Central Drugs Standard Control Organisation (CDSCO) Alert Summary

Overview

The CDSCO flagged select batches of two drugs as spurious and listed 111 other drugs and formulations as not of standard quality (NSQ) in their November 2024 update.

Spurious Drugs Identified

The flagged spurious drugs include:

• Pan D marketed by Alkem Laboratories.
• Augmentin 625 Duo marketed by GlaxoSmithKline Pharma.

The alert does not name the drug manufacturers as the batches were reportedly not produced by them but were imitated by unauthorized entities.

Investigation and Regulatory Surveillance

An investigation has been initiated to identify unauthorized manufacturers. The CDSCO conducts continuous surveillance by sampling drugs from sales/distribution points and maintains a monthly list of spurious drugs to inform stakeholders.

Non-Standard Quality (NSQ) Drugs

A total of 111 drugs were identified as NSQ, categorized by the following:

• 41 drugs identified by central drug laboratories.
• 70 drugs flagged by state drug testing labs.

Examples of NSQ drugs include:

• Ozomet PG2 tablets by Ozone Pharmaceuticals (hypertension medication).
• Tofajak tablets by Cipla (treatment for rheumatoid arthritis).
• Monit SR30 tablets by Intas Pharma (chest pain medication).

Geographical Production Insights

Most of the NSQ drugs were produced in major pharmaceutical hubs like Ahmedabad, Baddi, Puducherry, Haridwar, and Roorkee.

Significance of Reporting

The increased reporting from state drug authorities to the central database signifies improvement in the tracking and availability of quality medicines.