India’s health ministry has told that country’s Supreme Court that Quintiles treated survivors of the 1984 Bhopal gas disaster as “guinea pigs” who volunteered to participate in two clinical trials for drugs.

In two instances, the Indian government said Quintiles did not meet some standards, according to a report published Tuesday by The Times of India newspaper. More than 500,000 people were injured when exposed to poisonous gas and thousands of people died at Bhopal in what has been called the world’s worst industrial accident. 

Quintiles (NYSE: Q), the world’s largest life science services company which conducts clinical trials around the world and has helped develop or commercialize all top-50 best-selling drugs, denied the charges.

“The implication of the December 17th Times of India story is that companies conducting clinical research in India do not maintain the standards there as they do in other countries. That is not the case,” Phil Bridges, director of corporate communications for Quintiles, told WRALTechWire in response to questions submitted to the company. 

The two complaints focused on inspections in 2010 and 2011 involving separate drugs. 

  • “Finding of the inspection of one clinical trial conducted at BMHRC showed some deficiencies like non-payment of compensation to the trial subjects for participation and non-reporting of serious adverse events within prescribed time limit,” said the report about 2010, according to the newspaper. Quintiles was “merely warned” by India’s Drug Controller General, the report said..
  • “Finding of the inspection [in 2011] showed deficiencies like non-payment of compensation to trial subjects and non-reporting of serious adverse events in time,” the paper said. Quintiles was “only warned” in March of the next year.

Bridges said Quintiles had “queries raised by the Drug Controller General of India (DCGI), Quintiles received queries from the DCGI following their inspections to which we responded with appropriate supporting documentation.”

“This was done to verify that all requisite procedures regarding ethical and regulatory compliance were in place, that these procedures were followed during the conduct of clinical trials at Bhopal Memorial Hospital and Research Centre (BMHRC) and that we had complied with the International Conference on Harmonization (ICH) of Good Clinical Practice (GCP) and local regulations,” he added.

Pharmaceutical giant Sanofi also was criticized before the high court, the newspaper reported.

India Controversy

Drug trials in India have created a great deal of controversy in recent months. In October, Quintiles closed a Phase 1 drug trial unit based in India.

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 newspaper in London.

The use of “guinea pigs” in the latest stories out of India are not new.

Using the term “guinea pigs,” the Court itself in September told the Indian government that no trials on new drugs should be approved until a “mechanism is put in place to monitor them.” 

 Later-stage drug trials across India are continuing for Quintiles, but the company did shut down a Phase 1 testing unit in India in October. Quintiles did not disclose why the unit was shut down other that to cite changing business conditions. The Phase 1 group was the only one Quintiles operated in India, according to Bridges

Quintiles’ Response

While Bridges said that the company “does not comment on legal proceedings,” he did provide a lengthy defense of Quintiles operations in India. The company is one of the most widely used firms by pharmaceutical companies seeking to take new drugs to market.

“It is important to note that Quintiles conducts business in approximately 100 countries around the world,” Bridges explained. “The majority of the clinical studies we conduct are performed across multiple countries and continents all using the same protocols and patient protections.

“Because these global studies generate data that is ultimately submitted to multiple regulatory agencies around the globe, Quintiles conducts clinical trials to the same high standards around the world. Regardless of country, we strictly adhere to universally accepted ethical principles articulated by international and local guidelines, and these are supplemented by our own policies and procedures.

“With specific reference to the queries raised by the Drug Controller General of India (DCGI), Quintiles received queries from the DCGI following their inspections to which we responded with appropriate supporting documentation.

“This was done to verify that all requisite procedures regarding ethical and regulatory compliance were in place, that these procedures were followed during the conduct of clinical trials at Bhopal Memorial Hospital and Research Centre (BMHRC) and that we had complied with the International Conference on Harmonization (ICH) of Good Clinical Practice (GCP) and local regulations.”

[QUINTILES ARCHIVE: Check out more than a decade of Quintiles stories as reported in WRALTechWire.]