DISCOVER INDIA
The Emerging Hub for Orphan Drugs Market
India’s orphan drugs market size is valued at $1.5 bn in 2023 and is estimated to expand at a compound annual growth rate (CAGR) of 11.3% from 2022 to 2028 and will reach $3.5 bn in 2028.
In the Indian orphan drugs market, the top three therapeutic segments are Oncology, accounting for 40% of the market, rate genetic-disorders, accounting for 20%, and rare metabolic disorders, accounting for 15%.
The North Indian region is expected to dominate the Indian orphan drugs market, accounting for a market share of 35% in 2023.
Key Growth Drivers Fuelling Market
The prevalence of rare diseases in India is increasing, affecting 30 million people, and driven by factors like genetic disorders and lifestyle changes, making it a significant growth area.
A growing awareness of orphan diseases among patients, healthcare providers, and the public, spurred by media coverage and government initiatives, is fueling the market’s expansion.
Government support, including specific policies and financial assistance for orphan drugs, is boosting development, diagnosis, treatment, and affordability, shaping the market growth.
Increased investment in the research and development of orphan drugs by pharmaceutical companies, with USD 63 million dedicated to orphan drugs in 2022, highlights the market’s potential and responsiveness to government incentives.
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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