INDIAN AUTHORIZED REPRESENTATIVE

Cosmetics-Registration-in-India.com

We, COSMETICS REGISTRATION (INDIA) are a consultancy subsidiary of ARHAM CONSULTANTS (INDIA) PTY, New Delhi and are focused on the regulatory compliance of Cosmetics Imports Registration in India.

Indian Authorized Representative

The importer or the overseas manufacturers must comply with the Indian legislation and regulations in order to import, market, sell or register a cosmetic product in the Indian Territory. A formal appointment must be made of an authorized agent/ representative if the company doesn’t have a statutory personnel or a registered office in India. The authorized representative will take care of the pre-certification registration formalities and post market surveillance activities.

COSMETICS REGISTRATION (INDIA) offers an Authorized Representative service of independent registered business entities to the foreign applicant organizations as the Authorized Agent / Representative in compliance with the regulatory regulation in India and under the enactment of The Drugs & Cosmetics Act and Rules.

The legislation requires only one Authorized Agent or Representative office in India. COSMETICS REGISTRATION (INDIA) offers you official representation and an assortment of services without any conflicts in commercial activities such as product sales and multiple marketing and distribution channel development.

Full control on product distribution

In India, a lot of distributors are more than willing to become an Authorized Representative. This relationship comes with certain consequences which a manufacturer would prefer to avoid. With an Authorized Representative having a commercial interest in the venture, the foreign manufacturer is not able to partner with multiple distributors or change the distributors even under market challenges.

The appointment of an Authorized Representative in India is as per the CDSCO product registration regulations. The appointment and the subsequent product approvals remain in force for a period of 3 years. In case a commercially interested distributor is appointed as the Authorized Representative, he can challenge the company so that the status cannot be changed for the aforesaid duration of 3 years. This becomes more complicated when the manufacturer decides to realign distributors as this would require the registration process to be revisited, once again.

COSMETICS REGISTRATION (INDIA) offers consulting services which are professional and in compliance with the regulatory environment. The offered services of an Authorized Representative are strictly as per the regulatory space and are offered purely for a regulatory representation in India. The ambiguity on functional areas is completely omitted. Also, the Authorized Agent or Representative is legally liable for the regulation on cosmetic products and it is therefore very important that only a professional firm with specialization in regulatory services looks after the formal procedures. From a business perspective too, the interests should not lead to any conflict.

Our Core areas of work…

COSMETICS REGISTRATION (INDIA), facilitates the service of a legal Authorized Representative in India who will look after:

  • 1. The formal procedures on authorization wherein their name, registered office and address / contact details will be placed on the registration papers, product submissions and other documents to CDSCO
  • 2. Provide details on products and addresses of the Indian distributors to CDSCO, when required
  • 3. Provide assistance and coordination of timely audit/inspection of the overseas manufacturing site by CDSCO

In a synergy of efforts with the Indian Authorized Representative, our range of services includes:

  • . Regulatory Liasoning and Strategic Consultation
  • . PLC ‘Product Life Cycle’ advise
  • . Preparation of submission dossiers which are India specific
  • . Generating product approvals through timely submission of papers
  • . Labeling and designing leaflets for Consumer Information or Instructions
  • . Managing key functions – ADR reporting [Adverse Reactions], Complaint handling, Grievance settlement, Query management, Customer support, Product safety reporting and PSUR writing
  • . Complying with statutory requirements on Marketing Authorization
  • . Function as manufacturer’s extension for regulatory activities, generating Authorizations, submission of documents / submission material as required by CDSCO
Responsibilities

The Authorized representative in India, on behalf of the manufacturer (based outside of India), is wholly responsible for the legal liasoning, product registrations and regulatory compliance with CDSCO [Central Drugs Standard Control Organization] and performs legal obligations by acting as the Indian Authorized Representative and filling up for the physical presence of the manufacturer

The Authorized Representative, apart from being a resident of India and a registered commercial organization, should also have the necessary Drugs & Cosmetics licenses, relevant experience and the statutory infrastructure to deal with the matters. The responsibilities of the Authorized Representative make the firm liable for the foreign registrants legal existence in India under the Drugs and Cosmetics Act.

Under the legal power entrusted by the attorney of the manufacturer, the Authorized Representative in India works as the point of contact for legal queries, product registration and inquiries made by CDSCO. The Authorized Representative is also authorized to submit registration documents and the application form. The Representative, on behalf of the manufacturer, would also coordinate and administer the audit, quality tests or vigilance activities by CDSCO at the manufacturer’s facility.

Disclaimer:

All the information on various aspects of Cosmetics Registration process and regulations in India is the personal interpretation of the author as gathered from various online & offline source materials. None of the information on this site, in part or whole, is claimed to be an authoritative opinion or summary extract of any law or regulations ; readers are requested to validate the information from their own informed sources and act so on their own wise decision.

Resources:

The Drug & Cosmetics Act, 1940

Drug Controller of India, Ministry of Health, Government of India

Ministry of Finance, Government of India

Reserve Bank of India