Patient trials of an advanced pneumonia vaccine by the domestic unit of US drug giant Wyeth Inc. have been suspended by India’s drug quality regulator after the death of an infant on whom the vaccine was tested in a trial in Bangalore.

The child had a pre-existing cardiac disorder. Indian drug rules prohibit testing on human subjects with such conditions without the prior approval of the drugs controller general of India (DCGI), the drugs quality regulator.

The inclusion of an infant with a cardiac condition in the Wyeth vaccine test violates India’s drug testing rules that strictly monitor subjects on who such tests are conducted. Wyeth had been permitted to conduct tests only on healthy babies, according to the regulator. The trial was being conducted on healthy babies who were between 42 and 72 days old.

“The baby was suffering from a cardiac abnormality and should not have been included in the trial at all. It seems that the ‘inclusion-exclusion’ criteria protocol has not been adhered to by the investigator,” said Surinder Singh, drugs controller general. “We have suspended all further trials across the country.”

The incident brings to the fore an ongoing debate among the medical and drugs community in the country on allowing foreign companies to conduct what are called phase III trials here for a drug that is not marketed anywhere else in the world. Until January 2005, such human trials for a molecule developed outside India were allowed only under that the drug was already approved for use abroad and was being sold in the market.

Though the Indian regulator has suspended several drug trials in the past, all of them have been over adverse reactions or efficacy issues, and not for violation of the rules themselves, drug regulation experts said.

“This is the first reported instance I can recall,” said Chandra M. Gulati, one of India’s top experts in drug regulations, and editor of Monthly Index of Medical Specialities.

Under the inclusion-exclusion protocol, if the investigator or the company decides to include or exclude a subject from its trial not fitting into approved criteria such as age, weight and health conditions, it must take prior permission of the licensing authority, in this case, DCGI.

It was not immediately clear at which link in the testing chain the mistake occurred. Wyeth Ltd, the Indian unit, said the tests were conducted by GVK Biosciences Pvt. Ltd, contracted for the trials. But Singh said Wyeth had conducted the trials on its own.

A GVK Biosciences spokeswoman said it couldn’t comment because of “client confidentiality”. The tests were done at Bangalore’s St John’s Hospital’s National Academy of Health Sciences.

The Wyeth phase III trial—the final stage of testing before a drug is approved for sales—was part of global clinical trials to assess the safety, tolerability and immunogenicity of a pneumococcal conjugate vaccine that fights 13 strains of bacteria compared with seven strains in the company’s current vaccine, Prevenar, the only vaccine of its kind.

Singh said he would be sending his drug inspectors to investigate the death of the baby, next week. “Further action will be taken based upon the outcome of our investigation,” he said. “We want to take very stern action. You (the company) should select the right type of child and subject. When the child has died, you are telling us that the child had a cardiac abnormality. We will not allow companies to fiddle with the safety system set out for clinical trials in India.”

Wyeth said the child who died had been administered Prevenar and not the new 13-strain variant.

“The event occurred in the control group, which used the current worldwide standard vaccine for prevention of pneumococcal disease and which has been administered safely more than 200 million times worldwide during the past seven years,” a company spokesperson said in an email. The test was comparing efficacy of Prevenar and the new variant.

Gulati predicted Wyeth would be eventually held responsible even if it contracted a testing firm for the trials: “Ultimately, the sponsor (that is, the company) is legally responsible though if there is any injury, then in a court case summons will also be issued to the investigator (for negligence), hospital (for not monitoring the trial properly) and DCGI (for not conducting inspection of the trial).”

The trial, begun in 2007, was being conducted on 350 children in India. Some 250 have already been tested. Wyeth is still allowed to collect the data.