Indian Authorized Representative (IAR) Services
India, with its rapidly growing economy and vast consumer base, presents immense opportunities
for global brands. Are you ready to tap into this thriving market? Taevas offers comprehensive
Indian Authorized Representative (IAR) services to help clients navigate regional complexities
while entering the Indian market.
Who is an Indian Authorized Representative (IAR)?
An Indian Authorized Representative (IAR) is an entity or individual residing in India that acts as a representative of foreign businesses in India, and act as their extended arm for doing business in India. They act on behalf of the foreign entity to facilitate communication with Indian authorities, submitting documents, applying for licenses, and ensuring adherence to local laws and regulations.
Why Choose Taevas for Indian Authorized Representative (IAR) Services?
At Taevas, we understand the complexity of Indian regulations and provide the expertise needed to navigate them effectively. With our Authorized Agent services, you can confidently meet the regulatory standards, avoiding costly delays or compliance issues while ensuring your products are successfully launched and maintained in this critical market.
- Act as your Indian Authorized Representative (IAR) before health authorities, ensuring full compliance for product approvals.Â
- Coordinate and attend health authority meetings as required.Â
- Submit product applications/dossiers for seamless market entry.Â
- Manage health authority fee payments with precision.Â
- Provide consistent follow-ups on submissions to keep projects on track.Â
- Address queries and secure approvals with expertise.Â
- Handle product lifecycle management, including variations and renewals.Â
- Trusted by 258+ global clients for regulatory compliance and market entry success.Â
- With extensive knowledge across 23 markets, we ensure seamless compliance with international regulations.Â
- Our strong relationship with global regulatory authorities expedites the approval process, facilitating quicker market access.Â
- We mitigate delays in market entry that can lead to financial losses.Â
- We minimize the risk of non-compliance, preventing costly recalls and penalties.Â
- We offer end-to-end support that encompasses all aspects of regulatory compliance, from product registration to market entry, distribution, warehouse & inventory management in global markets.Â
- We deliver customized strategies that address the unique regulatory needs of each market, ensuring optimal outcomes.Â
- Act as your Indian Authorized Representative (IAR) before health authorities, ensuring full compliance for product approvals.Â
- Coordinate and attend health authority meetings as required.Â
- Submit product applications/dossiers for seamless market entry.Â
- Manage health authority fee payments with precision.Â
- Provide consistent follow-ups on submissions to keep projects on track.Â
- Address queries and secure approvals with expertise.Â
- Handle product lifecycle management, including variations and renewals.Â
- Trusted by 258+ global clients for regulatory compliance and market entry success.Â
- With extensive knowledge across 23 markets, we ensure seamless compliance with international regulations.Â
- Our strong relationship with global regulatory authorities expedites the approval process, facilitating quicker market access.Â
- We mitigate delays in market entry that can lead to financial losses.Â
- We minimize the risk of non-compliance, preventing costly recalls and penalties.Â
- We offer end-to-end support that encompasses all aspects of regulatory compliance, from product registration to market entry, distribution, warehouse & inventory management in global markets.Â
- We deliver customized strategies that address the unique regulatory needs of each market, ensuring optimal outcomes.Â
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Indian Authorized Representative Services for Medical Devices
India’s medical device market is experiencing rapid growth, outpacing many other major markets globally. Currently valued at $11B,
it is projected to reach $50B by 2025 & could potentially soar to $250B by 2047, reflecting a CAGR of 18-20%.
In India, the Central Drugs Standard Control Organization (CDSCO) is the primary regulatory authority overseeing medical devices in
the country.The regulatory framework is primarily governed by the Drugs and Cosmetics Act, 1940, and its subsequent rules, including
the Drugs and Cosmetics Rules, 1945, and the Medical Devices Rules, 2017. These regulations outline the requirements for the
manufacturing, import, sale, and distribution of medical devices in India.
