Drug makers must comply with revised norms: govt., Pg12

Key Highlights:

• The Union Health Ministry has mandated strict compliance with the revised Schedule M norms for drug manufacturers in India.
• Licenses of non-compliant pharmaceutical units will face cancellation as per the ministry's warning.
• This directive follows a report by the Tamil Nadu Drugs Control Department that found excess diethylene glycol (DEG) in Coldrif cough syrup samples.
• The compliance deadline for the revised Schedule M norms is December 31, 2025.

Detailed Insights:

• The revised Schedule M aligns Indian pharmaceutical standards with international Good Manufacturing Practices (GMP), emphasizing enhanced product quality and safety.
• The updated norms necessitate new infrastructure, including computerized storage systems and equipment validation for pharmaceutical manufacturers.
• Testing of cough syrup brands was initiated after reports of more than 10 children's deaths in Rajasthan and Madhya Pradesh.
• The Central Drugs Standard Control Organisation has recommended the cancellation of the manufacturing license of the unit producing Coldrif cough syrup.
• The Tamil Nadu Food and Drugs Administration has already issued a stop production order to the manufacturer of the implicated cough syrup.

Key Concepts Involved:

• Schedule M: Part of the Drugs and Cosmetics Act, it outlines Good Manufacturing Practices for pharmaceutical products in India.
• Good Manufacturing Practices (GMP): A system ensuring products are consistently produced and controlled according to quality standards.
• Diethylene Glycol (DEG): A toxic alcohol, its presence above permissible levels in pharmaceuticals can cause serious health issues.