Controversy over Injectable contraceptives in India: How to resolve it?

Dr. Devendra Kothari

Population and Development Analyst

Forum for Population Action

Are injectable contraceptives suitable for the Indian women? This blog weighs the pros and cons, so the policy makers could make an informed decision.

The contraception is anything that prevents a woman from becoming pregnant. Medical technology allows contraception through various means like sterilization, Pill, intrauterine device (IUD), condom, implants, injectables among others so that those not practicing abstinence can control conception. Injectable Contraceptives (ICs) are the fourth most popular method worldwide, after female sterilization, intrauterine device and oral contraceptives. Currently two brands of ICs are very popular: Depo-Provera and Noristerat. Of these, Depo-Provera also known as depot medroxyprogesterone acetate (DMPA) is by far the more widely-used.

The Depo-Provera is a reversible contraceptive and it can prevent pregnancy for three months. It decreases chances of benign breast disease. Also protects against endometrial cancer. Any nurse or trained non-medical staff can administer the injection. There is no need to book an appointment with gynecologist or doctor every time for a shot. However, there are a few disadvantages as well. Changes in menstrual bleeding are likely, including light spotting or bleeding. In fact, amenorrhea is a normal effect especially after the first year of use. These injections may also cause some weight gain. Severe headache, nausea, abdominal pain, hair loss, lack of sex drive and acne in some women has also been recorded. In addition, recent studies indicate that the drug may contribute to osteoporosis. Despite potential drawbacks, the available research indicates that the contraceptive's benefits appeared to outweigh its risks[1].

There was a long, controversial history regarding the approval of Depo-Provera in many countries including USA. The original manufacturer, Upjohn, applied repeatedly for approval to the U.S. Food and Drug Administration in 1973, 1975 and 1992, but the FDA repeatedly denied approval. Ultimately, on October 29, 1992, the FDA approved Depo-Provera, which had by then been used by over 30 million women since 1969[2]. FDA discussed thoroughly the side effects before approving it and also consulted experts within and outside USA including WHO.

Is it effective? Depo-Provera is as effective as sterilization and more effective at preventing pregnancy than several other spacing methods, including birth control pills, condoms and diaphragms or IUDs. A field based study, conducted by the Johns Hopkins Bloomberg School of Public Health[3] in 2006 states that “More than twice as many women are using injectable contraceptives today as a decade ago, and the numbers keep growing. Injectables appeal to the many women, especially young and poor who seek a family planning method that is effective and long-acting and can be used privately”. Injectable contraceptives are widely accepted in America, Europe, Africa and parts of Asia, especially in Bangladesh, Nepal, Thailand, Indonesia and even Pakistan (Table 1). Between 1995 and 2005 the number of women worldwide using ICs more than doubled. In 2005 over 32 million were using injectables. By 2015 worldwide use is projected to reach nearly 40 million - more than triple the 1995 level.

      Table 1 Estimated use of Injectables among married women ages 15–49, 2006

Country	Per cent currently using		Per cent of modern method users using Injectables
	Any method	Any modern method
Kenya (2003)	31	14	46
Egypt (2005)	57	7	12
South Africa (2003)	60	28	47
Bangladesh 2004	47	10	21
Cambodia 2005	27	8	29
Indonesia 2002–03	57	28	49
Nepal 2006	44	10	23
Source: Series K, Number 6. Injectables and Implants, Knowledge for Health Project, the Johns Hopkins Bloomberg School of Public Health, USA, 2006.

India and Injectable contraceptives:

ICs are available in more than 106 countries; however they are not the part of the public sector family planning program in India even after nearly two decades of discussions and scientific trials. It is interesting to note that ICs were approved for marketing by Government of India in 1993, and later they were introduced in the official family planning program. However, some women’s groups[4] led by politicians launched an intensive campaign against the introduction of injectables and succeeded in filing a petition in the Supreme Court, seeking a ban on such contraceptives. After much lobbying and pressure from women’s groups, the Ministry of Health and Family Welfare (MoHFW) finally dropped its plan to introduce injectables in the program. It was argued that the public sector wasn't equipped well enough to handle its use in a large-scale manner, and also manage its side effects, however approved the use in the private sector. ICs are easily available over the counter, even without a doctor’s prescription. But they are expensive.

After more than 15 years of scientific trials and experiments as well as widespread use of ICs in the neighboring countries as well as its easy availability in the open market, there was a hope that in order to increase the basket of choice of contraceptives for women, India may introduce ICs in its official program soon."Lot of work has been done on injectable contraceptives and we have come to the final stage where the Joint Technical Advisory Board will meet shortly and hopefully clear it,[5]" the  Health and Family Welfare Secretary Sujatha Rao told at the the First Asian Population Association Conference held in New Delhi on November 16, 2010. But, the Government later came under criticism for the proposed move, and wilting under pressure from some public interest groups and politicians dropped the idea of introducing injectable contraceptives in its program.[6]

The announcement was a big shock especially to those belonging to the lowest economic strata as well as followers of Islam who are having serious problem of unwanted fertility. They were looking forward to have ICs as part of a package of public sector reproductive or primary   health care services since these are expensive but convenient and very-very private. Available studies indicate that women in India by and large, no matter how poor or subjugated they may be, have a strong desire to control their fertility. However, as per the latest National Family Health Survey (NFHS-3), every fifth birth has been classified as unplanned or unintended (that is mistimed or unwanted at the time the women became pregnant).  It is estimated that more than 26 million children are born in India every year and out of this about 6 million births have been classified as unplanned. Approximately two-thirds of the unintended pregnancies resulted from non-use of contraceptives; clearly indicating the need for revamping the program. In addition, around one-third of unintended pregnancies resulted from the ineffective use of contraceptives, which suggests the need for improved counseling and follow-up of couples that adopt the method (Kothari, 2010)[7].

