In order to legally register, import and market, sell your medical products in India you need to be compliant to Indian regulations and legislation. When a company does not have a registered and physical office with statutory personnel and required licenses in India, a legal India Authorized Representative / Agent with the above needs is to be formally appointed. This Authorized Representative will also be held responsible for pre-certification and post-market surveillance inquiries.
Optimus will represent your organization as your official Indian Authorized Representative / Agent in accordance with India applicable regulatory legislation: The Drugs and Cosmetics Act and Rules.
Only one Indian Authorized Representative office is needed for the whole country. Optimus will represent you legally in India without any commercial conflict of interest activities like product distribution, product marketing, product sales etc.
Many product distributors are happy to take on the role of an official Indian Authorized Representative. This relationship would curtail the manufacturer’s ability to work with multiple distributors in India or change distributor/s due to performance challenges.
Since the appointed India Representative is identified on the CDSCO product registration documents and tied to the manufacturing site and product approval for its three year duration, if a distributor is appointed as the authorized representative, this relationship cannot be changed at least for a period of three years. Also, this can become problematic because if you decide to switch distributor/s you will need to start the registration process all over again.
Optimus is a professional regulatory consulting organization, which specializes purely in the medical product regulatory space and provides independent in-country representative services. Also, it is important to understand that the India Authorized Representative is legally responsible for your medical products in India and therefore it is extremely important to be represented by a professional firm that specializes in providing regulatory services and whose interests do not conflict with that of your company.
As your legal India Authorized representative, Optimus will:
- Provide authorization to place our name, local mailing address and phone/fax numbers on your product submissions and registrations to the CDSCO;
- Upon request by the CDSCO provide information about your products, and names and addresses of Indian distributors;
- Assist in coordination of an inspection if CDSCO selects your manufacturing site for an inspection/audit.
We also provide a wide range of additional services such as:
- Regulatory Strategy Consulting and Liaison
- Complete Product Life Cycle Management
- Compilation of India specific submission dossiers
- Submission management leading to approvals
- Labelling and Patient Information / Instructions for use leaflets
- Post marketing services including Complaint handling, Adverse incident reporting and product recall support as part of Product safety reporting, Query management, PSUR Writing & Submission activities
- All statutory Marketing Authorization holder’s requirements
- Act as your India Regulatory Department by Applying and Maintaining required Authorizations, Prepare and review regulatory submission material for compliance to India legislation etc.,
The India Authorized representative is responsible for product registrations and acting as the legal liaison between the manufacturer, based outside India and the Indian regulatory agency CDSCO (Central Drugs Standard Control Organization). Foreign manufacturers of medical products who do not have a registered, physical presence in India must appoint an Indian Authorized Representative.
In addition to being a resident or registered commercial organization of India, the India Authorized Representative must have the required statutory infrastructure and licenses along with prior experience in the industry. The India representative has significant responsibilities and is also legally liable for the product in India according to the Drugs and Cosmetics Act and Rules. The extent of responsibility is very different from the role of the “US Agent” representative required by the United States FDA.
The India Authorized Representative, through a legal Power of Attorney executed by the manufacturer, is authorized to submit product registration documents and act as a point of contact for any inquiries related to the product by the CDSCO. The Representative is also involved in vigilance activities and acts on the manufacturer’s behalf if an onsite inspection of the manufacturer’s facility is required.