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With over 20 drugs with sales worth $251 billion are going off-patent in the current decade, the Indian pharma industry need to address several challenges including the complex intellectual property (IP) landscape, lack of research and development (R&D) and innovation, regulatory compliance, among others in order to grab the opportunity, says a study conducted by the Department of Pharmaceuticals (DoP).
The study - an analysis on leveraging the patent cliff with drug sales worth $
251 billion going off-patent and analysis of different drug pricing methodologies for Indian generic pharmaceutical companies, was conducted by the Department by engaging Biovantis Healthcare Private Limited (Biovantis) based on independent research and analysis done by Biovantis.
The study observes that in the years between 2022-30, the pharmaceutical sector in India will undergo landmark changes as a number of drugs are expected to go off-patent and provide an opportunity for the entry of generic products. Expiry of patents is very promising for the Indian generic drug market as it is expected to expand and grow further with inclusion of these new drugs.
"With ongoing developments, India has started focusing on self-reliance at a large scale. Hence, it is imperative to identify these drugs beforehand, draft and implement strategies which help in their timely entry into the market by promoting generic drug manufacturing," says the study.
"By carefully assessing and managing the risks, Indian generic companies can navigate the regulatory landscape and seize market opportunities out of the impending patent cliffs," it added.
One of the key challenges and risks to be addressed by the Indian pharma firms to seize market opportunities out of the impending patent cliffs include complex IP landscape, as the originator companies choose to initiate patent litigation against the Indian generic manufacturer.
Resolving these disputes can be time-consuming and costly. This results in delays in the approval and launch of the generic version, as well as additional substantial legal costs for the Indian generic companies. Further, the patent landscape is dynamic, and new patents or changes to existing patents can impact the development of generic drugs.
"Indian companies need to closely monitor patent expiration dates, patent challenges, and legal developments to identify opportunities for generic drug development," it said.
While Indian generics have the technical know-how for these processes however it requires significant investment in research and development (R&D) and ensure bioequivalence with the original branded drug. Indian companies face the challenge of balancing R&D investments with the cost pressures of generic manufacturing.
Changes in regulations, guidelines, or interpretation of regulatory standards can create uncertainties and impact timelines for approval for Indian companies. There are challenges in obtaining the necessary data, navigating the regulatory requirements, and addressing any deficiencies or inquiries from the regulatory authorities. Non-compliance leads to delays in approvals or even rejection of the generic versions.
Like any industry, the pharmaceutical sector is subject to regulatory oversight and quality control measures to ensure the safety and efficacy of drugs. Occasional instances of quality and safety concerns have recently arisen due to factors such as manufacturing issues, inadequate quality control, human errors, or non-compliance with regulatory standards through-out the world and India is no exception to it.
However, many Indian companies have taken steps to address the issues and taken measures to comply with the tough regulatory standards. The increasing number of recognized manufacturing sites by US FDA can reinforce India’s credibility as a reliable and quality focused pharmaceutical manufacturer.
"The patent cliff is going to expand the market size for global generic drugs as the expiration of patents allows multiple companies to enter and compete. The US$ 251 billion patent cliff presents a substantial opportunity for generic companies to capture the market, share and generate revenue. However, navigating the competitive landscape requires strategic planning, international expansion, Life cycle management, efficient operations, regulatory compliance, and a focus on differentiation to succeed in the impending evolving and dynamic market," added the study.
Market Barriers can pose hurdles in accessing international markets as the Indian companies have to navigate complex regulatory processes and obtain marketing approvals from multiple authorities in different countries. Market-specific regional factors such as local pricing policies, reimbursement systems, and market acceptance of generics also pose challenges.
The Indian companies sometimes face hurdles in establishing relationships with distributors, pharmacy benefit managers (PBMs), or negotiating favourable reimbursement agreements with payers.
When multiple generic versions of a drug enter the market after patent expiry, it can lead to intense competition and price erosion over the period.
"Indian companies face challenges in maintaining profitability due to price erosion caused by increased competition from other generic manufacturers. Additionally, fluctuations in raw material costs and currency exchange rates can affect the profitability of generic drug manufacturing," added the study.
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