Morning-after pills to be sold without prescription in India
What's the story
The Indian government is considering allowing over-the-counter (OTC) sales of emergency contraceptive pills, popularly known as morning-after pills. The move would make these medications easily accessible at chemists and general stores, without the need for a doctor's prescription. This comes as part of an effort to combat the rising number of adolescent pregnancies in India.
Drug regulation
Regulatory changes to facilitate OTC sales
The Drugs Consultative Committee (DCC) is mulling adding certain strengths of contraceptive drugs under Schedule K, which would allow them to be sold OTC without a prescription. This change could significantly improve access to morning-after pills, which are currently not as easily available and depend largely on the discretion of chemists or stores.
Public health impact
Addressing adolescent pregnancies with improved access
Public health experts believe that easier access to morning-after pills could help tackle the rising cases of adolescent pregnancies in India. These cases are often linked to early sexual activity, lack of contraceptive knowledge, inadequate sex education in schools, and limited access to confidential reproductive health services. The proposed regulatory changes could be a step toward addressing these issues.
Safety measures
Boxed warnings to accompany emergency contraceptives
All emergency contraceptives, including Levonorgestrel, will have to carry boxed warnings. These warnings will be displayed on the main pack, carton label, and package insert. They will state that the pills do not protect against HIV or other sexually transmitted infections (STIs), should not be taken more than twice a month, and alternative contraception methods should be used after consulting a registered medical practitioner. Ulipristal, however, will remain prescription-only under Schedule H and is not part of the OTC consideration.
Digital access
Information accessibility through QR code
The boxed warning and insert will be available in all major regional languages and accessible via a QR code. This is part of an effort to ensure that people have easy access to detailed information about the contraceptives they are using. The Union Ministry of Health and Family Welfare has proposed these measures to the DCC as part of its agenda for a panel discussion on this issue.
Future implications
Expert panel's recommendations and potential impact
The expert panel also recommended adding Ulipristal, another emergency contraceptive, to the prescription-only list under Schedule H. It suggested reorganizing existing hormonal drug categories to eliminate overlaps. If approved by the panel and accepted by the apex drug controller, these changes, particularly the consideration of Levonorgestrel for OTC status, could make emergency contraception more accessible in India while also raising questions about counseling and safe use among adolescents.