Logistics major TNT India is establishing a temperature controlled warehouse (TCW) in Mumbai to store the samples of clinical trials and contract research consumables before it is flown to required destinations. The facility is being built according to regulatory norms and will also be certified by the Maharashtra Food and Drug Administration before it is commissioned by the end of this year.

The TCW will be established over an area of 5,000 sq ft. and is designed with three temperature options of ambient, frozen and cool conditions. The company will hire an additional 10 personnel including a trained pharmacist according to the regulatory requirements.

Mumbai was short-listed for the TCW because it is an export-import hub. "India is a much sought-after place as an outsourcing hub in clinical diagnostics. An increasing number of samples are flown into the country and in such scenario TCW is indispensable to provide reliable and timely service, Sanjiv Kathuria, business head, Air Express, TNT India told Pharmabiz.

The company's three year-old 'Clinical Express', a full service supply chain and logistic channel to carry blood samples, drugs, kits, reagents, vaccines, medical equipment like pace makers and diagnostic consumables in temperature-controlled parcels have provided safe and accurate delivery of products to the customers site. Presently, Clinical Express serves 60 of the total 120 clinical research organizations in India.

Besides a certified packaging system to transport samples, it also co-ordinates for dry ice supplies, provides information systems, expert guidance in customs clearance, validation services and project management.

Within its courier handling hubs in the country, the company has earmarked sanitized areas equipped with freezers for life sciences services. A typical operation for a clinical trial site includes distribution of drugs and kits to various sites, sample collections and transporting of reports. Stringent audits are also undertaken by the customers.

The logistics service which is customized comes at a premium price because of the best standard operating procedures.

Out of the total 1,200 employees at TNT India, 35 personnel (business development and operations) are for life sciences space. They undergo intensive training to handle samples and dry ice among others.

While Clinical Express is growing at 100 per cent annually, the company has managed to grab a 35 per cent market share because of high volumes and increased domestic movement. Other leading players in the clinical freight space are World Courier and Marken.

According to Kathuria, a visible trend in the last two years is that international movement is getting replaced with increased domestic deliveries. This is attributed to the growing number of clinical trial opportunities in the country. There is a lot of freight to not only metros but also to districts and towns have become important clinical research sites.

The challenges for companies like TNT in the clinical logistics support sector is to maintain the stability of samples and ensure professional handling of data logger electronic equipment box generating audit of the trial which is an important aspect during drug certification. There are also issues of surety, lack of airports, surface transport and non availability of dry ice during summer months. In addition, regulatory approval delays from the Drugs Controller General of India (DCGI) and Directorate General of Foreign Trade (DGFT) for issuance and renewal of licenses are also time-consuming, informed Kathuria.