Wednesday, December 2, 2009

I Pill Creates controversy

There was never a doubt that the i-pill and other emergency contraceptive pills (ECPs) would prove to be immensely popular among women in India when they were introduced two years ago. That's because India records 11 million abortions annually and a shocking 20,000 women die because of abortion-related complications. What better way then to have a pill that promises 95 per cent success if a woman takes it within 12 hours of having unprotected sex? Known as morning after pills-though a woman can take them even immediately after sexual intercourse-their efficacy to prevent pregnancy drops to around 58 per cent if taken between 12 hours and 72 hours.

After that period, the manufacturers of these pills are explicit that it will not be able to prevent pregnancy. They are also clear that these pills are an emergency contraceptive and, more importantly, not a substitute for regular contraception that provides comprehensive protection against an unwanted pregnancy.

Unfortunately, in India some of these messages don't seem to have gone out loud and clear, causing rising concern among some citizen groups about such emergency contraceptive pills being made freely available over-theounter (OTC). The controversy has taken on a moral shade with some activists objecting to the advertisements showing young girls as the end-users with a not so subtle implication that they had unprotected sex. Like N. Selvaraju, director, drug control, Tamil Nadu, says, "We are not against women's rights, but this is a moral concern. The advertising of this drug will mean that women will think, 'I can do anything and there is an easy way not to get pregnant'. We can't allow such an attitude to grow."

The state drug control directorate even sent a notice to a popular Tamil magazine for publishing advertisements of the i-pill. There are several such moral groups in India that want to ban advertisements promoting the ECP and also its over-thecounter sale. Women's right groups in Chennai along with the Tamil Nadu Government's Directorate of Drug Control claim that the i-pill advertisement violates the Drug and Magical Remedies Act of 1954. That saw the i-pill being prevented from being sold in Tamil Nadu despite being cleared by the Drug Controller General of India (DCGI).

On the other hand, the medial community and some women's rights groups have welcomed the ECP as a weapon of women empowerment. "Young girls didn't start having sex after the ECP was introduced as statistics of the high rate of abortions in the past indicate. Thanks to the ECP, there are ways to prevent unwanted pregnancies among a sexually active section of the society. It is a boon for a rape victim," says Rajashree Gawde, who works with Stree, a women's rights group in Pune. Gawde hopes ECP like the i-pill will continue to be available over-the-counter rather than as prescription drugs.

"Going to a doctor to get a prescription means loss of precious time during an emergency and negates the very purpose of the ECP," she reasons. The mounting pressure from panicking parents of young girls, some activists, state governments and the Advertising Council of India resulted in a review being undertaken by the DCGI. Much to the relief of the proponents of the ECP, the DCGI, however, decided against changing the OTC nature of the drug, saying it would defeat its purpose. Elsewhere, in Russia, the UK, the US, Canada and many Asian countries, these pills are available OTC. It is banned in the Middle East and parts of South America on religious grounds.

The controversy over the ECP, however, is unlikely to die down. While most doctors agree that the ECP is a safe option even for long-term use, there is little research on its misuse. Even though the pharmaceutical companies manufacturing these pills stress the word emergency, many doctors say that young women, even married women, use them as regular contraceptive pills. "I haven't really read up on the dos and don'ts of the drug. I have used them more than a couple of times a month," says advertising copywriter Ragini Ravichander from Bangalore. Literature provided by the pharmaceutical companies insists that the ECP must not be used more than once in a cycle, but then not too many people seem to be reading the fine print. Nausea or some bleeding are said to be among common short-term side effects.

"The problem is not with the i-pill or any of the other ECPs in the market; the problem is with the awareness. These pills should be sold with statutory warnings about what the i-pill can do as well as what it cannot do. Just popping the pill won't help. And both men and women need to realise the consequences," says Bangalore-based sociologist Ramani Rajaratnam. Dr Rita Bali, head of obstetrics and gynaecology of Bali Clinics, says: "There are many problems but ECP's benefits outnumber its disadvantages. Young women should be advised against its indiscriminate use. The advertisers should stress the emergency nature of the i-pill," Bali says.
With a combined annual sale of 8.2 million tablets, the pharma companies are splurging on their advertising campaigns but not enough awareness is being created to prevent its misuse. Thanks to the campaign, people are now acquainted with the fact that it provides freedom against unwanted pregnancies, but there's no stress on the word emergency.

Cipla's i-pill is the largest selling brand in India while other brands include Unwanted-72 from Mankind Pharma, EC2 by Zydus, Norlevo from Win Medicare and E-Pill by Panchsheel Organics.

The majority of the medical community has endorsed this form of emergency contraceptive as an OTC though some doctors feel it might be better regulated as a prescription drug. It is a move fraught with problems because in India even prescription drugs and drugs under Schedule H are easily available over-the-counter. "Making it a prescription drug will only increase fraud, time delays and definitely increase abortions in the country," says Hyderabad-based Dr Rakesh Malhotra, who has endorsed the ECP as a safe option provided the pharma companies are able to create awareness to prevent its misuse.

Gynaecologist Balakrishna Badigar says, "People need to understand that an i-pill cannot replace regular contraceptives. Also, it is to be used only in an emergency and cannot protect one from AIDS or other sexually transmitted diseases."
There is an urgent need for publicising the dos and don'ts about such pills, their side effects and possibly even a statutory warning. It could save a lot of concern and complications that usually happen, well, the morning after.


Source:http://in.news.yahoo.com/248/20091202/1612/tsc-problem-pill.html

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