Gujarat’s labour laws are business friendly

Gujarat’s labour laws are business friendly

Thermo Fisher Scientific’s new facility at Gujarat makes it one of only two to three small regional competitors in its space. Ram Gupta, President and Managing Director, Thermo Fisher Scientific, Fisher Clinical Services Division, reveals more to Sachin Jagdale

Thermo Fisher’s new facility at Ahmedabad became operational recently. What are the services on offer and who are the clients that have approached you for your services?

We will be dealing with Clinical Trial Supplies Management, which involves importation of Bulk Experimental Drug, storing it in an environmentally controlled warehouse, packaging it into individual patient kits and distributing the kits globally to multiple Investigation sites. Environmentally warehouses include Ambient (23 degree C); Cold (2-8 degree C); Frozen (-20 degree C). Temperature management is extremely important as the stability of the drug and its chemical composition may get affected with unfavorable fluctuations in temperature.

Distribution of patient kits to investigators located in global sites is yet another important aspect of our service. We also have to manage any returns and their destruction, if required, import and export services inclusive of all permits, licenses from Drug Controller General, India (DCGI), State Food and Drug Administration (FDA), Excise Customs, CBN, DGFT etc. We undertake Analytical Testing Services, stability and product release testing as well.

We have a broad client list that spans the globe. Our clients are all major global MNC pharmaceutical and biotechnology companies. We expect to develop many domestic and regional pharma and biotech companies, who are active in new drug discovery, as our clients.

How will Gujarat government’s red carpet welcome help companies like Thermo Fisher? Why did Thermo Fisher zero in on Gujarat for such as facility?

Gujarat has the first multi client pharma and biotech special economic zone (SEZ) formally approved and being developed by Zydus Cadila. Fisher needed to set up the Clinical Trial Supply Management facility in an SEZ to service global MNCs.

Gujarat’s pro-business environment was definitely helpful in getting some of the approvals and licenses in reasonable time. Speaking frankly, our investment was too small for a real red carpet welcome.

How will you differentiate Gujarat from other states in India in terms of providing good business opportunities?

In our business, it was a plus that Gujarat is a hub for many pharma companies and contract research organisations (CROs). Gujarat also has many trained pharmacy and engineering graduates in addition to clinical research professionals. This I think is one of the major pluses that Gujarat has. Gujarat’s labour laws are business friendly compared to many other states. In addition to this, compared to many other cities, Ahmedabad is improving in the Supply Chain Management field as well by having good air connectivity.

What kind of revenue generation you are expecting from this facility in the coming financial year?

As far as revenue generation is concerned, first year is a year when we go through many regulatory and client audits. We expect to start generating reasonable revenues from next fiscal year. We do not provide specific revenue numbers for individual divisions.

Gujarat is the largest pharma packaging solution provider in India. With well established packaging solution providers already in the market, how are you going to sail through such tough competition?

Not only Gujarat, but also in India there are only two to three small regional competitors in our space. Reason is our business in packaging for clinical trials research rather than for commercial drug packaging. We are not in the same business as the big pharma in Gujarat.

Thermo Fisher now has the largest presence in India of any company in its industry. Are we going to see many such facilities in ‘investor friendly’ Gujarat?

We have invested in a large 15 acres plot where we have space for any other sister company to set up a unit which is export oriented and serving the pharma or biotech industry sector.

List the key benefits that your clients will get from you.

Time to market will be the key benefit. India’s large and diversified patient data base provides an opportunity for global and domestic clients involved in drug discovery to submit final approval applications to U S Food and Drug Administration (USFDA) and other regulatory agencies faster for marketing in the regulated markets.

Smooth communication will be the next advantage. There is no language barrier. All professionals speak English. Under Intellectual Property Rights (IPR) India has passed the Trade Related Intellectual Property Rights (TRIPS) law in 2005 to honour product patents. Besides this, there may be some cost reduction potential depending on the scope of the clinical study.