DISCOVER INDIA

The Emerging Hub for Prescription Drugs Investments

The Indian prescription drugs market is expected to reach $65 billion by 2024 from $50 billion in 2021, growing at a CAGR of 10.7%.Ā 

Prescription Drug

The top three therapeutic segments in the market are cardiovascular, anti-infectives, and anti-diabetics with 30%,25% and 15% market share respectively

The Indian online pharmacy market is expected to grow at a CAGR of 25% and is expected to reach $5 billion by 2025

Key Growth Drivers Fuelling Market ā€‹

India has a high prevalence of chronic diseases, such as diabetes, hypertension, and cancer. This is also driving the growth of the Indian prescription drugs market, as these diseases require long-term treatment with prescription drugs.

The online pharmacy market is growing rapidly in India, as it is more convenient for patients to buy prescription drugs online. This is also driving the growth of the Indian prescription drugs market.

India has a large and growing population, which is expected to reach 1.4 billion by 2023. This is a major driver of the growth of the Indian prescription drugs market, as it means that there will be a larger pool of potential patients.

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.

Classify the Drug

The first step in the registration process is to classify the drug. The drug will be classified as either a Schedule X drug, a Schedule Y drug, or a Schedule Z drug. The classification of the drug will determine the level of regulatory scrutiny that it will be subject to.

Submit an Application

The foreign manufacturer must then submit an application to the Central Drugs Standard Control Organization (CDSCO) for registration of the drug. The application must include a variety of information, such as the name of the drug, the composition of the drug, the manufacturing process, and the clinical data for the drug.

Conduct Clinical Trials

If the drug is a new drug, the foreign manufacturer will need to conduct clinical trials in India to demonstrate the safety and efficacy of the drug. The clinical trials must be conducted in accordance with the guidelines of the CDSCO.

Obtain Approval

Once the application has been reviewed and approved by the CDSCO, the drug will be granted registration. The registration will be valid for five years and can be renewed.

Marketing in India

Once the process is completed the products can successfully market and sell in India. The IAR must ensure compliance with reporting changes, adverse events, recalls, to the CDSCO, if any.

Our Services

Empowering your Success in the Indian Market ā€‹

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 ā€˜Buildā€™ the infrastructure and set up processes; we ā€˜Operateā€™ the business, and when you feel ready, we ā€˜Transferā€™ the control to you