Given the mammoth size of India’s population (1.24 billion, second only to China), drug testing firms such as Quintiles have targeted the country for trials. But Quintiles, the world’s largest life science services firm, has shut down an early-stage test group there. As to why, the Durham-based company doesn’t have much to say.
Later-stage drug trials across India are continuing, Phil Bridges, head of corporate communications for Quintiles, told WRALTechWire.
But the closure of the Phase 1 group – the only one Quintiles (NYSE: Q) operates in India, according to Bridges – comes amid an uproar over India as a site for hundreds of trials. India’s Supreme Court is leading the charge.
“A heaven for clinical trials, a hell for India,” reads a headline in The Independent newspaper in London.
“Court orders government to regulate drugs testing by international pharmaceutical companies.”
Bridges confirmed the shutdown, when asked about it by WRALTechWire.
“The Board of Directors of Quintiles’ joint venture with Apollo Hospitals Enterprise took a decision to close the Phase I Unit in Hyderabad, India, due to a challenging external business environment. The Unit was closed on September 30, 2013,” Bridges said in a statement.
What exactly Bridges means by “a challenging external business environment” is unclear.
However, the news website Outsourcing-pharma.com, reports that the Quintiles decision came as “many” in the clinical testing business are “seeing their trial work delayed or halted” in the country.
The Supreme Court of India on Sept. 30 told the Indian government to develop a plan that would tighten clinical trials regulations. The judges said the testing had become a “hell for India,” according to The Independent.
Using the term “guinea pigs,” the Court told the government that no trials on new drugs should be approved until a “mechanism is put in place to monitor them,” according to the Independent.
Quintiles has tangled with the Indian government before. In 2010, Quintiles was caught up in a government audit of a drug trial. Outsourcing Pharma said the study of the Theravance antibiotic called Telvancin was being investigated by the Drug Controller general of India.
“All approvals were obtained from the relevant regulatory bodies and ethics committees before the trial began,” Quintiles told Outsourcing Pharma in an email at that time.
India a Key Market for Quintiles
Clinical trials is a bread-and-butter business for Quintiles, and the India market represents a huge opportunity. Quiltes has expanded aggressively in India. Its regional headquarters is in Mumbai. The company also built its first data center in India.
“Quintiles India is located amidst a rapidly growing local pharmaceutical market,” its website says.
“With five offices spread across the country, we help clients take advantage of a well-established corporate infrastructure, government policies favoring R&D, growth in the health insurance sector, and tertiary care and teaching hospitals available for trials.
“Other advantages: Quintiles India has solid relationships with leading medical centers and experienced English-speaking investigators. All studies are conducted to FDA and ICH GCP standards. Urban India’s literate population provides fast, efficient access to broad population groups with common and special disease profiles, allowing for rapid patient recruitment and faster study start-ups.”
Workers of the joint venture apparently were offered the opportunity to work elsewhere for Quntiles, thus having an option to being laid off.
“All employees of the Phase I Hyderabad Unit who opted to continue their careers with Quintiles were absorbed in our other businesses,” Bridges said.
He also pointed out that “[t]he decision has not impacted the rest of our business in India or our Early Clinical Development operations elsewhere in the world.
“We continue to operate our clinical pharmacology units in London and Overland Park, Kansas, as well as partner sites in the USA, EU and Asia and are well-positioned to provide a full suite of early clinical development solutions to customers,” he added.
“Quintiles continues its clinical work in India.”
[QUINTILES ARCHIVE: Check out more than a decade of Quintiles stories as reported in WRALTechWire.]