DISCOVER INDIA

The Emerging Hub for Over the Counter (OTC) Drugs Market

The Indian OTC drugs market is expected to reach $8.31 billion by 2028 from $6.3 billion in 2023, growing at a CAGR of 5.39%.

OTC2

In the Indian OTC drug market, the top three therapeutic segments are pain relief, accounting for 35% of the market, cold and flu with 25%, and vitamins and minerals with 15%.

The top three distribution channels are retail pharmacies, accounting for 60% of the market, online pharmacies, expected to account for 20% by 2028, and general stores, also accounting for 20%.

Key Growth Drivers Fuelling Market ​

The Indian online pharmacy market is expected to reach $12.1 billion by 2025, enabling in increased convenience of online shopping for medicines thus boosting the purchase momentum

By 2025, the demand for natural and herbal products in India is projected to reach $80bn, and this is driving growing preference for these products over synthetic drugs

In India only 30% have access to essential medicines and may of the Indians are turning to OTC drugs to treat minor ailments.

NAVIGATING THE REGULATORY LANDSCAPE

Step-by-Step Registration Process

Obtain an Authorized Representative

A foreign manufacturer must first obtain an authorized representative in India. The authorized representative will be responsible for registering the drugs and ensuring that they comply with Indian regulations.

Obtain Wholesale License

Obtain a wholesale license from the State Drugs Licensing Authority or CDSCO. Submit Form 8 or 8-A application to CDSCO along with required documents and fees.

Obtain Import License

Obtain import license under Form 10 or 10-A, which must be renewed every three years.

Comply with Regulation

Comply with regulations including labeling and storage requirements.

Notify Changes

Notify the IAR and report any post-approval changes to CDSCO. Assist with adverse event reporting and product recalls when necessary.

Our Services

Empowering your Success in the Indian Market ​

Taevas is at the forefront of this expansion, supporting businesses as they navigate and conquer new markets. Our comprehensive range of services for the life sciences include

Market access solutions
Embarking on Success with Taevas

Embarking on Success with Taevas

Taevas stands ready to serve as your custom-fit partner in India, catering to your unique business requirements.

As Your Market Entry Partner
  • As your Indian Authorized Representative (IAR), we ensure your regulatory compliance
  • We identify potential distributors for your products and facilitate initial connections
  • You will lead the further development of these distributor relationships
As Your Commercial Partner
  • Along with being your IAR, we also act as your centralized distributor in India
  • We identify and appoint local distributors in different regions of India, creating a wide and efficient distribution network
  • You can focus on your core business, while we handle the complexities of distribution
As Your Operational Partner
  • Along with being your IAR, we also initiate the building of your local presence in India
  • We put together a dedicated team who takes charge of sales partnerships and manages the nuances of business operations
  • We ‘Build’ the infrastructure and set up processes; we ‘Operate’ the business, and when you feel ready, we ‘Transfer’ the control to you