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.
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.
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.
Members – India, 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.
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.
