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