Sun Pharma’s letrozole under DTAB lens
The board, which is the ministry’s highest body on technical matters pertaining to pharmaceutical segment, is deliberating over drugs which are banned globally but still permitted in India.
Sun Pharmaceutical’s drug letrozole, which the company markets for infertility in pre-menopausal women, would come up before the Union health ministry’s Drugs Technical Advisory Board (DTAB).
The board, which is the ministry’s highest body on technical matters pertaining to pharmaceutical segment, is deliberating over drugs which are banned globally but still permitted in India.
Letrozole is the innovator drug of Swiss giant Novartis, which it sells under the brand name Femara as a once-daily oral prescription tablet for breast cancer but only in post-menopausal women.
However, in 2007, Sun got an approval from the then Drugs Controller General of India (DCGI) M Venkateswarlu to market the drug for infertility in pre-menopausal women.
Post the approval, there were allegations of discrepancy in the way the approval was granted.
According to C M Gulhati, editor of Monthly Index of Medical Specialties (MIMS), a journal for medical practitioners, as per the Drugs and Cosmetics Rules, even an old drug when used for a new indication is deemed to be a new drug, and must undergo a series of safety and efficacy studies in both animals and humans before it is allowed for use in public.
“Pre-clinical studies in female mice/rabbits followed by Phase I trials in 10 healthy volunteers and Phase II studies in 10-12 patients (to determine therapeutic use, dose and safety) should be done. But these studies to test letrozole for infertility in pre-menopausal women were not done by the innovator company as the drug was not intended for use in women of childbearing age,” says Gulhati, adding that the trial for letrozole for infertility by the generic company only involved Phase III studies on 55 women.
“That is too small a number to arrive at any conclusion.” When contacted, a Sun Pharma spokesperson said that the company had conducted a trial as required, subsequent to which marketing approval was received.
According to a Mumbai-based infertility expert, letrozole is an effective drug. “Infertility is a big problem in India with social implications. Letrozole is effective for this purpose and is approved in India for the same.”
Says another infertility expert attached with a leading hospital in Mumbai, “Letrozole is not allowed for infertility elsewhere as there were no such trials conducted. But in India as the drug has got approval for infertility it can be used.”
However, another infertility expert says that it is not very safe to use the drug in per-menopausal women as there are not sufficient studies to prove its safety. The annual sales of this drug in India could not be determined.
The board, which is the ministry’s highest body on technical matters pertaining to pharmaceutical segment, is deliberating over drugs which are banned globally but still permitted in India.
Letrozole is the innovator drug of Swiss giant Novartis, which it sells under the brand name Femara as a once-daily oral prescription tablet for breast cancer but only in post-menopausal women.
However, in 2007, Sun got an approval from the then Drugs Controller General of India (DCGI) M Venkateswarlu to market the drug for infertility in pre-menopausal women.
Post the approval, there were allegations of discrepancy in the way the approval was granted.
According to C M Gulhati, editor of Monthly Index of Medical Specialties (MIMS), a journal for medical practitioners, as per the Drugs and Cosmetics Rules, even an old drug when used for a new indication is deemed to be a new drug, and must undergo a series of safety and efficacy studies in both animals and humans before it is allowed for use in public.
“Pre-clinical studies in female mice/rabbits followed by Phase I trials in 10 healthy volunteers and Phase II studies in 10-12 patients (to determine therapeutic use, dose and safety) should be done. But these studies to test letrozole for infertility in pre-menopausal women were not done by the innovator company as the drug was not intended for use in women of childbearing age,” says Gulhati, adding that the trial for letrozole for infertility by the generic company only involved Phase III studies on 55 women.
“That is too small a number to arrive at any conclusion.” When contacted, a Sun Pharma spokesperson said that the company had conducted a trial as required, subsequent to which marketing approval was received.
According to a Mumbai-based infertility expert, letrozole is an effective drug. “Infertility is a big problem in India with social implications. Letrozole is effective for this purpose and is approved in India for the same.”
Says another infertility expert attached with a leading hospital in Mumbai, “Letrozole is not allowed for infertility elsewhere as there were no such trials conducted. But in India as the drug has got approval for infertility it can be used.”
However, another infertility expert says that it is not very safe to use the drug in per-menopausal women as there are not sufficient studies to prove its safety. The annual sales of this drug in India could not be determined.