SYLLABUS
GS-2: Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.
Context: The Union Health Ministry has directed all drug manufacturers to ensure strict compliance with the revised Schedule M norms under the Drugs and Cosmetics Act, 1940.
More on the News
- The Ministry warned that licences of non-compliant units would be cancelled.
- The directive followed an emergency meeting held with all States and Union Territories, after a report by the Tamil Nadu Drugs Control Department found above permissible levels of diethylene glycol (DEG) in samples of Coldrif, a cough syrup brand.
- This development came amid reports of the death of more than 10 children in Rajasthan and Madhya Pradesh, prompting nationwide testing of cough syrup brands.
Drugs and Cosmetics Act, 1940
• The act was enacted by the Parliament of India to regulate the import, manufacture, distribution, and sale of drugs and cosmetics in India.
Key Provisions:
- The Act defines standards for drug quality, misbranding, adulteration, and identification of spurious drugs.
- The Act empowers drug inspectors with authority to inspect premises and take action against violations.
- It provides for penalties and confiscation of illegal drugs and cosmetics to ensure compliance.
- The Act establishes technical advisory bodies such as the Drugs Technical Advisory Board and the Central Drugs Laboratory to maintain standards.
- The Drugs and Cosmetics Rules, 1945 specify detailed regulations for packaging, labelling, licensing, and sale of drugs.
- The Act incorporates clinical trial regulations and accommodates amendments to address advances in pharmaceutical science.
About the Revised Schedule M
• Schedule M prescribes Good Manufacturing Practices (GMP) for pharmaceutical production, ensuring safety, efficacy, and quality of medicines.
• It is a part of the Drugs and Cosmetics Act, 1940.
Key Features:
- Introduction of Pharmaceutical Quality Systems and Quality Risk Management.
- Requirement of computerised storage systems and equipment validation.
- Alignment with international GMP standards to enhance product quality and patient safety.
• Deadline for Compliance: December 31, 2025.
Additional Directions to States and UTs
- Ensure enhanced surveillance and timely reporting by all health facilities.
- Promote use of the Integrated Disease Surveillance Programme (IDSP) community reporting tool, now merged with the Integrated Health Information Platform (IHIP).
- Strengthen inter-State coordination for early reporting and joint regulatory action.
- Monitor rational use of cough syrups, particularly in paediatric cases.
Sources:
Economic Times.India Times
PIB
Times of India.India Times
The Print
Ptinews