An increasing amount of Western pharmaceutical companies are working with Indian pharmaceutical companies. Therefore, quality systems have become a major concern.
Schedule M of the Drug and Cosmetics Act (DCA) covers the concept of Good Manufacturing Practices (GMP), which list the obligations for the factory premises, materials, plant, and equipment. There are added detailed conditions for low volume injectibles, high volume parenterals, APIs, tablets, capsules, etc.
Schedule M covers the aspects of quality assurance, self-inspection and/or quality audit, and quality control systems constraints for pharmaceuticals/drugs. The quality assurance systems have to be in compliance with GMP, GLP (Good Laboratory Practice), and GCP (Good Clinical Practice). The self-inspection and quality audit should be an assessment of GMP conformity with a task force of in-house and/or external specialists to audit the execution and document alterations carried out. The quality control system has to comprise of sampling, specifications, testing, documentation, release procedures, and more.
Every type of drug manufacturing demands a license under the DCA. This license can only be acquired by an entity that is established in India. The State Government Drug Controllers can provide licensing to manufacturing concerns which deal with pharmaceutical/drug products. Particular items, like new drugs, large volume parenterals, vaccines, critical IVD kits and r-DNA derived drugs need the authorization of the Drug Controller General of India (DCGI) prior to the licensing process. The license is provided for every factory and for the pharmaceuticals manufactured within that factory. What this signifies is that separate licenses are required for different product groups.