At the government level, all notified medical products are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. The CDSCO is responsible for approval and regulation of New Drugs, Cosmetics and Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
A. Import License for Medical Devices:
At present, following notified Medical Devices are regulated under the said Act. License is valid for a period of three years from the date of its issue:
1. Disposable Hypodermic Needles.
2. Disposable Perfusion Sets.
3. Cardiac Stents.
4. Drug Eluting Stents.
5. Catheters.
6. Intra Ocular Lenses.
7. I.V. Cannulae.
8. Bone Cements.
9. Heart Valves.
10. Scalp Vein Set.
11. Orthopedic Implants.
12. Internal Prosthetic Replacements.
13. In-vitro Diagnostic Devices for HIV, HbsAg and HCV.
B. Import License for Cosmetic Products:
For the import of cosmetics into India, the cosmetic products need to be registered with the licensing authority as defined under Rule 21 of Drugs & Cosmetic Rules. The regulatory application needs to be submitted in Form 42 along with Soft copies of the information about the brands, products and manufacturer, product specification and testing protocol to receive the cosmetics registration certificate in Form 43.
A list of documents including Schedule D III, shall be submitted to CDSCO. The Cosmetics that are supposed to be imported are categorized into Brands. These brands are divided into following 4 main categories namely:
1. Skin products,
2. Hair and Scalp Products,
3. Nail and Cuticle Products and;
4. Oral Hygiene Products.
