After a fresh spate of child deaths linked to toxic cough syrup last month, India's drug regulator has ordered state authorities to ensure that all pharmaceutical factories comply with international manufacturing standards by January.

The Central Drugs Standard Control Organisation (CDSCO) on Friday directed state and union Territory (UT) drug controllers to launch immediate inspections and take action against units that have not upgraded facilities under the revised "Schedule M" norms, which mandate World Health Organization (WHO)-recommended good manufacturing practices such as batch testing and measures to prevent cross-contamination.

"In case any manufacturing unit is found non-complying with the requirements of revised Schedule M during inspections, strict action shall be initiated," Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi said in a notice, calling the matter a "top priority."

The move follows renewed alarm after the deaths of 24 children in Madhya Pradesh were linked to contaminated cough syrup in recent months — an incident that reignited global concern over India's pharmaceutical safety. The country had faced international outrage earlier after India-made syrups were tied to the deaths of more than 140 children in Africa and Central Asia, a crisis that tarnished its image as the "pharmacy of the world."

Under the government's 2023 directive, large pharmaceutical firms were required to meet Schedule M standards by June 2024, while small and medium enterprises (SMEs) with turnover below Rs 250 crore were granted time until December 2025. However, the CDSCO has now told states to begin inspections immediately for firms that have not applied for extensions, warning of strict enforcement of the Drugs and Cosmetics Act.

State regulators must also submit monthly reports to the Centre detailing inspections, observations, and follow-up actions, the order said.

The decision is expected to impact thousands of small and medium drug manufacturers, many of whom have been lobbying for additional time, citing the heavy cost of upgrades. Some have already opted to shut down or sell their units rather than invest in compliance.

"What good is quality if there is no affordability?" said Jagdeep Singh, secretary of the SME Pharma Industries Confederation, warning that mandatory upgrades could force closures and lead to job losses and higher drug prices.

Dr. Rajesh Gupta, president of the Himachal Drug Manufacturers Association, estimated that 4,000–5,000 units could shut down, potentially triggering shortages of essential medicines in the domestic market. Over 20 pharmaceutical associations have petitioned the Centre to reconsider the deadline or grant smaller firms—especially those with turnover below Rs 50 crore—further relief.

But regulatory experts say the recent deaths have made further extensions untenable. "Overall, it is good that the government has not extended the deadline further. The quality will be enhanced with this," said R. Udaya Bhaskar, former Director General of Pharmexcil and honorary director general of the All India Drugs Control Officers' Confederation (AIDCOC).

Sources said several state regulators have already started identifying non-compliant facilities and initiating action. However, one regulatory expert noted that the CDSCO's directive may raise procedural questions, as only the union Health Ministry has the authority to issue directions to states under the Drugs and Cosmetics Act.