The Centre requires MSME pharma firms to follow Schedule M of the Drugs and Cosmetics Act

Health Minister Mansukh Mandaviya stated on Tuesday that small medication manufacturers in India would now be required to adhere to the good manufacturing practises outlined in Schedule M of the Drugs and Cosmetics Act for improved quality assurance.

The implementation of Schedule M, which outlines practises related to shop floors, quality control systems, quality check labs, production, cleaning of equipment and housekeeping, among others, by pharmaceutical firms in the micro, small and medium enterprises sector will be phased in, the minister said following an interaction with industry representatives.

This will lessen the strain of complying with regulations, according to Mandaviya. “It is crucial for MSME pharmaceutical companies to pay attention to drug quality and swiftly adopt good manufacturing practises through self-regulation.”

The minister emphasised how vital it is for India to maintain its position as the world’s pharmacy. The health ministry has been taking steps to guarantee that the quality of medications created in India is not compromised, particularly in light of a few worldwide fatalities that have been linked to the use of medicines produced there.

Global Pharma Healthcare, located in Tamil Nadu, recalled a whole batch of eye drops in February. Cough medications shipped from India were responsible for 66 and 18 child fatalities in Gambia and Uzbekistan, respectively, last year.

“The quality of our goods has helped us establish our position as a leader in the pharmaceutical industry globally. To guarantee that we enhance our position in terms of value and quality, we must take all reasonable measures. Therefore, the need of self-control increases, stated Mandaviya.

In February, a session with state drug regulators was held in Hyderabad by the federal government. The two-day workshop included brainstorming sessions with the goal of developing a participatory strategy for the timely implementation of policies and activities.

The Indian Drugs Controller General has been ordered by the health minister to take harsh action against pharmaceutical businesses that produce fake medications.

He reaffirmed the government’s policy of having zero tolerance for producers that produce fake medications or don’t follow quality compliance regulations. “The quality of medicines made in India will not be compromised. To investigate drug manufacturing facilities around the nation, specialised teams have been created, he added.

According to Mandaviya, regulatory authorities have begun risk-based inspection and audit of production facilities to assure the best quality of pharmaceutical goods. According to a statement from the government, up to 137 businesses were examined, and 105 of them were given legal repercussions.

“31 enterprises have suspended production, and 50 firms have been granted ‘Cancellation and Suspension of Product/Section Licences’. Additionally, 73 businesses have received show-cause notices, while 21 firms have received warning letters, according to the statement released on Tuesday.

Along with Viranchi Shah, national president of the Indian Drug Manufacturers’ Association, and other office bearers of the industry advocacy organisation, the meeting on Tuesday was also attended by pharmaceutical secretary S Aparna, pharmaceuticals controller general Rajeev Raghuvanshi, and other senior authorities.