Strategies for Foreign Pharma and Biotech businesses in India

Establishing Pharma and Biotech businesses in India

Foreign pharmaceutical and biotech businesses aiming to establish a presence in India can benefit from tailored strategies to navigate the complex regulatory environment and tap into the market’s growth potential. Here are key strategies for success:

  1. Understand Regulatory Requirements: India’s pharmaceutical and biotech sectors are governed by stringent regulations. Familiarize yourself with the Drug Controller General of India (DCGI) regulations, clinical trial requirements, and intellectual property laws to ensure compliance and smooth entry.
  2. Partner with Local Entities: Collaborate with local partners, such as contract research organizations (CROs) and distribution networks, to leverage their market knowledge and established relationships. Strategic partnerships can facilitate quicker market access and help in navigating regulatory processes.
  3. Invest in Research and Development: Focus on R&D to develop products that cater to local needs and preferences. India’s growing emphasis on healthcare innovation and a strong pool of scientific talent offer opportunities for collaborative research and development.
  4. Adapt to Market Dynamics: Tailor products and services to meet the specific demands of the Indian market, including cost-effective solutions and culturally relevant healthcare products. Understanding local consumer behavior and healthcare trends can drive product acceptance and success.
  5. Leverage Government Incentives: Take advantage of government schemes and incentives designed to support foreign investments in the pharmaceutical and biotech sectors, such as tax benefits and subsidies for research and manufacturing.
  6. Ensure Quality and Compliance: Maintain high standards of quality and comply with both Indian and international regulations. Implement robust quality control measures to build trust and credibility in the market.
  7. Focus on Market Entry and Expansion: Develop a clear market entry strategy, including site selection for manufacturing or research facilities, and create a roadmap for scaling operations based on market demand and regulatory approvals.

Tecnova India supports foreign pharmaceutical and biotech businesses by providing strategic consulting services, regulatory guidance, and market insights. With its expertise in navigating the Indian healthcare landscape, Tecnova helps companies implement effective strategies, establish local partnerships, and achieve successful market entry and growth.

The Indian healthcare sector is anticipated to see a three-fold growth at a CAGR of 22% between the financial year 2016-2022. Pharma and Biotech businesses in India have attracted renewed global attention in the wake of the pandemic, which has firmly established FDI inflow in the country. The value of the pharmaceutical industry currently stands at USD 41.7 billion, which is anticipated to reach USD 65 billion by FY-2024 and USD 120 billion by FY-2030. India’s biotech industry is expected to scale USD 150 billion by 2025.

However, the fragmented pharmaceutical market is going through volatility and uncertainty. Changing FDI policy, compulsory licensing, increasing the number of drugs in NLEM (National List of Essential Medicines), etc., is making a significant difference. To scale high in the volatile world,  pharmaceutical companies must re-explore their traditional growth strategies. Also, prompt assistance from a consulting firm will help understand the market strategy and regulatory compliance in India.

Development in the Pharma and Biotech businesses in India in Recent times

The availability of well-trained medical professionals contributes to India’s competitive advantage. Moreover, India’s surgery expenses are around one-tenth that of Western Europe and the United States. As per the data from DPIIT (Department for Promotion of Industry and Internal Trade), the FDI inflows for the drugs and pharmaceutical industry stood at USD 19.41 billion from 2000 to 2022.

Around 2.18 billion COVID-19 vaccine doses have been administered nationwide till late September 2022. Moreover, the (ICMR) Indian Council of Medical Research has published treatment guidelines for around 51 common illnesses to help doctors, especially in rural regions.

Even the partnership of Serum Institute of India and US Company Novavax in June 2022 is among the recent development done to boost the Indian pharmaceutical sector.

The partnership was initiated to manufacture the Covid vaccine for the United States. Even India’s pharmaceutical exports have reached USD 23.04 in 2022. Among these formulations and biological contributes about 73.31% of the overall country’s exports. Moreover, Karnataka has declared its objective to be a USD 50 billion bio-economy, currently standing at USD 22.6 billion, by the financial year 2026.

