The recent irregularities reported in conducting of clinical trials by
Axis Clinicals, a Hyderabad based CRO, in Andhra Pradesh has once again
brought to focus the questionable ways in which clinical trials are
being done in India by the pharmaceutical companies and their agents.
The report said that the CRO conducted bio-equivalence studies for an
anti cancer drug on poor women early this year without securing their
informed consent. The episode came to light only last month when some
women belonging to this group complained of severe body ache, joint and
chest pain and extreme weakness after taking the drug. A few of them
even had difficulty in walking. The office of the DCGI raided the
premises of the CRO after report came in the media and suspended its
license. Axis also will be disallowed from conducting all
bio-availability and bio-equivalence studies at their centre for some
time now. Investigation carried out by the DCGI officials found
irregularities in procedures such as recruitments of subjects and in
taking their informed consents. The DCGI also found that the ethics
committee at the centre was not functioning independently as required
under the existing ICMR guidelines. Many such violations by CROs while
conducting clinical trials in India were reported in the recent past and
actions were taken against the offenders. But, these offences keep
occurring in various parts of the country and very few of them get
reported in the media.
After the action taken against the
Hyderabad CRO, the office of the DCGI decided to audit all CROs in the
country to ensure that the bio-availability and bio-equivalence studies
are performed strictly in accordance with the regulatory provisions and
prescribed guidelines. The DCGI office has already completed auditing of
CROs in Andhra Pradesh and Mumbai. The basic problem with the clinical
research in the country is that the sector is not at all effectively
regulated. The health ministry has been working for last ten years to
put in place a set of comprehensive rules to regulate clinical research
with huge flow of contract research jobs into the country. But that has
not happened yet. Ethics Committees at most of the trial sites are not
active with no monitoring of the trials. What the country has a set of
guidelines after amendment of the Schedule Y of Drugs & Cosmetics
Act and it is not yet notified. That is what emboldens the MNCs and CROs
to conduct trials as they do it now. Now in the case of CROs, a set of
draft rules for their mandatory registration was issued by the DCGI some
time in July 2009 after it was approved by the Drug Technical Advisory
Board. But the registration process is still not in place. The move to
make registration mandatory for CROs was taken after finding a spate of
irregularities in conducting trials in the past. In short, the slow
decision making process in the health ministry is the prime reason for
the whole chaos in clinical research front. The matter has to be taken
up by the health minister seriously and urgently if this critical sector
of the pharmaceutical industry has to function with some order.
