NEW DELHI: India’s drug regulator, the Drugs Controller General of India (DCGI), plans to tighten rules on the sale and distribution of emergency contraceptive pills, including levonorgestrel products sold under brand names such as Unwanted-72 and i-pill and ulipristal pills sold as ella.
The move, aimed at preventing habitual overuse and ensuring women have access to critical safety information, will require these pills to have QR codes on their packaging, according to two officials and a document reviewed by Mint.
The QR codes will link to detailed product information, including dosage, contraindications, drug interactions, side effects, storage instructions and patient advice. The warning will state that emergency contraception should not be used more than twice a month and does not protect against HIV or other sexually transmitted infections (STIs).
The measure follows similar government mandates for vaccines, antibiotics and other essential medicines.
The new QR-linked packaging will improve traceability, reduce misuse and bridge the information gap, said Dr. Archana Dhawan Bajaj, gynecologist and IVF expert at Nurture, Delhi.
“The main problem we’ve seen in clinical practice is that most women tend to use emergency contraceptive pills as a regular birth control method instead of a last resort,” Bajaj said, warning that frequent use can lead to menstrual abnormalities and hormonal changes. “The proposed QR code can help explain safe use.”
“Many women mistakenly believe that these pills protect against sexually transmitted diseases. QR warnings can correct this and provide users with verified information,” she added.
Queries sent to the DCGI health ministry spokesperson remained unanswered on Monday. Cipla Ltd, Mankind Pharma, Piramal Pharma and Hindustan Lifecare Ltd declined to comment.
In 2023, a government sub-committee was set up to recommend changes to the Drugs Rules 1945, which govern the retail sale of Levonorgestrel 0.75mg/1.5mg tablets.
According to the subcommittee’s report, the new package leaflets for emergency contraception must be comprehensive, listing the drug’s composition, dosage, pharmacological properties, contraindications, side effects, storage instructions and patient counseling information.
“All emergency contraception (Levonorgestrol / Ulipristol) should contain the following warnings in a box on the label of the primary container and carton and in the package leaflet: a. It does not offer any protection against HIV or other sexually transmitted infections. b. Do not take this medicine more than twice a month. c. The use of alternative methods of contraception is recommended in consultation with registered medical practitioners,” the statement said.
DCGI’s plan is significant for India’s $1.7 billion contraceptive market, which includes major manufacturers such as Mankind Pharma (Unwanted-72), Piramal Pharma (i-pill), Cipla (Crisanta and Ginette 35) and Hindustan Lifecare Limited (Saheli).
Poonam Muttreja, executive director of the Population Foundation of India, welcomed the move.
“Emergency contraception plays an important role in preventing unintended pregnancies, but to better advance India’s family planning goals, we also need better counseling, comprehensive sexuality education, and much greater involvement of men as informed contraceptive partners so that the responsibility for their reproductive health does not fall disproportionately on women alone,” she said.
Muttreja added that public awareness, easy access and clear guidelines from pharmacists and healthcare providers, including ANMs and ASHAs, are also important.
