The Central Drug Standard Control Organisation (CDSCO) is responsible for the so-called CDSCO registration, or CDSCO approval, of all drugs and medical devices in India. All cosmetic products that are imported for sale in India need to be registered with the licensing authority as defined under Rule 21 of Drugs & Cosmetic Rules, 1945.
No cosmetic shall be imported into India unless the product is registered under the rules by the licensing authority appointed by the Central Government under rule 21 or by any person to whom such powers may be delegated under rule 22
The regulations in India require that foreign manufacturers have an Authorized Representative in India who will act on their behalf as the point of contact for inspection authorities, assist in device approvals and registration process and vigilance/adverse event.
The BIS Registration is granted by BIS office after successful safety testing of the product as per notified Indian Standard and furnishing of necessary documents.
As per Section 3(aaa) of the Drugs and Cosmetics Act, 1940 and Rules, 1945, Cosmetic
means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into,
or otherwise applied to, the human body or any part thereof for cleansing, beautifying,
promoting attractiveness, or altering the appearance and includes any article intended for use
as a component of cosmetic
Yes, import of cosmetic is regulated in India under the provisions of the Drugs & Cosmetic Act, 1940 & Rules, 1945 vide Gazette notification G.S.R 426(E).
All imported cosmetic products covered under the definition of cosmetic are regulated under the provision of Drugs and Cosmetics Act, 1940 and Rules, 1945.
For the import of Cosmetics into India, the imported cosmetic products and manufacturing site are to be registered with Central Drugs Standards Control Organization by submitting an application in Form 42 to obtain Registration Certificate in Form 43.
Import of cosmetics in India needs to be regulated to ensure the quality of cosmetics being
imported into India and the safety of consumers using these cosmetics.
The Manufacturer himself/The Authorized Agent of the Manufacturer/The Subsidiary of the Manufacturer/any other importer can be an applicant for issuance of Registration Certificate for import of cosmetics into India.
A fee of Two Thousand US dollars or its equivalent in Indian rupees per category of cosmetic and a fee of Fifty US dollars for each variant shall be paid along with application in Form 42.
Yes. If a unit pack (Kit, Palettes etc.) containing different colors, shades, flavours, fragrances or other inherent characteristics apart from the base formulation which is sold as a single unit pack in retail, then it will be considered as a single variant
As per Rule 129C of Drugs and Cosmetics Rules, 1945, if the application is complete in all respects and information specified in Schedule D III is in order, the licensing authority shall, within six months from the date of receipt of an application, issue such Registration Certificate, and in exceptional circumstances and for reasons to be recorded in writing, the Registration Certificate may be issued within such extended period, not exceeding three months, as the licensing authority may deem fit. However, CDSCO targeted timeline for processing of applications is 90 days as per Circular dated 30.05.2014
A Registration Certificate in Form 43, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issuance.
What if my registration certificate is going to expire?
Ans: Provided that if application for a fresh Registration Certificate is made within six months before the expiry of the said certificate, the existing Registration Certificate shall be deemed to continue to remain in force until orders are passed on the application.
Importer has to apply for endorsement to the existing Registration Certificate along with
the requisite documents except fees if the category is already registered and provided that the additional product(s) are being manufactured at the same manufacturing site. If additional category needs to be added, fees of 2000 USD per category needs to be paid.
Change in product composition, change in the method of testing, minor change in manufacturing process not affecting the final product specifications, updating in labels and packaging (provided proper justification should be provided for the above changes).
Legible Original label for proposed products along with their variants (if any) as per Drugs and
Cosmetics Rules, 1945 which includes following:-