Sunday, June 24, 2012

Pharma Industry : CDSCO is the culprit (State of Apathy in its extreme)

If you are interested in knowing how the pharma industry has been
taking us for a ride with the connivance of CDSCO, read this recent
Editorial from: Economic and Political Weekly. Other articles
circulated earlier spoke of pricing, costing, huge profits and
looting. This article talks of Govt allowing medicines to be produced
and sold without proper clinical trials or post marketing follow up in
the case of new drugs. Learn how drugs banned abroad are allowed in

State Apathy in Its Extreme

Vol - XLVII No. 24, June 16, 2012 Editorials

Drug regulation in India seems only to serve the interests of
industry; the citizen does not matter.

What does the union government do when a parliamentary committee,
after 18 months of painstaking investigation, reports that the Central
Drugs Standard Control Organisation (CDSCO) has been looking after the
interests of the pharmaceutical industry at the cost of the ordinary
consumer? And when the committee backs its indictment with detailed
case studies and offers recommendations? The government, of course,
appoints a committee to look into the parliamentary committee's

The report of the Parliamentary Standing Committee on Health and
Family Welfare minces no words to describe the rot in the CDSCO. It
points out that "most of the ills besetting the system of drugs
regulation in India are mainly due to the skewed priorities and
perceptions of CDSCO. For decades together it has been according
primacy to the propagation and facilitation of the drugs industry, due
to which, unfortunately, the interest of the biggest stakeholder, i e,
the consumer has never been ensured." The sales turnover (domestic
plus export) of the India's pharmaceutical industry is estimated at
over Rs 1,00,000 crore a year. Ever since the patent regime was
modified in 2005, pharma multi­nationals have been jostling to expand
their footprint in India.

Even in a country accustomed to the knowledge that the citizen is the
least of the concerns of the State's many agencies, the parliamentary
committee's report is shocking. As it notes, medicines are the only
commodity where consumers cannot make informed choices. They depend
solely on three main actors: the drug regulators, the pharmaceutical
companies and the prescri­bing doctors. Therefore, the state's
responsibility to regulate the import, manufacture and sale of safe
and standard quality medicines should be "sacrosanct".

The parliamentary committee report is, however, replete with details
about what can only be described as criminal neglect. For example, 33
new drugs were approved between January 2008 and October 2010 without
clinical trials on Indian patients. Clinical trials help to identify
differences that can alter the metabolism, efficacy and safety of the
drug when taken by people of different ethnicities. There was no
"scientific" evidence to prove that these drugs are effective and safe
for Indian patients and no surveillance data on them was forthcoming.
However, the Drug Controller General of India can approve a drug
without clinical trials, in the "public interest". But the committee
noted that there is no explanation of what constitutes public interest
and none of the 33 drugs are meant for emergency treatments. The files
of three drugs thus approved had "disappeared" when the committee
asked for them. Again, out of randomly selected 42 drugs, the
committee found that 13 medicines banned in developed countries for
reasons of safety were being sold over the counter in India. It also
found that the "invisible hands of drug manufacturers" guided and
wrote the so-called expert opinion signed by medical professionals and
doctors (the annexures to the report carry photocopies of a number of
these opinions, some of them are identical!). There is no permanent
panel of medical experts attached to the CDSCO and individual doctors
and experts from prestigious medical institutions are asked to give
their opinions before the drugs are marketed. While the number of
applications for approvals has been growing rapidly, the CDSCO is
woefully understaffed to handle the approximately 20,000 applications
annually and myriad other tasks.

The report details numerous other problems in the approval. For
example, drugs not yet launched were already being sold in the market
and that too without any post-surveillance submissions. There is no
transparency in the selection of experts on the drugs advisory
committees. There is no mechanism for controlled post-marketing Phase
IV studies on patients which have helped developed countries to
identify major adverse effects and thus ban such drugs.

The committee has also noted that there are a number of allied issues
that have been neglected over the years. Among these are the severe
shortage of drug inspectors to visit the 10,500 manufacturing units
and 6,00,000 retail units and the machinery to enforce the Drugs and
Cosmetics Act and Rules in general. In the same budget session of
Parliament when the report was tabled, the government acted with
alacrity on the textbook cartoon complaint and the media too went to
town on the controversy. However, a report on such an important part
of medical care that deals with safe medicines for lakhs of people
received routine response from the government and cursory coverage by
the media.

The report has recommended that the mission statement of CDSCO be
formulated to convey in unambiguous terms that "the organisation is
solely meant for public health". The parliamentary committee's
findings should have galvanised the government into taking remedial
measures on a war footing and chalking out strategy for a complete
overhaul of the regulatory and approval process. The former should
include an immediate investigation into the cases of collusion between
CDSCO officials and certain pharma giants followed by swift punitive
action wherever necessary. There is no doubt that this report lists
the causes, symptoms and cure for the deep-rooted malady that afflicts
the CDSCO. If only it had prescribed a medicine for the state's apathy
towards the health of its citizens.
Dr P Vyasamoorthy, 30 Gruhalakshmi Colony Secunderabad 500015 Ph
040-27846631 / 9490804278.

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