Pharmaceutical units unable to comply with the revised Schedule M manufacturing protocols are increasingly shutting down operations across Himachal Pradesh’s key industrial clusters, including Baddi-Barotiwala-Nalagarh.
Over the past few months, around 10 to 12 firms have surrendered their manufacturing licences, reflecting the mounting pressure on small and medium enterprises (MSMEs) to meet stricter regulatory standards.
Out of the state’s 655 drug manufacturing units, only 116 firms have applied for the required upgrades. Meanwhile, nearly 400 MSMEs, largely with investments below Rs 50 crore, are currently under the scanner of state drug regulators.
The enforcement drive follows the December 31, 2025, deadline for compliance with the revised norms, which align manufacturing practices with WHO.
The Drug Control Administration (DCA) has intensified inspections to ensure adherence. State Drugs Controller Dr Manish Kapoor said inspectors were tasked with reviewing 360 units across industrial clusters, of which 270 have already been inspected since November 2025.
Of these, around 70 units are not operational, including those that have surrendered licences. Several others have been issued “stop manufacturing” orders due to non-compliance, while some have opted for voluntary closure to facilitate upgrades.
The revised Schedule M mandates extensive improvements in manufacturing infrastructure and systems. These include upgrades to plant and equipment, implementation of robust pharmaceutical quality systems, product quality reviews, and enhanced quality risk management.
Companies are also required to adopt stringent data integrity practices and pharmacovigilance mechanisms to track adverse drug reactions.
The urgency for reform is underscored by rising instances of substandard drugs. In a recent monthly alert, 37% of drug samples from Himachal-based manufacturers failed quality parameters.
Deficiencies ranged from particulate matter in injections and microbial contamination to incorrect pH levels, lack of sterility and inadequate assay values, clear indicators of poor compliance with Good Manufacturing Practices.
However, the financial burden of upgrading facilities, often running into several crores, has deterred smaller firms.
Persistent issues such as inadequate heating, ventilation, and air conditioning (HVAC) systems, including non-functional Air Handling Units (AHUs), have been flagged as critical violations.
While the transition is challenging, regulators appear firm in their approach. Experts argue that compromising on quality is not an option, as substandard drugs pose serious public health risks.
