The Centre announced on Tuesday that Schedule M of the Drugs and Cosmetics Act, 1940, will be made gradually mandatory for small and medium-scale businesses to enhance quality assurance in light of heightened worldwide scrutiny of Indian pharmaceutical products.
Mansukh Mandaviya, the union minister of health, has urged micro, small, and medium-sized pharmaceutical manufacturing businesses to adopt Good Manufacturing Principles (GMP) through self-regulation. This will ease the burden of compliance and aid in quality assurance, according to Mandaviya.
The Drugs and Cosmetics Act of 1940’s Schedule M addresses good manufacturing practices for Indian pharmaceutical manufacturing facilities.
Mandaviya stated that there should be no compromise in the quality of medications produced in India and that MSME pharmaceutical enterprises should quickly migrate toward GMP through self-regulation. At a meeting with MSME pharmaceutical companies on Tuesday in Delhi, he declared, “Strong action to be taken against companies that make spurious drugs.”
According to a government release, Mandaviya has ordered the Drugs Controller General of India (DCGI) to take harsh action against any pharmaceutical manufacturing facility that produces fake medications. According to the health ministry, the government has zero tolerance for producers who produce fake medications or don’t follow quality compliance regulations.
According to Mandaviya, strict measures have been implemented, and special teams have been formed to inspect drug manufacturing facilities.
The Union Minister added that the regulatory authorities had begun risk-based plant inspection and auditing to guarantee the best quality pharmaceutical products. He claimed that 137 businesses were examined, and 105 businesses had their actions done against them. Thirty-one businesses have suspended production, while 50 have been handed Cancellation and Suspension of Product or Section Licenses. Additionally, 73 companies have received show-cause notices, while 21 have received warning letters.
This action, according to Viranchi Shah, National President of the Indian Drug Manufacturers Association (IDMA), will guarantee that every firm works toward full compliance. “The drugmaker now needs to address those problems and close those gaps if there are any compliance deficiencies. India is doing a fantastic job of providing medications to the rest of the globe, and the government has made it abundantly clear that no compromise on quality would be allowed.”
Industry insiders claimed that of the country’s 10,000 or more medication units, just a tiny minority do not adhere to quality standards. India has a domestic pharmaceutical market worth Rs 18 trillion and exports medicines worth Rs 25 trillion.
The government is concerned about recent occurrences involving cough medicines that were delivered from India to places including Sri Lanka, Uzbekistan, and the Gambia. The Center mandated that government laboratories analyze cough syrups before they are exported.
