**Policy Summary:**
This order, issued by the Licensing Authority Cum Drugs Controller General of the Central Drugs Standard Control Organisation, Ministry of Health and Family Welfare, Government of India, cancels Registration Certificate RCCOS000393, dated 11.09.2017, granted to Ms. UNITED DISTRIBUTORS INCORPORATION, located at 409, Nirman Kendra Off. Dr. E Moses Road Mumbai India 400011. The registration certificate allowed the firm to import cosmetics manufactured by Ms. Gulf Center for Soap and Chemical Industries L.L.C., P.O. Box, 10706, Dubai United Arab Emirates.
The cancellation, effective immediately, is a result of violations pertaining to the labelling provisions for imported cosmetics under the Drugs and Cosmetics Rules. A show cause notice was issued on 15.02.2019, under Rule 21b, providing Ms. UNITED DISTRIBUTORS INCORPORATION with seven days to respond to the alleged violations. As no response was received, the Licensing Authority inferred that the firm had no defense to offer. This action is taken without prejudice to any other legal action.
The order is issued under the authority of Rule 21 b of the Drugs and Cosmetics Rules, and in accordance with Rule 129 C of the same rules, which governs the import of cosmetics.
The order, dated 7th March 2019 (File No: COS17000570), is issued by Dr. S. Eswara Reddy, Licensing Authority Cum Drugs Controller General. Copies of the order have been sent to Ms. Gulf Center for Soap and Chemical Industries L.L.C, all port offices of CDSCO, and the order file.
Key Entities Referenced
Central Drugs Standard Control Organisation: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
Drugs and Cosmetics Rules, 1945: A set of rules in India that govern the import, manufacture, distribution, and sale of drugs and cosmetics.
UNITED DISTRIBUTORS INCORPORATION: An authorized agent based in Mumbai, Maharashtra, India, previously holding Registration Certificate No. RCCOS000393 for import of cosmetics.
Mumbai, Maharashtra: City in India where UNITED DISTRIBUTORS INCORPORATION is located.
Gulf Center for Soap and Chemical Industries L.L.C.: A cosmetics manufacturer located in Dubai, United Arab Emirates, whose products were imported into India by UNITED DISTRIBUTORS INCORPORATION.
Dubai, United Arab Emirates: Location of Gulf Center for Soap and Chemical Industries L.L.C., a manufacturer whose products are impacted by the order.
Drugs and Cosmetics Act, 1940: An act in India to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
Dr. S. Eswara Reddy: Licensing Authority Cum Drugs Controller General, who issued the order cancelling the Registration Certificate.
File. No: COS/17/000570
(Government of India)
Central Drugs Standard Control Organisation (HQ)
Directorate General of Health Services
Ministry of Health and Family Welfare
(Cosmetic Division)
FDA Bhawan, Kotla Road
New Delhi-110002
Dated: mt» 7
Ferg MAR 2019
ORDER
WHEREAS, Rules 129 to 129 C of the Drugs and Cosmetics Rules, 1945 specify the
provisions for grant of Registration Certificate for import of Cosmetics.
AND WHEREAS, the firm M/s UNITED DISTRIBUTORS INCORPORATION _,409,
Nirman Kendra Off. Dr. E Moses Road Mumbai (India) — 400011 hereinafter referred as
“Authorized Agent” was granted Registration Certificate bearing No. RC/COS-000393 in
Form 43 dated 11.09.2017 having validity up to 10.09.2020, for import of Cosmetics into
India manufactured by M/s. Gulf Center for Soap and Chemical Industries L.L.C. P.O.
Box, 10706, Dubai _- (United Arab Emirates) under the provisions of the Drugs &
Cosmetics Act, 1940 and Rules made there under.
AND WHEREAS, a show cause notice was issued by the Licensing Authority under rule
21(b) on dated 15.02.2019 to M/s UNITED DISTRIBUTORS INCORPORATION, 409,
Nirman Kendra Off. Dr. E Moses Road Mumbai (India) — 400011 for violation of the
provisions of labelling for imported cosmetics under Registration Certificate RC/COS-
000393 dated 11.09.2017. In the show cause notice, an opportunity was given to you to
submit your reply within 07 days.
AND WHEREAS, no response has been received for the violations mentioned in the
show cause notice till date. As such it is inferred that you have nothing to say in this
regard.AND THEREFORE, the undersigned being the Licensing Authority empowered under
Rule 21 (b) of Drugs and Cosmetics Rules, keeping in view of the violation of the
provisions of labelling for imported cosmetics under Drugs and Cosmetics Rules,
hereby cancel the Registration Certificate RC/COS-000393 dated 11.09.2017, granted
for the import of cosmetics under the provision of Rule 129 C of Drugs and Cosmetics
Rules, 1945 with immediate effect.
This action is taken without prejudice to any other legal action which may be
taken in future against the Agent in the above matter.
(Dr. S. Eswara Reddy)
Licensing Authority
Cum Drugs Controller General (1)
To
M/s UNITED DISTRIBUTORS INCORPORATION, 409, Nirman Kendra Off. Dr. E
Moses Road Mumbai (India) — 400011
Copy to:
1. M/s. Gulf Center for Soap and Chemical Industries L.L.C, P.O. Box, 10706, Dubai -
(United Arab Emirates)
2. All port offices of CDSCO.
3. Order file