Problem pill

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.