**Summary:**
This circular, issued by the Drugs Controller General of India, Central Drugs Standard Control Organization on June 29, 2015, clarifies the implementation of Rule 135B of the Drugs and Cosmetics Rules, 1945. This rule, amended via Notification No. GSR 718E dated October 13, 2014, prohibits the import of cosmetics tested on animals after the rule's commencement. Further to Circular No. 18122013DCPart File dated 13.02.2015, importers of already registered cosmetic products must submit an original undertaking from the manufacturer (legal/actual brand owner) to CDSCO, stating that the products to be imported have not been tested on animals on or after November 12, 2014. New applicants must submit this undertaking with their import registration dossiers. An acknowledgement copy from CDSCO, received upon submission of the undertaking with the application, can be presented at port offices for consignment clearance. The circular is addressed to all Port, Zonal, and Sub-zonal offices of CDSCO, the Indian Beauty and Hygiene Association (Mumbai), and the Federation of Indian Chamber of Commerce and Industry (New Delhi). Copies have been sent to the PS to JSR and the PS to Director D, both at the Ministry of Health & Family Welfare in Nirman Bhawan, New Delhi.
Key Entities Referenced
Directorate General of Health Services: An agency of the Government of India responsible for public health.
Central Drugs Standard Control Organization: National Regulatory Authority responsible for regulating pharmaceuticals and medical devices in India.
Drugs Controller General India: Head of the Central Drugs Standard Control Organization (CDSCO) in India.
The Drugs and Cosmetics Rules, 1945: A set of rules in India that govern the import, manufacture, distribution, and sale of drugs and cosmetics.
Rule 135B: A specific rule within The Drugs and Cosmetics Rules, 1945, prohibiting the import of cosmetics tested on animals.
Indian Beauty and Hygiene Association, Mumbai: An industry association representing beauty and hygiene product manufacturers in India, located in Mumbai, Maharashtra.
Federation of Indian Chamber of Commerce and Industry, New Delhi: A non-governmental trade association and advocacy group based in New Delhi.
Ministry of Health Family Welfare, Nirman Bhawan, New Delhi: A ministry within the Government of India responsible for health policy. Nirman Bhawan is the building where the Ministry is located, in New Delhi.
Directorate General of Health Services
Central Drugs Standard Control Organization
Office of Drugs Controller General India
FDA Bhawan, Kotla Road, New Delhi
File No. DDC(1)/Cos/Misc-024/14(01) Dated:
29 JUN 2015
Circular
The Drugs and Cosmetics Rules, 1945 were amended vide Notification No.
GSR 718(E) dated October 13, 2014 incorporating Rule 135B, prohibiting the import
of Cosmetics that have been tested on animals on or after the commencement of these
Rules.
Accordingly a circular No. 18-12/2013-DC/Part
File dated 13.02.2015 was
issued for the smooth implementation of the said notification. In this connection it is
further stated that matter was further considered on the basis of representations
received and it has been decided that the importer shall submit original undertaking
from the manufacturer (Legal / Actual brand owner) of the already registered products
with CDSCO stating that the cosmetic products to be imported in to the country have
not been tested on animals on and after 12.11.2014. New applicants shall however
submit this undertaking along with import registration dossiers to CDSCO. The
acknowledgement copy in lieu of submission of this undertaking along: with
application as received by the applicant from CDSCO can be produced at port offices
for clearing their consignments imported.
(Dr. GIN. Singh)
Drugs Controller General (D
To,
1. All Port / Zonal / Sub-zonal office of CDSCO
2. Indian Beauty and Hygiene Association, Mumbai
3. Federation of Indian Chamber of Commerce and Industry, New Delhi
Copy to:
PS to JS(R), Ministry of Health & Family Welfare, Nirman Bhawan, New Delhi
PS to Director (D), Ministry of Health & Family Welfare, Nirman Bhawan, New Delhi