Home India Ministry of Health and Family Welfare Surrender of Cosmetics Import Registration Certificates of M...
Date: 2024-08-06 Category: Not Applicable State: Union Government Country: India

Surrender of Cosmetics Import Registration Certificates of M/s Johnson & Johnson Pvt. Ltd L.B.S. Marg Mulund Mumbai Maharashtra India

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

Key Changes

  • M/s. Johnson & Johnson Pvt. Ltd. stopped importing cosmetics under these registration certificates approximately one and a half years ago.
  • The firm's last month of import was between November and December 2022 and most of the batches will expire by September & November 2025.
  • The authorized agent in India remains responsible for the quality, safety, and regulatory compliance of imported cosmetic products already available in the country.
  • Cancellation of 14 Cosmetics Import Registration Certificates previously held by M/s. Johnson & Johnson Pvt. Ltd. (now M/s. JNTL Consumer Health (India) Private Limited).
  • The cancellation is effective immediately.
  • The listed registration certificates pertain to imports from various legal manufacturers including M/s. Johnson & Johnson Consumer Inc. (USA), M/s. Cilag GmbH International (Switzerland), M/s. Johnson & Johnson (Thailand) Ltd., M/s. Johnson & Johnson Korea Ltd., and M/s. Johnson & Johnson China Ltd.

What it means

  • The gazette notification announces the cancellation of Cosmetics Import Registration Certificates held by M/s. Johnson & Johnson Pvt. Ltd. (now M/s. JNTL Consumer Health (India) Private Limited).
  • This cancellation is a result of the company's request following a global restructuring plan where the consumer health business, including cosmetics, was demerged into a new legal entity, M/s. JNTL Consumer Health (India) Private Limited.
  • M/s. JNTL Consumer Health (India) Private Limited has already been granted fresh Import Registration Certificates for cosmetics.

Impact Analysis

M/s. JNTL Consumer Health (India) Private Limited

  • Action Items: Continue to ensure quality, safety and regulatory compliance for products already in the market.

Central Drugs Standard Control Organisation (CDSCO)

  • Action Items: Ensure continued monitoring of product quality, safety and regulatory compliance of cosmetic products already available in the market.

Zonal, Sub Zonal and Port Offices of CDSCO

  • Action Items: Enforce the cancellation of the specified import licenses at respective zones and ports.

Consumers

  • Action Items: Continued access to safe and compliant cosmetic products already available in the market.

