Engineering in India

IPS adds Indian office

by Gil Y. Roth

Integrated Project Services (IPS), an engineering, design/build, validation and compliance company, recently opened two offices in India: Hyderabad and New Delhi. The offices will focus on oral solid dosage, biopharmaceuticals and injectable containment facilities using potent and cytotoxic compounds.

In a press statement, David Goswami, P.E., principal and president, IPS, commented, “These new offices formalize our presence in this growing drug development region to meet client demand for engineering and technical expertise. By focusing on technically complex and high performance areas, we believe that our combination of global capabilities and in-depth knowledge delivers compliance-driven projects that improve operational performance and accelerate time-to-market.”

A few weeks after the announcement, I had a telephone interview with Mr. Goswami to talk about the company’s expansion into the region.

Contract Pharma: Why enter India? This is the first international expansion for IPS, correct?

David Goswami: Two years ago, we really did not want to go beyond the U.S. We were satisfied with where we were. The only non-U.S. office we had was in Puerto Rico. Other than that, we had no strategic plans to go beyond the U.S.

However, in the new era of globalization, a lot of our clients are going all over the world and are especially looking to the Far East. This is happening for many reasons. Large pharmaceutical companies are trying to get partners to do contract manufacturing, and CMOs are trying to find less expensive ways of making drugs. So more and more we see a lot of our clients are heading that way.

Wyeth, a large client of ours, asked us to do masterplanning for them all over the world: Spain, Montreal, Brazil, Taiwan, China. So they took us around and that’s when we started looking into this expansion. We felt that if we have an office in India, it will probably help us with western companies heading to the region, and also with Indian companies that are looking to enter the U.S. If we’re doing projects for them over there, then they’re likely to work with us when they come over here.

CP: Which side is a more important client base for you?

DG: They’re equally important. Our main goal isn’t necessarily to do work only for U.S. Pharma companies. What’s important is that we have a consistent, trained workforce over in India, one that we can keep intact. It’s hard to keep that workforce intact when projects aren’t consistent, so we needed to have a base that works there and is available over there.

Our goal is really to go after both domestic clients in India — because we want to know how it gets done in India — and to keep our workforce together so we will be ready when projects like Wyeth’s become available.

Also, you need a workforce that knows how to handle projects in India.

CP: What differences do you see between U.S.-based projects and India-based ones?

DG: The biggest difference is that I’ve noticed in India is that they plan quite a lot — maybe that’s a European influence — and it takes a bit of time to get approvals. After that, they want to get the project done very fast. And they do tend to get projects completed quickly. They can put six to eight months into the planning stage, and then they want the project completed in six months. That’s the number one difference, in terms of execution.

There are also cultural differences and technical ones. We’re training them in how we do things in our western operations. The drawings are different; the contractor demands are different. A lot of things are done by contractors over there that they don’t do here.

So there are differences, and we’ve learned a lot in the last two years.

CP: How closely will the India operations be tied to those of IPS’ domestic offices?

DG: Quite a bit, and that’s where we want to differ from some of our competition, where the India offices are almost separate from the main operation. We want to be more involved, so they see our faces and get our knowledge.

CP: Are there other regions you’re looking to expand into?

DG: Not at the moment. We’ve been asked to see if we can do something in Ireland, but we want to make sure this works before we go to the next level.

We are working in China quite a bit. Interestingly, as soon as we declared we were available for international work, we found some interest over there. Right now, there are five or six companies we’ve consulted for in China. They seem comfortable with a company from the U.S. guiding them on GMPs and other FDA needs. So we’re getting a lot of calls from there, more in a consulting nature. They’re very interested in sterile facilities.

CP: But there’s not an impetus to open an office there?

DG: Not yet. What clients there are really looking for is our knowledge of FDA requirements. Having said that, we do have a full engineering project going on in China for Wyeth. We did the masterplan for that and it made more sense for us to handle the project. However, it’s not easy, because of the logistics, so we’ve joint-ventured with, Hooker Cockram, an Australian company that has an office in China. So, if we go beyond consulting in that region, and into full engineering, it’ll probably need to be tied in with another company.

CP: What types of facilities are driving the Indian business?

DG: Cancer drugs are important, both sterile and solid dosage. We’re seeing a lot of highly potent compounds, but these cytotoxins have special engineering needs. There’s a lot more money to be made if they get approved, so even from a CMO standpoint, companies are trying to build facilities to accommodate them.

We’re getting calls directly from companies, saying, “We want to build high potency.” These operations typically use isolation technology, which is expensive, and there’s no domestic equipment manufacturer there doing it well. So they’re finding that these are fairly expensive propositions.

One large Indian company called us recently. They weren’t very happy with domestic conceptual designs for a new project. In sterile operations, a lot of things have happened recently with isolation technology and micro-environments, and these Indian firms want to know what’s going on.

CP: Are western CMOs looking to get into India?

DG: Western CMOs are trying make products more cheaply, so they’re trying to get into these markets. These are usually sub-contracting arrangements, as opposed to CMOs trying to build and staff in India on their own.

Some generic companies are also looking to build. Barr Labs, which bought Pliva, is going to build a contract clinical lab in India for research. That’s the next wave in India: contract clinical research.

Bristol-Myers Squibb is going to expand its contract re-search alliance with Biocon, and they’re building a facility in Bangalore. They’ve asked us to help them with that. There are also mid-sized and generic companies going over there, but they’re looking to tie in with local companies. The big companies already have research facilities over there. Pfizer has a huge facility in India, as does Wyeth.

Gil Roth has been editor of Contract Pharma since its inception in 1999.