India Medical Device and Pharmaceutical Regulations

India’s Ministry of Health and Family Welfare (MoHFW) and the Central Drugs Standard Control Organization (CDSCO) are the main regulatory bodies that are responsible for overseeing pharmaceuticals and medical devices within India. The CDSCO exercises regulatory control over the import of drugs and devices, and approves new medical products and clinical trials. The CDSCO also oversees the Drugs Consultative Committee (DCC), the Drugs Technical Advisory Board (DTAB), and the Central Licensing Approving Authority (CLAA), the body responsible for ensuring medical device compliance.

The Drugs and Cosmetics Act

The manufacturing, importing, sale, and distribution of pharmaceuticals and active pharmaceutical ingredients (APIs) in India are regulated under the Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945. The drug product and the manufacturing site must both be registered before the drug can be imported into the country. For products classified as new drugs, the new drug approval must be obtained as a pre-requisite for submitting the registration and import license application. A new drug is defined as a drug that has not been used in India to any significant extent under the conditions prescribed, recommended, or suggested in the product’s labeling, and has not been recognized as effective and safe by the appropriate licensing authority in India.

Under the Drugs and Cosmetics Act, the regulation of the manufacturing, sale, and distribution of drugs and devices is primarily the concern of state authorities. Central authorities are responsible for approving new drugs, controlling the quality of imported drugs, coordinating the activities of state organizations, and providing expert advice to bring about a uniformity in enforcing the Drugs and Cosmetics Act.

The Medical Devices Rules

Medical devices and in vitro diagnostics (IVDs) in India are regulated under the Medical Device Rules that came into effect in 2018. Medical devices are categorized into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk), or Class D (high risk) devices. IVDs are categorized separately using the same class names and risk levels from Class A to Class D.

The Central Licensing Authority is the authoritative body that oversees the importation of all classes of medical devices; the manufacture of Class C and D medical devices; the clinical evaluation and approval of investigational medical devices; and the clinical evaluation and approval of new IVDs. The responsibility of overseeing the manufacture of Class A and B medical devices and the sale, stocking, exhibiting, and distribution of all classes of medical devices is delegated to state licensing authorities.

For more detailed information regarding the requirements and process for registering medical devices and pharmaceuticals in India, please see Medical Device Registration in India and Pharmaceutical and API Product Registration in India.

India Medical Device and Pharmaceutical Regulatory Resources

For more free information and resources on the Asian medical device and pharmaceutical regulations and healthcare markets, please check out our Resource Center and Blog.