, Chennai - "There are moments when one becomes careless and things go out of control which leads to unwanted and unplanned pregnancy. NOT ANY MORE... Mis-take morning after pills helps you to tackle mistakes positively."
When these words appeared on Chennai's billboards this June, it looked like revolution was at hand. Protesters against emergency contraceptives (EC) seemed like fringe groups and their objections transient. Today, the product is off the shelf in the city's drug stores thanks to a seizure by the state Directorate of Drug Control (DDC) on 22 September, without legal grounds.
The drugs seized on 22 September are contraceptives based on levonorgestrel, which is used to prevent pregnancy after unprotected intercourse.
Their contention? That the drug induces abortion (and is not a contraceptive); therefore its sale without prescription is illegal. And that there was no public debate before it was included in the Schedule M of the Drugs and Cosmetics Act (DCA), 1940 to make the drug available over the counter.
It is a fallout of their protest that the Directorate of Drug Control of the Tamilnadu Government seized the entire stock of one such emergency contraceptive, Mis-take, worth Rs.50 lakhs. Sporadically, other OTC emergency contraceptives have also been taken off the druggists' shelves in the state.
Since July 2006, Insense Care, the marketing arm of Intra-Labs had been aggressively promoting Mis-take through ads on billboards, in newspapers and other media. However, both Mis-take and NorLevo, both OTC levonorgestrel drugs from Win Healthcare Ltd., had been in the eye of a controversy, till all stocks of Mis-take were confiscated on 22 September.
Intra Labs' representative Mukesh Jain says the raid and the seizure have no legal backing. "Chemical analyses by us and by Suryan Pharma (the generic manufacturer) have proved that the molecule in the seized strips is levonorgestrel and not mifepristone, as alleged by protesters," says Jain. Mifepristone is an abortifacient i.e., it induces abortion after fertilisation has taken place. Levonorgestrel, on the other hand, is used as part of combination oral contraceptive pill and in high doses can be used to prevent pregnancy after unprotected intercourse. "The dosage is 0.75 mg, as recommended by the Drug Controller of India and we are selling it as a Schedule M drug, for which we have the requisite licence. How can the state government contravene an order issued by the central ministry?" wonders Jain.
When contacted, a senior official at the state's Directorate of Drug Control, speaking on condition of anonymity, gave me the official line that the drug was seized under the Drugs and Cosmetics Act. No other clarification was forthcoming on what the offence was. But the Act empowers the Drug Controller to seize drugs only if they do not adhere to prescribed standards, or are misbranded, adulterated, spurious.
Two weeks after the seizure, Intra Labs is still awaiting a notification from the DDC on why the drugs were seized. According to them, Tamilnadu is the only state to have initiated such an action when there were around a dozen brands being sold in the country.
But the protesters, speaking through their counsel B S Ajeetha, say the drug induces abortion and is not a contraceptive. "If you were to carefully read the advertisement, they say it inhibits implantation by altering the endometrium (inner lining of the uterus). That can only happen after the fertilisation has happened (i.e., after the pregnancy has started). It is really irrelevant whether the embryo is two days old or two weeks," says Ajeetha.
While abortion is not illegal in India, it is governed by the Medical Termination of Pregnancy Act. "Under this act, both surgical and chemical abortion can be performed only on prescription and after permission has been issued by Resident Medical Officer of a government hospital," says Ajeetha. She adds that they are not against women's rights to abortion in the case of unwanted pregnancies or when there has been a crime against the woman, but asserts that making the drug available without a prescription is questionable. "There has been little public debate over the necessity of the drug. We are investigating if this order (September 2005) is legally sustainable," she says.
Opening a second front of attack, the organisations object to explicit instructions on how to use the product in the advertisements. The organisations believe the text is objectionable and promotes 'free sex'. Words such as '..when one becomes careless, or things get out of control' have raised their hackles. "It takes away responsibility from the act of sexual intercourse. And the branding (Mis-take) is also not so subtle insinuation that pre-marital sex is alright," says Ajeetha.
Intra Labs had subsequently withdrawn the offending ads and inserted new ones which targeted married couples and spoke of using emergency contraceptive as a 'Plan B' when the first line of contraception failed. On the other hand they also point out to the social marketing programme of the Central Health and Family Welfare ministry, which not only focusses on making the product universally accessible but also its promotion. "Products like Mala-D (oral contraceptive pills) were promoted using simple language that reached out to many. By keeping jargon out of the branding and usage instruction, we were only trying to make the product accessible," says Jain.
Supporting his point of view is renowned sexologist Dr Narayana Reddy. "Rape or coerced sex often goes unreported. Many don't seek medical help given the stigma. For them to bear the rapist's child is a punishment and many seek abortion," says Reddy. According to him, nearly 40 percent of abortions in the country are unsafe. Making emergency contraceptive available over the counter will be a boon for such women, he says. "Instead, why doesn't the DDC target the OTC sale of prescription only drugs such as sildenafil citrate (popularly viagra)? Let's also not forget the role the parents have to play in sex education," he says.
In addition, the number of centres where pregnancy can be terminated under the MTP Act is limited and spread unequally (Union Health and Family Welfare Ministry statistics indicate around 11,000 recognised medical termination of pregnancy (MTP) clinics in the country.) "When access to medical treatment is neither universal nor uniform, making such drugs easily available will to an extent address the issue," says Dr Reddy.
But the medical field is a divided house. Fora such as Federation of Obstetrics and Gynaecologists Societies (FOGSI) say the implications of the abuse of OTC emergency contraceptives have not been fully addressed. FOGSI's Chennai representative Dr Jayashree Gajaraj points out that studies have not been clear about what the effect of the steroid would be if it is taken more than once in a single menstrual cycle. Nor have efforts to create awareness about the product been sustainable.
"In May 2001, the Consortium for Emergency Contraception in India had recommended that helplines be set up and an OTC sale order be followed up with counselling. Till 2003, helplines on emergency contraceptive were run with pharma industry support, but the initiative ran out of steam," Dr Gajaraj says.
While the protesters see the September 2005 order as a half-thought-out move executed under pressure from pharma MNCs, institutions such as Family Planning Association of India (FPAI) believe that state-run family planning machinery could be a better way of distributing ECs. Dr Lourdes Mary, a counsellor of FPAI, Tamilnadu, feels that social marketing of ECs is best done through public health centres and state-run health institutions, especially since only 48 percent of those currently married practice any form of contraception (National Population Policy 2000).
All things said, the protests against the OTC sale could spell trouble for the fledgling movement to promote use of contraception, especially to women in vulnerable situations.