Adopt WHO-Standard Manufacturing Practices, Centre Tells Pharma Companies
The Indian government has taken a significant step towards enhancing the quality and safety of pharmaceutical products in the country.
Union Health Minister Mansukh Mandaviya announced that pharmaceutical companies with an annual turnover exceeding ?250 crore will be required to adopt Good Manufacturing Practices (GMP) within six months. Meanwhile, those with a turnover below ?250 crore have been given a 12-month timeline to comply with the new regulations.
Non-compliance with the stipulated timelines may lead to penalties under the provisions of the law. The approval and implementation of the draft of Schedule M of the Drugs and Cosmetics Act, prepared in 2018, will govern these practices.
India is a crucial exporter of medicines to Low and Middle-Income Countries (LMIC), and WHO GMP certification is a prerequisite for pharmaceutical manufacturing in the country. While approximately 2,000 MSME units have already obtained this certification, there are about 8,500 units in the MSME category that still need to meet the new requirements.
The revision of Schedule M was deemed necessary as many drug manufacturers had not properly implemented the existing regulations. Risk-based inspections exposed various issues, including inadequate documentation, lack of process and analytical validations, and faulty design of manufacturing and testing areas.
Introducing the revised Schedule M will bring about several major changes to upgrade manufacturing units. These changes include the implementation 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, suppliers' audit and approval, stability studies under recommended climate conditions, proof of GMP-related computerized systems, and specific requirements for hazardous, biological, radiopharmaceutical, and phytopharmaceutical products.
These updates will address deficiencies in documentation, failure investigation, and the employment of technically qualified personnel, ensuring that the right individuals are assigned to the appropriate tasks. The revised Schedule M will support the development of a robust quality management system, ensuring the production of medicines that meet globally accepted standards.
The new regulations are a result of advancements in Pharmaceutical and Manufacturing Sciences over the past 15-20 years. By aligning with global standards, especially those set by the WHO, India aims to maintain its position as a reputable provider of high-quality drugs to the global market.
Legal Executive at TATA1MG| JCCL, Mumbai University| Corporate Law Enthusiast
1 年I have a question with regards to the same. Does this mean that the pharma companies do not require WHO-GMP certificate but only a GMP certificate which is in compliance with WHO guidelines?