CDSCO's Directive for Strict Compliance with Testing Standards

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Dated: 20.10.2025

CDSCO’s Directive for Strict Compliance with Testing Standards

The safety and quality of pharmaceutical products are of paramount importance, as they directly impact public health. In light of recent concerns, the Directorate General of Health Services (DGHS), under the Central Drugs Standard Control Organisation (CDSCO), has issued a directive to all State and Union Territory Drug Controllers to ensure strict compliance with the Drugs Rules, 1945, particularly concerning the testing of raw materials and finished formulations.

The Context: A Wake-Up Call

Recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups, have raised serious concerns about the quality of pharmaceutical products. Investigations have revealed lapses in the testing of raw materials, including excipients and active pharmaceutical ingredients (APIs), before their use in manufacturing. Additionally, some manufacturers have failed to test each batch of finished products, leading to the release of substandard drugs into the market.

Legal Mandates Under the Drugs Rules, 1945 

The Drugs Rules, 1945, explicitly mandate the testing of raw materials and finished products to ensure compliance with prescribed standards. Specifically:

Rule 74(c) and Rule 78(c)(ii): These rules require licensees to test each batch or lot of raw materials and finished products in their own laboratories or in laboratories approved by the licensing authority.
Schedule U: Manufacturers must maintain detailed records of these tests, ensuring traceability and accountability.

The Directive: Strengthening Compliance

The DGHS has urged State and UT Drug Controllers to take proactive measures to enforce these regulations. Key actions include:

Monitoring During Inspections: Regular inspections should ensure that manufacturers are conducting mandatory testing before the manufacture and release of products.
Sensitizing Manufacturers: Drug controllers are advised to issue circulars to educate manufacturers about the importance of compliance with testing requirements.
Vendor Qualification: Manufacturers must establish robust vendor qualification systems and source raw materials, including excipients, only from reliable and approved vendors.

The Way Forward

This directive underscores the critical role of regulatory authorities and manufacturers in safeguarding public health. By adhering to the Drugs Rules, 1945, and implementing stringent quality control measures, the pharmaceutical industry can prevent incidents of substandard or contaminated drugs reaching the market.

Conclusion

The recent incidents serve as a stark reminder of the consequences of non-compliance with drug safety regulations. It is imperative for all stakeholders in the pharmaceutical supply chain to prioritize quality and safety at every stage of production. The DGHS’s directive is a step in the right direction, ensuring that the health and safety of the public remain uncompromised.

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Source: CDSCO

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