Success Story Of The Pharma Industry In India
India's Pharma Success: Time To Pivot?
The pharmaceutical sector in India, which is worth approximately $50 billion, is projected to expand to $130 billion by 2030, with a growth rate of 10.7% every year. Living up to its reputation as the leading provider of pharmaceuticals globally, India currently holds the title of the largest vaccine producer on the planet, supplying 60% of the world's vaccine needs. Moreover, it is also the biggest supplier of generic medications, shipping its products to more than 200 nations.
The pharmaceutical industry in India is relatively new, and the success of this can be attributed to the commitment, insight, and forward thinking of the founders of major Indian pharmaceutical companies such as Sun Pharma (led by Dilip Shanghvi), Dr. Reddy's Laboratories (headed by K Anji Reddy), Lupin (founded by Dr. Desh Bandhu Gupta), Cipla (established by Dr. Y K Hameid), Wockhardt (led by Dr. Habil Khorakiwala), Biocon (led by Dr. Shaw), Serum Institute (founded by Dr. Poonawala), and Bharat Biotech (headed by Dr. Krishna Ella), among others.
The writers of this blog post feel lucky to have had the chance to collaborate with such outstanding individuals. This encounter has offered us valuable perspectives into their deep comprehension of the pharmaceutical industry, and a recognition of their dedication to guaranteeing that top-notch medications are available, easily reached, and reasonably priced for patients worldwide.
According to the recent report from the Indian Ministry of Health and Family Welfare, the pharmaceutical industry in India holds the third position worldwide in terms of quantity and the fourteenth position in terms of worth. However, there is a significant disparity between the two, as the value of the Indian pharmaceutical industry is only a fraction of the global pharmaceutical market. This is mainly because the success of Indian pharmaceutical companies primarily relies on the production of generic drugs. Nevertheless, the major drawback for the Indian pharmaceutical sector lies in its inadequacy in developing innovative drugs.
As far as we know, only one new and creative drug from Indian pharmaceutical companies has been approved in the USA using the 505(b)(1) regulatory method. However, a few drugs with small advancements are also approved through the 505(b)(2) regulatory process in the USA and are available for use in India. One reason for the lack of groundbreaking and innovative drugs from India is the extremely high cost of bringing a new drug to market, which can range from $1.3 to $2.5 billion. The cost of clinical development alone makes up around 50-58% of the total expense. On the other hand, many major pharmaceutical companies focus their research and development efforts on expanding the lifespan of existing drugs through making minor changes and investing heavily in the release plan.
Additionally, it is worth mentioning that smaller companies are now becoming the main source of innovation, with 80% of all projects moving from the discovery phase to filing coming from Emerging Biopharma (EBP). EBP refers to companies that spend less than $200 million per year on research and development or have global revenues of less than $500 million. This highlights the need for practical strategies to increase productivity in research and development. Dr. Sumith Kularatne, Executive VP at On Target Laboratories (USA), explains, "Although the biotech industry is facing challenges due to market fluctuations, we remain optimistic about the future of businesses thanks to ongoing innovation."
Additionally, big pharmaceutical companies continue to depend greatly on biotechnology for innovative ideas. The innovation of biotechnology involves the implementation of research and development strategies as well as effective management capabilities. Ways to effectively carry out R&D strategies include attracting and retaining experienced professionals, using outsourcing models, engaging in co-development and partnering, establishing joint ventures, and utilizing offshoring techniques. On the other hand, successful management of R&D relies on being open to technological advancements and having a strategic understanding of complex factors such as investors, funding, competitors, and more.
According to Dr. Amit Biswas2, an advisor specializing in managing pharmaceutical research and development, the Indian pharmaceutical industry is experiencing a shortage of highly skilled professionals in the area of drug discovery and development despite having a large number of scientists and researchers. However, he believes that India has the potential to establish a thriving ecosystem for pharmaceutical innovation by promoting collaboration and partnerships between the industry, academia, and publicly funded research institutes. By joining forces, these entities can ensure that the most talented individuals contribute to the international growth and prosperity of the Indian pharmaceutical sector, spanning from early drug discovery and development to advanced manufacturing processes.
The advancement of new and creative products, whether they are groundbreaking or small improvements, will greatly contribute to the growth of the pharmaceutical industry in India in the near future. India has made considerable strides in developing complex generic drugs and has even received approval for a few biosimilars. The Indian environment provides a distinct advantage when it comes to conducting clinical trials for complex generic drugs. In India and its neighboring regions, there are clinical sites that are both cost-effective and efficient, with a proven history of making valuable contributions to clinical trials.
CLINEXEL, a Clinical Research Organization (CRO) that offers a range of services, was established with the goal of utilizing the advantages provided by the local ecosystem to aid small and medium-sized pharmaceutical companies in delivering efficient, high-quality, and cost-effective solutions for clinical development. CLINEXEL currently assists in the development of six programs focused on oncology, infections, respiratory conditions, and kidney diseases. Furthermore, CLINEXEL possesses extensive knowledge and experience in supporting start-ups and smaller biotechnology companies in their worldwide clinical development endeavors. Moreover, CLINEXEL maintains a robust network spanning the United States, Europe, and emerging economies to provide assistance for global clinical trials.
By utilizing various methods to improve efficiency, the expenses associated with clinical trials and the overall development of drugs can be dramatically reduced. Numerous real-life examples, including certain clinical programs backed by CLINEXEL, have demonstrated the successful implementation of different strategies. These strategies include negotiations with regulatory agencies before starting the trials, seeking scientific advice, designing clinical studies in an efficient manner, opting for cost-effective trial sites that maintain high standards of data, and creating streamlined operational processes.
The importance of including skilled and seasoned clinical research experts, thorough investigation, and ongoing communication with regulatory organizations cannot be overstated when it comes to achieving efficiency and success in the initial and crucial phases of clinical trials. These same principles also hold true for studies conducted following approval, with the goal of maximizing the potential of a product through expedited processes for products with incremental advancements. Hence, the triumph of developing new drugs is greatly reliant on a successful partnership between a pharmaceutical or discovery company and a proficient contract research organization (CRO) who possess a deep comprehension, specialized knowledge, and ample experience in carrying out clinical trials for groundbreaking therapies.
The Indian government has acknowledged the importance of developing and gaining worldwide recognition for innovative medications produced by Indian pharmaceutical companies. In order to support the Indian pharmaceutical industry, the government has initiated various grants and funding programs under the "Make in India" campaign. It seems that the tides have turned for the Indian pharmaceutical industry, as now is the perfect time to shift towards innovation and the development of new drugs. This shift can be attributed to several factors, such as a change in the approach to pharmaceutical research and development, successful global regulatory approvals for new drugs through efficient clinical trials, and supportive legislation and regulations in India that encourage innovation.
In order to make this happen, it is necessary to implement an improved clinical development approach that takes advantage of the benefits provided by the Indian clinical trial environment. This goal can be accomplished by teaming up with a knowledgeable clinical research organization, like CLINEXEL, that has a thorough comprehension of India's strengths and a deep understanding of the worldwide drug development industry, along with established connections on an international scale.
