Fast and Reliable Medical Device Regulatory


Q1. How Cosmetic is defined in India as per Drugs & Cosmetics Act?

Answer. 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 cosmetics.

Q2. Is cosmetics regulated in India?

Answer. Manufacturing & Imports of cosmetic products are regulated in India under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945. The imports of cosmetics were not notified by Gazette notification G.S.R 426(E).

Q3. What are the requirements for import of Cosmetics in India as per GSR 426 (E)?

Answer. For the import of Cosmetics in India, the imported cosmetic products are required to be registered with Central Drugs Standards Control Organization by giving application in Form 42 and Schedule D (III), Power of Attorney and a fee of USD 250 per category of cosmetics as per the DCGI guidelines to obtain Registration certificate in Form 43.

Q4. Who can be an importer of Cosmetics into India?

Answer. Manufacturer, An Authorized Agent of the Manufacturer/Subsidiary of the Manufacturer/any other importer having IEC issued by DGFT can be an applicant for issuance of Registration certificate for import of cosmetics into India.

Q5. What is the time period for Grant of Registration Certificate in Form 43?

Answer. As per Rule 129C provided that if the application is complete in all respects and the 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.

Q6. What is the Validity of a "Registration certificate" in Form-43 for Cosmetics in India? Answer: A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue.

Q7. How to register additional product(s) in the already granted/valid Registration Certificate in Form 43?

Answer. 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 products being manufactured at the same manufacturing site. If additional category needs to be added fees of 250USD per category needs to be paid. Validity of the endorsement issued for these additional products will be same as of main registration certificate.

Q8. How much fees for issuance of duplicate copy of "Registration certificate" in Form- 43Cosmetics in India?

Answer. A fee of one hundred US dollars or its equivalent shall be paid to obtain a duplicate copy of the Registration Certificate.

Q9. Who can issue free sale certificate for Imported Cosmetic products?

Answer. Free sale certificate can be issued by the National Regulatory Authority of Country of origin. In case if it is not issued by National Regulatory Authority from the country of origin then from other competent Associations/ organizations duly authenticated from the Indian embassy of country of origin need to be submitted.

Q10.What information is required on the free sale certificate for the imported Cosmetic products?

Answer. Information required includes the Name and Address of the legal and actual manufacturer with cosmetic products defining all of their variants.

Q11. What are the major changes on granted Registration certificate that require an applicant to make a fresh Registration?

Answer. The following changes which require a fresh registration are as follows –Any change with respect to manufacturer (legal/ actual) like change in constitution, change in name, change in address, including merger and acquisitions etc. Any change with respect to importer/ Indian Agent like change in constitution change in name also needs to be notified to CDSCO and fresh RC to be obtained within 90 days.

Q12. What are the minor changes which do not require fresh registration and only notification or amendment may be obtained? Answer. Change in 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).

Q13. What is the time limit for submission of Query Response?

Answer. As per DCGI guidelines the response need to be submitted within 45 days.

Q14. Who issues No objection certificate for import of Cosmetic products for R&D purposes like packaging trials, consumer studies, shelf life studies and transport studies?

Answer. ADC’s at the Port offices of CDSCO can issue the above mentioned No Objection Certificates.

- CMEF: 15- 18 May 2017, Shanghai
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- NSICON 30-Nov-3rd Dec 2017, Nagpur (India)
- Arab Health 29th Jan-1st Feb 2018, Dubai