Difference Between Indian and American Lifestyle

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Women in India have been able to use hormone-free birth control pills for almost 30 years. Why is the remedy apparently only available in one other country? A search for clues.

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Sophie Dowding has been looking for a way to use contraception for four years. Three estrogen-progestin combination preparations, a mini pill and the copper IUD - everything frustrates the 20-year-old psychology student. The copper spiral has slipped and therefore become unsafe. In turn, she feels the side effects of the pill are "terrible": acne, mood swings, headaches and even fainting attacks due to lowered blood pressure. Her flatmates in Liverpool feel the same way. But one evening in February, she leaves the Netflix series Explained: sex sit up and take notice. A hormone-free pill is briefly shown below on contraception. Saheli, as her name is, has been around for almost 30 years - but only in India. What's it all about?

The medicine contains 30 milligrams of the active ingredient centchroman or ormeloxifene. Both names are common. The active pharmaceutical ingredient belongs to the group of so-called selective estrogen receptor modulators (SERM). Ormeloxifene works by blocking the estrogen receptors in the uterus. The chance that an egg can implant there, a basic requirement for pregnancy, decreases significantly. The hormonal activity of the ovary, however, remains unchanged. Ormeloxifene is said to work in higher doses as an emergency contraceptive even after unprotected sex. The active ingredient is hormone-free, but has a hormone-like effect. The manufacturer describes the contraception as non-steroidal.

In the female body, the steroid hormones progesterone (the body's own progestin) and estrogen, in the right interaction, regulate the development and maintenance of a pregnancy. In the case of common contraceptive pills, these hormones are used to prevent exactly that. They prevent ovulation, for example. However, this can have the side effects mentioned. According to the manufacturer's promise, there should be none of this with the Indian preparation Saheli due to the different mode of action. After the first three months with two pills a week, one per week is sufficient in the long term.

But ormeloxifene can lengthen the cycle. According to guidelines from the Indian Ministry of Health and Family and the scientists involved in the synthesis, this is the case for eight percent of women and especially during the first three months. While less than one in 100 women becomes unintentionally pregnant with contraception with progestin-estrogen pills, with ormeloxifene it is two in 100 women, as stated in the Indian governmental guidelines. The method of contraception is "promising" primarily because it is also suitable for women who are breastfeeding. In clinical studies with breastfeeding women, the substance could only be detected in milk in small amounts, so that this has no effect on infants.

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Contraceptives as part of government family planning

Since its synthesis, the active ingredient ormeloxifene has been closely linked to government interests in family planning and the limitation of population growth in India. The state-run Central Drug Research Institute (CDRI), founded in 1951, was designed to provide affordable health care. In the 1960s, the government promoted research into safe and better tolerated alternatives to hormonal contraceptive pills. In 1967 the CDRI was able to synthesize ormeloxifene, but it was not until 1991 that the active ingredient was approved. Two pharmaceutical companies received the licenses, and the pill came onto the market in 1992. To this day, the company Torrent Pharmaceuticals, which is part of an international group, sells the active ingredient as a contraceptive, according to its own information. The state-owned company HLL Lifecare (HLL) also sells the pills under the brand name Saheli. They are available in pharmacies without a prescription. A strip of eight tablets sells for 25 rupees, the equivalent of just under 30 cents.

The contraceptive method has been subsidized by the state since the mid-1990s, and 100,000 women are said to have used it successfully by 1996. In order to spread the pill and make it better known, the state-owned pharmaceutical company HLL is receiving financial support: According to the HLL annual report, that was 50 million rupees for the period from March 2018 to March 2019, which corresponds to a good 580,000 euros. HLL produced almost 66 million Saheli tablets in the same period. Since April 2016, the contraceptive has also been distributed free of charge in pharmacies, hospitals and health centers under the name Chhaya as part of the state family planning program. Until then, national efforts to lower birth rates focused primarily on the not harmless and irreversible female sterilization, making it the most common method of contraception in India. According to the ministry's annual report, a good 3.3 million women were sterilized through the state family planning program between 2018 and 2019 alone. At the same time, 136 million individual pills containing ormeloxifene were made available as Chhaya, but only 1.4 million were actually distributed.

Outside of India, the active ingredient is largely unknown to this day. It hardly plays a role in scientific studies or in media reports. Ormeloxifene is not approved as a contraceptive in the USA or the EU - not even in Great Britain and Germany. From a purely legal point of view, individual imports in this country would only be possible via a pharmacy in accordance with Section 73.3 of the German Medicines Act, provided a doctor's prescription is available. Jennifer Feische from Ilapo (Internationale Ludwigs-Arzneimittel) explains this. So far, no one has ordered contraceptives from the wholesaler, which specializes in the import and export of pharmaceuticals. That would also be very expensive: For a pack of 28 tablets you would have to pay 100 euros in a pharmacy in this country, plus an additional 200 euros in transport costs. This is due, among other things, to the logistical effort involved in individual orders and the quality controls, says Feische. At the moment, the goods are already subject to quotas, "because there seem to be partial delivery bottlenecks". The manufacturers did not comment on the reasons for this in response to inquiries.

