Centre mandates Drugs and Cosmetics Act's Schedule M for MSME pharma units
The adherence by pharma firms in the micro, small and medium enterprises sector to Schedule M will be implemented in a phased manner
Small drugmakers in India will have to compulsorily follow good manufacturing practices detailed in the Schedule M of the Drugs and Cosmetics Act for better quality assurance, health minister Mansukh Mandaviya announced on Tuesday.
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The adherence by pharma firms in the micro, small and medium enterprises sector to Schedule M, which details out practices related to shop floors, quality control system, quality check labs, production, cleaning of equipment and housekeeping, among others, will be implemented in a phased manner, the minister said after an interaction with industry representatives.
“This will help in quality assurance and also reduce compliance burden,” Mandaviya said. “It is important for MSME pharma companies to be alert to quality of drugs and expeditiously move towards good manufacturing processes through self-regulation.”
It is important for India to maintain its reputation as the pharmacy of the world, the minister stressed. The health ministry has been taking measures to ensure that the quality of medicines made in India is not compromised, especially after a few incidents of deaths globally, allegedly due to consumption of drugs made in the country.
In February, Tamil Nadu-based Global Pharma Healthcare recalled an entire lot of eye drops. Last year, cough syrups exported from India were linked to deaths of 66 and 18 children in Gambia and Uzbekistan, respectively.
“Our global position in the pharmaceutical sector is created through the quality of our products. We must undertake all possible steps to ensure that we strengthen this position in terms of value and quality. Hence, the role of self-regulation becomes critical,” said Mandaviya.
The central government had in February conducted a workshop in Hyderabad with state drug regulators. As a part of the two-day camp, brainstorming sessions were conducted with a view to evolve a participative approach for time-bound implementation of policies and programmes.
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The health minister has also directed the Drugs Controller General of India to take stringent action against those pharmaceutical manufacturing companies that are making spurious drugs.
He reiterated the government’s zero tolerance towards manufacturers not adhering to quality compliance and making spurious medicines. “There shall be no compromise with the quality of drugs manufactured in India. Special squads have been formed to inspect drugs making companies across the country,” he said.
In order to ensure the highest quality of pharma products, Mandaviya said regulatory authorities have started risk-based inspection and audit of manufacturing units. As many as 137 firms were inspected and action has been taken against 105 firms, the ministry said in a statement.
“Production has been stopped at 31 firms and ‘Cancellation and Suspension of Product/Section Licenses’ have been issued against 50 firms. In addition, a show cause notice has been issued to 73 firms, and warning letters to 21 firms,” said the statement issued on Tuesday.
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Tuesday’s meeting was also attended by pharma secretary S Aparna, drugs controller general Rajeev Raghuvanshi and other senior officers, along with Viranchi Shah, national president of the Indian Drug Manufacturers’ Association and other office bearers of the industry lobby group.
