EU health agency questions Indian company's research

The Indian pharmaceutical research company GVK Biosciences is under examination by the European Medicine Agency after an inquiry ordered by the European Commission questioned the safety of several medicines the company tested.

The drugs were being subjected to "bioequivalence testing," which is done for generic medicines whose patents have expired. GVK Biosciences, like other generic drug manufacturers, must prove in clinical trials that their particular preparation is safe and provides treatment results comparable to the original medicine.

GVK Biosciences' clinical trials conducted between 2008 and 2014 came to the attention of the European Medicines Agency (EMA) in May after the French drugs regulatory authority ANSM pointed out possible manipulation of electrocardiogram (ECG) results for clinical tests of some drugs produced by the Hyderabad-based company.

Sabine Jülicher, head of the EMA's medical product authorizations unit, wrote in a statement that studies conducted by the ANSM raised "concerns about the reliability of the tests," and that "falsifications of electrocardiograms were detected in each and every one of the nine trials inspected by the ANSM."

EMA declined to answer more detailed questions about the GVK Biosciences case, but said in a statement that it was "currently reviewing all available data to determine which medicines are affected by the inspection findings."

8 percent of trials

GVK Bioscience's CEO Mani Kantipudi told DW that the EMA's accused his company of using one person's ECG data for different volunteers who underwent the tests. The research firm responded by submitting results by four independent cardiologists who said that in some cases, it was clear that the ECG results were from different people, but some test results were inconclusive. Kantipudi added that these discrepancies constituted only 8 percent of all tests conducted in his company.

Another important point, according to Kantipudi, was that the ECGs had nothing to do with the drug itself: "The drug is tested for bioequivalence, and the ECG is just a safety measure to ensure that the volunteers who come in go back healthy."

Kantipudi said an ECG, which measures a person's heartbeat, does not predict how the drug behaves or what it does. "If the drug is for a cardiovascular disease, then an ECG does come into play," he said. "But most of these studies are not for heart-related illnesses but for other kinds of diseases and for those diseases, the ECG is not a marker at all."

The ethics of clinical trials

GVK Biosciences is not new to controversy. In 2009, an audit by the Drug Control General of India (DGCI) revealed that the Hyderabad firm had violated testing protocols while testing a vaccine for pneumonia. According to Indian business magazine Mint, an infant with a cardiac condition was included in a test, violating laws which stated that only healthy babies could be used for clinical trials. International drug companies often conduct trials in Indian cities to take advantage of lower costs.

Amit Sengupta, a physician and medical health activist illustrated this with an example of a wide-scale testing of the human papillomavirus (HPV) vaccine in India's southwestern state, Andhra Pradesh. The vaccine was produced by Merck and GlaxoSmithKline.

"The trials were conducted among adolescent girls living in hostels without any form of informed consent being taken," Sengupta told DW. Later, when the issue was publicized, there was no way of following up on the thousands of girls who had been tested with the vaccine, because no records had been kept. Indian law had no rules for compensating victims in such cases. As a result, no one knew what happened to the girls and in any case, the Indian law had no rules for compensating victims of drug trials.

Lax laws, according to Sengupta led to "a fast expansion of clinical trials without concomitant increase in capacity for regulation, which has led to huge ethical violations in the way these trials are conducted."

A suspension could cause several drugs to be withdrawn from the European market, which would leave consumers without the generic medicines they take.

Germany's Federal Institute for Drugs and Medical Devices is reportedly checking up to 176 approvals for medicines from 28 companies and will let consumers know only once all tests for the drugs are completed.