CHENNAI: The Central Drugs Standard Control Organisation (CDSCO) is likely to recommend a ban on the over-the-counter (OTC) sale of all hormonal contraceptive drugs, including oral emergency contraceptive pills (ECP).
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 these drugs prescription-only drugs. TNIE has learnt that the panel will soon submit a report.
At present, 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, 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.
Experts have said that 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 sub-committee’s mandate was to study the issue and make a recommendation on whether such a ban is needed.
Dr Pinkee Saxena, professor, 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).
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 American College of Obstetricians and Gynaecologists. Notably, the WHO and most countries are in favour of the ECP being available over the counter.
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 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 withgynaecological problems, these drugs contraceptives can aggravate the condition, she said. “The doctor can check the contraindications and prescribe,” sheadded.
Dr Jaishree Gajaraj, while welcoming a ban on OTC sale of other hormonal contraceptives, stressed that ECPs should be available without prescription. "Many women will be unable to consult a doctor in a timely manner. 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.
Chennai-based reproductive rights activist Archanaa Sekar said a ban on OTC sale of ECPs will be a huge setback to reproductive and sexual health rights of women. "The government should look into why misuse and overuse of contraceptives are occurring rather than contemplating something like this. Not many will have access to doctors to get prescriptions. They may also struggle to pay consultation fees for the doctors. There will be several practical difficulties,"she added.