Samir Vyas, Country Manager, Agilent India says India companies are now moving into the global biopharma market and gives his views on the role of policies like Make in India/Atmanirbhar Bharat, a more vigilant US FDA after the sartan episode and Agilent solutions for these challenges, in an interaction with Viveka Roychowdhury
India is termed the ‘Pharmacy of the global South and is preparing to meet a sizeable portion of the global demand for COVID-19 vaccines. Where is the country ranked globally in the pharma and biopharma world?
There is no doubt that India has the potential, capability, and capacity to supply good quality and effective therapeutic, nutritional, and wellbeing products with higher affordability. India ranks third worldwide in the production of pharmaceuticals, where eight out of ten global generic companies are from this country. Although Indian companies are known for producing generic pharma drugs, many companies are now moving into the global biopharma market to enable revolutionised treatment and prevention of many disabling and life-threatening diseases. India is among the top 12 destinations for biotechnology in the world, with approximately three per cent share in the global biotechnology industry.1
In recent times, India has strongly emerged as a global pharmacy, with the effective supply of critical medicines to over 150 countries. India is fast emerging as the vaccine hub for the world with the capacity of contributing around 60-70 per cent of the global vaccine supply for COVID-19.
But even with the many achievements, India finds itself critically dependent on external sources for crucial parts of the value chain like certain key starting materials and APIs, which need to be imported. How has this hampered the growth of the country’s biopharma sector?
While it is true that India used to import almost 70 per cent of raw materials for pharmaceutical manufacturing, we focused more on building the capacity for finished products and continued our dependency on offshoring the starting materials.2 This pandemic has exposed and highlighted the need for India to come up with strategic initiatives and a robust plan to reduce the dependency of sourcing the starting materials and equipment for requirements as critical as public health care. Long manufacturing cycles and stringent quality standards resulted in low margins for pharma companies and encouraged them to import APIs, rather than produce them domestically. Although, it has become evident that the impact of supply chain disruption was relatively less on the biopharma segment rather than the generic pharma industries.
Can policies like Make in India/Atmanirbhar Bharat set this balance, right? What is your take on this?
I am confident that these measures will facilitate growth for the Indian pharma/biopharma industries, thus creating a more self-reliant and sustainable ecosystem. We expect a more focused approach from the government with respect to capacity building, ease of doing business and growing investment towards infrastructure development. Having said that, it would be equally important to maintain excellent partnerships and continue collaborating with global companies to enable exchange of technology, competency, and experience in creating safe and affordable medicines.
Global regulators are becoming more stringent and holding pharma companies accountable for the quality of their suppliers as well. The recalls of medicines with trace amounts of carcinogenic NDMA in medicines is a recent ongoing example. How can Agilent help companies for analysis and QC of input materials, as regulators up the ante by mandating more stringent testing at every point of the value chain?
The healthcare sector operates in a very dynamic environment and small changes in regulatory or safety guidelines have a significant impact. Historically, the pharmaceutical industry has been functioning with good manufacturing and laboratory practices and with time we have seen the journey of regularity and compliance evolution to provide the safest medicine. During FY 2015-19, we saw a rising trend with an increase of ‘warning letters’ issued by the US Food & Drug Administrator (FDA), whereas FY 2020 has shown a significant drop which is likely due to restriction in travel/inspection because of COVID-19.
Another major focu...
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