In an effort to ensure drug quality and patient safety, Karnataka has mandated that only pharmaceutical firms compliant with Schedule M’s Good Manufacturing Practices (GMP) rules will be eligible to supply medicines to state government hospitals and health-centres.
Glimpse:
The new directive seeks to weed out substandard and poorly manufactured drugs from public-health supply. By restricting procurement to Schedule M-certified makers, the state aims to improve drug quality, reduce incidences of counterfeit or “not-of-standard-quality” (NSQ) medicines, and rebuild trust in public hospital supplies.
The shift comes alongside wider efforts by regulators such as Central Drugs Standard Control Organization (CDSCO) to enforce revised Schedule M norms across India including inspections and compliance audits.
The government of Karnataka has taken a strong stance to safeguard drug quality in public sector hospitals. A recent directive states that only pharmaceutical companies whose manufacturing units comply with Schedule M will be permitted to supply drugs to government hospitals and public health facilities. Schedule M describes the minimum requirements for drug manufacturing, including GMP-level quality control, hygiene standards, documentation, and facility audits all geared toward ensuring drug safety and consistency.
This move arrives at a time when regulators nationwide are ramping up enforcement: the central regulator has recently instructed state authorities to begin inspections under the revised Schedule M rules, and to take action against firms that fail compliance a push spurred in part by recent episodes of substandard batches and drug-quality failures.
For hospitals and procurement agencies in Karnataka including KSMSCL this means future tenders and drug-supply contracts will explicitly require Schedule M compliance. Non-compliant firms may be excluded from bidding, reducing the risk of substandard or counterfeit drugs entering the public supply chain. According to industry observers in Karnataka, many manufacturers have already begun upgrading their facilities to meet the revised standards. d public-health standpoint, the expectation is that this measure will reduce incidents of drug failures or quality lapses in government hospitals, improve accountability, and restore public trust in state-supplied medicines especially critical for essential medicines, sterile injectables, IV fluids, and other high-risk categories.
“By limiting procurement to Schedule M-compliant firms, we are raising the bar on drug-quality standards because every hospital supplied by the state deserves medicines that meet the highest safety and manufacturing norms.”
By
HB Team
