The government has banned three popular
medicines, the widely prescribed anti-diabetes drug pioglitazone, painkiller analgin and anti-depressant in the wake of health
risks associated with them. While it's believed that pioglitazone can cause heart failure and increases the risk of bladder cancer,
analgin has been discarded the world over on grounds of patient safety.
Deanxit, on the other hand is a harmful combination, which has been long banned
even in Denmark, its country of origin.
his decision comes in
the wake of a strong stand by the government on suspending marketing of all
drugs prohibited for sale in other countries like the US, the UK, EU and
Australia.
The ministry of health and family welfare has suspended the
manufacture and sale of all three drugs under Section 26A of the Drugs and
Cosmetics Act, 1940 with immediate effect, through a notification issued on
June 18, informed sources told TOI. While the ministry has been dilly-dallying
on withdrawing analgin and deanxit for years now, despite pressure from a
parliamentary panel, the decision on the diabetes drug pioglitazone has taken
the industry completely by surprise.
The decision to ban
pioglitazone and its combinations will hit the Rs 700-crore market for such
drugs and adversely impact a clutch of companies including Abbott, Sun Pharma,
USV, Lupin, Ranbaxy and Wockhardt.
Pioglitazone
combination is a bigger market than plain pioglitazone itself which is has
posted a strong double-digit growth, with over 30 companies marketing the drug.
The top-selling brands of posiglitazone include Pioz MF G and Pioz (USV), Gemer
P (Sun Pharma), Tribet (Abbott), Tripride (Micro Labs) and Gluconorm PG
(Lupin). (See chart)
Popular pain-reliever
analgin is a relatively small market with brands like Baralgan and Novalgin
(Sanofi Aventis), as most companies fearing a ban have already pulled out from
the market, industry experts said. The third drug, a combination of
Flupenthixol and Melitracen sold as Deanxit (Lundbeck), Placida (Mankind),
Franxit (Intas) and Restfull (Lupin) is facing a ban because deanxit is
prohibited for sale in Denmark, its country of origin, and also, the
combination is not sold in major countries.
Under the Drugs and
Cosmetic Rule 30-B, the import and marketing of any drug the use of which is
prohibited in the country of origin, is banned in India. A parliamentary panel
report on health earlier this year had rapped the government for dilly-dallying
on withdrawing deanxit and analgin, which are not sold in markets globally.
The family of
'glitazones', used for blood glucose lowering properties, has been mired in
controversy since the beginning, with many drugs under the class having already
been banned globally, and in India. Three years back, another drug from this
family, rosiglitazone, marketed by a host of companies including GSK India was
banned, following a decision taken in Europe.
In the case of
pioglitazone too, France has already taken it off the shelves, while in the US
it is sold with a boxed warning. The warning emphasizes that it may cause or
worsen heart failure, and its use for over a year may be associated with an increased
risk of bladder cancer.
Doctors
here in India had said in a study last year that more robust data on use of
pioglitazone on Indian patients was needed. Till that time, the patient should
be adequately informed about this adverse effect and the drug should be used in
as small a dose as possible, with careful monitoring and
follow up. Earlier this month, the ministry had suspended sale of
dextropropoxyphene, sold as Wockhardt's Proxyvon, a widely-used pain-killer.
Source: Times of India
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