India needs to step up more as a strategic innovator in the global supply chain

In a free wheeling conversation, US-based Hari Kiran Chereddi, MD, HRV Global Life Sciences explains to Viveka Roychowdhury that “where biotech meets geopolitics, compliance is a currency” and therefore the future of pharma supply chains is a “distributed orchestration, rather than centralised ownership”

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HRV Global Life Sciences specialises in ‘virtual Active Pharmaceutical Ingredient (API) manufacturing’, what does the term entail? Is it like a super CDMO, which contracts out manufacturing to mid-sized pharma companies in India and then meets the sourcing requirements of global MNC pharma?

We're just not transforming typical pharma manufacturing. I do not want to put ourselves in a box of saying we're a CDMO or a CMO or all those terms that are out there today. We're basically reimagining the whole manufacturing setup. Unlike traditional companies that rely on owning and operating factories, we've activated a big network of underutilised globally compliant, be it USFDA, EU GMP or the likes, API production facilities across the country. The average utilisation of USFDA-approved manufacturers in the country is about 50-70 per cent, as per an AT Kearney-OPPI report.

We pull all together into a single tech-enabled platform, allowing us to deliver regulatory-grade APIs across countries without the need to invest in a physical infrastructure. The model is not outsourcing, more an orchestration, where we have led with compliance, filing our own US Drug Master Files (DMFs), Certificates of Suitability (CEPs) and managing global regulatory audits as well.

As a case in point, in the last nine months alone, we have filed about 10 or 11 US DMFs and three CEPs at a pace rarely matched by even large legacy manufacturers. What sets us apart is that we sponsor the regulatory journey and the product journey of some of what we offer, owning the quality and compliance from dossier creation to delivery.