​Ensure compliance, Pg6

Key Highlights:

• The Union Health Ministry has mandated strict drug compliance from Indian drug manufacturers, aligning with revised Schedule M norms.
• This action followed a report by the Tamil Nadu Drugs Control Department that found excessive levels of diethylene glycol (DEG) in samples of Coldrif cough syrup.
• The cough syrup is suspected to be linked to the deaths of at least 14 children in Rajasthan and Madhya Pradesh.
• The Central Drugs Standard Control Organisation has recommended the cancellation of the manufacturing license of the implicated firm.

Detailed Insights:

• The Tamil Nadu Drugs Control Department identified non-compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) at the manufacturing facility.
• The contaminated batch of cough syrup used non-pharmacopoeial grade propylene glycol as an excipient, potentially leading to contamination with DEG and ethylene glycol.
• The incident highlights the need for stringent quality control in the pharmaceutical sector to ensure the safety and efficacy of drugs produced under the Atmanirbhar Bharat initiative.
• Effective monitoring, regular inspections, and strict enforcement of regulations are crucial to prevent the production and distribution of substandard drugs that endanger public health.

Key Concepts Involved:

• Schedule M Norms: Guidelines for Good Manufacturing Practices (GMP) that pharmaceutical manufacturers must adhere to in India.
• Diethylene Glycol (DEG): A toxic alcohol that, when present in drugs, can cause kidney failure and death.
• Good Manufacturing Practices (GMP): A system ensuring that products are consistently produced and controlled according to quality standards.