Case Study: Bioequivalent Studies in India

A leading pharmaceutical company was focusing its attention on India to conduct bioequivalence studies with clinical end points.

The prevalence of disease indications and the ability to recruit patient numbers within an appropriate timeframe were important factors of influence for the sponsor, while increased pressure on today’s pharmaceutical companies to realise cost efficiencies prompted them to conduct clinical trial studies in this region.

Realising tax efficiencies

Traditionally, India was considered a difficult location from a logistics point of view. However, the strategic location of Fisher Clinical Services in one of India’s Free Trade Zones has offered many advantages:

  • A duty free enclave, deemed to be a foreign territory for the purposes of trade operations, duties, and tariffs
  • No import licence required
  • No import / export taxes applicable (service tax, VAT, excise and custom duty)
  • No routine examination by customs officials of import or export cargo

However, the sponsor also needed to evaluate the breadth of services that could be provided by Fisher Clinical Services to facilitate clinical trial supplies in this region. To this end, the sponsor and Fisher Clinical Services India put a team together to discuss the sponsor’s immediate and long-term strategy for India.

Reduced inventory and shipment costs

The team analysed the sponsor’s proposed distribution model and expected shipping requirements to deliver clinical trial materials on-time and in-full to investigator sites across the region.

It was decided that the best route-to-market for this sponsor was to have a central hub that all products could be dispatched from at appropriate times to accommodate clinical trial timelines. This empowered the sponsor to send bulk shipments of clinical supplies to this hub, reducing inventory and shipping costs to the region.

As many investigator sites were located in remote areas, Fisher Clinical Services worked closely with the sponsor’s team to validate the proposed logistics plan in advance.

Regulatory support

The strategic location of Fisher Clinical Services in the Free Trade Area, and the regulatory expertise of the local team, facilitated the import of clinical trial materials into India. This immediately resulted in time savings of up to eight weeks for the sponsor.

In addition, the simplicity of regulatory processes for this Free Trade Zone in India allowed the team to finish a packaging project in advance of expected timelines for this sponsor, which brought forward the start date of its clinical trial.

Cold chain compliance

The sponsor was particularly keen to ensure that its temperature-sensitive clinical supplies would not be compromised in any way. It was important that its compounds would be maintained at their specified temperature during storage and transportation.

The Fisher Clinical Services facility at Ahmedabad was chosen by the sponsor due to its good manufacturing practices (GMP). Its redundant compressors and back-up power generators ensure temperature compliance, whether ambient, refrigerated, or frozen.

In addition, all Fisher Clinical Services shipments were tracked and traced, giving visibility of all supplies in motion and at rest.

Visibility

Having total visibility of all supplies was of utmost importance to the sponsor to ensure its intellectual property (IP) was maintained across the supply chain. The sponsor received customised monthly reports from the Global Logistics Helpdesk at Fisher Clinical Services demonstrating chain of custody across the supply chain.

New studies

This leading pharmaceutical company continues to deploy clinical end point bioequivalence (BE) studies in India in partnership with Fisher Clinical Services.

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