Medical devices in India are classified into four categories based on their risk level:
Class A
Low Risk
Class B
Low Moderate Risk
Class C
Moderate High Risk
Class D
High Risk
Roles & Responsibilities:
IAR provides necessary licenses & documents for products registration.​
Submit MD-14 for product registration & MD-15 (Import License)​.Â
Handle imports and customs clearance.​
Manage product recalls if any issues arise.​Â
Analyze targeted distributors based on product needs.​
Stay updated on regulatory changes and ensure ongoing compliance.​Â
Indian Authorized Representative for personal care & beauty
India’s beauty & personal care market is projected to grow from approximately $25.96B in 2023 to $34B by 2028, reflecting a CAGR of around 10-11%. Premium products are expected to grow at a 54% CAGR, with fragrances, makeup, & men’s grooming growing at 20-40% CAGR from FY21-26.Â
The Central Drugs Standard Control Organization (CDSCO) is the primary regulatory authority responsible for overseeing personal care and beauty products in India.  Â
Personal care and beauty products in India are regulated under the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945. These long-standing regulations have evolved over the years to keep pace with modern products and international standards. They outline the legal framework for the manufacture, import, sale, and distribution of cosmetics in the country. Â
The CDSCO classifies cosmetics into 80 different categories, covering a broad range of products such as Skincare products, Hair and scalp care products, Nail care products, Oral hygiene products, etc. Â
Roles & Responsibilities:
Submit form COS-1 for product registration & manages Form COS-2 (Import License)​Â
Manage cosmetic product registration for import via the Central Government’s online portal – SUGAM.​Â
Ensure compliance with all import prohibition guidelines.​Â
Handle imports and customs clearance.​Â
Manage product recalls if required. ​Â
Adhere to Label Compliance. Â
Indian Authorized Representative for Food Supplements
The dietary supplements market in India, valued at $3.9B in 2020, is projected to reach $10.2B by 2026, reflecting a remarkable 22% year-on-year growth rate. India has a 2% share in the global nutraceuticals market with a market value of $4B & is expected to show a growth of $18B by 2025. Â
The Food Safety and Standards Authority of India (FSSAI) is the principal regulatory body responsible for food and dietary supplements in India. FSSAI ensures that all products in the market meet safety, quality, and labeling standards, promoting public health through proper regulation of food safety. Â
The regulatory framework governing food and dietary supplements in India includes both the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945. These rules outline the legal requirements for the manufacturing, importing, and distribution of supplements, ensuring that they meet stringent standards of safety and quality before reaching consumers. Â
Roles & Responsibilities:
Handle licensing & approvals for market entry and distribution.​Â
Hold a valid FSSAI and Central Licensing Authority license.​
Stay updated on regulatory changes and ensure compliance.​Â
Support with imports and customs clearance if required.​Â
Assist with FSSAI approvals for formulation, categorization, labels, and claims.​Â
Indian Authorized Representative for Pharmaceuticals
India holds a prominent position in the global pharmaceutical market, currently valued at $50 billion. The market is expected to grow to $65 billion by 2024 and $130 billion by 2030, showcasing India’s importance as a hub for pharmaceutical products.  Â
The key regulatory authority overseeing pharmaceuticals is the Central Drugs Standard Control Organization, or CDSCO. CDSCO plays a pivotal role in regulating the import, manufacture, and sale of pharmaceutical drugs across the country. Â
The regulatory framework is primarily governed by the Drugs & Cosmetics Act, 1940, along with the Drugs & Cosmetics Rules, 1945. These form the backbone of pharmaceutical regulations in India, ensuring that safety, efficacy, and quality are upheld at all times. Â
Â
The CDSCO categorizes drugs under different classifications: Â
- Promising New Drugs (ND) Â
- Subsequent New Drugs (SND) Â
- Fixed-Dose Combinations (FDC) Â
- Investigational New Drugs (IND) Â
Roles & Responsibilities:
Must hold a valid wholesale license.​Â
Ensures compliance with Drugs & Cosmetic Act, 1940 & related rules.​Â
Submits Form-40 for drug registration and manages Form-41 (Registration Certificate).​Â
Handle imports and customs clearance.​Â
Reports post-approval changes to CDSCO.​Â
Assists with adverse event reporting and product recalls.​Â
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Our global presence
Taevas helps global life sciences innovators with global expansion strategies to connect with audiences worldwide and make it accessible for millions of people around the world.
Our global presence
Taevas helps global life sciences innovators with global expansion strategies to connect with audiences worldwide and make it accessible for millions of people around the world.
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Frequently Asked Questions
Who is an Indian Authorized Representative (IAR)?​​
The Indian Authorized Representative (IAR) is a locally registered entity with the CDSCO, authorized to submit registration applications on behalf of foreign manufacturers and serve as a liaison between the CDSCO and the foreign manufacturer.​​
What are the prerequisites for an IAR?​​​
 Be any company or business entity incorporated in India with an active Corporate Identification Number (CIN).​​​Â
- Be a resident of India.​​​
- Acquire Power of Attorney (POA) from the foreign manufacturer​​​
- Possess a Manufacturing, Wholesale, or Distributor License under the Drugs and Cosmetics Act, 1940, and Rules 1945.​​​
Which products import would require an IAR?​​​​
IAR is required for any foreign company that wants to launch its products in India​​​​.Â
How I will be benefitted to appoint you/Taevas as my authorized agent instead of my existing distributor in India?​
Foreign manufacturers have the option to designate importers or distributors as their IAR. Nonetheless, opting for an independent IAR service provider is strongly advised as their authorized representative in the Indian market. Choosing an independent agency offers the manufacturer the flexibility to appoint multiple distributors and importers under their IAR.​
Is it possible to appoint more than one IAR for the same device?​​
Yes, Foreign Manufacturer can have multiple IARs.
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