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Biopharmaceutical Alliance

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June 20, 2024

Why in news?

Recently, the biopharmaceutical alliance was launched to build a resilient supply chain in the biopharmaceutical sector.

What are Biopharmaceuticals?

  • Biopharmaceuticals are complex medicines made from living cells or organisms.
  • Production – They are often produced using cutting-edge biotechnological methods.

                       Biopharmaceuticals

  • Types – There are two classes of biopharmaceuticals.
  • Biologics – It include medicines that generally come from living organisms, which can include animal cells and microorganisms, such as yeast and bacteria.
    • Insulin became the first biologic cleared for human use in 1982.
  • Biosimilar – It is a biologic that is highly similar to another biologic that is already patented (original biologic).
    • A human growth hormone was first biosimilar, which was approved in Europe.

              BiologicsAndBiosmilars

  • Biologics cannot be copied exactly, and so biosimilar are not identical to their original biologic.
  • Usage – They are potential for precise and targeted treatments, usually injected into the body.
  • Challenges – They tend to be heat sensitive and easy to contaminate.
  • They are difficult and expensive to make, store and transport.

What is Biopharmaceutical Alliance?

  • Need – There was a huge drug supply shortages seen during the Covid-19 pandemic.
  • The production of essential raw materials and ingredients of pharma products are concentrated in a few countries posing a greater risk in supply chain.
  • Formation – It was initially organized during the U.S.-Korea Critical and Emerging Technology Dialogue in 2022.
  • The first meeting of the Alliance was held in San Diego during the Bio International Convention 2024, the world’s largest biopharmaceutical exhibition.
  • MembersIndia, US, South Korea, Japan and the EU.
  • Primary focus – To identify and mitigate the weaknesses in the bio-pharmaceutical supply chain through advanced manufacturing technologies and robust research and development (R&D) initiatives.
  • Importance – It is a crucial step towards enhancing economic security and public health resilience on a global scale.

What are the key objectives of the Biopharmaceutical Alliance?

  • Building a resilient supply chain – It involves ensuring the production of essential raw materials and ingredients is diversified and not overly concentrated in a few regions.
  • Coordinating bio-policies and regulations – By harmonizing standards and procedures, it will facilitate smoother cross-border collaborations.
  • It may also reduce bureaucratic hurdles that can impede the swift delivery of critical biopharmaceutical products.
  • Supporting research and development – It places a strong emphasis on joint R&D efforts.
  • By pooling resources and expertise, the member countries intend to accelerate innovation in the biopharmaceutical field.
  • It also plans to ensure that new and effective treatments are developed and made accessible more rapidly.
  • Creating a detailed supply chain map – A comprehensive pharmaceutical supply chain mapping will identify critical nodes and potential points of failure within the supply chain.
  • This will enable the alliance to proactively address weakness and enhance the overall resilience.

What is Indian Pharmaceutical Alliance (IPA)?

  • It is an association of 23 leading research-based pharmaceutical companies in India, committed to patient care globally.
  • Formation – IPA began its journey in 1999 with six top drug makers - Cipla, Dr Reddy’s, Lupin, Piramal, Ranbaxy and Wockhardt - as its founding members.
  • Aim – To create a collaborative environment for the Indian pharma industry to discover, develop and deliver quality-assured medicines equitably.

                      IPA

  • Significance – It has evolved as the most potent voice for the Indian pharma industry, promoting high standards in pharmaceutical production and quality assurance.
  • IPA companies collectively account for
    • 85% of the private sector investment in pharmaceutical R&D
    • 80% of India’s exports of drugs & pharmaceuticals
    • 62% of the price controlled medicines
    • 60% of the domestic market sales

India's Pharmaceutical Sector

  • Market Size – It is currently valued at $50 Bn.
  • India is the largest provider of generic drugs globally, accounting for 20% of the global supply by volume.
  • Globally, India ranks 3rd in pharmaceutical production by volume.
  • Export market – India supplies
    • Over 50% of Africa’s requirement for generics
    • About 40% of generic demand in the US
    • About 25% of all medicine in the UK.
  • Vaccine market – India accounts for about 60% of global vaccine demand.
  • It is the leading supplier of DPT, BCG and Measles vaccines.
  • 70% of WHO’s vaccines (as per the essential Immunization schedule) are sourced from India. 
  • Measures – 100% Foreign Direct Investment (FDI) in the pharmaceutical sector is allowed under the automatic route for Greenfield pharmaceuticals.
  • 100% FDI in the pharmaceutical sector is allowed in brownfield pharmaceuticals, wherein 74% is allowed under the automatic route and thereafter through the government approval route. 
  • The Production Linked Incentive (PLI) scheme to boost domestic manufacturing and reduce dependency on imports.
  • The 'Pharma Vision 2020' aims to make India a global leader in end-to-end drug manufacturing. 

References 

  1. The Hindu | Biopharmaceutical Alliance
  2. FDA| Biopharmaceuticals
  3. IPA| Indian Pharmaceutical Alliance
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