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Authorized Agency in India

Being compliant to the provisions specified in the Drugs and Cosmetics Act and Rules of India is the first pre-requisite to be able to able to legally register, import and market your company’s products in India. The first of these require that a company without a registered and physical office in India and /or without statutory personnel and required licenses must appoint a legal entity as its Authorized Indian Representative/ Agent who, after fulfilling all the criteria listed in the Act, would be held accountable for pre-certification and post-market surveillance inquiries. This Authorized Indian Representative, who could be a person or a company, would be granted Power of Attorney by the foreign company who wants to register and sell its product(s) in India, a mandatory requirement for companies looking to import medical devices and regulated drugs to India.

Transparency has always been our hallmark and Admirus would represent you legally in India without any commercial Conflict of Interest activities like product distribution, product marketing, product sales etc.
 

“The Honey Trap – Beware of the Fine Print”


There are many Indian distributors/importers who would be willing to also be your Authorised India Agent. However, this is a potentially risky situation for your company’s business operations as a Conflict of Interest would arise. If the distributor, who is also your authorised representative, is unable to meet your target sales, you cannot appoint another distributor without his no-objection-certificate* or till the completion of the mandatory three year term of agreement. Even if you were to terminate your agreement with this license holder and appoint a fresh distributor, the whole process would be very time-consuming and tedious, not to mention that your product will not be available in the market for the entire duration of this process. It is therefore advisable to ensure that the representative you appoint should be someone who can keep your interests in mind and be suitably empowered to change the distributor in case the performance is not satisfactory.

 

* 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 and a NOC from the former is required to appoint another distributor.

 


Admirus prides itself in providing top-notch independent in-country representative services. As your Authorised Indian Representative, we would be legally responsible for your products in India and therefore our interests would never conflict those of your company.


Bottomline: With Admirus, you can Retain full control over your product distribution.

 Responsibilities we undertake as your Indian Authorized Agent
  • -  Being Legally Responsible for all Liabilities of the Product in India
  • -  Being the Communication Link between the Manufacturer and the Central Drugs Standard Control Organization (CDSCO).
  • -  Providing Answers to all queries from CDSCO or from users
  • -  Being the Authorized Signatory for all legal documents required to be submitted to CDSCO.
 From Admirus AuthoRep Services Desk
  • -  Preparation of all mandatory Documentation and Master Data File for Registration procedures.
  • -  Scrutiny and Processing of applications to obtain Import Licenses (Form 10) for selected distributors and importers.
  • -  Formulation of Answers on your company’s behalf to all queries posed by CDSCO, including details of device, manufacturer, distributor, etc.
  • -  Assistance from our experienced professionals during inspection of site and/or product by CDSCO during selection process.
  • -  Post market Surveillance and Complaint Treatment.