India is growing rapidly as a destination for medical device and pharmaceutical manufacturing. Costs to manufacture in India are generally significantly less than the costs in China. With more and more Western medical companies sourcing or manufacturing their medical devices or drugs in India, quality management in India has become a key issue.
Pacific Bridge Medical has extensive experience with helping a number of international medical companies set up their quality management systems in India. Our India quality control/quality assurance experts can help your medical company’s Indian operations and suppliers ensure compliance with all relevant quality standards.
INDIA’S GOOD MANUFACTURING PRACTICE (GMP) STANDARDS
India’s GMP standards for medical devices and drugs are covered in Schedule M and Schedule M III of the Drugs and Cosmetics Act (DCA):
- Schedule M describes the quality assurance, self-inspection and/or quality audit, and quality control system requirements for medical devices and pharmaceuticals; it also lists the requirements for the factory premises, materials, plant, and equipment.
- These requirements are based on World Health Organization guidelines.
- For drugs, there are also additional specific requirements for small volume injectables, large volume parenterals, APIs, tablets, capsules, etc.
- India’s GMP regulations are now more aligned with ISO 13485. Standardizing quality requirements will help manufacturers in India register their medical devices more effectively.
INDIA QUALITY CONTROL/QUALITY ASSURANCE FOR MEDICAL DEVICES
- Depending on the type of medical device, the Drug Controller General of India (DCGI) and the State FDA will approve or determine the medical device licensing process. The application for a manufacturing license may include manufacturing processes, product details, and information about the staff. In addition, there are many state and local level licenses that are needed to manufacture a medical device. Therefore, understanding the regulations of a particular Indian State is important when deciding on a manufacturing site location.
INDIA QUALITY CONTROL/QUALITY ASSURANCE FOR PHARMACEUTICALS
- Quality management systems in India should ensure compliance with India GMP, GLP (Good Laboratory Practice), and GCP (Good Clinical Practice). The self-inspection and quality audit should be an evaluation of GMP compliance with a team of in-house and/or external experts to audit the implementation and document changes made. The quality control system should include sampling, specifications, testing, documentation, release procedures, etc.
- Under the Drugs and Cosmetics Act of 1940, all drug manufacturing requires a license. This license can only be given to an entity based in India. The State Government Drug Controllers can oversee the manufacturing of most drug products. Certain items, such as new drugs, large volume parenterals, vaccines, critical IVD kits and r-DNA derived drugs require the approval of the Drug Controller General of India (DCGI) before the license can be granted. The license is given for each factory and for the drugs made in that factory. In other words, there are different licenses depending on the product group.
Do you need assistance with India quality control/quality assurance from expert GMP consultants? Contact us now for a free consultation that will assess your unique quality auditing needs.
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