E-drug: Illegal promotion of Letrozole in India
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Anti-cancer drug being illegally promoted as "Infertlity Cure" in India
An expensive anti-cancer agent letrozole is being promoted illegally
and unethically to gynaecologists for "improving" fertility in females in
India by Mumbai-based Sun Pharmaceuticals, Delhi-based Dabur
India Ltd., Chennai-based Fourrts Laboratories Ltd. and
Hyderabad-based Natco Pharma Ltd. The drug is approved for the
treatment of breast cancer only by the Drugs Controller General,
India (DCGI).
Promoting medicines for unapproved uses is unlawful in India. Such
drugs are deemed to be misbranded under the provisions of Drugs
and Cosmetics Act and manufacturers are punishable with fine and
imprisonment ranging from one to two years.
Curiously enough two companies, Sun Pharmaceuticals and Dabur
are marketing the same drug under two different brand names each.
According to drug experts this is strange and is apparently meant to
corner a bigger pie of the same drug's market through multiple
branding.
Responding to the allegation of illegal promotion, Sun Pharma-
ceuticals has acknowledged that its "marketing people might have
gone overboard" in promoting the drug without DCGI permission.
However investigations reveal that Sun Pharma circulated thousands
of promotional leaflets throughout India under the title "Letroz - the
New Perspective in Ovulation Induction." Letroz is Sun
Pharmaceutical's brand name of letrozole.
Furthermore, scores of seminars were held all over India where
gynaecologists were invited to listen to lectures by Company-
sponsored fertility experts endorsing the use of letrozole in infertile
women. The seminars were continuing right into early September.
Letrozole is embryotoxic and fetotoxic as per the literature issued by
the original discoverer, Novartis, and endorsed by drug regulators
from the United States, Britain and Australia. Even in India, the drug's
monograph as approved by the DCGI acknowledges these serious
side effects. Letrozole is also teratogenic and can cause
malformation of babies. Even at minuscule doses of 0.03mg/kg
(about 1/10th of normal human per kg dose) the drug can lead to
foetal domed head and cervical vertebral fusion.
Administering a drug for unapproved indications can lead to legal
action both against the prescribers and the producers under various
laws including Consumer Protection Act.
Dr. Chandra M. Gulhati
Editor, MIMS INDIA
503 Mansarovar
90 Nehru Place
New Delhi, India
E-mail: seeemgee@yahoo.co.uk or mims@ndb.vsnl.net.in
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