[india-drug] Maharashtra State Pharmacy Council's Drug Information Centre: LETROZOLE

["dicmspc" <dicmspc@hathway.com>]

Dear I-drug colleagues,

I am writing for the first time since the inception of our drug
information centre a year ago.

Recently our drug information center has received many queries regarding
the prescribing of an anti-cancer drug Letrozole (mainly used in
treatment of breast cancer) for other conditions like infertility. You
may please note that the pack insert of LETROZ of Sun Pharma has under
Warning "To be supplied on prescription of a Cancer
Specialist/Institution/Hospital only". However, according to Drugs And
Cosmetics Act 1940, the registered pharmacist in retail drugstore,
should dispense medicines against the prescription of registered medical
practitioner only. It does not define or specify the need for specific
specialization of a medical practitioner to prescribe certain drugs and
therefore, when retail chemist dispenses drug like Letrozole after
receiving prescription of registered medical practitioner, he does not
violate the act in any way and he is only carrying out his duties as
Pharmacist. How does one define Cancer Specialist by looking at the
prescription brought by patient to retail drug store?


However, in some places in Maharashtra, recently the state FDA has
carried out inspections of drug stores and held the retail pharmacist
responsible for dispensing the prescription of Letrozole coming from
RMPs who are not Cancer Specialists & some retail chemists were
questioned by FDA inspectors for the same reason. These pharmacists have
sought the advice of our drug information center and therefore I would
like to receive your comments in this matter, which will be useful for
us to disseminate same correct information to pharmacists in the state.
In fact, by printing WARNING on label, manufacturer and government have
safe guarded their position leaving retail pharmacist vulnerable and
confused.



regards

Dr. (Mrs.) Sampada Patvardhan (Ph.D.Tech. Pharmacology)                  

In-Charge, Maharashtra State Pharmacy Council's Drug Information Centre
E.S.I.S. Hospital Compound, L.B.S. Marg, Mulund (W), Mumbai-400 080 India
Phone: 25930607  Telefax: 25684291/25684418
e-mail: dicmspc@yahoo.co.in  OR dicmspc@hathway.com