Even American biotech company Vaxart has declared to commence with clinical trial phase II of oral tablet Covid-19 vaccine in India. In addition, Bharat Biotech has received prequalification approval from WHO for Rotavac 5D regarding the prevention of rotavirus diarrhea.

Furthermore, NPPA (National Pharmaceutical Pricing Authority) has fixed the retail prices for 84 formulations of drugs which includes drugs that are used in treating diabetes, headache, high blood pressure etc.

Government Policies that Ensure Easier Indian Market Entrance for Global Biotech Companies

The Government of India has undertaken several initiatives to support the Pharma and Biotech businesses in India. As discussed in the Union Budget 2022-2023, USD 982.91 million was allotted to the Human Resources for Health and Medical Education. USD 11.28 billion was allotted to the MoHFW (Ministry of Health and Family Welfare). Furthermore, AB-PMJAY (Ayushman Bharat- Pradhan Mantri Jan Arogya Yojana) was granted a budget of USD 840.32 million.

The Government of India, the Government of Meghalaya, and the World Bank signed a health project worth USD 40 million in November 2021. The project intends to enhance and uplift the quality of health services and strengthen the state of Meghalaya to combat health exigencies, including COVID-19.

The pandemic has propelled the expansion of India’s pharma sector. As per the survey conducted by the Finance Minister, in 2021, FDI inflow has remained buoyant at a rate of 53%. The competitiveness and availability of good quality medicine have positioned the country highly in the Global market, making India the Pharmacy of the World’.

In addition, per the Union budget 2022-2023, the Department of Biotechnology was granted an amount of USD 343,56 million for developing genetic engineering, agriculture biotechnology, basic infrastructure, and more. The Indian Government and Karnataka government together a start-up named Biomoneta. The venture intended to incorporate air decontamination technology for eliminating the airborne Covid virus with efficacy of 99.99%.

All these allocations create a robust healthcare system and pave the way for foreign firms to establish their ventures. Moreover, Government is highly concerned regarding domestic pharma companies. Therefore, the Department of Industrial Policy and Promotion (DIPP) has also asked to allow 100% FDI in the Indian pharma sector.

Enlisting Consulting Firms for Business Expansion in India

India holds a significant position in the global pharmaceuticals sector. The Indian Pharmaceutical market will expand three times in the coming year, per the Indian Economic survey. The Indian healthcare sector is moving at a brisk pace owing to its robust coverage, services, etc. It is anticipated that the pharma market is going to reach USD 65 billion by the financial year 2024. Even the biotechnology sector is projected to hit USD 150 billion in the coming years.

The growth reflects a prominent scope for foreign investors to come and settle their business operations. Moreover, as Union Ministry allows 100% FDI, it has become easy for foreign investors to enter the Indian market.

Moreover, the prompt assistance of top pharmaceutical consulting firms in India like Tecnova will further enable international companies to comprehend the dynamic of the Indian market.

Firms like Tecnova offer prompt assistance to foreign investors in India’s pharmaceutical registration and also enable them to lay out manufacturing set-up. A foreign firm will have to undergo company or Firm registration, CDSCO Registration, trademark registration, etc.

Pharmaceutical regulatory consulting firms in India like Tecnova Global help foreign companies get a hold of the market and provide end-to-end assistance at every stage of their ventures

Reference

https://bit.ly/3BQ5l54
https://bit.ly/3dN41YF
https://bit.ly/3dK4GtX
https://bit.ly/3E0QZl4
https://bit.ly/3reQhcg

Tags:

INDIAN HEALTHCARE AND BIOTECH SECTOR , MEDICAL REGISTRATION IN INDIA , PHARMA AND BIOTECH BUSINESS IN INDIA , PHARMA REGULATORY CONSULTANTS IN INDIA , PHARMACEUTICAL CONSULTING

