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News Mind and Body

Potential Ban On Over-The-Counter Hormonal Pills: What We Know

An expert sub-committee formed by CDSCO is all set to recommend that the Drugs and Cosmetic Rules of 1945 are suitably amended to make the oral emergency contraceptive pills prescription-only drugs

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Purnima Luthra
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The CDSCO (Central Drugs Standard Control Organization) is likely to initiate the recommendation of a ban on the over-the-counter sale of hormonal contraceptives, including all emergency contraceptive pills. An expert sub-committee formed by CDSCO is all set to recommend that the Drugs and Cosmetic Rules of 1945 be suitably amended to make these drugs prescription-only. 

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Meanwhile, critics argue that this restriction would make it even harder for women to access necessary healthcare in emergencies. 

The New Indian Express reported that the panel will submit a report soon. Concurrently, under the National Reproductive and Child Health Programme, the Drug Controller General of India (DGCI) allows for the sale of 0.75mg tablets of Levonorgestrel to be sold without prescription as an emergency contraceptive. ECPs, which are better known as the morning-after pill, were introduced in India in 2002 and can prevent a pregnancy if taken within 72 hours of unprotected sex.

What do Experts say?

Experts have said that the availability of the drug OTC may prevent unwanted pregnancies and avert abortions. However, in Tamil Nadu, and other parts of India, ECPs are notoriously difficult to access at pharmacies. Other hormonal contraceptives available OTC include the Combined Oral Contraceptive (containing estrogen and progestin, it is taken daily) and the Progestin Only Pill (also taken daily).

Interestingly, the six-member expert sub-committee was formed after the Tamil Nadu government proposed a ban on the OTC sale of hormonal contraceptives citing "its irrational usage" at the 62nd Drugs Consultative Committee meeting held in September 2023.

The subcommittee’s mandate was to study the issue and recommend whether such a ban is needed. Dr Pinkee Saxena, professor, of the Department of Obstetrics and Gynaecology, Lady Hardinge Medical College, is the chair of the sub-committee. The other members include MN Sridhar, Joint Director of Drugs Control cum Controlling Authority (in-charge), and a representative from the Indian Council of Medical Research (ICMR).

Corresponding to this, a highly-placed source privy to the deliberations of the panel told TNIE that although the committee is yet to submit the final report, it is overwhelmingly in favour of making prescriptions from a physician mandatory for the purchase of contraceptives, including ECPs. “The physician should assess the benefit and risk ratio of the person taking it... The issue was discussed and the consensus is that there should be some bar,” the source said.

The panel also relied on available evidence along with recommendations from the World Health Organization (WHO) and the American College of Obstetricians and Gynaecologists. Notably, the WHO and most countries are in favour of the ECP being available over the counter.

Will women's health be adversely affected?

Speaking to TNIE, M N Sridhar said the expert sub-committee will also take legal opinions before submitting its recommendations to CDSCO. “We are concerned about the health of the women. There will be no restriction in accessing the drugs but they can get it after consulting the doctor,” Sridhar said. However, gynaecologists were divided on the issue. While Dr T Ramani Devi, president of the Tamil Nadu Federation of Obstetricians and Gynaecologists, welcomed a ban on  OTC sales of ECPs, senior gynaecologist and obstetrician Dr A Jaishree Gajaraj differed.

According to Dr Ramani Devi, hormonal contraceptives can cause many problems, including pulmonary embolism, nausea, and irregular bleeding. For women with gynaecological problems, these drugs contraceptives can aggravate the condition, she said. “The doctor can check the contraindications and prescribe,” she added.

Women on X

Dr Jaishree Gajaraj, while welcoming a ban on OTC sale of other hormonal contraceptives, stressed that ECPs should be available without a prescription. "Many women will be unable to consult a doctor on time. Making it a prescribed drug will lead to more illegal abortions and unwanted pregnancies," she cautioned. "Instead, women can be advised to consult a gynaecologist within three days of taking the ECP," she suggested.

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