Not condoms or pills, but monthly shots

New Delhi: A once-a-month contraceptive shot is set to give women more control over their bodies and prevent unwanted pregnancies, although the burden of contraception will still fall largely on them as male condom usage and sterilization have plunged.

While the use of condoms has declined 52% in eight years till 2016, vasectomy cases have fallen 73%, according to the health ministry. The use of birth control pills has also dropped 39% between 2008-16.

That may change soon, with an expert group approving fixed-dose combinations (FDCs) of synthetic oestrogen and progesterone and medroxyprogesterone 25 mg and estradiol cypionate 5 mg injection. The contraceptive offers protection to women of reproductive age when injected monthly.

The combination of oestrogen and progesterone was banned in August 1989. In 2017, an expert group under the chairmanship of the then director general the Indian Council of Medical Research (ICMR), Dr Soumya Swaminathan, recommended that the Drug Controller General of India (DCGI) remove the ban on the combined injectable contraceptive cyclofem (the combination of progesterone and oestrogen) so that it can be made commercially available.

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In March 2018, the directorate general of health services (DGHS) constituted a sub-committee under the chairmanship of Dr Nilima Kshirsagar, national chair in clinical pharmacology at ICMR, to examine the feasibility of lifting the ban on contraceptive cyclofem.

The expert committee found enough evidence about the safety and efficacy of the injectable FDC and recommended de-notification of the injectable preparation of synthetic oestrogen and progesterone as the country needs to expand choices of injectable contraceptives available to Indian women.

“The issue of the need of this FDC was deliberated upon at great length. The experts opined that there is a need to provide more options for long acting contraceptive agents to Indian women. This is in line with the government policy,” the expert committee said. Mint has reviewed the document.

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The recommendation is based on the clinical trials of cyclofem conducted on 1,275 subjects. The product was imported for this study. The FDC is already approved in countries of Latin America, South East Asia and Africa, Sri Lanka and Bangladesh. “Available data shows that FDC injectable containing synthetic oestrogen and progesterone is safe,” said Kshirsagar.

The experts thus recommended revocation of the ban on it. Experts also recommended that FDC medroxyprogesterone acetate 25 mg and estradiol cypionate 5 mg be considered a new drug. The combination is also included in the list of essential medicines of the World Health Organization as an injectable contraceptive.

The recommendation by the experts assume significance for India where men are reluctant to use contraception, experts say. In Kerala, where 96% of men are literate, condom use dropped 42%, according to the 2017 health ministry report. The use of contraception in India has reduced from 56.3% in 2005-06 to 53.5% in 2015-16, after gradually increasing until 2005-06. Significantly, male sterilization is at its lowest in decades and female sterilization is also on the decline.

Nevertheless, according to the data from the National Family Health Survey, a large-scale nationally representative survey conducted in 2015-16, more than a third of men felt that contraception is a “woman’s business” and that a man should not have to worry about it.