India is hoping to create a worldwide competitive biopharmaceutical industry which addresses its major concerns with the current roadblocks of affordable healthcare. The DBT (Department of Biotechnology) is primed to put forth biosimilar drugs for diseases like diabetes, rheumatoid arthritis, and cancer according to The Pharma Letter.
India has long been a significant entity in the global pharmaceutical industry, however, nowadays it sags about 10 or 15 years behind the current leaders of the industry. The gap, according to the government is there because of disconnected centers of excellence, along with uncertain funding and less focus on translational research.
The Indian government recently approved a Biopharma Mission for the production of indigenous and affordable vaccines and biotherapeutics to fill to fill the gap. The Mission will also promote product discovery and early-stage manufacturing boosting innovation. Insulin, erythropoietin, chorionic gonadotropin, streptokinase, interferon, and heparin are the present biosimilars from India. But with the Biopharma Mission India will now start manufacturing pneumococcal, human papillomavirus (HPV), and dengue vaccines indigenously,
The inaugural industry-academia mission was set up to boost the biopharmaceutical development throughout India. The government just launched the Innovative in India (i3) program which will create and enabling ecosystem, which will promote entrepreneurship and indigenous manufacturing within the biotech sector.
The Biotechnology Industry Research Assistance Council (BIRAC) is to implement the $250 million Mission. (The World Bank will foot half of the bill for the mission), which will be assisting the preparation of India’s tech and product development abilities within the biopharmaceutical sector, in hopes of achieving a level that it is globally competitive for the next 10-15 years, and will transform the health standards of India’s population through affordable product development.
The Mission is also to use an integrated, holistic method for strengthening and supporting the whole of India’s product development value chain to accelerate research leading to better and more productive product development. This figures to bolster short-term product development to address the public health needs, and in turn, create a long-term system for funneling continuous products.
According to officials, the Mission is poised to make a broad and major social impact by improving health care products and affordable solutions, as well as increasing boosting the economy by way of market capitalization of the biopharma sector. Their target is to bring India’s global biopharmaceutical contribution up from 3% to 5% before the year 2022.
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Another goal is to attain a $100 billion biotechnology industry by 2025. According to experts, this will be achieved by Mission helping to decrease India's dependency on imported biopharma products, reducing the out-of-pocket costs, enhancing outsourcing capabilities and ensuring an IP driven bio-economy. The Mission is to be led by the Department of Biotechnology (DBT), Ministry of Science and Technology and will be implemented by the DBT’s Biotechnology Industry Research Assistance Council (BIRAC).
The World Health Organization (WHO) is inviting manufacturers to present versions of products on the WHO Essential Medicines List: rituximab (used principally to treat non-Hodgkin's lymphoma and chronic lymphocytic leukemia), and trastuzumab (for breast cancer). This was announced after a conference in Geneva between national regulators, pharmaceutical industry groups, patient and civil society groups, and WHO discussing ways to increase access to biotherapeutic medicines.
This decision by the WHO will hopefully prove to be positive for India and its drug makers like Biocon, Dr. Reddy’s, Hetero, and Torrent, which market rituximab. Biocon, Torrent-Reliance Life Sciences, and Cadila Healthcare currently sell trastuzumab in India, Biocon’s version is under review by the USDA at the moment.
Assistant Director-General for Health Systems and Innovation at the WHO, Marie-Paule Kieny stated that innovator biotherapeutic products are often too expensive for many countries, and so biosimilars were a good opportunity to expand access and support countries to regulate and use these medicines. What this means is that if the WHO finds the biosimilars submitted for prequalification are comparable to originator products in terms of quality, safety, and efficacy, the medicines will be listed by WHO and become eligible for procurement by United Nations agencies.
The nurturement of next generation technical skills is why the World Bank approved the loan for the i3, which is providing advanced shared facilities for conducting validating experiments and lab tests. It also links sites for clinical trials with networks of expert advisors and international bodies, as well as strengthen all institutions involved in the facilitation and adoption of global innovations, technologies, and licensing models.
The government set up BIRAC five years ago and the Mission project is designed to support it through innovative start-ups and collaborations through strategic partnerships.
Harsh Vardhan Minister for Science and Technology said the Mission is expected to be a game changer for the Indian bio-pharmaceutical industry. While Secretary of the Department of Biotechnology and chairman of Birac K Vijay Raghavan said the endeavor would help nurture next-generation technical skills and support institutions in the adoption of global innovations, technologies, and licensing models. Raghavan said, "It will provide young entrepreneurs the confidence as well as the systemic support to pursue their aspirations in biotechnological innovation, and transform India into a global hub for cutting-edge biotechnology research and development."
India is finally catching up with itself here and seems to be turning the corner and coming back to the biotech table.