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Strategies for Foreign Pharma and Biotech businesses in India

Establishing Pharma and Biotech businesses in India

Foreign pharmaceutical and biotech businesses aiming to establish a presence in India can benefit from tailored strategies to navigate the complex regulatory environment and tap into the market’s growth potential. Here are key strategies for success:

  1. Understand Regulatory Requirements: India’s pharmaceutical and biotech sectors are governed by stringent regulations. Familiarize yourself with the Drug Controller General of India (DCGI) regulations, clinical trial requirements, and intellectual property laws to ensure compliance and smooth entry.
  2. Partner with Local Entities: Collaborate with local partners, such as contract research organizations (CROs) and distribution networks, to leverage their market knowledge and established relationships. Strategic partnerships can facilitate quicker market access and help in navigating regulatory processes.
  3. Invest in Research and Development: Focus on R&D to develop products that cater to local needs and preferences. India’s growing emphasis on healthcare innovation and a strong pool of scientific talent offer opportunities for collaborative research and development.
  4. Adapt to Market Dynamics: Tailor products and services to meet the specific demands of the Indian market, including cost-effective solutions and culturally relevant healthcare products. Understanding local consumer behavior and healthcare trends can drive product acceptance and success.
  5. Leverage Government Incentives: Take advantage of government schemes and incentives designed to support foreign investments in the pharmaceutical and biotech sectors, such as tax benefits and subsidies for research and manufacturing.
  6. Ensure Quality and Compliance: Maintain high standards of quality and comply with both Indian and international regulations. Implement robust quality control measures to build trust and credibility in the market.
  7. Focus on Market Entry and Expansion: Develop a clear market entry strategy, including site selection for manufacturing or research facilities, and create a roadmap for scaling operations based on market demand and regulatory approvals.

Tecnova India supports foreign pharmaceutical and biotech businesses by providing strategic consulting services, regulatory guidance, and market insights. With its expertise in navigating the Indian healthcare landscape, Tecnova helps companies implement effective strategies, establish local partnerships, and achieve successful market entry and growth.

The Indian healthcare sector is anticipated to see a three-fold growth at a CAGR of 22% between the financial year 2016-2022. Pharma and Biotech businesses in India have attracted renewed global attention in the wake of the pandemic, which has firmly established FDI inflow in the country. The value of the pharmaceutical industry currently stands at USD 41.7 billion, which is anticipated to reach USD 65 billion by FY-2024 and USD 120 billion by FY-2030. India’s biotech industry is expected to scale USD 150 billion by 2025.

However, the fragmented pharmaceutical market is going through volatility and uncertainty. Changing FDI policy, compulsory licensing, increasing the number of drugs in NLEM (National List of Essential Medicines), etc., is making a significant difference. To scale high in the volatile world,  pharmaceutical companies must re-explore their traditional growth strategies. Also, prompt assistance from a consulting firm will help understand the market strategy and regulatory compliance in India.

Development in the Pharma and Biotech businesses in India in Recent times

The availability of well-trained medical professionals contributes to India’s competitive advantage. Moreover, India’s surgery expenses are around one-tenth that of Western Europe and the United States. As per the data from DPIIT (Department for Promotion of Industry and Internal Trade), the FDI inflows for the drugs and pharmaceutical industry stood at USD 19.41 billion from 2000 to 2022.

Around 2.18 billion COVID-19 vaccine doses have been administered nationwide till late September 2022. Moreover, the (ICMR) Indian Council of Medical Research has published treatment guidelines for around 51 common illnesses to help doctors, especially in rural regions.

Even the partnership of Serum Institute of India and US Company Novavax in June 2022 is among the recent development done to boost the Indian pharmaceutical sector.

The partnership was initiated to manufacture the Covid vaccine for the United States. Even India’s pharmaceutical exports have reached USD 23.04 in 2022. Among these formulations and biological contributes about 73.31% of the overall country’s exports. Moreover, Karnataka has declared its objective to be a USD 50 billion bio-economy, currently standing at USD 22.6 billion, by the financial year 2026.

