Schedule M norms: Pharma units stare at deadline crisis

Ambika Sharma

Tribune News Service

Solan, November 13

With the Union Ministry of Health and Family Welfare showing no signs of extending the December 31 deadline for implementing the revised Schedule M manufacturing norms, hundreds of pharmaceutical units in Himachal Pradesh are staring at an uncertain future.

Out of 655 drug manufacturing units in the state, only 116 firms have complied with the new norms, while around 400 small and medium enterprises (MSMEs), with investments below Rs 50 crore, fear regulatory backlash if the Centre refuses to grant more time. Once upgraded, these facilities would meet World Health Organisation (WHO) standards, enhancing India’s pharmaceutical credibility globally.

The ministry’s rigid stance follows repeated cases of toxic cough syrups causing fatalities, making it clear that the government is in no mood to relax quality enforcement timelines. Non-compliant units could face risk-based inspections, suspension or even cancellation of licences.

Confirming the intensified scrutiny, Dr Manish Kapoor, State Drugs Controller, said inspections were already planned before the Drugs Controller General of India (DCGI) issued fresh directions. “Independent audits are underway and closure warning notices form part of our ongoing efforts to uphold stringent quality standards,” he said.

Dr Kapoor added that while the government had earlier allowed MSMEs to apply for extensions, only a limited number did so. “Verification inspections of all firms that did not apply are now being carried out. It’s incorrect to assume non-compliance, each case will be assessed individually,” he clarified.

The Himachal Drugs Manufacturers Association (HDMA), however, says that debt-ridden MSMEs are struggling to raise funds for the required infrastructure upgrades. “Despite our best efforts, adopting the revised standards by December 31 is extremely difficult,” said Sanjay Sharma, HDMA spokesperson. “Non-compliance will mean suspension or cancellation of licences. We request the government to extend the deadline by two years, till April 2027, to give long-standing units a fair chance to adapt.”

As the clock ticks toward the year-end deadline, the industry finds itself at a crossroads, caught between regulatory rigidity and financial reality.