The Central Drugs Standards Control Organisation (CDSCO) is weighing new rules for emergency contraception.
An expert committee under India’s top drug regulator has recommended mandatory boxed warnings on emergency contraceptive pills, advising that they should not be used more than twice a month and that other contraceptive options be preferred.
The Drug Consultative Committee of the Central Drug Standard Control Organisation (CDSCO) also advised adding a clear warning that these pills—commonly called morning-after pills which contain levonorgestrel as an active pharmaceutical ingredient—do not protect against HIV or any sexually transmitted infections.
The recommendations were made at a meeting chaired last month by Drug Controller General of India Rajeev Singh Raghuvanshi.
According to the meeting minutes reviewed by India Today, the panel has asked that the warnings appear prominently on the primary pack, outer carton and in the package insert, alongside guidance urging users to consult registered medical practitioners for suitable alternatives.
STATES’ CONCERNS SPUR STRICTER OVERSIGHT
The push for tighter labelling comes amid renewed demands from some southern states, particularly Tamil Nadu, to move emergency contraceptive pills from Schedule K to Schedule H of the Drugs and Cosmetics Rules, 1945—effectively making them prescription-only.
Tamil Nadu’s drug authorities have repeatedly expressed concerns that easy access to emergency contraceptives could harm young girls, citing reports of adverse effects such as heavy menstrual bleeding.
Some gender-rights advocates, however, warned that restricting access or adding discouraging warnings could function as a “shadow-ban,” undermining women’s reproductive autonomy.
“This is too much,” said a gender rights activist.
Emergency contraceptive pills have been available in India since 2003 and are roughly 85 percent effective in preventing pregnancy when taken within 72 hours of unprotected intercourse. Some of the popular brands include i-pill and Unwanted-72, among others.
HOW INDIA REGULATES ORAL CONTRACEPTIVE PILLS
India offers two broad categories of oral contraceptives: hormonal and non-hormonal. Non-hormonal pills, approved since 1990, contain the non-steroidal compound centchroman (ormeloxifene) and are taken once a week.
Sold under brand names such as Chhaya and Saheli, they work by preventing sperm from reaching the egg and are generally considered safer than hormonal options.