Key Entities Referenced

M/s. Johnson & Johnson Pvt. Ltd. (Currently named as M/s. JNTL Consumer Health (India) Private Limited): Indian subsidiary of Johnson & Johnson, now operating as JNTL Consumer Health (India) Private Limited, responsible for importing and marketing cosmetic products. M/s. Johnson & Johnson Consumer Inc.: US-based legal manufacturer of cosmetic products imported by M/s. Johnson & Johnson Pvt. Ltd. (now M/s. JNTL Consumer Health (India) Private Limited). M/s. Cilag GmbH International: Switzerland-based legal manufacturer of cosmetic products imported by M/s. Johnson & Johnson Pvt. Ltd. (now M/s. JNTL Consumer Health (India) Private Limited). M/s. Johnson & Johnson (Thailand) Ltd.: Thailand-based legal manufacturer of cosmetic products imported by M/s. Johnson & Johnson Pvt. Ltd. (now M/s. JNTL Consumer Health (India) Private Limited). M/s. Johnson & Johnson Korea Ltd.: Korea-based legal manufacturer of cosmetic products imported by M/s. Johnson & Johnson Pvt. Ltd. (now M/s. JNTL Consumer Health (India) Private Limited). M/s. Johnson & Johnson China Ltd.: China-based legal manufacturer of cosmetic products imported by M/s. Johnson & Johnson Pvt. Ltd. (now M/s. JNTL Consumer Health (India) Private Limited). Central Drugs Standard Control Organisation (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India. Cosmetics Rules, 2020: The regulatory framework governing the import, manufacture, sale, and distribution of cosmetics in India. Rule 13 is specifically mentioned in the gazette. National Company Law Tribunal (NCLT): A quasi-judicial body in India that adjudicates issues relating to Indian companies.
Official Source Record View Original Source →
See Full Document Text
File No. COS-11011(LL1612024-eottice Government of lndia Directorate General of Health Services Central Drugs Standard Control Organisation (Cosmetics Division) FDA Bhawan, Kotla Road, New Delhi-110002 [6 oateo: AU6 202{ Subject: Surrender of Cosmetics lmport Registration Certificates ofMls Johnson & Johnson Pvt. Ltd., L.B.S. Marg, Mulund (\r!) Mumbai, Maharashtra (lndia) - 400 080 - reg This is with reference to the letter received from M/s. Johnson & Johnson Pvt. Ltd. (Currently named as M/s. JNTL Consumer Health (lndia) Private Limited), L.B.S. Marg, Mulund (W) Mumbai, Maharashtra (tndia) - 400 080 on subject cited above. The subject firm is holding the following Cosmetics lmport Registration Certificates for the purpose ol lmport of Cosmetics registered by the below mentioned legal manufacturer: Sr.No. RC nos. Validity Registered Legal Number period manufacturer of products L RCTCOS- 17-Apr- M/s. Johnson & Johnson 03 I8, 0 16 dated 2027 Consumer lnc., 199, Grandview t8-Apt-2022 Road, Skillman, NJ-08558, USA - (United States) Telephone No.: 1-908-874-1000 FAX: 1- 908-874-1000 E-Mail : SShidhor@its.jnj.com 2. RC/COS-578 20-Sep- M/s. Cilag cmbH lnternational, 02 dated 21-Sep- 2026 Division Johnson & Johnson Consumer 2021 Europe, Gubelstrasse 34, CH-6300 Zug, - (Switzerland) Telephone No.: 0582315050 FAX: 0582315051 E-Mail : mfrei@its.jnj.com 5 RC/COS-s78 07-Jun- M/s. Cilag GmbH lnternational, 01 dated 08-Jun- 2027 Division Johnson & Johnson 2022 nsumer Europe, , Gubelstrasse 34 cH-6300 Zug, - (Switzerland) Telephone No.: 41582315050 FAX: 1582315051 E-Maitmfrei@its. n .com 4 RC/COS. 28-Jul- M/s. Johnson & Johnson 03 45OlL4 dated 2026 (Thailand) Ltd., 106 Moo 4, 29-July-2021 Latkrabang lndustrial Estate, 5 RC/COS- Chalongkrung Road, Lamplatew, 01 4501L4, Latkrabang, Bangkok 10520, Endorsement Thailand - fihailand) Telephone No. 1 dated No.: 662-326-0906 FAX: 0-2739- 06-Sep-2021 4716 E-Mail : 6 RC/COS- ssamant9@its.jnj.com 01 450174, Endorsement No. 2 dated L0-Mar-2O22 7 RC/COS- 22-Sep- M/s. Johnson & Johnson 38 45UL4 dated 2026 Korea Ltd., 61, Daesin-ro 164 beon-gil, 23-S,ep-2027 Heungdeok-gu, B Endorsement Cheongju-si, 01 No. 1 dated Chungcheongbuk-do, - Korea (South t4-Jan-2022 Korea) I Endorsement Telephone No.: 8227988081 01 2 No. dated 22-Apr-2022, nbelokar@ its.jnj.com 10. Endorsement 01 No. 3 dated O2-May-2022 v.. Endorsement 01 No. 4 dated OZ-May-2022 L2. Endorsement 01 5 No. dated OS-May-2022 13. Endorsement 01 No. 6 dated \O-May-2022 L4. RC/COS- 04-Apr M/s. M/s. Johnson & Johnson 03 China Ltd., No. 001135 dated 2027 3285 05-Apr-2022 Dongchuan Road, Minhang Oistrict, Shanghai, P. R. China 200245 - (China) Telephone No.: 86-21- FAX: 64302010 86-21- 64304220 E-Mail : SShidhor@its.ini.com It is started in the letter that as a part of global restructuring plan' the consumer Health Business including the portfolio of cosmetic products of M/s. Johnson & Johnson Private Limited in lndia has separated and demerged witheffect from 2 January 2023, into a new legal entity under the name M/s. JNTL Consumer Health (lndia) Private Limited through a scheme of arrangement and demerger which was sanctioned by the Hon'ble NCLT (National Company Law Tribunal), Mumbai. lt also intimated that they stopped importing any Cosmetics under the aforesaid Registration Certificate numbers since last one and half year. Funher, a fresh lmpon Registration Certificate for the Cosmetics was already been granted to M/s. JNTL Consumer Health (lndia) Private Limited and henceforth will be imported by them. The firm has mentioned that their last month of lmport was between November and Decembet 2022 and most of the batches will get expire by September & November 2025. ln view of the above and as per the request of the subject firm, the lmport of Cosmetics Registration Certificates granted under the Rule 13 of Cosmetics Rules, 2O2O as mentioned above in the name of M/s. Johnson & Johnson Pvt. Ltd., (Currently named as M/s. JNTL Consumer Health (lndia) Private Limited), L.B.S. Marg, Mulund (W) Mumbai, Maharashtra (lndia) - 400 080, is hereby cancelled with immediate etfect subject to condition that the authorized agent in lndia shall be responsible for Quality, Safety and Regulatory compliance for the imported Cosmetic Products which are already available in the country, if any. This is for your lnformation. Yours faithfully, q.U.^e (Dr. Rajeev ng shi) Drugs Controller neral (lndia) To M/s. Johnson & Johnson Pvt. Ltd., (Currently named as M/s. JNTL Consumer Health (lndia) Private Limited), L.B.S. Marg, Mulund (W) Mumbai, Maharashtra (lndia) - 400 080. Copy to: 1) All Zonal, Sub Zonal and Port Offices ol CDSCO. 2) CDSCO Website

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