India's Drug Regulator Sets January Deadline for Global Manufacturing Standards
India's top drug regulatory authority has issued a firm directive to state governments, demanding strict enforcement of global-standard good manufacturing practices across the pharmaceutical industry. The Drugs Controller General of India (DCGI) Dr Rajiv Singh Raghuvanshi has set a clear deadline of January 2026 for complete compliance with revised Schedule M norms.
In a significant move that leaves no room for further extensions, the DCGI has instructed state drug regulators to immediately begin planning inspections of manufacturing facilities. This decision comes as the December 2025 deadline approaches for implementing the upgraded manufacturing standards.
Immediate Action Against Non-Compliant Units
The regulatory crackdown begins immediately with units that never applied for extension of the revised Schedule M implementation. State drug controllers have been ordered to initiate immediate inspections and take necessary action against these companies, as the new norms are already applicable to them.
According to the DCGI's letter, manufacturing units that applied for extension and received the January 1, 2026 deadline will face inspections starting next year to verify their compliance status. The regulator has made it clear that strict action will be taken against any unit found non-compliant during these inspections.
The enforcement strategy involves monthly reporting by state regulators, who must submit detailed accounts of inspections conducted, observations made, and actions taken against violators.
Tragic Incidents Prompt Stricter Regulations
The push for upgraded manufacturing standards gained urgency following several tragic incidents involving contaminated medicines. Most notably, 22 children lost their lives after consuming contaminated cough syrup in Madhya Pradesh's Chhindwara district.
Investigations revealed alarming findings - at least three brands of cough syrups contained dangerously high levels of the contaminant diethylene glycol. The worst case showed 48.6% contamination in syrup manufactured by Tamil Nadu-based Sresan Pharmaceuticals.
These domestic tragedies followed international incidents in 2022 and 2023 when Indian-manufactured cough syrups exported overseas were found to contain unacceptable levels of diethylene glycol and ethylene glycol contaminants.
Pharma Industry Compliance Timeline
The revised Schedule M requirements, which upgrade "good manufacturing practices" to "good manufacturing practices and requirements of plant and equipment for pharmaceutical products," were officially notified in 2023.
The implementation timeline was structured based on company size:
- Large pharmaceutical companies with turnover exceeding Rs 250 crore were given six months to comply
- Smaller manufacturing units received a one-year extension to implement the stricter norms
Smaller companies seeking extension had to apply to the DCGI with detailed upgrade plans. India's pharmaceutical landscape includes approximately 2,000 large manufacturing units, most of which had already complied with similar WHO standards required for exports.
The bigger challenge lies with the 8,500 smaller manufacturing units that required significant infrastructure modifications to meet the new standards. These units had sought additional time for the substantial upgrades needed.
The DCGI's latest directive makes it clear that no further extensions will be granted, and the pharmaceutical industry must meet global quality standards by the January 2026 deadline to ensure drug safety and maintain India's position as the 'pharmacy of the world'.
