Drug Controllers Urged to Ensure Rigorous Testing of Pharmaceutical Products Before Market Release

The Drugs Controller General of India has urged state drug controllers to rigorously test pharmaceutical products before market release following tragic incidents of children's deaths linked to contaminated cough syrup. The advisory highlights the need for compliance with safety standards in drug manufacturing.

The Drugs Controller General of India (DCGI) has called on state and Union Territory drug controllers to enforce testing of raw materials and finished pharmaceutical products. This action follows reports of child fatalities linked to contaminated cough syrup in Madhya Pradesh and Rajasthan. Five children in Madhya Pradesh are critically ill, and 20 have died from kidney infections after consuming syrup containing Diethylene Glycol (DEG) and Ethylene Glycol (EG).

In Rajasthan, at least three children have reportedly died after consuming cough syrup in various districts. The DCGI's advisory highlights that inspections revealed some manufacturers are not testing each batch of excipients and active ingredients for compliance with standards before use. This lack of testing was found during investigations into drugs deemed Not of Standard Quality.

Ensuring Compliance with Drug Standards

The DCGI has repeatedly stressed the importance of testing raw materials, including excipients, before using them in pharmaceutical formulations. Recent reports from Chhindwara, Madhya Pradesh, have raised concerns about the quality of cough syrups linked to child deaths. The advisory, dated October 7, emphasises that manufacturers must test each batch of excipients and active ingredients to ensure they meet prescribed standards.

According to the Drugs Rules, specifically rule 74 c and rule 78 c ii, licensees must test each batch or lot of raw materials used in product manufacturing. They must also test each batch of the final product in their laboratory or an approved one. Records or registers detailing these tests must be maintained as specified in Schedule U.

Strengthening Vendor Qualification Systems

The advisory urges all State and UT Drug Controllers to ensure testing is conducted before manufacturing and releasing batches to the market. This can be achieved through monitoring during inspections and sensitising manufacturers via circulars. Additionally, it is crucial that manufacturers have a robust vendor qualification system and source raw materials, including excipients, from reliable approved vendors only.

Inspections at manufacturing facilities revealed that some manufacturers are not conducting necessary tests on each batch of excipients and active ingredients. These tests are vital for verifying compliance with prescribed standards before using them in formulations and finished products.

The DCGI's advisory underscores the critical need for stringent testing protocols to prevent further incidents related to contaminated pharmaceutical products. Ensuring compliance with drug standards is essential for safeguarding public health and preventing tragedies like those reported in Madhya Pradesh and Rajasthan.

With inputs from PTI