Newsletter Sep - Dec 2010

Women’s groups and health groups have been consistently opposing the introduction of long-acting injectable contraceptives in the family planning programme for almost 2 decades. No sooner do we oppose one injectable the government comes out with an action plan for another. Two years back it tried to promote Net-En and Cyclofem; and when those were opposed, it tried to bring in Depo- Provera. Again and again the ‘basket of contraceptive choices’ is used to make the introduction of all these provider controlled methods sound women friendly. Hence over the decades, we have argued our case in court, and outside it, yet the government is undeterred. This time it is the Health Secretary who has written to the Drug Technical Advisory Board [DTAB] requesting them to reconsider their decision on Depo-Provera (DMPA - Depo medroxy progesterone acetate).

DMPA, a three monthly progestogen only contraceptive injection was never really tested in the Indian population. Instead, the Drugs Controller General of India granted license for its use in India, in the mid-nineties, with the proviso that the manufacturer Max Pharma conduct post marketing studies. Women’s groups in several cities responded with strong protests highlighting the hazards of the contraceptive and problems with service delivery.

 A petition filed in the Supreme Court against hazardous drugs included DMPA, and was referred to the DTAB for review. In a meeting in 1995, the DTAB categorically stated that “Depo-Provera is not recommended for inclusion in the Family Planning Programme.” Echoing the concerns raised by women’s groups, the DTAB felt:

• The target based approach of the government program may lead public health personnel to impose DMPA on women without checking for contraindications and without explaining properly other possible hazards including permanent sterility.

• [Given] the almost superstitious belief in the power of injections, “gullible women would be more than willing to use this injection thus rendering them vulnerable to misuse of DMPA”.

• The health of the DMPA user has to be monitored to watch for the array of disturbing side effects of DMPA. The Indian public health system is too inadequate, inefficient and indifferent to do this work properly.

• Up to 2/3rd of women on DMPA experience menstrual chaos, which may be “culturally” unacceptable to the women.

The above considerations hold good even today. While the central government removed targets in the family planning programme, many state governments decided to continue with them. And the array of disturbing side effects of DMPA has only increased. A black box warning was added to the package insert of DMPA as its use was linked to loss of bone density. Recent research also indicates the possibility that DMPA increases the risk of HIV acquisition, especially in young women.

Underscoring the concerns raised by DTAB, the report of a post marketing study done by Population Council (published in 2003) found that: Despite training, MBBS doctors had poor recall of contraindications, indications, side effects and management of side effects. The report recommended that doctors specialising in obstetrics and gynaecology would be more suitable for delivery of injectables. It is of course a moot point whether the skills of specialists should be used to treat the serious health problems of women or to increase the basket of contraceptive choice.

An equally significant finding of the survey was that women did not find the contraceptive suitable.

• Only 27% remained with the method for the third injection. (A spacing method should be suitable for at least 2 years).

• 87% reported side effects, the most common being bleeding disturbances. The large majority of women who reported experiencing one or more side effect indicated that the condition was “very severe” as opposed to “somewhat severe”.

• Significantly a number of women stopped using contraceptives all together due to their experience with Depo-Provera.

So there is really no reason for the health secretary to seek a fresh review of the DTAB decision. Nonetheless, the ministry claims, “Fortunately, we now have enough manpower and infrastructure thanks to the National Rural Health Mission” to use DMPA in the public sector.

This is an entirely fallacious argument since the only new cadre of health workers that has been created is Accredited Social Health Activists (ASHA) who have neither the qualifications nor expertise for delivery of injectables. The shortage of Ob/Gynae’s remains acute, and they cannot even cope with their own responsibilities leave alone deal with increased morbidity caused by injectables. Hence, the health system remains incapable of dealing with the safe delivery of a contraceptive requiring intensive medical support.

In response to this initiative by the ministry, a memorandum was submitted to the DTAB by us and other concerned organizations/individuals. We demanded that the DTAB:

• Continue to restrict the administration of DMPA to the private sector and allow only Ob/Gynae’s to administer it.

• Disallow NGOs such as DKT, Parivar Seva Sanstha and Janani from propagating its use.

• Reject the health ministry’s present request to introduce DMPA in the National Family Welfare Programme.