1.CDSCO Authorized Agent Support

i) DRUGS & BIOLOGICAL:

Foreign companies without a physical presence in India can enter the Indian market by appointing an "Authorized Agent." This agent, based in India, is empowered by the foreign company to handle product registration and market the company's products within the country.

An "Authorized Agent" refers to an individual or entity in India that has been officially appointed by the foreign company. This agent will be responsible for managing the import, distribution, and all business activities related to the foreign company's products in India, ensuring full compliance with the Drugs and Cosmetics Act and other applicable regulations.

The Authorized Agent must hold a valid wholesale license for the sale and distribution of products in India and is responsible for submitting applications to the Central Licensing Authority i.e., CDSCO for drug registration.

ii) Cosmetics:

Foreign companies without an establishment in India can enter the Indian market by appointing an "Authorized Agent" to register and market their products.

An "Authorized Agent" refers to a person or entity in India authorized by the foreign company. The agent is responsible for managing the import and business activities of the company in India, ensuring compliance with the Drugs and Cosmetics Act and all relevant regulations.

The Authorized Agent must be capable of submitting applications to the Central Licensing Authority i.e., CDSCO for cosmetic mport registration. For foreign companies without local business operations or partners in India, an Authorized Agent facilitates the entire registration process for importing cosmetic products through the SUGAM online portal. Only agents with the necessary licenses OR permissions, such as TEXA GLOBAL, can apply for this registration.

Additionally, the Authorized Agent ensures that the imported cosmetic products comply with all prohibition guidelines related to cosmetic imports into India.

iii) Medical Devices & IVDs:

Foreign companies without an establishment in India can enter the Indian market by appointing an "Authorized Agent" to handle product registration and marketing.

An "Authorized Agent" refers to an individual or entity in India, authorized by the foreign company, responsible for managing the import and business operations of the company. This includes ensuring compliance with the provisions of the Drugs and Cosmetics Act.

The Authorized Agent must hold a valid wholesale license or FORM MD 42 for the sale and distribution of products in India and must be capable of submitting applications to the Central Licensing Authority  i.e. CDSCO for medical device registration. Given the complexities of operating in India—such as high costs, compliance requirements, accounting, taxation, and closure policies—it can be challenging for foreign manufacturers to manage operations independently.

TEXA GLOBAL, a leading business and compliance consultancy, offers continuous support for marketing medical devices in India. Likewise, TEXA GLOBAL ensures that all necessary regulatory compliances are met, allowing you to focus on your core business operations without the burden of navigating complex regulatory requirements.

2.FSSAI Authorized Agent Support

Food, Food Supplements and Functional Foods:

A "Food Importer" refers to a Food Business Operator engaged in, or intending to engage in, the import of food articles, food supplements, and functional foods into India. The importer must be duly licensed under the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011, in accordance with the provisions of the Act.

Any foreign company seeking to enter the Indian market without an established business presence or local partner can benefit from the services of an Authorized Agent. The Authorized Agent handles all the necessary licensing and approvals, streamlining the process for your organization to enter the market, distribute products, and reach target clients effectively.