Good manufacturing norms may be mandatory for all drug firms
NEW DELHI : The union health ministry may shortly notify proposed amendments to rules in order to make good manufacturing practice (GMP) mandatory for all pharmaceutical firms after a spate of scandals linking Indian-made drugs to children’s deaths abroad. With the Indian drugs failing quality checks in other countries, the government recently made GMP mandatory for micro, small and medium enterprises manufacturing drugs.
India is the largest supplier of medicines to low-middle-income-countries (LMIC), which requires the World Health Organization’s GMP certification. Only 2,000 of the 10,500 manufacturing units in the country have the certification.
GMP, as mandated by the WHO, prescribes essential standards to enhance product quality through control measures related to materials, methods, machinery, processes, personnel, facilities, as well as the environment. A meeting was recently called by the Drugs Controller General of India (DCGI) Rajeev Raghuvanshi with industry stakeholders and drug firms.
Meetings or workshop have also being held with state drug controllers to sensitize them about the enforcement of the new GMP regime. “Revision in schedule M of the Drugs and Cosmetics Rules is the new legislation and hence there are several doubts and queries with the pharma companies about its implementation.
In the past, DCGI held several meetings with the state drugs controllers to discuss the subject matter and now it’s the turn of pharma companies and associations," said one of the state drug controllers. “GMP under schedule M is under revision and it under active consideration of the health ministry to publish final notification on revised schedule M," said Raghuvanshi to all pharma stakeholders in a communication seen
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