Indian Industry Should Focus On Business Risk Mitigation Initiatives To Grab Global Opportunities: DoP Study

New Delhi: The Indian pharmaceutical industry needs to focus on various measures including investment in incremental innovation, market and product differentiation, cost reduction and improving efficiency, partnership for technology, market access, and risk sharing, among others to mitigate business risks, according to a study organised by the Department of Pharmaceuticals (DoP).

Indian generic companies have a limited risk appetite for the new drug development. However, the Indian companies are not hesitant to invest in research and development (R&D) of generic incrementally innovative pharmaceutical formulations.

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.

R&D investment allows generic companies to expand their product portfolio by developing and launching a wider range of generic drugs. This diversification enables them to target different therapeutic areas, address unmet medical needs, and cater to a larger customer base. Generic companies in managing the lifecycle of their products effectively.

By investing in R&D, they can extend product life cycles through various strategies such as line extensions, reformulations, and developing combination therapies. This allows them to maximize product value and market presence even after the expiry of the reference product’s patent. A well-diversified portfolio enhances revenue opportunities and reduces dependency on a few products.

Unique product portfolio opens doors for Indian generic companies to collaborations and partnerships with other global pharmaceutical companies, research institutions, and academic organizations.

By investing in research, generic companies can discover more efficient manufacturing techniques, improve quality control processes, and reduce production costs. This can result in competitive pricing, higher profit margins, and improved operational efficiency.

By diversifying their product portfolio, Indian generic companies can target a broader range of therapeutic areas, which allows them to access larger markets and reach a wider customer base and more stable revenue streams. Different products may have varying lifecycles, market dynamics, and competitive landscapes. By having a mix of products at different stages of their lifecycle, Indian generic companies can balance revenue fluctuations and maintain a consistent revenue stream over time.

Indian generic companies need to always look for partnerships and collaborations to take advantage of the potential opportunities created due the patent expiration. Collaborating with partners who have expertise in specific therapeutic areas or technologies allows generic companies to gain valuable insights and knowledge. Regulatory requirements for generic drug approvals vary across different regions, and partnering with companies or organizations experienced in navigating regulatory landscapes can help expedite the approval process.

Partnering with established pharmaceutical companies or distributors can help Indian generic companies gain access to established distribution networks and market channels across the globe. By joining forces with complementary partners, generic companies can offer value-added services, differentiated product formulations, or unique therapeutic combinations.

Developing generic alternatives to branded drugs requires significant investments in R&D, clinical trials, and regulatory compliance. By partnering with other companies or organizations, the financial burden and risks associated with these activities can be shared.

Partnering with innovative pharmaceutical and biopharmaceutical companies or research institutions may open avenues for in-licensing or acquiring new drug candidates or technologies. This enables generic companies to expand their pipeline, explore new revenue streams, and drive future growth. Partnering with other pharmaceutical companies can facilitate portfolio expansion and diversification.

Conducting thorough market research is essential for Indian generic companies to understand the demand, competition, pricing dynamics, and regulatory landscape in different geographies. By identifying market opportunities, unmet needs, and emerging trends, Indian generic companies can develop targeted strategies for market entry and expansion.

Acquiring or merging with local companies or competitors in target markets can expedite market entry and expansion for Indian companies.

In some cases, Indian generic companies may enter into agreements with the original brand manufacturer to produce and market an “authorized generic” version of the drug, said the study pointing to an example in which Dr Reddy’s Laboratories Ltd has expanded its collaboration with Amgen in India to market and distribute three of the latter’s medicines in the domestic market.

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