicated immediately down the line to every retailer, wholesaler, and consumer, backed by an effective drug recall mechanism. The priority must be actionable safety over digital platforms.”
livemint.com
“Practically, universal digital disclosure is not possible. With manufacturers producing crores of batches and over 8 lakh retail chemists across India, making every record available to all consumers adds no serious value.”
livemint.com
Rajasthan government document
Government communication from Rajasthan’s food safety and drug control department
“It is proposed that a suitable provision may be incorporated in the Drugs and Cosmetics Act, 1940 and Rules thereunder, 1945 for creation of a digital platform on which the quality-testing reports of drugs carried out by the manufacturers may be made available in the public domain to enable the general public to access the quality-testing reports of medicines being used by them, and thereby provide greater transparency regarding the quality of drugs.”
livemint.com
Sources
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