A rising number of Western pharmaceutical manufacturers are partnering with Indian pharmaceutical producers. As such, quality control has developed into a major issue.
Schedule M of the Drug and Cosmetics Act (DCA) oversees the notion of Good Manufacturing Practices (GMP), which list the requirements for the factory sites, equipment, production facility, and materials. There are additional comprehensive conditions for the production of low volume injectable, high volume parenterals, APIs, tablets, capsules, etc.
Schedule M covers the areas of quality assurance, self-inspection and/or quality audit, and quality control systems restrictions for pharmaceuticals/drugs. The quality assurance systems are required to be in accord with GMP, GLP (Good Laboratory Practice), and GCP (Good Clinical Practice). The self-inspection and quality audit should be an evaluation of GMP compliance with an organization of internal and/or external experts for review and implementation as well as document modification carried out. The quality control system must include sampling, specifications, testing, documentation, release procedures, etc.
Every type of drug production does require licensing under the DCA. Licenses can only be obtained by a unit that is established within India. The State Government Drug Controllers supply licensing to production units that deal with pharmaceutical/drug products. Specific products, such as novel drugs, large volume parenterals, vaccines, critical IVD kits and r-DNA derived drugs require the approval of the Drug Controller General of India (DCGI) preceding the licensing process. Licenses are required for each factory and for the pharmaceuticals produced within any factory. What this demonstrates, is that unique licenses are compulsory for specific product groups.