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India strict against firms making false drugs after Gambia AKI deaths


Union Health Minister Mansukh Mandaviya on Tuesday asked small and medium-sized drug manufacturers to be alert to the quality of drugs and ‘expeditiously’ move towards good manufacturing practices through self-regulation.

His remarks came after India-made cough syrups were linked to the deaths of children in The Gambia and Uzbekistan.

He also said that Schedule M of the Drugs and Cosmetics Act of 1940 would be made compulsory for micro, small and medium-sized firms (MSME) in a phased manner.

Schedule M details good manufacturing practices to be followed by drug manufacturing companies.

“There shall be no compromise with the quality of drugs manufactured in India,” he said, adding that stringent action will be taken against companies that make spurious drugs.

Strongly stressing the need for self-regulation in the MSME pharma sector, the health minister underscored its importance for India to maintain the status of ‘pharmacy of the world.’

“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,” he stated.

Mandaviya also directed the Drugs Controller General of India (DCGI) to take stringent action against all pharmaceutical manufacturing companies that make spurious drugs.

“There shall be no compromise with the quality of drugs manufactured in India,” he said.

After India’s image got a knocking, the Union health ministry tightened scrutiny of cough syrup last month. The government has made it mandatory for pharma companies to obtain a certificate of analysis from a government laboratory before exporting products.

Highlighting that the government has zero tolerance towards manufacturers not adhering to quality compliance and making spurious medicines, he stated that special squads have been formed to inspect drug making companies and stringent action has been taken.

In order to ensure the highest quality of pharma products, the regulatory authorities have started a risk-based inspection and audit of plants.

He said that 137 firms were inspected and action has been taken against 105 firms.

Further, production has been stopped at 31 firms and cancellation and suspension of product/section licenses have been issued against 50 firms.

In addition, show cause notices have been issued to 73 firms and warning letters have been issued to 21 firms.

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