Setting Up A Healthcare Business In India

Consultants For Indian Manufacturing Sector

COVID-19 is the best time for Setting Up A Healthcare Business In India. India is a major generic drug manufacturer and the world is seeing India as a Healthcare hub. Covid has pushed the world to accept the significance of planning, producing and procuring generic pharmaceutical products. Exports across the globe have been affected immensely and companies are entering pharmaceutical business across the globe. India has proved its manufacturing capabilities and responsibilities by quickly becoming the top PPE kit and face mask supplier.

Indian Healthcare Sector Market Trends

1. India’s domestic market turnover has reached to US $20.03 billion in 2019
2. Compound Annual Growth Rate (CAGR) of 9.8 percent.
3. By 2025, the pharma sector country is expected to grow to approximately US $100 billion
4. Medical devices segment is expected to be at approximately US $25 billion.
5. In 2019-20, India made exports of US $20.70 billion
6. In 2019-20, India is the country world’s largest supplier of generic drugs
7. India occupying about 22 percent of global export volume in the industry.

Indian Wellness Sector Market Trends
1. Wellness expected CAGR of approximately 18-40 percent by 2024.
2. The market size is also likely to touch $33.37 billion by 2024
3. OTC drug market was evaluated at US $6.38 billion with a CAGR of 19.4 percent in 2019
4. OTC drug market is expected to reach to a total market value of US $15.48 billion by 2024.
5. Similarly, nutraceuticals or health supplements market is India is also expected to grow to a market share of approximately US $18 billion by 2025.

Why Advisors For Healthcare Business In India are important?
1. Starting a pharmaceutical business for procuring or producing medical devices and/or drugs comes with a few challenges.
2. In India, the regulatory framework for importing/producing drugs and medical devices is given, is quite complex.
3. Central Drugs Standard Control Organisation (CDSCO) oversees and regulates the entire process. The authority is responsible for any type of medical product registration in India.
4. CDSCO is responsible for approval of new drugs, import registration, clinical trials, and licensing, Large Volume Parenteral (LVP), vaccines, license approval of blood banks, r-DNA products, medical devices, and banning of drugs and cosmetics.

Therefore, opting for Consultants For Healthcare Business In India is the best course of action. Healthcare Business consultants in India are well-informed about the regulatory framework and guidelines. They know how departments and its officials work on ground zero.

Regulatory Requirements for Setting up a Pharmaceutical Business in India

1. Central Drugs Standard Control Organisation (CDSCO)
The organisation holds regulatory control over the import of drugs and devices, approval of certain licenses as Central License Approving Authority (CLAA), approval of new drugs and clinical trials. The authority also oversees meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB).

2. Pharmacist

3. Wholesale Drug License/Stock and Sales
The time line for this license is 45 days.

4. Registration Certificate for Drugs (RC, Form 41)

5. Drug Import License (Form 10)

6. Application Form for Medical Devices/Import Medical Devices (Form MD14, MD15)

How SM Management Services can help Setting up a Healthcare Business in India

Here’s a range of services offered by India Entry Services in pharmaceutical and healthcare sectors along with other healthcare consulting firms in India.

1. Drug, Medical, Devices and Cosmetic Registration with Drug Authority of India.
2. Identification & then selection of Partner(s) – Distribution, Clinical Trials and others.
3. In-Licensing and Out-Licensing of Products.
4. Setting up offshore R&D Labs in India.
5. Market Research & India market entry strategy.
6. JVs/Acquisitions
7. Project Management for setting up Greenfield/Brownfield
8. Sourcing of API’s, Formulations and Intermediates from India
9. 360 degrees competitive assessment
10. Road-shows to connect with key decision makers and influencers

Conclusion – Setting Up A Healthcare Business In India has its own challenges. Regulatory frameworks across the states, changing economy and dynamic work culture are often hard to cope with. However, with the significant expertise in business set up and incubation, India Entry Services make India as quite a favourable place for doing business.

How We Help Investors:

1. Research Content Provider
2. Location Analysis
3. Policy Advisory/Representation
4. Stakeholders Meeting
5. Issue Resolution
6. Regulatory Clearance Facilitation