India Mandates Testing of All Pharmaceutical Batches After Tragedy

The Central Drugs Standard Control Organisation (CDSCO) has mandated that all pharmaceutical manufacturers conduct rigorous testing of every batch of raw materials and finished products. This directive follows the tragic deaths of more than 20 children in Madhya Pradesh and Rajasthan, attributed to adulterated cough syrups.

In an official communication dated October 8, 2025, Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI), underscored the urgency of compliance with the Drugs Rules, 1945. He stated that testing must encompass all components, including excipients and active pharmaceutical ingredients (APIs), prior to market release. The CDSCO’s directive aims to bolster the safety of pharmaceuticals in India, ensuring that manufacturers adhere to stringent quality control measures.

Recent inspections of cough syrup manufacturing facilities revealed alarming lapses among certain producers. These manufacturers failed to perform the essential batch-wise testing of both raw materials and finished formulations. Such oversights violate specific provisions outlined in Rules 74(c) and 78(c)(ii) of the Drugs Rules, 1945, which are designed to safeguard public health.

The enforcement of these testing measures is now a priority for the CDSCO, as the organization seeks to prevent further incidents that could endanger lives. Given the serious implications of the recent deaths, state and union territory drug controllers have been instructed to ensure compliance with these regulations across all manufacturing sites.

The CDSCO’s directive reflects a broader commitment to enhancing pharmaceutical safety and quality in India. By holding manufacturers accountable for thorough testing, the regulatory body aims to restore public confidence in the healthcare system and prevent future tragedies linked to contaminated products.

As the situation develops, stakeholders in the pharmaceutical industry will be closely monitoring the implementation of these new testing protocols. The CDSCO’s actions underscore the critical importance of stringent quality control in safeguarding public health.