Authorized Agent/ In–Country Representative

Qaaf Healthcare International can act as a company agent or representative on behalf of our client or company in India as mandatory requirement under Drug and Cosmetic Act & Rules and also for Food safety and Standards Authority of India (FSSAI) Act. With this mutual collaboration and agreement our client has the freedom to choose any distributor of his choice. Change of distributor can be done as and when required by our client or company by cancelling the distributor license, which gives our clients the flexibility of hassle free cost effective solution and also ensures that no distributor can take any undue advantage of his position.

The definition of an in-country representative differs broadly across the spectrum of jurisdictions where one is required from an establish business entirely licensed as the medical devices or medicinal product or biotechnology product or cosmetics or bulk API, to a natural person residing in the country. The requirement for an in-country representative generally can be met in several ways. Most common among, assigning a distributor or importer or employing third –party professional representative services.

In general in-country representative acts as a liaison between a foreign manufacturer and the local competent authority, to facilitate identification of the appropriate local entity for product questions and/or complaints. The in-country representative is available to receive user complaints, forward these to the manufacturer and submit the required reports to the regulatory authority.

In practical terms, an in-country representative eliminates the need for regulatory authorities to communicate with a foreign entity, possibility in a different language and time zone, about import safety and compliance information for the products on their markets. The official title of the in-country representative differs from country to country, with the EU and GHTF term “Authorized Representative” commonly used generically.

In order to lawfully register, import and distribute market, sell your pharmaceutical/medical devices/food products/cosmetics/herbal in India, Qaaf Healthcare International provides an end to end solution from dossier preparation, submission, follow up with CDSCO, Labeling requirements and obtaining the relevant certification. 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/in-country representative with the above needs is to be formally appointed.

Qaaf Healthcare International will represent your esteemed organization as your official Indian Authorized Representative/Agent/in-country representative in accordance with India statutory requirement The Drugs and Cosmetics Act 1940 and Rules 1945.

Only one Indian Authorized Representative office is needed for the whole country. Qaaf Healthcare International will represent you officially in India without any commercial conflict of interest activities like product distribution, product marketing, product sales etc.

Reason for not appointing a distributor or sales agent as an in country representative/authorized agent

• Manufacturing process or design of medical devices or intellectual property might be disclosed to the distributor during the dossier preparation and submission
• Distributor main focus is sales and marketing, having them handle regulatory affairs work could be an additional burden
• Issue of registration certificate with distributor name means company is locked for 3 years, if the company wish to change or add distributors company has to start the process all over again, as there is no provision of transferring the registration certificate in India.
• ADR/SAE, recall can create a conflict of interest with your distributor
• Pharmacovigilance study of the product under consideration may be affected
• All report and confidential data of company’s products may be publically open

Roles and responsibility of an authorized agent/in country representative

• In country representative must be residence of India with experience in pharmaceutical/healthcare industry
• Holds the Power of Attorney to submit dossier to CDSCO
• Authorized agent/in country representative must have drugs wholesale licenses like Form 20-B and Form 20-21B