On the lines of its Production Linked Incentive (PLI) scheme, government of India is mulling a Research Linked Incentive (RLI) programme to galvanize pharmaceutical research for development of biotechnology products, said Dr V G Somani, Drugs Controller General of India, speaking at 72nd Indian Pharmaceutical Congress in Nagpur. Looking at the purported success of production-linked incentives, research linked incentive might provide the firm foothold that pharmaceutical industry needs to become the global manufacturing hub.
Although the majority of the private capex incentivised by the PLI scheme will manifest only by financial year 2024, experts believe that the scheme will integrate supply chains and reduce import dependency. A much more profound impact will be brought about by research linked incentive programme as R&D plays a crucial role in advancing drug discovery, developing new treatments, and improving existing medications. It also helps to drive innovation through the identification and utilization of potential opportunities for cost-effective production of quality drugs. Furthermore, R&D helps to ensure consistency in product quality and safety standards while maintaining regulatory compliance. Considering this, it is imminent that R&D will play an indispensable role in the Indian pharmaceutical industry's success.
Accelerating Research and Development
The Indian pharmaceutical industry has become recognized for its ability to provide highly effective and affordable medicines worldwide. While being at forefront of the market of generic drugs and supply, it is now time to direct its business towards innovation and patents. The industry is however making giant strides in self-reliance and the government is acknowledging the primacy of self-reliance and technological advancement. The initiative can be supplemented by boosting local R&D, setting up research centers and offering rewards to the research that is relevant to the industry. According to IBEF, India stands 3rd, in the world regarding pharmaceutical production and 14th in the value. India has developed and has a mature domestic pharmaceutical industry with a wide network of about 3,000 pharma companies and 10,500 production sites. Even though the outbreak of Covid-19 pandemic has been contained, the pharmaceutical companies of India are still conducting R&D.
Regulatory Challenges in Pharmaceutical Research
Statistical analysis of the field at both descriptive and inferential levels reveals that the Indian pharmaceutical industry has experienced continuous growth in recent years. Expectations have increased for both production and the value of the trade balance. The Indian pharmaceutical industry has been keen on a huge expansion over the past decade, albeit extremely uneven, with over 20,000 registrations; the industry accounts for approximately 70% of the country's demand and consists of a highly fragmented market with price competition and government price controls exacerbated. As a result, firms in this sector vary widely in their ability to innovate, and they can be grouped into three types—innovators, niche operators, and manufacturers—each of which demonstrates the need for a different innovation strategy to sustain their growth and development. From an industrial marketing perspective, the most relevant aspect of the Indian pharmaceutical industry is that it is in the process of transformation and trying to gain more credibility at the national and international level. The pharma industry has experienced numerous regulatory developments and several pharmaceutical companies are rethinking their regulatory approval and drug development strategies.
"Introduction of new Indian Pharmacopoeia 2022 and several amendments in rules for drugs and medical devices have been done to establish a dynamic pathway for ensuring patient safety while encouraging the growth of the sector,” said Somani.
Pharmaceutical Companies Expanding their R&D Capabilities
Pharmaceutical industry leaders believe that more investment in innovation and research and development will drive domestic industry growth. According to a recent report by IBEF, the Indian domestic pharmaceutical market was valued at USD 42 billion in 2021 and is expected to reach USD 65 billion by 2024 and further reach approximately USD 12-130 billion by 2030. For pharmaceutical services and APIs, R&D focuses on developing chemical processes for the synthesis of APIs and intermediates for use by the company's global generics division. These innovations are sold directly in emerging markets and to third parties in developed markets. R&D in this category also supports the company's custom pharmaceutical line, leveraging the strengths of its development expertise to create solutions for established and emerging pharmaceutical companies.
The Need to Push Pharmaceutical Research
As the Indian pharmaceutical industry places great emphasis on research and development, expanding the R&D ecosystem and increasing pharmaceutical exports, India has become a global healthcare giant by 2022. The COVID-19 pandemic has changed public perception of drug research. It demonstrates the importance of investigating new treatment modalities, conducting complex clinical trials, and developing the expertise and skills to guide the drug discovery and development process. "Various factors from the government will contribute to the growth of the Indian pharmaceutical market. For example, there are initiatives such as Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana and Ayushman Bharat Yojana under the National Health Protection Scheme (NHPS). One of the most notable actions taken so far is the launch of the PLI scheme to encourage local production of APIs, key starting materials (KSM) and drug accelerators in India," said Sanjeev Jain, MD, Akums Pharmaceutical.
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