30th September 2013, SC hearing on PIL:
"No Clinical trial on 'Global clinical trials' including New Chemical Entities without
proper mechanism” - Supreme Court -
In Such a short period how a large number of clinical trials on NCEs has been approved
which is risky , the court asked the Government to submit all data related to approved
162 clinical trials to review.
The clinical trials conducted in Indore was subject matter of an investigation by
the Economic offence Wing (EOW) of MP which submitted its report on 24-06-2011.
It pointed out several illegalities in conduct of clinical trials.
March 2011- December 2011
Debate took pace with regard to clinical trials in India, in the Rajya Sabha. In
the final answers given by the Minister of Health and Family Welfare, it was acknowledged
that there are loop-holes and weaknesses in the legal regime.
March 2009 –Dec 2010
Number of RTIs filed with MGM Medical College by number of doctors asking for information
on Clinical Trials but information denied by MGM Medical College under Section 8(1D)
of RTI Act.
12 July 2010 to December 2011
Debate in Vidhan Sabha- After attempts to obtain information under the RTI failed
questions raised by MLAs in Madhya Pradesh Vidhan Sabha. The trials conducted specially
in Indore was subject of discussion which have been referred to in detail in the
Petition. In short, it came out from the debate that doctors in indore have been
conducting trials on their patients, deriving huge income. Trials were also conducted
on mentally ill patients, children and adolescent girls. The trials of drugs like
‘Tadlafil’ was conducted without approval of licensing authority,trials in private
clinics by Govt doctors were done.
2010 to January 2012
Articles were published in several Newspapers and magazines wherein the fact of
illegal and clinical trials in the country including Madhya Pradesh were highlighted.
It was pointed out as to why India has become a centre for conducting clinical trials
by the Multi-national drug companies.
As per the News clippings of Indian Express, English daily, the State Government
imposed a fine of Rs 5000/ only on 12 doctors involved in drug trials for not providing
relevant information to the state Government. No penalty or punishment was imposed
on the Doctors who had conducted the illegal and unethical clinical trials
Newspaper report in the Hindu wherein it was stated that 2 doctors of Indore who
were involved in clinical trial of drug Tadalafil were restrained from conducting
clinical trials for a period of 6 months.
Writ Petition Filed.
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