CHENNAI: The Contraception Action Network in collaboration with Jhatkaa.org has launched an online campaign demanding the Central Drugs Standard Control Organisation (CDSCO) make clear regulations on emergency contraceptive pills (ECPs) and ensure their continued over-the-counter (OTC) access.
The network consists of around 70 members from across India, including NGOs, activists and researchers. The campaign follows TNIE’s exclusive report stating CDSCO’s Drugs Consultative Committee is planning to propose a regulation declaring ECPs as prescription-only drugs.
The statement said, Levonorgestrel (1.5mg), an ECP available OTC, has been a lifeline for women, transmen, adolescent girls and sexual assault survivors across the country, preventing unintended pregnancies and cutting down on unsafe abortions.
“Any shift towards making ECPs prescription-only threatens the health and autonomy of women and trans, non-binary and gender-queer individuals,” it said.
The network said that sexual assault survivors from rural, under-resourced areas are already reeling from the massive deficit of registered medical practitioners.
“In fact, HLL Lifecare Ltd, the public sector undertaking driving India’s family planning mission in rural India, has flagged challenges in rural populations’ access to reproductive healthcare and repeatedly stressed that oral contraceptives should be available without prescription or a sale licence requirement,” it added.
Pointing out that India is yet to finalise a list of OTC medicines, the statement noted that any drug that is not under Schedules H, H1 or X of the Drugs and Cosmetics Rules, 1945, can be sold over the counter.
Since no Levonorgestrel-only pill has been specified in said Schedules, they should be available OTC without a prescription.
“However, many states across India practice shadow bans as a result of ambiguity regarding the sales licence requirement,” it added.
The statement further said that CDSCO’s recent announcement failed to address the complexities and confusion surrounding emergency contraception. While the regulatory body’s recent press release claimed that there is no immediate change in how ECPs are sold currently, it failed to provide clear guidelines on the future of emergency contraception access, it said.
“There is still widespread confusion, and the resultant lack of clarity creates ambiguity not just for women but also for healthcare providers and pharmacists,” the statement said.
“Access to ECPs is not just a matter of convenience, it is a matter of life and death for women. In India, over 80,000 maternal deaths per annum are due to unsafe abortions,” the campaigners added.
They demanded that Levonorgestrel ECPs must remain an OTC drug. They also urged the government to clearly mention in Schedule K of The Drugs and Cosmetics Rules, 1945, that the Levonorgestrel-only pill is exempted from the sales licence requirement, thus ensuring easy access. Moreover, an awareness drive should also be carried out to dispel misconceptions about ECP access, they added.