|
 Three years ago, Dinesh Thakur exposed how India's then largest
drugmaker and his former employer, Ranbaxy Laboratories, failed to
conduct proper safety and quality tests on drugs and lied to
regulators about its procedures.
He made his name, and almost $48 million as a whistleblower award
from the United States, when U.S. regulators fined Ranbaxy $500
million for violating federal drug safety laws and making false
statements to the Food and Drug Administration (FDA).
Ranbaxy said the fine marked the resolution of past issues and it
continued to make safe, effective and quality medicines.
Thakur's fresh case, a Public Interest Litigation (PIL) suit, is
listed on the Supreme Court website for hearing on Friday.
It alleges that responses provided to him by government show how lax
regulation can lead to potentially harmful medicines being sold in
India without proper approvals.
The suit, which names as respondents the health ministry, the Drugs
Consultative Committee and the Central Drugs Standard Control
Organization (CDSCO), would not result in penalties but sets as
objectives the creation of a framework for the recall of drugs and a
commission to examine faulty drug approvals.
The head of the CDSCO, GN Singh, said: “We welcome whistleblowers,
we have got great respect, but their intentions should be genuine,
should be nationalistic... I don't have any comment on this guy."
The other named parties did not respond to requests for comment.
Thakur, who said there was no financial motive for the suit, spent
much of 2015 working with lawyers to file more than 100 public
information requests on how state and central drug authorities had
responded to cases where rules had been broken, some of which first
came to light five years ago.
Thakur says the responses he obtained show CDSCO and the health
ministry have still not adequately investigated and prosecuted those
breaches, despite saying they would.
"An overwhelming number of non-standard-quality drugs are not
prosecuted in criminal cases, since state drug controllers only
impose minor administrative penalties on the offenders," Thakur says
in the lawsuit, citing government data.
The health ministry and CDSCO did not respond to requests for
comment on its penalty policy.
NO INQUIRY
Thakur, who worked for Ranbaxy for two years from 2003 before
turning whistleblower, is now chief executive of Florida-based
MedAssure Global Compliance, which advises drug companies on quality
and safety.
[to top of second column] |
After the Ranbaxy settlement in the U.S. in 2013, Thakur said the
authorities in India did not contact him about it or probe the
reasons for the fine, nor did they respond when he approached them
through 2014.
The ministry and CDSCO did not respond to requests for comment on
their response.
The Ranbaxy case prompted the FDA to increase inspections of Indian
pharmaceutical plants. Products from 44 such plants are now banned
for sale by overseas authorities but still sell in India.
Thakur's suit refers to the case of Buclizine, a drug made by
Belgian firm UCB but since sold to Mankind Pharma for marketing in
India.
The CDSCO allowed UCB to sell Buclizine as an appetite stimulant in
2006, though it was not approved for that purpose in Belgium and
banned in several other countries.
UCB was not asked for clinical studies, the parliamentary committee
found.
UCB said it couldn't answer current questions related to Buclizine
but that it observed all regulatory, legal, quality and safety
regulations.
The CDSCO website says its expert advisory committee found “no
convincing literature to support the drug’s use as an appetite
stimulant” in 2013 but agreed to give Mankind Pharma time to make a
case for the drug.
Since then, Mankind Pharma Managing Director Sheetal Arora told
Reuters it had received no official request for data to prove the
safety and efficacy of the drug, which it was still selling.
The parliamentary committee demanded an investigation and the drugs
regulator committed to one in 2013. Thakur received a statement from
the health ministry last year, seen by Reuters, showing no inquiry
had begun.
The regulator did not respond to requests for comment.
(Editing by Clara Ferreira Marques and Will Waterman)
[© 2016 Thomson Reuters. All rights
reserved.] Copyright 2016 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
