India’s CDSCO
Medical Devices
The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for medical devices. The Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible for the approval of the manufacturing of specific medical devices.
In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India’s Drugs & Cosmetic Act and Rules (DCA).
CDSCO Medical Device Definition:
The Drug and Cosmetic Act defines medical Devices as;
substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);
substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940;
More Resources:
- Cosmetic and Drug Act of 1940.
- CDSCO website.
- To access more information click on the ‘Read More’ Tab.
Pharmaceuticals
The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals. The Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible for the approval of the manufacturing of certain drugs (vaccines, large volume parenteral, blood products, r-DNA derived), and new drugs. In India, the manufacturing, import, sale, and distribution of drugs are regulated under India’s Drugs & Cosmetic Act and Rules (DCA).
More Resources:
- CDSCO website
- To access more information click on the ‘Read More’ Tab.
Nutraceuticals
In India Nutraceuticals are known as “Foods for special dietary uses” and are defined as products that shall provide a physiological benefit and help maintain good health. The regulation for nutraceuticals can be found under Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.
CDSCO Nutraceutical Categories:
In India, nutraceuticals are divided into 8 different categories; Functional foods, Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Specialty food containing plant or botanicals, Foods containing Probiotics, Foods containing Prebiotics and Novel Foods.
CDSCO Nutraceutical Commercialization:
To commercialize Nutraceuticals in India, it is mandatory to register them with Food Safety and Standard Authority of India (FSSA) authority, that has very complex confusing procedures.
More Resources:
- To access more information click on the ‘Read More’ Tab.