Quintiles shutters Phase I unit in India
The decision came from the Board of Directors of Quintiles’ joint venture with Apollo Hospitals Enterprise, which decided to close the operation on September 30, 2013, Phil Bridges, Quintiles spokesman, told Outsourcing-Pharma.com.
“All employees of the Phase I Hyderabad Unit who opted to continue their careers with Quintiles were absorbed in our other businesses,” Bridges said. “The decision has not impacted the rest of our business in India or our Early Clinical Development operations elsewhere in the world.”
According to India’s CDSCO (Central Drugs Standards Control Organization), which recently released a list of all of the clinical trials that were under review in the country, Quintiles is currently running four clinical trials for sponsors Otsuka, AstraZeneca and Roche.
And Quintiles seems confident that its early phase development services will not be hampered by the unit’s closure.
“We continue to operate our clinical pharmacology units in London and Overland Park, Kansas, as well as partner sites in the US, EU and Asia,” Bridges added.
Clinical Trial Issues in India
But the decision for Quintiles to close its Phase I unit comes as many in the industry are seeing their trial work halted or delayed there.
The Supreme Court of India recently called for all of the data supporting trial approvals made by CDSCO in July and August. The action was spurred by an NGO’s petition requesting an inquiry on how only a limited number of adverse events and deaths during clinical trials were attributed to the trials.
That request for data comes as the country is still trying to iron out its policies on compensating clinical trial patients, and other ways to strengthen the regulation of clinical trials.
