DISCOVER INDIA
The Emerging Hub for Biologics Market
India’s biosimilars market size was valued at $349 Mn in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 25.2% from 2022 to 2030 and will reach $2108 Mn in 2030.
In the Indian biologics market, the top three therapeutic segments are oncology, accounting for 40% of the market, immunology, accounting for 25%, and autoimmune diseases, accounting for 15%.
In the Indian biologics market, the top distribution channels are hospitals, accounting for 60% of the market, retail pharmacies, expected to account for 20% by 2030
Key Growth Drivers Fuelling Market
With over 70 million diabetics and 1.2 million new cancer cases annually, plus a predicted 25% rise in arthritis incidence by 2030, the demand for long-term biologic treatments is growing.
The World Bank predicts a 7% yearly growth in average Indian household income over the next five years, expanding the financial means to afford biologics.
A 50% increase in clinical trials over the past five years and a rising demand for effective and safe biologics signify a shift towards enhanced patient care.
Investing over $1 billion in the past five years, the Indian government’s financial and tax incentives are making biologics more affordable and accessible.
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.
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
Unleash your business potential with seamless market entry and expansion solutions to captivate Indian market, and maximize business impact.
Propel your brand to new heights with dynamic strategies and captivating digital journeys, outpacing your competition in India.
Ignite your brand’s growth and multiply revenue with cohesive expert sales and distribution strategies strategies across Indian market.
DECODING THE PATHWAYS
Launchpad to the Indian Pharmaceutical Market
Partnering with a Distributor
Collaborate with an Indian Authorized Representative
Establish Your Own Entity
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
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