How good is the pill really?

But how useful would it be to order Saheli from India? How good is the pill actually? Scientists working for the World Health Organization (WHO) examined the effectiveness and side effects of ormeloxifene as a contraceptive in a scoping review in October 2019, i.e. a review of 33 primary studies between 1976 and 2017. All came from India, half from researchers * inside the CDRI, i.e. the institute that discovered the active ingredient. Not only did they find 2.6 to 10.2 percent unwanted pregnancies. Side effects were also reported in 13 of the studies, the most common being persistent bleeding and cycles of 45 days and more. And: The side effect profile is similar to that of hormonal contraceptive pills, it is said. The WHO authors also criticize: “The studies on side effects are of poor quality with a small sample size.” Their conclusion: There was a lack of international, reliable studies over a longer period of time. There was also insufficient evidence on ormeloxifene as an emergency contraceptive.

Another study from India, which was also published in October 2019, based on documents from a family clinic in the northeastern state of Arunachal Pradesh, recorded more side effects than stated by the state and manufacturer: Over 15 percent of the 146 women examined (some of whom stopped taking during the period abort) had late menstrual bleeding and almost 11 percent had irregular cycles, three of whom became pregnant.

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What about international markets?

Is that why Saheli is lacking approvals elsewhere? In fact, HLL intended to launch the pill in around the mid-2000s in South America and the United States. In 2008 this was finally achieved in Peru. The company writes on its website that HLL was able to register its first pharmaceutical product outside of India in Peru. Under the name IvyFemme, Saheli came onto the market there as a contraceptive and, according to the State Medicines Agency, is still available on prescription to this day. This does not seem to have worked in other countries. Why? HLL did not respond to this when asked.

The director of the state research institute CDRI, Tapas K. Kundu, explains in turn: "Our efforts are still ongoing to bring this innovative discovery into international markets, together with pharmaceutical companies in India." One of his predecessors at the institute, Ved Prakash Kamboj, was instrumental involved in the synthesis of the active ingredient. He suspects that it is simply too costly to conduct clinical studies in several countries to market the drug internationally. Says Kamboj, "The contraceptive market is practically dominated by hormonal pills that are marketed by large pharmaceutical companies."

That shouldn't change for the time being: Christian Egarter heads the clinical department of gynecological endocrinology and reproductive medicine at the Medical University of Vienna. In 2015 he was involved in a scientific publication on selective estrogen receptor modulators. Ormeloxifene, he estimates today, is unlikely to be of “any major importance in contraception” in the industrialized countries in the foreseeable future. Because there was a lack of studies on the actual efficiency and possible side effects. In any case, Egarter suspects that we can hardly count on alternatives to the contraceptives commonly used up to now: Internationally, the WHO and the Population Council are currently researching in this area.

The latter is a US non-commercial organization founded in 1952. Its population policy, especially during the first decades, is criticized today: At that time, the aim was to limit undesirable population growth, especially in countries in the Global South - including India -, often at the expense of self-determination. Today, the organization focuses primarily on the prevention and treatment of HIV infections and AIDS and advocates better access to contraceptives around the world. The Population Council is currently researching a hormonal contraceptive gel for men together with an institute of the US Department of Health.

But such efforts are exceptional. Pharmaceutical companies have largely withdrawn from research on contraceptives, says Egarter from the University of Vienna. His prognosis is pessimistic: "We will probably see few breakthroughs in the near future."

This is probably also due to the fact that not only research and development, but also the approval processes for drugs are expensive and time-consuming. An application to the European Medicines Agency (EMA) costs almost 300,000 euros, it usually takes at least a year for a possible approval, but it can take significantly longer. According to the EMA, no application for approval has yet been submitted via the centralized procedure, which would allow an active ingredient to be approved throughout the EU. In Germany, too, according to the Federal Institute for Drugs and Medical Devices, this has not yet been attempted for ormeloxifene as a contraceptive.

This annoys young women in Liverpool. They did research and started an online petition. They have also written to the Health Committee of the British Parliament. They are calling for Saheli to be approved in the UK. "I know that this is very optimistic," says Sophie Dowding. But she is "absolutely frustrated" that the pill is neither known nor researched outside of India. At least that should change your petition.

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This text originally appeared on June 28, 2020 on www.enorm-magazin.de and is part of the “Heilt the Planet” focus of the 03/20 issue of enorm magazine.