Even American biotech company Vaxart has declared to commence with clinical trial phase II of oral tablet Covid-19 vaccine in India. In addition, Bharat Biotech has received prequalification approval from WHO for Rotavac 5D regarding the prevention of rotavirus diarrhea.

Furthermore, NPPA (National Pharmaceutical Pricing Authority) has fixed the retail prices for 84 formulations of drugs which includes drugs that are used in treating diabetes, headache, high blood pressure etc.

Government Policies that Ensure Easier Indian Market Entrance for Global Biotech Companies

The Government of India has undertaken several initiatives to support the Pharma and Biotech businesses in India. As discussed in the Union Budget 2022-2023, USD 982.91 million was allotted to the Human Resources for Health and Medical Education. USD 11.28 billion was allotted to the MoHFW (Ministry of Health and Family Welfare). Furthermore, AB-PMJAY (Ayushman Bharat- Pradhan Mantri Jan Arogya Yojana) was granted a budget of USD 840.32 million.

The Government of India, the Government of Meghalaya, and the World Bank signed a health project worth USD 40 million in November 2021. The project intends to enhance and uplift the quality of health services and strengthen the state of Meghalaya to combat health exigencies, including COVID-19.

The pandemic has propelled the expansion of India’s pharma sector. As per the survey conducted by the Finance Minister, in 2021, FDI inflow has remained buoyant at a rate of 53%. The competitiveness and availability of good quality medicine have positioned the country highly in the Global market, making India the Pharmacy of the World’.

In addition, per the Union budget 2022-2023, the Department of Biotechnology was granted an amount of USD 343,56 million for developing genetic engineering, agriculture biotechnology, basic infrastructure, and more. The Indian Government and Karnataka government together a start-up named Biomoneta. The venture intended to incorporate air decontamination technology for eliminating the airborne Covid virus with efficacy of 99.99%.

All these allocations create a robust healthcare system and pave the way for foreign firms to establish their ventures. Moreover, Government is highly concerned regarding domestic pharma companies. Therefore, the Department of Industrial Policy and Promotion (DIPP) has also asked to allow 100% FDI in the Indian pharma sector.

Enlisting Consulting Firms for Business Expansion in India

India holds a significant position in the global pharmaceuticals sector. The Indian Pharmaceutical market will expand three times in the coming year, per the Indian Economic survey. The Indian healthcare sector is moving at a brisk pace owing to its robust coverage, services, etc. It is anticipated that the pharma market is going to reach USD 65 billion by the financial year 2024. Even the biotechnology sector is projected to hit USD 150 billion in the coming years.

The growth reflects a prominent scope for foreign investors to come and settle their business operations. Moreover, as Union Ministry allows 100% FDI, it has become easy for foreign investors to enter the Indian market.

Moreover, the prompt assistance of top pharmaceutical consulting firms in India like Tecnova will further enable international companies to comprehend the dynamic of the Indian market.

Firms like Tecnova offer prompt assistance to foreign investors in India’s pharmaceutical registration and also enable them to lay out manufacturing set-up. A foreign firm will have to undergo company or Firm registration, CDSCO Registration, trademark registration, etc.

Pharmaceutical regulatory consulting firms in India like Tecnova Global help foreign companies get a hold of the market and provide end-to-end assistance at every stage of their ventures

Reference

https://bit.ly/3BQ5l54
https://bit.ly/3dN41YF
https://bit.ly/3dK4GtX
https://bit.ly/3E0QZl4
https://bit.ly/3reQhcg

Tags:

INDIAN HEALTHCARE AND BIOTECH SECTOR , MEDICAL REGISTRATION IN INDIA , PHARMA AND BIOTECH BUSINESS IN INDIA , PHARMA REGULATORY CONSULTANTS IN INDIA , PHARMACEUTICAL CONSULTING