The Drugs Technical Advisory Board (DTAB), the Union health ministry's highest decision-making body on technical matters, has refused to give its nod on the recommendations of the department of family welfare for introduction of injectable contraceptive Depot medroxyprogesterone acetate (DMPA) in the public health facilities under the National Family Planning Programme.
On the recommendation of the department of family welfare, the DTAB discussed the issue at its last meeting. In the meeting, the members were briefed that the department of family welfare in the ministry of health and family welfare has written to the office of DCGI that it is proposed that DMPA may be included in the public health facilities under the National Family Planning Programme by the government of India to provide alternative choice available to the women for family planning.
DMPA is a hormonal injectable contraceptive having Depot medroxyprogesterone. The sustained level of medroxyprogesterone acetate present in the injection suppresses ovulation in the women. It can protect against pregnancy for a period of 11-14 weeks. DMPA, when administered at the recommended dose to women every 3 months, inhibits the secretion of gonadotropins which, in turn, prevents follicular maturation and ovulation and results in endometrial thinning. These actions produce its contraceptive effect.
This is not the first time that this issue is being discussed by the DTAB as the matter was earlier considered by the DTAB in its 60th meeting held on 10th October, 2011 where it was noted that it has long been known that Depo-Provera causes bone loss.
Besides, it has recently been discovered that the osteoporotic effects of the injection grow worse, the longer Depo-Provera is administered and may remain long after the injections are stopped, and may be irreversible. For these reasons, on November 17, 2004 the United States Food and Drug Administration (FDA) and Pfizer agreed to put a black box warning on Depo-Provera's label, to highlight special problems particularly those that are serious, and to give healthcare professional a clear understanding of a potential medical complication associated with the drug.
Refusing to give its nod, the DTAB asked the Department of Family Welfare to consult the leading gynaecologists in the country. “In view of the above it was recommended that the Department of Family Welfare may examine the matter in consultation with the leading gynaecologist of the country for examining the effects of the use of the drug under National Family Planning Programme of the Government of India”, the DTAB said.