The central government’s plans to introduce a new rule under the
existing Drugs and Cosmetics Act to compensate clinical trial victims
has been challenged before the Lucknow bench of the Allahabad High
Court.
In a public interest petition (PIL), Lucknow based health activist
Raahul Dutta has questioned several provisions in the Drugs and
Cosmetics (3rd Amendment) Rules 2011 notified by the central government
on November 18th. Dutta has stated that the current Drugs and Cosmetics
Act 1940 do not have a provision for such rule making (to control
clinical trials and compensate mishaps).
In response to the petitioner’s plea to protect the life and health of
clinical trial volunteers, the High Court on December 19th asked the
central government to spell out the detailed procedure, the scheme and
the methodology by which misuse and hazards associated with clinical
trials are monitored and checked.
The PIL had alleged that the current laws are inadequate to handle
proper regulation of human clinical trials conducted by pharmaceutical
companies in the country.
The government was compelled to frame rules to monitor clinical
trials and provide compensation for clinical trial victims after a
Parliamentary Committee triggered probe (carried out by the Union Health
Ministry) found dozens of cases where clinical trial deaths were not
compensated.
Based on the petition, the High Court has sought details of the
action taken so far against persons who undertake clinical trials in
hazardous and unsafe conditions from the central government within a
month.
Taking note of the petition, High Court judges Pradeep Kant and
Devendra Kumar Upadhyaya, said that if the petitioner’s claim is
correct, clinical trials should not be allowed in such manner.
The court has also included Uttar Pradesh State Government as a party to the case.
“We are informed that the clinical trials are continuously taking
place but apparently there is no law to the safety of the subjects. The
Central Government is therefore, advised to take immediate steps for
safety of the subjects”, the Order stated.
According to Dutta, the government is attempting to regulate clinical
trials and related compensations under the Sections (12 and 33 of the
Act) that deal with import, manufacture and sale of drugs and cosmetics.
“None of these chapters confer the power to make rules for clinical
trials. The substantive part of the 70 year old Act has not mentioned
clinical trials wording even once”, he explained.
On the merits of the draft rule notified by the government, Dutta
said that it does not have a mechanism to define minimum compensation
for clinical trial mishaps.
“The government has washed its hands by shifting the burden of right
of the (clinical trial) subjects to the sponsor agents (company or
agency that runs the clinical trial). The Drugs Controller General of
any other government agency has neither power nor obligation to grant
any kind of compensation to the subjects”, he complained.
The matter will come up for hearing before the HC in January.
