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NEW DELHI: Women's organisations and health experts, including a member of the Population Council of India, have impressed upon the Drug Technical Advisory Board (DTAB) to disallow the use of Depot medroxyprogesterone acetate (DMPA) – an injectable contraceptive used in the family planning programme.
The DMPA, a progestogen-only contraceptive injected every 3 months, was licensed by the Drugs Controller of India in the 1990s. An intervention petition filed in the matter led to the 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 in India. Even at that time women's groups had objected to the licensing because of the many contraindications and unmanageable side effects already known, they have said in a statement issued here on Friday.
Since then, more data has become available and now DMPA's use has been linked to loss of bone density and increased susceptibility of the user to HIV. In more than 15 years since the licence was granted no reliable treatment for heavy bleeding suffered by a many women administered DMPA has been found, the statement said.
The women's organisations said that contrary to the claims of the health secretary nothing had improved in the public health system. Though the UPA government had promised to increase proportionate expenditure on health, it had not materialised. The only personnel that have been added are ill-trained Accredited Social Health Activists (ASHAs) in the rural areas who have no relevance in delivery of injectable contraceptive.
Further data from post-marketing study done by the Population Council is rather discouraging. Despite training, MBBS doctors showed poor recall of indications, side effects and management of side effects. Doctors specialising in obstetrics and gynaecology faired better and the study recommended these specialists administer the injectable contraceptive. If the government does not have enough specialists to deal with serious health problems among women, can they be deployed to improve the basket of choices of contraceptives, they asked.
In the light of data thrown up by post-marketing studies, they have demanded the DTAB to restrict the use of DMPA to obstetricians and gynaecologists and extend this restriction to NGOs using them in their programme.
The women's organisations 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. They are appalled by the repeated attempts by the government to introduce them in the family planning programme in total disregard of women's health.
The statement was signed by Mohan Rao, a member of the Population Commission of India; Betsy Hartmann, Director, Population and Development Program, Hampshire College, United States; Veena Poonacha, Director, Research Centre for Women's Studies, SNDT University, Mumbai; Nalini Vishvanathan, United States; Anveshi Research Centre for Women's Studies, Hyderabad; Centre for Women's Development Studies, Delhi; Global Sisterhood Network, Australia; Majlis, Mumbai; Sama Resource Group for Women and Health, Delhi; and Saheli women's Resource Centre, Delhi.
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