Why in news?
To enhance the quality of medicines produced in India, the government updated Schedule M of the Drugs and Cosmetics Rules in December 2023. In 2025 the compliance deadline for small manufacturers was extended to give them more time to upgrade their facilities. Schedule M lays down Good Manufacturing Practices (GMP) for pharmaceutical companies.
Major updates in the revised norms
- Pharmaceutical Quality System (PQS): Companies must establish a structured quality management system covering the entire product lifecycle from development to distribution.
- Quality Risk Management (QRM): Risk assessments are required to identify potential hazards and implement appropriate controls. This encourages a proactive approach rather than only testing finished products.
- Data integrity: The concept of ALCOA + (Attributable, Legible, Contemporaneous, Original, Accurate plus Complete, Consistent, Enduring and Available) is emphasised to ensure records cannot be falsified.
- Validation and sanitation: Processes, equipment and computer systems must be validated. Buildings must be designed for easy cleaning, with proper ventilation, lighting and water supply.
- Supply chain traceability: Manufacturers must qualify and monitor vendors of raw materials and track products through distribution to detect counterfeits.
- Pharmacovigilance: Companies must collect and report adverse drug reactions and update product information based on post‑marketing surveillance.
Compliance timeline
Large pharmaceutical manufacturers were required to comply by June 2024. Micro, small and medium‑sized enterprises (MSMEs) received an extension until December 2025 to allow for investments in upgrades. Failure to meet these requirements may lead to licence suspension or closure.
Benefits of the revision
- Aligns India’s GMP standards with international benchmarks, boosting confidence in Indian medicines.
- Reduces incidents of contamination, substandard drugs and recalls, improving patient safety.
- Encourages digitisation and automation, making manufacturing more efficient and traceable.