The New Indian Express: Chennai: Tuesday,
September 24, 2013.
The Union
Ministry of Health and Family Welfare has not provided any document to support
its ban on anti-diabetes drug pioglitazone from June to July this year,
indicating that the action was taken without proper enquiry, according to a
city-based diabetologist.
In a reply to
an RTI query by diabetologist Dr B Mukesh, the ministry did not furnish any
document that led to the drug’s ban. It did not provide detail on people
adversely affected by the drug, as requested by the applicant.
The doctor
requested in June for various documents including those that recommended the
suspension of the drug (now the ban has been revoked). He also sought
particulars of persons adversely affected by the drug with their medical
records, that reportedly led to the suspension.
The
Directorate General of Health Services attached to the ministry which gave a
reply after more than a month neither furnished the requested documents nor
mention that is it had any document to justify the ban.
It simply
stated that the drug was banned as certain reports published in medical
journals raised safety concerns on continued use of the drug.
“But except
for that reply, they did not give me any documents that supported the ban. It
shows they did not probe further or verify the reports in the journals to find
details of the patients who suffered bladder cancer due to the usage of this
drug,” the doctor claimed.
The reply
also mentioned Drugs Technical Advisory Board’s subsequent recommendation to
revoke the ban following the opinion of an expert committee and the conditions
for marketing including warning for patients in packages. “This is a molecule
used for many years. What’s the need for ban and revoke it. This has only
caused a scare among those who have been using the drug for a long time,” the
doctor said.
It is to recall
that Pioglitazone, which was sold under different names by several companies,
was banned from manufacture, sale and distribution in the month of June for its
alleged links to urinary bladder cancer. The suspension resulted in protests
from a section of the medical fraternity. The DTAB lifted the ban in the end of
July.
The drug is
banned in France, sold with risk warning in the US and Europe and restricted to
existing prescriptions in Germany.
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