The Hindu: Bengaluru: Tuesday, January 16, 2018.
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.