Mandaviya says Schedule M compliance to be mandatory for MSME pharma firms, triggers confusion among stakeholders

Union Minister Mansukh Mandaviya made the announcement on Tuesday.

The Union government on Tuesday said that it would make rules for good manufacturing practices compulsory for pharmaceutical companies belonging to the MSME sector in a phased manner even though compliance to such practices were made mandatory by law more than two decades ago.

Union Health and Pharmaceutical Minister Mansukh Mandaviya met the representatives of the medium and small scale industries and told them that GMP practices shall be made compulsory for them in a phased manner, causing confusion among the stakeholders.

While some of the companies said they didn’t understand what the government intended to do since compliance of Schedule M – the section in the Drugs and Cosmetics Act that deals with GMP norms – was a must to obtain manufacturing licenses, industry watchers told DH that over the years the government gave a lot of concessions to the medium and small scale industries.

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The MSME sector, on the other hand, argued that strict implementation of Schedule-M would involve a lot of investment – probably in the range of Rs 8-10 crore – and they simply could not afford it. It will make more economic sense for them to wind up their operations rather than spending such an amount on GMP norms.

“Schedule M is the soul of quality. Yet for politico-economic compulsions and financial implications for the industry both the regulators and the regulated have been dragging their feet,” C M Gulhati, an industry veteran and editor of Monthly Index of Medical Specialities told DH. “The implementation has both ‘software’ and ‘hardware’ implications.”

While software includes employment of qualified quality staff, purchase of machinery and strict implementation of standard operating procedures, for most small and medium industries the problem lies in hardware because it involves new location, environment and above all separate buildings for formulation units.

Some of the stipulations mean that industrial units are to be relocated while in other cases, old buildings are needed to be demolished and new constructions will be required to meet Schedule M conditions. “This is easier said than done,” Gulhati said.

With the quality of Indian medicines under scanner after multiple made-in-India cough-syrup triggered adverse health incidents in foreign countries, Mandaviya said Schedule M would be made compulsory for the MSME pharma sector in a phased manner.

“This will help in quality assurance and also reduce compliance burden’, he said, noting that the government had zero tolerance towards manufacturers not adhering to quality compliance and making spurious medicines.

Experts, outside the government, hold a different view. “The government had given substantial concessions to MSMEs existing in 2001 from compliance with Schedule M. I have no confidence that this recent directive will be implemented properly,” commented Dinesh Thakur, the whistleblower against Ranbaxy Pharmaceuticals.

“How exactly are they going to monitor compliance? The State Drug Regulators, who are tasked with inspections and ensuring compliance have no incentive to enforce such a directive,” said Thakur, the co-author of a book titled Truth Pill on Indian pharmaceutical industry.