CDSCO Mandates Strict Testing for Cough Syrups and other formulations Amid Child Death Crisis

CDSCO Mandates Strict Testing for Cough Syrups and other formulations Amid Child Death Crisis

In a stern response to a string of tragic child fatalities linked to contaminated cough syrups, Central Drugs Standard Control Organisation (CDSCO) has issued an urgent advisory demanding unwavering compliance with drug testing protocols. The directive, sent to all state and union territory drug controllers on October 7, underscores the life-or-death stakes in pharmaceutical manufacturing and aims to prevent future lapses that could endanger public health.

Alarming Spike in Child Deaths Sparks Regulatory Crackdown

The advisory comes on the heels of devastating reports from across the country where several children have succumbed to illnesses tied to adulterated cough syrups. Preliminary investigations by drug authorities revealed that these incidents were directly attributable to substandard and contaminated formulations, raising grave concerns over the quality of pediatric medications in the country.

Health experts and officials have long warned about the vulnerabilities in India’s vast pharmaceutical sector, but these recent cases have ignited a firestorm of scrutiny. “The loss of young lives is unacceptable and preventable,” said a senior CDSCO official,  “This advisory is a clarion call to enforce the rules that protect our most vulnerable populations.”

Key Mandates: Testing Every Batch, No Exceptions

At the heart of the notification is a zero-tolerance policy for skipping essential quality checks. Manufacturers are now required to rigorously test every batch of raw materials including critical excipients-before incorporating them into production lines. This extends to verifying active ingredients against prescribed standards, ensuring no contaminants slip through.

Under Rules 74(c) and 78(b)(i) of the Drugs Rules, 1945, licensees must conduct in-house or third-party laboratory analyses for both raw materials and finished products. All findings must be meticulously recorded in registers as outlined in Schedule U, providing a transparent audit trail for regulators.

The CDSCO emphasized that finished cough syrups must undergo comprehensive testing before release into the market. “Any deviation from these protocols will invite severe repercussions,” the advisory warns, signaling potential license suspensions or closures for non-compliant firms.

Vendor Vetting and Systemic Safeguards Urged

To root out risks at the source, the regulator has directed state controllers to monitor manufacturers’ supply chains closely. Firms must source raw materials exclusively from “reliable approved vendors,” with circulars and other oversight mechanisms deployed to enforce accountability.

Further, drug controllers are tasked with ensuring that testing infrastructure—whether in-house labs or external facilities—meets international benchmarks. The advisory calls for proactive measures, such as unannounced inspections, to verify compliance and prevent the kind of oversights that led to the recent tragedies.

“You are requested to acknowledge receipt of this letter and intimate the action taken in this regard,” the document concludes, placing the onus on regional authorities to act swiftly.

Broader Implications for Pharma Industry and Public Health

This move is poised to reshape operations across India’s $50 billion pharmaceutical industry, which supplies a significant portion of the world’s generic drugs. Industry watchers predict a short-term surge in compliance costs, but long-term gains in trust and safety. The CDSCO, under the Ministry of Health and Family Welfare, has reiterated its commitment to upholding the highest standards through its New Delhi headquarters and nationwide network. For more details, stakeholders are directed to the CDSCO website.

Click here to know more and access the official guidance document

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