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

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.

Where others have attempted to do an aggregation of APIs in a very fragmented manner, we’ve built a scalable regulatory first platform, where we’ve consolidated multiple Indian manufacturers under one umbrella. And today, our portfolio that we sell, make, distribute close to about 450- 470 different products, whereby global buyers have access to Indian manufacturers with speed, reliability and trust.

Our growth actually has been powered by this very unique approach. We’ve been able to achieve about 75 per cent revenue CAGR over the last seven years, and have been consistently profitable, entirely debt free from day one. We have a greater than 35 per cent return on capital employed. Probably this year, I think we are targeting 40 per cent internally. So, our model ensures that we go to market very, very quickly. It also reduces costs and enhances compliance assurance and also creates these long-term partnerships.

This is the first time India’s fragmented GMP certified capacity has been aggregated. We have also extended our model beyond human APIs by now actively entering veterinary APIs with about 10 products in the pipeline for 2025. We are exploring forward integration into finished dosage forms, and we have been focusing on underserved therapeutic care categories like rare diseases, women’s health and oncology. A case in point is our recent shipment to Mendoza, Argentina, of anti-diabetic medications (USFDA qualified Metformin (1000mg)) the first ever Indian formulation after 31 years to Argentina.

And in fact, that got made in an extremely well reputed manufacturing site here in India. This was applauded by the President of Argentina. We are working with them to create local partnerships.

To sum up, HRV Global Life Sciences is about smarter, faster, more compliant ways to scale companies. We are currently at consolidated annual revenues of Rs 419 crores as of March 2025, with a seven year CAGR of
75 per cent.

We have not just disrupted the game, we’re changing the board the game is played on. People say that we have seen some of these things come up, but not at the size and scale that we have done in about five and a half years as a bootstrapped company.

HRV Global was started five and a half years ago?
HRV as a company was officially incorporated in 2016, but I started spending significant time on it from January 2019. Previously, I led the intermediates division and sales at Sriam Labs, a wholly owned subsidiary of Laurus Labs. While technically associated with the company for six and a half years, the real hockey stick growth began when we reimagined our model during COVID—when most were pausing, we were building. As a fun fact, I took 291 RT-PCR tests during that period—that’s the number of days I was on the road during this time.

Does the company have its own manufacturing sites? 

We do not have any manufacturing sites at all. We only underwrite capacities. Wherever there is free capacity, with an existing product that matches our interest, we go ahead and underwrite that capacity.

That’s one way. The second thing that we do is we also have a big portfolio team that brings in new products. For example, more than 60 USDMFs filed for Pantoprazole. Everybody is playing in exactly the same field and wants to continue to get a share of this business across the world. And the only two logical points that people come to a table is that the quality is better, or the price is cheaper.

It’s like, going and buying a car and saying, I expect the car to have steering and a brake. And that typically is what has become of generics manufacturing.

We’ve moved ahead of that and said that we will pick products which have not more than two regulated players in the market. For example, there are only three buyers for some of the products we make in the world, with only one maker in India. Their problem is that their finished dose is no longer viable because the only manufacturer of API does not want to drop prices. When we went back and looked at it, we were able to offer close to about 45 or 48 per cent saving on the first pass. All three manufacturers who had decided to pull out or reduce their overall sales size in the market, have now decided to come back because suddenly this whole thing becomes very meaningful and profitable for them. We’ve seen a lot of people do this, especially in petrochemicals, and agriculture where regulations are as limited as required.

In spite of this, we’ve still been able to post about 10 per cent EBITDA, without a bank loan to worry about. At five years, we’re just getting warmed up, with the volumes and places that are getting added. We haven’t even broken a sweat. Companies now come tousandsaywewantto invest, but we say we don’t need money. So, it’s a very beautiful spot to be in personally, as a promoter.

Opportunities are coming in, from various parts of the world, where we put a lot of underutilised manufacturers who’ve actually not been exposed to some of these markets, and to the product portfolio that we’re bringing into the game. The only way that I’m looking at it is that we want to quickly scale and expand to more countries. My only largest challenge is how to make more of myself in the company!

Youmentionedsponsoring the regulatory journey and not just aggregating contract manufacturing. I would assume that you are aggregating or sponsoring the regulatory journey of much smaller companies, of mid-size companies and not the big pharma companies in India. Quality has been an issue. So when you sponsor the regulatory pathway, their quality benchmarks and GMPs to the companies that you’re selling to, which would be in regulated markets, how do you do that and what kind of safeguards are there?

For one, we are not talking to any of the big boys. And incidentally, one thing I can tell you is that as early as last month, one of them approached and said, how can we work together? So, it was a good feeling for us, but we just left it there because we strongly believe that right now, we want to choose people who we can actually work with, instead of a big system that they want to change.

We have two-three sets of manufacturing partners. One set who already have approvals (for example from the US FDA) and second set who have built FDA class facilities and don’t know how to get approved.

