No clarity on probe into clinical trial violations

Drug regulator refuses to share its findings under the RTI

January 16, 2018 12:09 am | Updated 12:09 am IST - Bengaluru

Nearly seven years after the Indian drug regulator, the Drug Controller General of India (DCGI) began investigating nine Andhra-based clinical research organisations (CROs) over allegations of coercing people into joining clinical trials, it has refused to share its findings under the Right to Information (RTI) Act.

When public-health activist and whistle-blower in the Ranbaxy cheating case, Dinesh S. Thakur, and Prashant Reddy Thikkavarapu, assistant professor at Hyderabad’s National Academy for Legal Studies and Research (NALSAR), asked the DCGI for the investigation’s findings, the regulator cited Sections 8(1)(e) and (h) of the RTI Act to deny the information.

These two sections, respectively, exempt a public authority from disclosing information if such disclosure violates the authority’s “fiduciary relationship” with another body (the CRO in this case), and if it impedes an investigation.

“Both grounds are quite silly,” Mr. Reddy told The Hindu . “The fiduciary relationship is one of trust, but a regulator’s relationship with a company it is regulating is not one of trust — it is merely enforcing the law.”

In 2011, the DCGI began looking into nine firms, including Visakapatnam’s Actimus Bio-Sciences and Hyderabad’s GVK Biosciences.

In Actimus’s case, several students had complained that the CRO had illegally detained them and tested drugs on them. In GVK’s case, a 24-year-old man had died while participating in a study on blood pressure drug Felodipine.

Media reports also alleged that the man had been participating in several clinical-trials simultaneously, risking his own health and the quality of GVK’s data.

Starting in 2014, the DCGI also began investigating GVK Biosciences, along with the Chennai-based Quest Life Sciences and Mumbai-based Alkem Laboratories, after European regulators found these firms to be manipulating trial data.

The European Medicines Agency, among other regulators, banned drugs approved based on data from these companies.

Around 700 drugs tested by GVK Biosciences, at least one tested by Quest, and at least one tested by Alkem were pulled out from European markets.

When Mr. Thakur and Mr. Reddy requested information on the DCGI’s inquiry into these companies, it was also denied. However, the regulator said it had cancelled Quest’s licence to conduct bioequivalence studies for 15 days, an inadequate punishment given the scale of Quest’s misconduct, said Mr. Reddy.

The DCGI investigation into data fraud and ethical violations by CROs has a bearing on patient-safety in India, because these companies also test the quality of drugs in the Indian market. Fraudulent data could mean that dangerous and ineffective drugs become available to patients.

“If Quest was guilty of such terrible violations, their licence should have been cancelled so as to penalise them — a suspension of 15 days is a cruel joke on the law,” said Mr. Reddy.

He said the company should have been tried for cheating and forgery. The allegations of ethical violations against Actimus, GVK and seven other companies are also punishable under the Indian Drugs and Cosmetics Act.

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