E-DRUG: Drug regulation & harmful medicines - from India
Need effective drug regulation as harmful medicines flood market
Gopal Dabade, Aug 16, 2013 :
The Drug Controller of India (DCI) - the highest drug regulatory
authority in the country that is supposed to supervise the safety of medicines
consumed by all - has done a great flip-flop.
The controller banned sale and manufacture of two drugs, Analgin and
Piaglitazone, on the ground that both these medicines can cause harm to human
life. But what shocked everybody was that on July 20, media carried reports
that the ban was revoked. One keeps wondering about the reasons behind these
decisions. How can medicines that were declared harmful are again back in the
market and that too within a span of one month? The DCI rushed to suspend the
drug even without consulting the Drug Technical Advisory Board, the normal
go-to decision-maker in such cases. One wonders if the drug industry is behind
Obviously, the DCI is not functioning scientifically. This office is supposed
to be ever-vigilant and should keep track of the situation globally.
Unfortunately, India does not have a proper mechanism as most drug-reactions in
the country go unreported although� efforts are being made by the
government to streamline the same. In its Action Taken Note (on the 59th
Parliamentary Committee Report) submitted to the Parliamentary Standing
Committee in December 2012, the Health Ministry had made the following
commitment: 'It has since been decided that whenever a drug is banned due to
adverse drug reactions in countries with well-developed and efficient
regulatory system, namely, the US, UK, Australia, Japan and Canada, the
manufacture, import and marketing of such drugs would be immediately put under
suspension till the safety of the drug is examined and established in the
Analgin [metamizole], the pain-reliever has been in the Indian market for
several decades now. Many countries all over the world have withdrawn the
medicine from 1970 onwards on
the ground that it can cause a life-threatening condition known among the
medical fraternity as Agranulocytosis, a condition where the defense cells in
body disappear. There exist several scientific studies regarding the harmful
effects of Analgin. The DCI move to ban Analgin was long awaited in India and
was welcome but one was totally shocked by the reports that the same was
revoked. Is it because Analgin has a sale of Rs 100 crore?
Pioglitazone is a recent medicine introduced to manage the common type of adult
diabetes. The medicine is available at affordable prices but requires the
prescribing doctors to keep looking for problems that�may be caused often
during its long term use. So it definitely needs to be used with all
precautions. Like it can worsen heart failure and may cause bladder cancer.
Unfortunately, Pioglitazone is sold extensively in combination with other
anti-diabetic drugs like metformin and glimepiride. Such combinations are
totally unscientific and escalate the risks associated. Of the total Rs 700
crore sales from the combinations, only Rs 100 crore is of pioglitazone and the
rest are of the all unscientific combinations.
If this drug is removed from market then the next choice is Gliptins. But most
of Gliptins are under patent and so unaffordable to the vast majority. In most
countries, there is a restriction on the use of pioglitazone and the only
country to ban it has been France. Why did the DCI not ban unscientific
combinations of pioglitazone? There is another side to the story as to why the
DCI suspended pioglitazone. A doctor wrote to DCI as to how he had around
half-dozen cases of cancer of urinary bladder all of which were on
pioglitazone. This is not conclusive because tobacco use also can cause cancer
of urinary bladder.
In 1960, Frances Kelsey was hired by the Food and Drug Administration (FDA) in
USA. At that time, one of her first assignments at the FDA was to review
application for the drug Thalidomide as a sedative and painkiller with specific
indications to prescribe the drug to pregnant women for morning sickness.
Despite pressure from thalidomide's manufacturer, Kelsey persisted in
requesting additional information regarding the side effect. Kelsey's
insistence that the drug should be fully tested prior to approval was fully
justified when the births of deformed infants in Europe were linked to
thalidomide ingestion. She was hailed as a heroine for averting a similar
tragedy in the USA. She had prevented the birth of hundreds or indeed thousands
of armless and legless children. This particular incident triggered�
stricter drug testing reforms for new drugs to avoid similar problems. As a
result of her blocking American approval of Thalidomide, Kelsey was given the
'President's Award for Distinguished Federal Civilian Service' by President
John F. Kennedy.
Indian market is virtually flooded with several medicines that are dangerous
and harmful. Few examples are nimesulide, thioridazine, carisoprodal,
phenylpropanolamine and several unscientific combinations, all with huge sales.
India urgently needs persons of the integrity, honesty and uprightness
like that of Kelsey to ensure safe drugs for the innocent patients.
(The author is president, Drug Action Forum
Dr Gopal Dabade,
Dharwad 580 002
Dr Gopal Dabade <firstname.lastname@example.org>