Enforce global standards by Jan, launch inspections: DCGI to states, Pg14.

Key Highlights:

• DCGI has directed states to enforce Good Manufacturing Practices (GMP) aligned with global standards by January 2026.
• No extension was granted on the December 2025 deadline for implementing revised Schedule M.
• The directive follows incidents of contaminated cough syrups, including a recent case in Madhya Pradesh where 22 children died.
• State drug regulators are instructed to begin inspections, prioritizing units that did not apply for an extension.

Detailed Insights:

• The revised Schedule M, notified in 2023, upgraded GMP to include requirements for pharmaceutical product plan and equipment.
• Smaller pharmaceutical manufacturers were initially given a year's extension to implement stricter norms, provided they applied to the DCGI with an upgrade plan.
• Stricter norms were introduced after incidents in 2022 and 2023 where exported cough syrups from India contained excessive levels of diethylene glycol and ethylene glycol.
• Approximately 2,000 large pharmaceutical manufacturing units in India, largely compliant due to adherence to WHO norms for exports, were given six months to comply.
• Around 8,500 smaller manufacturing units requested more time to implement the norms due to required infrastructure modifications.
• State regulators must submit monthly reports on inspections, observations, and actions taken against non-compliant units.

Key Concepts Involved:

• Good Manufacturing Practices (GMP): A system ensuring products are consistently produced and controlled according to quality standards.
• Schedule M: Part of the Drugs and Cosmetics Rules, outlining GMP requirements for pharmaceutical manufacturing in India.
• Diethylene Glycol: A toxic contaminant found in some cough syrups, leading to health issues and fatalities.