No clarity on probe into clinical trial violations

No clarity on probe into clinical trial violations

Context

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

Who filed the RTI?

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 finding

DCGI’s response

The regulator cited Sections 8(1)(e) and (h) of the RTI Act to deny the information

What do these two sections entail?

Exemptions: 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

Section 8

Exemption from disclosure of information

• Section 8(1)(e): Information available to a person in his fiduciary relationship, unless the competent authority is satisfied that the larger public interest warrants the disclosure of such information;
• Section 8(1)(h): Information which would impede the process of investigation or apprehension or prosecution of offenders;

Counterargument

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.

Background

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

Actimus case:

• 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.

Other cases

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

Ban imposed by European regulators: 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

Significance of the matter

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