The Central Drugs Standard Control Organization (CDSCO) is responsible for overseeing the approval, manufacture, import, sale, and distribution of drugs in India, ensuring that all drugs meet strict standards for safety, efficacy, and quality. This regulation ensures that only safe and effective products reach consumers and that they comply with Indian health and safety guidelines.
Local manufacturers must acquire a manufacturing license from the State Licensing Authority before producing any drug products. Compliance with Good Manufacturing Practices (GMP) is mandatory to maintain high production standards, and regular quality control measures must be followed to ensure the drugs are safe for consumer use. Additionally, manufacturers must meet the necessary documentation requirements, such as product approval and testing certificates.
For importers, securing an import license is essential to legally bring drugs into India. They must provide various documents, including a ‘Certificate of Free Sale’ from the country of origin, drug registration certificates, and details on the drug’s manufacturing process and safety data. Importers are also required to comply with the same standards of product quality and testing as local manufacturers.
ACPL offers comprehensive support to drug companies in navigating India’s regulatory landscape. We assist with obtaining manufacturing and import licenses, ensuring compliance with GMP, handling product registration and drug approvals. Our expertise in regulatory requirements allows companies to meet legal standards quickly and efficiently, minimizing the risk of delays and ensuring smooth market entry.
Partner with ACPL for seamless support and focus on growing your pharmaceutical business while we manage the regulatory complexities !!
