A GVK Bio whistle-blower's personal crisis led to EU suspending approval for its generic drugs.

A torrid love affair between two employees resulted in the international scrutiny of GVK Biosciences and a >ban on marketing of around 700 generic drugs tested by the facility.

The employee, in love with a junior, left with her in 2011, prompting the girl’s parents to approach the police. As a result, GVK Biosciences — one of the largest Contract Research Organisations based in Hyderabad — dismissed the employee.

The police, during the investigation, went through the employee’s emails and found that he had written to every major drug regulatory authority in the world raising doubts about the quality of clinical research conducted at GVK Biosciences. The disgruntled employee’s emails served their intended purpose, at least for him.

International medicine agencies sought to inspect GVK Biosciences’ Hyderabad facility and alleged manipulation of data by the organisation. The European Union banned 700 drugs tested by GVK Biosciences in July this year after which the Indian government >suspended the EU Free Trade Agreement (EU FTA) talks that were to resume in August after a two-year break.

An affair gone awry

» The GVK staffer wrote to global drug authorities raising doubts on clinical trials. » This was after his termination for eloping with a colleague » Based on his emails, EU banned GVK Bio's generic drugs » India suspended talks on the FTA

A GVK Biosciences spokesperson, in a written statement to The Hindu, confirmed the developments. “Based on the anonymous emails received, a joint inspection was triggered by various International Regulatory Authorities at GVK Biosciences, Hyderabad, Clinical Unit between June 25 and July 4, 2012.

“It was found that the employee, though married and blessed with two children, had an illegitimate affair. He resigned from GVK Biosciences in September 2011 to sort out/resolve this issue but started blaming GVK Biosciences for his personal issue,” said Dorothy Paul, the company’s spokesperson.

The employee did not respond to email queries sent by The Hindu on October 6.

Between January and October 2013, the whistle-blower sent 15 emails to the United States Food & Drug Administration (USFDA), the World Health Organization (WHO), the Austrian Agency for Health and Food Safety (AGES) and the National Agency for Medicines and Health Products Safety (ANSM), requesting them to audit the facility. The emails have been seen by The Hindu.

“After thorough internal investigations on the anonymous emails, GVK Biosciences filed a police complaint,” added the spokesperson. Citing his reasons for the revelations in one of the 15 emails to USFDA, the employee wrote, “cruel politics of selfish senior employees” prompted him to complain against GVK Biosciences.

Reacting to the ban by European drug regulators, the Commerce Ministry said in a release that it was “disappointed by and concerned” at the ban on “one of the flagship sectors of India”, as the story snowballed into the latest setback to the reputation of India-made generic drugs.

The ban had come in the backdrop of increasing tensions, with multinational pharmaceutical companies accusing India of having a hostile intellectual property climate. The Indian generic drug-makers had countered by accusing big pharma of using patents as an excuse to keep affordable Indian medicines from the access of poor patients.

“The IPA is deeply concerned about the damage it has caused to the reputation of the Indian pharmaceutical industry as a reliable supplier of safe, effective and quality medicine at very competitive prices to the EU Member States and their people. The banning of these 700 drugs merely on a suspicion of “manipulation” of ECGs of healthy volunteers and without sufficient evidence was uncalled for. The inspector had erred, yet the Agency did not intervene, in spite of the error being brought to its notice by the government. It only leaves doubt about its intention,” said D.G. Shah, secretary-general of Indian Pharmaceutical Alliance (IPA), a lobby of domestic drug-makers.

G.N. Singh, Drug Controller-General of India (DCGI), confirmed that he knew about the whistle-blower. “We do not know why the whistle-blower — if that was his intention — did not approach the Indian regulators first. Having said that, one must understand that there is a bigger game being played out here. I have repeatedly stated that multinational pharmaceutical companies constantly use incidents like this to bring disrepute to Indian generic drug makers,” he said.