[india-drug] Letrozole

[Raj Vaidya <pharmhin@sancharnet.in>]

Letrozole
---------

Trade complaints against Dabur, Fourrts, Natco for promoting letrozole
for unapproved use

Friday, October 17, 2003 08:00 IST    - PharmaBiz
Joe C Mathew, New Delhi

Even as Drugs Controller General, India (DCGI) has sought explanation
from Mumbai-based Sun Pharmaceuticals for unlawfully promoting
anti-cancer drug letrozole in the treatment of female infertility,
three more companies are
allegedly engaged in similar activity. 

According to trade sources, Delhi-based Dabur India Ltd, Chennai-based
Fourrts Laboratories Ltd. And Hyderabad-based Natco Pharma Ltd have
been promoting their own brands of letrozole to gynaecologists as
infertility treatment. DCGI has approved the drug for the treatment of
breast cancer only. Worldwide, letrozole is not used for any disorder
except breast cancer. 

Dabur is selling the same drug under two brand names: Trozet for cancer
and Foliripe for infertility. The brand name Foliripe is suggestive of
ripening of ovarian follicles. 

Fourrts is selling the drug under the trade name of Letrofil while
Natco's brand name is Letronete. As reported earlier Sun Pharma is
marketing the drug under two brand names: Letroz and Letoval. 

It should be noted that the promotion of medicines for unapproved uses
is unlawful and such drugs are deemed as misbranded under the
provisions of Drugs and Cosmetics Act. The manufacturers are punishable
with fine and
imprisonment ranging from one to two years. 

According to sources in the retail trade, sales representatives of some
companies have been advising them to remove the package insert while
selling letrozole. Government-approved package insert recommends the
use of
letrozole in cancer only. This is being done so that patients
prescribed letrozole for infertility do not ask inconvenient questions.


According to medical experts, the Western countries ensure that all
medicines supplied to public carry approved labeling and patient
information leaflet duly cleared by the drug regulators. This ensures
that consumers get accurate
information on medicines. It is known that the system is not yet in
place in India. 


Forwarded by:

                      Raj Vaidya, M.Pharm,
                      Community Pharmacist,
                      Hindu Pharmacy,
                      Cunha Rivara Road, P.B.No. 149,
                      Panaji - Goa - India 403001.
                      Tel : 91-832- 2223176, 2432903 (O), 2463926 (R).
                      Email : pharmhin@sancharnet.in


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