India may face drug shortages and increased drug prices due to lobby groups and associations unable to comply with revised Schedule M rules mandated by the health ministry. Smaller companies will have one year to meet requirements.
Industry executives say several lobby groups and associations that represent medium and small enterprises have expressed their inability to follow the health ministry’s new rules and expect several units to close, which could lead to drug shortages and price increases in India.
The health ministry recently notified the revised Schedule M rules for good manufacturing practices and requirements of premises, plant, and equipment for pharmaceutical products, including an annual product quality review, quality risk management, and a pharmaceutical quality system.
Mansukh Mandaviya, the health minister, proposed making Schedule M mandatory for pharma MSMEs in phases in July 2018. From August 1, 2023, medication firms with yearly sales over ₹250 crore must comply with the criteria within six months, according to the health ministry. He added smaller enterprises will have a year to comply.
The implementation of updated Schedule M for the small and medium sectors will be difficult, said Sanjay Singla of Laghu Udyog Bharti (LUB), a small company association affiliated with the Rashtriya Swayamsevak Sangh. He said they value quality but the update will cost.
“In the process many units will see closures, resulting in drug prices going up and shortages,” added Singla.
He claimed small and medium firms have too little time. “The implementation of the new norms would be challenging for smaller firms, which may lead to a rise in near term capex and a permanent increase in operating costs,” stated.
Punjab Drug Manufacturers’ Association (PDMA) said the new standards will make manufacture of National List of Essential Medicines (NLEM) medications, which are price-controlled, unviable because their cost will surpass the ceiling price.New rule in India may cause hike in price of drugs, shortages
Conclusion
Lobby organizations and associations refusing to respect health ministry standards may cause drug shortages and price increases in India. Several operations may close due to the updated Schedule M rules for good manufacturing procedures and pharmaceutical product premises, plant, and equipment. The health ministry requires pharma producers with yearly sales over ₹250 crore to comply within six months starting August 1, 2023. Smaller enterprises have one year to comply.
