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Focus on Indian Generics and Api Industry PowerPoint Presentation

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Description : Check out this medical PowerPoint presentation titled "Focus on Indian generics and API industry: Impact of current pandemic and a way forward" by Mandakini Goel, M. Pharm., PhD.

This medical PowerPoint presentation is about the Indian generics and API (Active Pharmaceutical Ingredient) industry.

The COVID-19 pandemic has significantly impacted the Indian generics and API (Active Pharmaceutical Ingredient) industry, which is a key player in the global pharmaceutical industry. India is one of the largest producers and exporters of generic medicines and API in the world, supplying over 20% of the worlds generic drugs.

Impact of the pandemic:

Disruption in the supply chain: The pandemic has disrupted the supply chain of raw materials, affecting the production and supply of APIs and finished products.
Shutdown of manufacturing facilities: The lockdowns and restrictions on movement imposed by the government have led to the closure of manufacturing facilities, leading to a shortage of essential medicines.
Reduced demand for non-COVID drugs: With the focus on COVID-19 treatment, there has been a reduction in demand for non-COVID drugs, leading to reduced production and sales.
Increase in prices of raw materials: The pandemic has led to an increase in the prices of raw materials required for the production of drugs, leading to an increase in the cost of production.

Way forward:

Diversification of the supply chain: The Indian pharmaceutical industry needs to diversify its supply chain by reducing dependence on a single source of raw materials and exploring new sources.
Investment in technology: Investment in technology such as automation, artificial intelligence, and machine learning can help reduce the dependence on human labor, increase efficiency, and reduce costs.
Focus on R&D: The Indian pharmaceutical industry should focus on R&D to develop new drugs and reduce dependence on imported raw materials.
Increase in domestic production: The Indian government should encourage the production of APIs and finished products within the country by providing incentives and simplifying regulatory processes.
Collaboration with global partners: Collaboration with global partners can help in the sharing of knowledge, technology, and resources, leading to a reduction in the cost of production and improvement in the quality of drugs.

In conclusion, the Indian generics and API industry has been severely impacted by the COVID-19 pandemic, and it is important for the industry to take proactive measures to reduce dependence on a single source of raw materials, increase investment in technology, and focus on R&D to emerge stronger from the crisis.

Tags : Indian generics and API industry, Active Pharmaceutical Ingredient industry, pharmaceutical industry, generic medicines, pharmaceuticals, pharmaceuticals PowerPoint presentations

Published on : Jun 23, 2023 | Views : 853 | Downloads : 0

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Slide 1-

Focus on Indian generics and API industry: Impact of current pandemic and a way forward Mandakini Goel, M. Pharm., PhD November 2020 1
Slide 2-

Table of Contents Overview of Indian pharmaceutical industry Growth drivers Challenges Optimization of API supply and product portfolio 3 8 9 10
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3 Overview of Indian pharmaceutical industry Indian pharmaceutical industry is 3rd largest by volume and 13th largest by value. India is the largest generic drugs provider. Pharmaceutical export from India was USD $20.7 billion in financial year 2020 as compared to USD$19.14 billion in 2019. Low cost of production, availability of skilled manpower and in-house R&D increases efficiency of Indian companies.
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4 Overview of Indian pharmaceutical industry API companies dominate the overall manufacturing scenario Of the total 623 API manufacturers, only 48 are established 68% of the API manufacturers are supplying APIs to local markets only 390 dose manufacturers are developing finished dose formulations for different geographies. Source: Cortellis Generics Intelligence *Established – Companies with years of experience supplying active ingredients to regulated market.; Less Established – Less of a track record in supplying to regulated markets, either in terms of years of history or number of products supplied. Still considered as capable of supplying regulated markets. Potential Future – Interest in supplying regulated markets, but with limited or no known performance; Local – Supplying only to their local and other less-regulated markets; do not currently have the capability of passing inspections by regulatory bodies like the US FDA.
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5 Overview of Indian pharmaceutical industry 250+ Indian API manufacturers are manufacturing 1-20 confirmed APIs Aurobindo, Cipla, Hetero, MSN and Sun Pharmaceutical are manufacturing >200 APIs More than 50% of the dose manufacturers have marketed <50 products in different markets 38 Indian Dose/US generics/US specialty manufacturers have launched products in North America Source: Cortellis Generics Intelligence Number of APIs manufactured Number of products marketed
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6 Overview of Indian pharmaceutical industry Indian API manufacturers proactively file US Drug Master File (DMF) and EU Certificate of Suitability (COS) These are required to prove the quality, safety and efficacy of the API for obtaining IND/NDA/ANDA approval. In addition to local supply, US and EU are the major markets for API manufacturers, as indicated by the number of filings Source: Cortellis Generics Intelligence Number of active USDMFs Number of Valid COS
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7 Overview of Indian pharmaceutical industry Indian pharmaceutical players are more focused on US as potential market Number of active US DMF filings held by Indian API manufacturers was consistent over the periods from 2016 onwards Indian players hold valid COSs to support marketing authorisation applications in EU, another potential market Source: Cortellis Generics Intelligence
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8 Impact of COVID-19 and a way forward Impact of COVID-19 on Indian pharmaceutical industry Short-term Long-term Supply chain disruption Lower capacity utilization Medication shortage R&D shifts Change in consumption pattern Approval delays of non-COVID products Shift towards self sufficiency Optimization of R&D spends Change in global demand scenario a Way forward Focus on being self-reliant Optimize the supply chain/distribution Prioritize product portfolio depending on global demands
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9 Optimization of API supply and product portfolio How does the API manufacturing landscape looks like? What is the scale of manufacturing the desired API? How is the regulatory history of the API manufacturer? What are the products which are going to get off-patented in near future and can be added to product portfolio? How many of these have a commercial potential? What are the different launched formulations? How is the US generic forecast? What is the status of API availability? Key considerations
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Interested in learning more? Visit: clarivate.com/genericsintelligence