The third type is those who have built a facility, but don’t know how to talk or think about a regulatory standpoint. The good part is we have ROW and regulated market players. So if I underwrite a capacity, for example, a pantoprazole’s capacity, I’m able to not only sell to the US, but I also have these semi-regulated markets that we’re able to play with.

And what we have kept at the bottom of this whole model is that we should be the last man standing, even if it means to go ahead if the big players change the price points in any market.

Those are the key tenets we’ve laid out. Some of these things as a model are evolving extremely well for us because we are realising more new things together. I’m not looking at it in a myopic view.

And the other thing that has worked very well is that if one unit runs into a regulatory problem, we have a blend of such facilities. So, we tell customers that we are going to make sure that even if we are not your primary source, we have to be your source number two and three. Here is where we are going to give you both options , and how we are helping people. In fact, this started during the COVID pandemic.

We are asking how we can sustain and secure the supply chain as part of this process. Supply chain is already very crucial. We have a great product. It has to reach the patient in the form that it’s supposed to reach the patient and benefit the patient rather than harm the patient.

What is the impact of certain policies like the US BioSecure Act, the reciprocal tariffs being levied by US President Trump and the intention to move manufacturing back to the US? How do these policies affect initiatives like yours, which is primarily built on the premise that you manufacture in a lower cost economy like India and semi- regulated markets.

You asked about the BioSecure Act. Today in my world, where biotech meets geopolitics, compliance is a currency. We’re not a stopgap arrangement to the US or in a trade war. It is more a scalable long-term answer to showing how we can help in reducing dependence on China, and also redefine the trust in life sciences, especially from an India standpoint.

The new tariffs, like the ones you brought up, are more than just that. It’s a very clear indication of changing global patterns. We have talked about China plus one for three years. India Pharma needs to see it not as an interruption, but more as an opportunity for recalibration, with higher duties on certain imports and particularly APIs.

In fact, we were trying to buy something from China for a US customer. When we said that the API is being tariffed at 20 per cent, the manufacturer in China replied back the next morning, saying that they would absorb the duty. And that was very surprising.

So it’s not just about the cost or volume. The future obviously belongs to countries that can offer speed with compliance and scale with trust.

I’m no expert in politics but looking at how things have evolved from a Biosecure Act to reducing manpower at the US FDA. Now they are talking about how to double down on regulatory precision and digital supply chain transparency whereby partners in the US and beyond have access to consistent and de-risked ingredients. The BioSecure Act will talk about finished dose formulations but to actually become an API powerhouse or actually make them in the US, It will probably take the US at least two decades before they even come to a situation where they can go head on with these people.

So, in the long term these tariffs may have the potential to speed up and decouple some of these tendencies. India needs to step up more not only as a manufacturer but a strategic innovator in the global supply chain.

I think we’re waiting for the US market to open up. I don’t know what this morning is going to look like. But that is anyone’s guess and anyone’s best effort at it.

There are wars/conflicts in major geographies, including the latest one at India’s border, which could cause major disruptions to life science supply chains. How will life science supply chains need to change to become more agile and resilient, while meeting growth targets?

Geopolitical shocks—from tensions at the borders to all- out wars—are no longer exceptional occurrences but the new normal of operations. The life sciences industry needs to cease viewing supply chain resilience as a back-up and begin viewing it as core strategy.

At HRV, we see the future of pharma supply chains in terms of distributed orchestration, rather than centralised ownership. That’s what our virtual model allows us to do—we de-risk through diversification. Rather than being dependent on one facility or one geography, we orchestrate capacity from a network of federated GMP- compliant partners placed across India. This enables us to quickly reroute, scale or replace production without any compromise on compliance or delivery timelines.
To remain nimble and yet achieve growth goals, firms require:
◆ Multi-sourcing of key APIs from regions with varying risk profiles
◆ Real-time visibility on production and logistics through AI and digital twins ◆ Regulatory redundancy, with duplicate facilities already audited and approved for business continuity
◆ Disputes will rise and fall. But those who invest in robust ecosystems—not linear chains—will succeed.

What’s your take on addressing the reputational impact of unfavorable regulatory decisions regarding pharma GMP that come up from time to time?

Reputation in life sciences is not ternary—you’re either trusted or you’re not. And one regulatory misstep, even in isolation, can have a long shadow.

Our method is straightforward: We insure compliance before we insure capacity. We don’t merely plug in manufacturing partners— we elevate them. We conduct pre-audit mock inspections, facilitate DMFs readiness, and assume ownership of regulatory filings in our name.

If there’s a red flag—a warning letter—we directly deploy standby capacity across our network so that customers experience zero disruption. This is only made possible because our architecture is designed on regulatory elasticity—having vetted substitutes ready.

Even more significant, we communicate actively with customers. Transparency, documentation, and ownership are powerful tools for turning an anticipated reputational risk into an evidence point of resilience.

The takeaway for the industry? GMP is not a check box. It’s a mentality. And in a world where perception creates value, trust is the new molecule.

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