Ease of Doing Business for MSMEs: The minister also assured that “Schedule M” would be made compulsory for the MSME pharma sector. “Schedule M,” under the Drugs and Cosmetics Act, deals with the practices associated with the manufacturing of pharmaceuticals that must be followed in India.
Ease of Doing Business for MSMEs: The Union Health and Family Welfare Minister, Dr Mansukh Mandaviya, held a meeting with pharma MSMEs on Tuesday, during which he appealed to pharma manufacturers to maintain the quality of drugs they produce, according to a statement released by the Press Information Bureau.
“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,” Mandaviya was quoted as saying.
The minister emphasised the role of MSMEs in making India “The Pharmacy of the World” and called for self-regulation in the MSME pharma sector. “Our global position in the pharmaceutical sector is established through the quality of our products. We must take all possible steps to strengthen this position in terms of value and quality. Hence, the role of self-regulation becomes critical,” he stated.
The minister also assured that “Schedule M” would be made compulsory for the MSME pharma sector. “Schedule M,” under the Drugs and Cosmetics Act, deals with the practices associated with the manufacturing of pharmaceuticals that must be followed in India. Regarding the implementation of “Schedule M,” the minister commented, “This will help ensure quality assurance and reduce compliance burden.”
Taking into account the issues and criticism India has faced in the past due to incidents related to deaths in Uzbekistan, the USA, the Marshall Islands, and the Gambia caused by spurious drugs from India, Dr Mandaviya said, “There shall be no compromise with the quality of drugs manufactured in India. Special squads have been formed to inspect drug manufacturing companies, and stringent actions have been taken.” He also directed the Drug Controller General of India (DCGI) to take stringent action against all MSME pharma sector companies producing spurious drugs.
The minister stated that the authorities have begun risk-based inspections and audits of pharma manufacturing units to ensure compliance. He added that action has been taken against 105 out of the 137 firms inspected. Production has been halted at 31 firms, and manufacturing licenses of 50 firms have been revoked. A show cause notice has been issued to 73 firms and warning letters are issued against 21 firms.