The level of unwanted fertility can also be measured by comparing the total wanted fertility rate with the total or actual fertility rate. The total wanted fertility rate represents the level of fertility that theoretically would result if all unwanted births were prevented.  The proportion of births that were unwanted was the highest for births to women from the “bottom of pyramid”. NFHS-3 data  reveals that in India, the total wanted fertility rate of 2.4 children per woman, belonging to the lowest economic strata is lower by 1.5 children (that is by 38 percent) than the actual or total fertility of 3.9 children per woman. This means the women belonging to low economic strata have more children than they actually want and this can be seen throughout the country (NFHS-3, 2007)[8]. The data also indicates that the level of unwanted fertility decreases sharply among women from the lowest economic strata to the women in the wealthiest strata from 1.5 children per woman to 0.3 children per woman. Further, among various religious groups, the level of unwanted fertility was highest among Muslims (1.1 children per woman).   It means total fertility would drop substantially if their unwanted fertility could be eliminated. And here modern contraceptive methods especially effective spacing methods could  play an important role. 

The findings of the group discussions indicate that women in the Kacchi Basti (slums)[9]  want wider choice of methods like injectables to be part of the official Family Welfare Programme to improve ‘choice’ and ‘convenience’. Although injectable contraceptives have been kept out of the public sector program, they are available in the private health sector. In our study area a large number of women knew about injectable contraceptives and some of them were using Depo-Provera, though they found it expensive. However they considered it more convenient in comparison with taking pills every day, or inserting an IUD or telling their husbands to use condom. The women of the study area were convinced that an injectable is actually a more convenient means of contraception than the existing ones. One of the women told in the group discussion:

“I was not keen on the third child since I was already having two children - a boy and a girl. I had a lot of arguments with my husband because of this.  I tried to convince him, but in vain.  I came to know about injection from my friend and took it from the local clinic Aadhar (a clinic run by the Parivar Seva in the slum). I had some health problems like bleeding, back pain, nausea, joint pain and headache.  Despite these problems, for me the injection was a blessing, as I was relieved from conceiving again and again”. 

Although injectable contraceptives are not included in the Family Welfare Programme of India, it is surprising that more than half of the currently married women are aware of this spacing method. And in some poor performing States like Uttar Pradesh, the awareness was more than 80 per cent among women. Further, the proportion of women in India who know about injectables increased from 19% in NFHS-1 (1992-93) to 52%t in NFHS-3 (2005-06). And the level of awareness is relatively high among women belonging to lower strata.  Although the use of injectables is extremely low in India, it is relatively more popular among the women belonging to lowest strata (NFHS-3).

The right to decide freely and responsibly the number and spacing of children and to have the information, education and means to do so is well recognized as an important component of reproductive rights. Contraceptives enable men and women to exercise these rights. Modern technology has provided us with a range of contraceptive choices. The distribution pattern of usage of various methods to prevent pregnancies is called "method mix". India is unique in that female sterilization is the predominant method, since it is aggressively promoted by the program. India's family planning program has largely failed to encourage the use of reversible methods, particularly among young women (age 15-25) who are in the most fertile years of their reproductive period. And there is urgent need to promote convenient and effective spacing methods like ICs. Here mass media campaigns have the potential to provide visibility to this product, spread information, build interest and influence public opinion.  Such campaign will change the mindset of the policy makers.

The next blog discusses how a maverick Indian scientist developed a revolutionary, easily reversible birth control method for man but how the system discouraged it.

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[1] For details, see: Lande, R. and Richey, C. “Expanding Services for Injectables,” Population Reports, Series K, No. 6. Baltimore, INFO Project, Johns Hopkins Bloomberg School of Public Health, December 2006.

   

[2]See, Leary, Warren E. (October 30, 1992). "U.S. Approves Injectable Drug As Birth Control", The New York Times.

[3]  For reference, see footnote 2.

[4]  For details, see: Sarojini NB and Laxmi Murthy. 2005. Why women's groups oppose injectable contraceptives, Indian Journal of Medical Ethics. 2(1)

[5] See Times of India dated November, 17, 2010

[6] See, Times of India dated March 28, 2011

[7] For details, see: Kothari, Devendra. 2010.  “Empowering Women in India through better Reproductive Healthcare”, FPA Working Paper No 5, Jaipur: Forum for Population Action.

[8] IIPS.  2007.  India: National Family Health Survey, 2005-06. Mumbai:  International Institute for Population Sciences.

[9] [9] For details, see; The Status of Reproductive Health in Jawahar Nagar Kacchi  Basti (Slums), Jaipur, India. Forum for Population Action, Jaipur, 2010.