There are fears that some manufacturers of oral progesterone—the hormone administered to support high-risk pregnancy—are promoting the drug as a "tonic" even for normal pregnancy.
A recent Monthly Index of Medical Specialities (MIMS) editorial states, "In its package insert, a Mumbai-based company is advising doctors to use its brand 'to help pregnancy', whatever it means." In other words, it is being prescribed for patients with no documented deficiency of progesterone. "Should it be given to every woman who is not short of progesterone?" asks Dr Chandra Gulati, Delhi-based editor at MIMS.
All gynaecologists TOI spoke to, however, categorically denied coming across any unethical promotion of the hormone.
"How can a pharma company promote it? It is the doctor who is prescribing it," says Mumbai's Dr Duru Shah, past president at Federation of Obstetrics and Gynaecological Societies of India (FOGSI).
So when is progesterone use considered medically prudent in pregnancy? Dr Ashwini Bhalerao-Gandhi, consultant gynaecologist at Mumbai's Hinduja Hospital, says this hormone is prescribed in such cases as threatened abortion or if a woman has conceived after fertility treatment.
Vadodara's Dr Pankaj Desai, current president at Federation of Obstetrics and Gynaecological Societies of India, specifies, "Chances of pre-term labour are effectively prevented by giving progesterone in later parts of pregnancy. It can also prevent abortion in high-risk pregnancies which are because of some hormonal problems. But as to whether it has a role in routine and low-risk pregnancy, the answer is clearly no. It is absolutely irrational and unnecessary."
Promotion of progesterone as a tonic, then, is a violation of Drugs and Cosmetics Act, 1940, which states: "A drug shall be deemed to be misbranded if it is made to appear of better or greater therapeutic value than it is really is. If its label or container or anything accompanying the drug bears any statement, device or design which makes any false claim for the drug or which is false or misleading in any particular."
If used in early pregnancy, the MIMS editorial says, progesterone can cause congenital anomalies including hare lip and heart defects. A latest US study suggested at least a two-fold rise in risk of hypospadias (a uro-genital defect) among boys born by mothers who took progesterone before or during early pregnancy.
"Some advanced countries like Australia have not permitted the use of oral progesterone for any indication." And yet, a Mumbai doctor says some doctors may prescribe it if they are "hyper-careful".
Monthly Index of Medical Specialities says the reason some companies "mispromote" progesterone is because this product lies outside price control.
"The bulk drug price of micronised progesterone is about Rs 8,000 for one kilogram (that is, Rs 8 per gram). The total production cost of a strip of 10 tablets of 200 mg progesterone is Rs 17.50 (Rs 16 for drug plus conversion cost of Rs 1.50). The strip is being sold to patients for Rs 180. Thus it carries a huge profit margin."
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