Are Indian vaccine makers ready to supply to the world?, Health News, ET HealthWorld
“India is capable of producing Covid-19 vaccine for the entire world” – Bill Gates
With more than 23 million cases and 800,000+ deaths globally, Covid 19 has been described as the first modern pandemic. Over 150 groups are working independently on developing a Covid-19 vaccine, with Russia claiming the first successful vaccine, the Sputnik V. Developing a vaccine is only the first part of the puzzle – Once the world has a vaccine, the next challenge will be to make it available to the global population at the earliest and at a competitive price point.
India, the largest manufacturer of vaccines by number of doses globally with close to 50% market share, will play a critical role in making the vaccine available to large sections of the developing world.
According to a CEPI study, globally companies can produce 2-4 billion covid vaccine doses by end 2021, of which India will corner a majority share, due to large existing production capacity and continuous investments in capacity addition and technology upgradation.
For example, Pune based Serum Institute of India (SII), world’s largest producer of vaccines by volume, alone has an additional capacity of 400-500 million doses at present, with planned additional investments lined up.
In order to ensure India leverages its inherent advantage in vaccine manufacturing, all elements of the supply chain need to ensure complete readiness.
While major vaccine manufacturers such as SII are partnering with multiple research teams to ensure access to the vaccine formulation, suppliers of ancillary equipment, global organizations and logistics service providers need to provide extensive support to ensure equal access to the affected sections of world population.
Following are the key focus areas for the Indian manufacturers to get a head-start in the race to immunize the world population:
- Securing Supplies: Securing supply of glass vials, stoppers and other ancillary packaging equipment will be a key requirement for large-scale manufacturing of the vaccine. Fears of shortage of glass vials globally have led to companies striking partnerships with suppliers early.
India, with a robust vaccine manufacturing ecosystem, has a network of suppliers with enough available capacity to meet the enhanced demand for glass packaging due to the covid-19 vaccine.
Major players, such as Schott Kaisha, Gerresheimer, Borosil and Piramal Glass, have made recent investments in capacity augmentation and have sufficient incremental capacity available to meet the increasing demand.
Authorities must ensure that the incremental supplies of ancillary equipment are not contracted by global players and should rather be made available to the lowest cost manufacturer with a ready vaccine formulation to ensure enough availability domestically and for other nations.
- Supply Chain Agility: Vaccines are sensitive products and need a temperature-controlled environment and specialized handling procedures to ensure no loss in potency and efficacy. While air transport seems the logical choice, the grounding of most passenger flights, which also carry goods, has drastically reduced the available airfreight capacity.
Lessons from previous outbreaks, such as the bird-flu crisis and Ebola epidemic suggest that manufacturers and governments should tie up capacities in advance to ensure cost-effective and timely delivery of the vaccine.
India, already a major supplier to developing countries, is expected to supply the vaccine to 75+ low-income developing countries, making the cost of the vaccine a key consideration.
Maintaining a delicate balance between cost, safety and time to market necessitates the need for exploring multimodal solutions for the distribution of the vaccine, requiring mobilization of large quantities of cold chain equipment. India must ensure availability of end-to-end cold chain enabled solution to ensure safe transfer of the vaccine from its plants to other developing countries.
- Manufacturing Capacity Augmentation: In anticipation of successful trials of the Oxford vaccine, SII has plans to invest close to 200 million dollars to prepare nearly 300 million doses prior to final approval.
In addition, SII has received at-risk funding of 150 million USD from Bill and Melinda Gates Foundation to augment production capacity and de-risk production of potentially successful candidates from AstraZeneca and Novavax.
While SII, with its deep pockets, private ownership and support of global organizations has the requisite risk appetite, other Indian companies are not seen making advance investments for manufacturing the vaccine, leading to eventual delays due to production capacity constraints.
The government and the private sector need to work together to ensure they can take calculated risks by providing financial support and signaling on vaccine quantities they plan to procure basis population groups they recommend being immunized first to ensure the capacity of other players is fully utilized and any incremental additions are executed at the earliest
- Geo-political considerations: When vaccines are ready, the entire world would be in need of the vaccine right away. Vaccine makers must align the nations’ lawmakers and politicians to establish the right geo-political strategy.
First is to balance to domestic vs. exports. Second, among exports which countries would get priority access versus others. Though this sounds like a problem down the line, it is critical to think ahead and align with law makers.
While India is expected to have a major role in manufacturing the vaccine, it will need to align with the overall global need, to ensure a fair and equitable distribution of the vaccine between countries, and within our own population.
It will be a strategic tightrope for India to balance between our domestic requirements and its commitments to other developing countries. Though India is one of the hardest hit countries, it will be detrimental to our global ambitions & geopolitical relations to block our entire production for domestic use.
- Quality process: While the race for the covid vaccine has been unprecedented in terms of timelines, manufacturers need to ensure all standard quality norms and testing procedures are duly followed, as even the most minute of misses can be potentially catastrophic.
The world has already been witness to political administrations acting in hurry – the procurement of faulty testing and PPE kits from China in the early days of the pandemic are clear signals that panic is reigning supreme.
While the damage from faulty testing and protective kits is controllable, the impact of a less than perfect vaccine can potentially cause more harm than the virus itself.
The government authorities must ensure that all testing procedures and other quality control measures with the necessary timeframes are duly followed in the development and large-scale manufacturing of the eventual vaccine.
There is little time to lose – Ensuring a ready supply chain for the vaccine while maintaining all necessary checks and balances will enable us to leverage our vaccine manufacturing capacity to protect our population while helping the developing world in this hour of crisis.
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