The Indian government has taken measures to strengthen the manufacturing practices of pharmaceutical companies. The Centre announced that companies with a turnover of over Rs. 250 crores will be given six months to adopt Good Manufacturing Practices (GMP), while those with a turnover of less than Rs. 250 crores will be given 12 months to do the same. The deadline for completion of GMP norms is set to begin on August 1.
Union Health Minister Mansukh Mandaviya stated that Schedule M of the Drugs and Cosmetics Act, which deals with GMP for pharmaceutical manufacturing units, has not been properly implemented by most drugmakers, but he assured that this will change now. Companies that fail to comply with the timelines will face penalties as per the provisions of the law after two reviews are conducted – after six months and one year.
Currently, there are approximately 10,500 manufacturing units in the country, with around 8,500 falling under micro, small, and medium-level enterprises (MSMEs). The introduction of a revised Schedule M aims to upgrade these units and ensure better quality standards.
The revised Schedule M will bring significant changes, including the introduction of a Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), Product Quality Review (PQR), equipment qualification and validation, change control management, self-inspection and quality audit teams, supplier audit and approval, stability studies based on recommended climate conditions, validation of GMP-related computerized systems, and specific requirements for manufacturing hazardous, biological, radiopharmaceutical, and phytopharmaceutical products.
These updates are expected to address various deficiencies related to documentation, failure investigation, and the employment of technically qualified personnel. The goal is to ensure that the right person is assigned the right job in pharmaceutical manufacturing, enhancing overall product quality and safety.
With the implementation of the revised Schedule M and stricter adherence to GMP, the government aims to elevate the standards of pharmaceutical manufacturing in the country and provide better quality products to consumers. This move is part of the government’s ongoing efforts to enhance healthcare standards and ensure the safety and efficacy of drugs produced in India.
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