Union Health Minister Mansukh Mandaviya has directed the Drugs Controller General of India (DCGI) to take stringent actions against those pharmaceutical manufacturing companies that make spurious drugs.
“It is important for MSME pharma companies to be alert to the quality of drugs and expeditiously move towards Good Manufacturing Processes (GMP) through self-regulation,” the minister said as he met representatives from pharma companies in the MSME space here on Tuesday.
“There shall be no compromise with the quality of drugs manufactured in India”, he emphasized, in an apparent reference to companies engaged in making spurious drugs.
Strongly stressing the need for self-regulation in the MSME pharma sector, Mandaviya 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.
Highlighting that the current government has zero tolerance towards manufacturers not adhering to quality compliance and making spurious medicines, the minister said that special squads have been formed to inspect drugs making companies.
To ensure the highest quality of pharma products, the minister said the regulatory authorities have started the risk-based inspection and audit of manufacturing units. He stated that 137 firms were inspected, and action has been taken against 105 firms.
Production has been stopped at 31 firms and ‘Cancellation & 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.