Thursday, November 25, 2010
DTAB Urged to Deny Permission to Injectible Contraceptives DMPA
Women’s organizations and leading health experts including Member Population Commission urge the Drug Technical Advisory Board [DTAB] to deny permission to use DMPA in the mass family planning programme
DMPA, Depo medroxy progesterone acetate, a three monthly progestogen only contraceptive injection was licenced for use by the Drugs Controller in the nineties. An intervention petition filed in the matter had led to DTAB restricting its use to private market. The approval itself was based on the manufacturer Max Pharma carrying out post marketing studies as this injection was not properly researched into in India. Even at that time women’s groups had objected to the licencing because of the many contraindications and unmanageable side effects already known.
Since then more data has become available and now its use is linked with loss of bone density and increasing the susceptibility of the user to HIV. In more than fifteen years since the licence was granted there is no reliable treatment for heavy bleeding suffered by a substantial proportion of women administered DMPA.
DTAB at the time had refused to revoke the licence but had restrained the government from using it in the family planning programme as the members had felt that the almost superstitious belief of women in the power of injections would render them to misuse of the injections. The health of the 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 two-thirds of the women on DMPA suffer menstrual chaos which may be culturally unacceptable to women.
Women’s organizations have asserted that contrary to the claims of the health secretary nothing has improved in the public health system. Though the UPA government had promised to increase proportionate expenditure on health this has not materialized. The only personnel that have been added are ill trained ASHAs in the rural areas who have no relevance for delivery of injectable contraceptive.
Further the data from post marketing study done by the Population Council is rather discouraging. Despite training, MBBS doctors had poor recall of contraindications, indications, side effects and management of side effects. Doctors specialising in obsterics and gynaecology [OB/GYNs] were better and the study recommended that these specialists are suitable for delivery of injectables. If the government does not have enough specialists to deal with serious health problems of women, can they be deployed to improve the basket of choices of contraceptives, ask womens’s groups.
They have demanded that in the light of the data thrown up by post marketing studies the DTAB should restrict the use of DMPA to OB/GYNs and extend this restriction for NGOs as well who are using this injection in their programme.
Women’s organizations have consistently opposed the introduction of all long-acting hormonal injectables, including Net-En, and implants such as Norplant, due to their hazardous side effects, potential of abuse and inability of the health system to deliver them safely and they are appalled by repeated attempts of the government to introduce them in the family planning programme in total disregard of the health of women.
Dr. Mohan Rao, Member, Population Commission of India
Dr. Betsy Hartmann, Director, Population and Development Program, Hampshire College, USA
Dr.Veena Poonacha, director, Research Centre for Women' s Studies, SNDT University, Mumbai,
Dr. Nalini Vishvanathan, USA
Anveshi Research Centre for Women's Studies, Hyderabad
Centre for Women’s Development Studies, Delhi
Global Sisterhood Network, Australia
Sama Resource Group for Women and Health, Delhi
Saheli women’s Resource Centre, Delhi
November 25,2010, Delhi
Contact firstname.lastname@example.org, Saheli Women’s Resource Centre, Under Defence Colony Flyover, New Delhi 110024