CDSO's Tactical Overhaul in Cough Syrup Manufacturing Set to Transform Pharmaceutical Standards

The Central Drugs Standard Control Organisation (CDSO) has audited nearly 90% of India's cough syrup manufacturers, aiming to rectify compliance issues by the next season. Through enhanced audits and revised regulations, the CDSO seeks to elevate pharmaceutical standards, impacting both the domestic industry and the global market.

The Central Drugs Standard Control Organisation (CDSO) has undertaken a comprehensive audit of almost 90% of the country's cough syrup manufacturers, aiming to address quality concerns by the upcoming season, according to a top official.

In his remarks at the 11th Global Pharmaceutical Quality Summit, Sanjiv Singh Raghuvanshi, the Drugs Controller General of India, highlighted the dual auditing process now involving both state and central regulators, in accordance with revised manufacturing norms. He detailed the extensive inspections, revealing that over 1,250 out of 1,300 manufacturers have been physically audited, leading to serious repercussions for major non-compliances.

Raghuvanshi affirmed that eliminating the entrenched issues in cough syrup manufacturing is on the horizon, following risk-based inspections and enforcement of Rule M standards. Despite serving 850 Corrective and Preventive Action notices in recent months, satisfactory responses remain pending, underscoring the ongoing challenges in the pharmaceutical sector.

(With inputs from agencies.)