India’s Central Drugs Standard Control Organization (CDSCO) is currently organizing efforts to transition from a paper to an electronic document management system. The CDSCO is responsible for the approval and issuance of licenses for various medical products, such as vaccines, IV fluids, and blood products, among others, manufactured either in India or overseas. It regulates the manufacture, sale, and distribution of medical products.
The number of manufacturers, suppliers, and importers filed in the current system is about 8,000 to 10,000. Registrations, evaluations, approvals, issuing of licenses, and approval for clinical trials are all filed as physical documents. To improve the management of this vast amount of paperwork, the CDSCO plans to scan and archive these documents in electronic form.
The CDSCO also plans to implement a Document Management System to build a completely computerized drug control system. This full electronic system would cover the online processing of registration, issuing and renewing licenses, dissemination of policy documents and guidelines, and managing user feedback.
The CDSCO will be working with a private firm to implement this process.