In order to maintain the quality of medicines and reduce the compliance burden on the pharma sector, the government of India has decided to make it mandatory for medium, small, and micro drug-makers (MSMEs) to follow good manufacturing practices prescribed in ‘Schedule M’ of the Drugs and Cosmetics Act.
The decision was taken at a meeting of representatives from MSME pharma companies with the Union minister of chemicals and fertilizers and health and family welfare Mansukh Mandaviya on 11 July in New Delhi. The Schedule M of the Drugs and Cosmetics Act 1940 deals with good manufacturing practices for pharma manufacturing units in India.
Calling for self-regulation in the medium, small, and micro enterprises (MSME) pharma sector, Mandaviya directed the Drugs Controller General of India (DCGI) to take action against all pharmaceutical manufacturing companies making spurious drugs.
“It is important for MSME pharma companies to be alert to the quality of drugs and move toward good manufacturing processes (GMP) through self-regulation”.
The decision comes amid reports of a few deaths due to consumption of drugs made in India. Last year, cough syrups exported from India were linked to the deaths of children in Gambia and Uzbekistan.
Stressing the need for self-regulation, he 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 we strengthen this position in terms of value and quality. Hence, the role of self-regulation becomes critical,” he stated.
On the basis of the industry’s assurance, the government decided to make Schedule M compulsory for the MSME pharma sector in a phased manner. “This will help in quality assurance and also reduce compliance burden,” the minister said.
“There shall be no compromise with the quality of drugs manufactured in India,” he emphasized, adding the government has zero tolerance towards manufacturers not adhering to quality compliance and making spurious medicines.
The minister said special squads have been formed to inspect drugs-making companies and stringent action has been taken against those flouting norms.
The regulatory authorities have started risk-based inspections and audits of plants. 137 firms have been inspected and action has been taken against 105. Production has been stopped at 31 firms and the licenses of 50 firms have been canceled or suspended. In addition, show cause notices and warning letters have been issued to 94 firms.
Pharma secretary S Aparna, drugs controller general Rajeev Raghuvanshi and senior officers from the department attended the meeting. Viranchi Shah, national president of IDMA, was also present with other office bearers.
