Will States Meet the January 1 Deadline for Pharma Compliance?
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Synopsis
The Central Drugs Standard Control Organisation has set a stringent deadline for pharmaceutical firms to comply with international manufacturing standards. As states gear up for inspections by January 1, 2026, the stakes are high for industry compliance. Will small businesses survive this regulatory shift?
Key Takeaways
- January 1, 2026 is the compliance deadline for all pharmaceutical firms.
- Strict actions will be taken against non-compliant units.
- Schedule M norms were revised in 2023 to meet global standards.
- Small firms are at risk of financial strain due to compliance costs.
- The directive follows a serious public safety incident.
New Delhi, Nov 8 (NationPress) The Central Drugs Standard Control Organisation (CDSCO) has mandated that state drug regulators conduct inspections of all pharmaceutical facilities to ensure adherence to global manufacturing standards by January 1, 2026.
In a notice issued on November 7, Drug Controller General of India (DCGI) Rajeev Raghuvanshi instructed all state and union territory drug controllers to provide monthly updates on their findings and any actions taken during these inspections.
“If any manufacturing unit is discovered to be non-compliant with the updated requirements of Schedule M during these inspections, stringent measures will be enforced,” the directive specifies.
The CDSCO Schedule M regulations outline India’s standards for pharmaceutical companies regarding good manufacturing practices, which were updated in 2023 to better align with international norms.
While larger pharmaceutical companies are expected to meet a deadline of June 2024, smaller enterprises have been granted until December 2025 under a previous extension. Industry associations have requested additional time, citing the potential financial burden on smaller businesses.
This new directive concludes a one-year grace period that was provided to micro, small, and medium pharmaceutical firms—those with an annual turnover of Rs 250 crore or less—to comply with the revised Schedule M.
“We urge you to begin preparations for conducting inspections of manufacturing units that have requested an extension for the revised Schedule M, with the compliance deadline set for January 1, 2026,” Raghuvanshi emphasized in his communication.
The central drug authority has denied industry requests for more time following the connection of a toxic cough syrup from a Chennai facility to several child fatalities in Madhya Pradesh in September.
In late 2023, the government directed drug manufacturers to enhance their facilities to meet World Health Organisation guidelines, including implementing measures to prevent cross-contamination and enabling batch testing of produced medications.
Point of View
We believe it is essential for the pharmaceutical industry to adhere to global standards to ensure public safety. The stringent measures proposed by the CDSCO are necessary to prevent future incidents and bolster trust in healthcare products. Compliance may pose challenges, especially for smaller firms, but the long-term benefits outweigh the immediate hurdles.
NationPress
08/11/2025
Frequently Asked Questions
What is the deadline set by CDSCO for pharmaceutical compliance?
The Central Drugs Standard Control Organisation has set a deadline of January 1, 2026, for pharmaceutical firms to comply with international manufacturing standards.
What actions will be taken against non-compliant manufacturing units?
If any manufacturing unit is found to be non-compliant during inspections, strict actions will be initiated as per the CDSCO directive.
What are Schedule M norms?
Schedule M norms are India's guidelines for pharmaceutical companies on good manufacturing practices, which were revised in 2023 to align with international standards.
What is the impact of the new directive on small pharmaceutical firms?
The new directive ends a grace period for micro, small, and medium pharmaceutical firms, which may face financial difficulties due to compliance costs.
Why was there urgency in enforcing these regulations?
The urgency stems from a tragic incident where a toxic cough syrup linked to a Chennai factory was responsible for child deaths in Madhya Pradesh.
