Drug Regulator Calls Schedule M Adoption ‘Top Priority’, Orders Immediate Inspections Across India

Last Updated:November 08, 2025, 12:00 IST

Schedule M lays down India’s Good Manufacturing Practice standards for medicines. CDSCO has ordered states and UTs to begin immediate inspections to ensure compliance

Good Manufacturing Practices are globally recognised standards that ensure drugs are consistently produced and controlled according to quality benchmarks. (Representative image)

Calling the implementation of India’s revised manufacturing standards for medicines a “top priority", the country’s apex drug regulatory body, the Central Drugs Standard Control Organisation (CDSCO), has directed all states and Union Territories to begin immediate inspections, News18 has learnt.

In an official communication dated November 7, CDSCO’s chief and Drugs Controller General of India (DCGI), Rajeev Singh Raghuvanshi, issued a directive to inspect manufacturing units that have “not applied for extensions under the revised Schedule M".

Good Manufacturing Practices, or GMP, are globally recognised standards that ensure drugs are consistently produced and controlled according to quality benchmarks. Schedule M under India’s Drugs and Cosmetics Rules lays down these GMP requirements — covering facility design, equipment, hygiene, documentation, and quality assurance systems that manufacturers must follow.

What Does The Latest Order Say?

The letter, seen by News18, stresses that while companies granted extensions have time until 1 January 2026 to implement the new requirements, units that did not seek an extension must be inspected and, where necessary, prosecuted without delay.

“…you are requested to initiate planning for carrying out relevant inspections of manufacturing units who have applied for extension of revised Schedule M and the effective date for revised Schedule M implementation for them is 1 January 2026, to verify their compliance with the requirements," the letter states.

“However, immediate inspection and action shall be initiated right now for those units who have not applied for the extension, as the revised Schedule M is already applicable for such units."

Apart from ordering inspections and enforcement measures, the regulator has warned that any manufacturing unit found non-compliant during checks will face strict action under the Drugs and Cosmetics Act and related rules.

The directive also requires monthly compliance reports from all states and Union Territories, detailing inspections conducted, observations made, and actions taken. The DCGI said the exercise must be treated as a “top priority" to ensure strict nationwide adherence to the upgraded GMP framework.

Notified in December 2023, the revised Schedule M aims to modernise India’s manufacturing standards and align them with global benchmarks for drug quality, safety, and documentation practices.

Himani Chandna

Himani Chandna, Senior Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India's COVID-19 battle, she brings a seasoned perspective. She is particular...Read More

Himani Chandna, Senior Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India's COVID-19 battle, she brings a seasoned perspective. She is particular...

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