The Central Drug Standard Control Organisation (CDSCO)
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.
Procedure for Issue of Cosmetic Registration Certificate:
- The manufacturer or by his authorized channel in India or by the subsidiary in India authorized by the manufacturer.
- The application form must be submitted to the office of the DCGI under Indian Ministry of Health and Family Welfare, New Delhi (Both as a hard Copy and Soft Copy)
- The application must be submitted
- Form – 42
- along with a cover letter
- Power of Attorney
- Schedule DIII
- Original or copy of a label
- FSC/Marketing Authorization letter/Manufacturing License (if any)
- Product specification and testing protocol
- List of countries where Market Authorization or Import Permission or Registration has been granted
- Pack insert ( if any)
- Soft copies of the information about the brands, products and manufacturer.
- Receipt of the application form
- The Drug Controller General office will issue an acknowledgement i.e. copy of duly stamped cover letter.
- Registration fee
- USD 2000 or equivalent per category
- Waiting period before issue of registration certificate
- Drug Controller General’s office would issue a registration certificate within six months from the date of submission of application.
- The validity period of the registration certificate
- The registration certificate would be valid for three years.
- A single application and a registration certificate in Form 43 may be issued for import of one or more than one cosmetics manufactured by the same manufacturer only if the cosmetics are manufactured at one factory or more than one factory functioning combined as a single manufacturing unit.
- A Registration Certificate is sooner suspended or cancelled shall be valid for 3 years from the date of its issue only if an application for a new Registration Certificate is made within 6 months before the expiry of the said certificate, the existing Registration Certificate shall continue to remain until orders are passed on the application.
- No cosmetic shall be imported with the specifications mentioned in schedule S and schedule Q or any other standards of quality, safety and other provisions under the rules. If a cosmetic is not included under schedule S then it shall meet with specifications under the rules and standards applicable to it in the country of origin.
- The registration certificate is not required for Import of cosmetics for Research and development (R&D) purposes like packaging trials, consumer studies, shelf life and transport studies. In such cases, the importer has to get the necessary permission from CDSCO (HEAD QUARTERS). The importer must give written statement that these products are not released for domestic sale.
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:-
- Name of Cosmetic
- Name and address of the manufacturer and name of the country where the product has been manufactured. If the product has not been manufactured in a factory owned by the manufacturer, the name and address of the actual manufacturer or the name of the country where it has actually been manufactured as “Made in …….. (Name of country)” should be there on the label.
- Further, for very small size container where the address of the manufacturer cannot be given, the name of the manufacturer and his principal place of manufacture shall be given along with pin code.
- Use Before
- Direction for safe use/Caution
- Batch no
- Manufacturing License no.( If any)
- Registration Certificate Number and R.C holders name and address.
- Information (if any) as per Part XV of Drugs and Cosmetics Rules, 1945.