CDSCO Completes Comprehensive Audit of 90% of India's Cough Syrup Manufacturers Following Safety Concerns
核心洞察
The Central Drugs Standard Control Organisation (搜索) has audited over 1,250 out of 1,300 cough syrup (搜索) manufacturers across India following quality concerns and child deaths linked to contaminated products.
Maharashtra FDA (搜索) and CDSCO (搜索) jointly conducted 64 risk-based inspections between April 2025 and January 2026, resulting in stop production orders, license suspensions, and warning letters for non-compliant facilities.
Over 850 Corrective and Preventive Action notices have been served to manufacturers, with satisfactory responses still pending from many companies.
The Central Drugs Standard Control Organisation (搜索) (CDSCO (搜索)) has completed a comprehensive audit of nearly 90% of India's cough syrup (搜索) manufacturers, examining over 1,250 out of 1,300 facilities nationwide as part of an intensive regulatory overhaul following safety concerns and reported child deaths linked to contaminated products.
Speaking at the 11th Global Pharmaceutical Quality Summit, Drugs Controller General of India Sanjiv Singh Raghuvanshi detailed the extensive inspection program that has resulted in serious repercussions for manufacturers with major non-compliances. The auditing process now involves both state and central regulators working in accordance with revised manufacturing norms.
Risk-Based Inspection Program Intensifies
Between April 1, 2025, and January 31, 2026, the Maharashtra Food and Drug Administration (搜索) and CDSCO (搜索) jointly conducted 64 risk-based inspections across Maharashtra state to assess compliance of drug manufacturing units. These inspections resulted in various enforcement actions including Stop Production Orders, license suspensions and cancellations, warning letters, and Show Cause Notices, depending on the severity of non-compliance identified.
The initiative has provided valuable insights into manufacturing practices and led to relevant corrective and preventive actions aimed at improving the regulatory framework, according to senior officials. Since the nationwide risk-based inspection program began in December 2022, over 905 units have been inspected, resulting in more than 694 enforcement actions.
Response to Contamination Crisis
The intensified inspection program was initiated following reports of child deaths in Madhya Pradesh and Rajasthan allegedly linked to contaminated cough syrups in 2025. CDSCO (搜索) launched risk-based inspections of drug manufacturing units in six states after collecting 19 samples, including cough syrups, antipyretics (搜索), and antibiotics (搜索).
Despite serving over 850 Corrective and Preventive Action notices in recent months, satisfactory responses remain pending from many manufacturers, underscoring ongoing challenges in the pharmaceutical sector. Raghuvanshi affirmed that eliminating entrenched issues in cough syrup (搜索) manufacturing is on the horizon following the risk-based inspections and enforcement of Schedule M standards.
Revised Manufacturing Standards Implementation
The regulatory overhaul includes implementation of revised Schedule M guidelines under the Drugs & Cosmetics Act 1940. The Union Ministry of Health and Family Welfare extended the compliance deadline for pharmaceutical MSMEs to December 31, 2025, providing an additional 12 months for companies with turnovers less than Rs. 250 crore to meet the new requirements.
Around 80% of India's 10,500 drug manufacturing units fall under the MSME category. Companies seeking the extension were required to file applications by May 11, 2025, with detailed upgradation plans. Inspections of MSME firms that submitted upgradation plans began in January 2026.
Enhanced Quality Standards
The revised Schedule M guidelines mandate several key improvements including modernized facilities to prevent contamination (搜索) and improve cleanliness, validated equipment with stringent maintenance requirements, environmental controls adhering to global standards for air, water, and waste management, robust Pharmaceutical Quality Systems to guarantee consistent quality, and regular Product Quality Reviews to ensure ongoing compliance.
Originally mandated in December 2023, the revised guidelines required units with turnovers above Rs. 250 crore to comply within six months, while smaller manufacturers had a one-year timeline. Drug manufacturers meeting the initial deadline for large companies in June 2024 have already completed their transitions to the new standards.