Centre Directs States to Strengthen Drug Quality Checks and Regulate Cough Syrup Use in Children
SDG 3: Good Health and Well-Being | SDG 12: Responsible Consumption and Production
Institutions: Ministry of Health and Family Welfare | Central Drugs Standard Control Organisation (CDSCO)
The Ministry of Health and Family Welfare (MoHFW) convened a high-level meeting chaired by Union Health Secretary Smt. Punya Salila Srivastava with all States and Union Territories to address growing concerns around the quality and misuse of cough syrups, particularly among children. The meeting follows directions from Union Health Minister Shri J. P. Nadda and called for urgent enforcement of the Revised Schedule M of the Drugs and Cosmetics Rules, 1945, which prescribes Good Manufacturing Practices (GMP) and facility standards for all drug producers. States were instructed to conduct risk-based inspections, identify and take strict action against non-compliant units, and ensure enhanced surveillance and timely reporting from all healthcare facilities through the IDSP-IHIP platform.
The meeting also emphasised rational use of cough syrups, highlighting that most childhood coughs are self-limiting and do not require pharmacological treatment. States were urged to curb the irrational sale and formulation of cough medicines, strengthen pharmacy regulation, and promote public awareness on the safe and limited use of paediatric syrups. Risk-Based Inspections (RBI) have already been initiated across 19 manufacturing units in six States to strengthen quality assurance and prevent recurrence of lapses seen in earlier international cases.
What are the Drugs and Cosmetics Rules, 1945?
A key regulatory framework under the Drugs and Cosmetics Act, 1940, these rules govern the manufacture, sale, import, labelling, and quality control of medicines and cosmetics in India. They empower authorities to license producers, inspect facilities, and enforce safety standards, forming the legal basis for provisions like Schedule M, which defines Good Manufacturing Practices (GMP) to ensure public health protection.
The Revised Schedule M of the Drugs and Cosmetics Rules, 1945 is Indiaβs updated framework governing Good Manufacturing Practices (GMP) for pharmaceutical companies. Schedule M sets the minimum mandatory standards that every drug manufacturing unit in India must meet to ensure quality, safety, and consistency of medicines. It covers requirements for infrastructure, equipment design, hygiene, documentation, testing, personnel training, waste disposal, and environmental controls within factories.
The 2023β24 revision of Schedule M, implemented by the Central Drugs Standard Control Organisation (CDSCO) was a major policy reform aimed at aligning Indian pharmaceutical manufacturing with global regulatory standards such as those of the WHO, US FDA, and EU EMA. It introduced stricter norms for air handling, cross-contamination prevention, traceability, and batch documentation, and made adherence mandatory for all manufacturers, not just exporters.
Embedded within this framework, Good Manufacturing Practices (GMP) are the operational principles that ensure that every step of drug production-from procurement of raw materials to packaging and distribution-follows a controlled, validated, and auditable process. In short, GMP ensures that each batch of medicine is produced and tested under the same rigor as the previous one, preventing variations that could harm patients.
Together, the Revised Schedule M and GMP system mark Indiaβs move from reactive inspection-based oversight to a preventive, systems-driven approach, safeguarding both domestic consumers and Indiaβs reputation as a global supplier of affordable medicines.
Relevant Question for Policy Stakeholders:
How can India build an integrated pharmacovigilance system that links manufacturing quality data, prescription behaviour, and community reporting to safeguard child health and drug safety?
Follow the full news here: https://www.pib.gov.in/PressReleasePage.aspx?PRID=2175135