Free Trade Zone (SEZ) & Simplified Regulatory Packaging Processes Attract Leading Pharmaceutical Company to India
Our client, a leading pharmaceutical company, focused 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 two important factors of influence for the Sponsor. In addition, the increased pressure on today’s pharmaceutical companies to realize cost efficiencies prompted this Sponsor to conduct clinical trial studies in this region.
Realizing tax efficiencies While traditionally India had been considered as a difficult location from a logistics point of view, the strategic location of Fisher Clinical Services in one of India’s Free Trade Zones, also known as Special Economic Zones (SEZ), 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 & 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 & shipment costs The team analyzed the Sponsor’s proposed distribution model and expected shipping requirements in order 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, from which all products could be dispatched 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 and, immediately resulted in time savings of up to 8 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, with redundant compressors and back-up power generators to 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 in order to ensure its Intellectual Property was maintained across the supply chain. To this end the Sponsor received customized 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 the experts of choice – Fisher Clinical Services.