The Indian Drug Manufacturers’ Association, under the guidance from the Ministry of Health & Family Welfare and the Ministry of Chemicals and Fertilisers, said it will observe Good Manufacturing Practices Day on October 10 beginning this year.
The day will be marked by conducting training and sensitisation sessions for quality control staff in manufacturing companies and for pharmacy students.
The inauguration and launch of National cGMP Day shall be held in the online presence of Dr Mansukh Mandaviya, Minister of Health & Family Welfare, S Aparna – Secretary, Department of Pharmaceuticals, and Rajeev Singh Raghuvanshi, Drugs Controller General of India.
GMPs are aimed primarily at managing and minimising the risks inherent in pharmaceutical manufacturing to ensure the quality, safety and efficacy of products. Unlike consumer goods, quality is not a product selection factor for the patients who consume medicines. Patients rely on the manufacturer for quality assurance.
Schedule M that specifies the requirements of Good Manufacturing Practices (GMPs) under the Drugs and Cosmetics Rules is being upgraded to the international standards. Schedule M is a part of Drug and Cosmetic Act 1940. Schedule M contains standards about company premises, quality control system, quality control laboratories, GMP in production, cleaning of equipment, housekeeping, cross-contamination and other related topics.
India has around 10,500 pharmaceutical manufacturing units with almost 2,000 having WHO GMP certification. Of the 10,500 drug firms, it is estimated that 8,500 are MSMEs (micro, small and medium enterprises).
The Health Ministry had instructed pharma companies to become compliant with the World Health Organisation’s (WHO) GMP standards to ensure quality for domestic use and export purposes in August. The Ministry had said large manufacturers with an annual turnover of over Rs 250 crore will be given six months to become WHO GMP compliant and those with a turnover of less than Rs 250 crore will be given 12 months for the transition.
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