(MENAFN- Live Mint)

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 formulations, 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 carry 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 counselling guidance. Warnings will state that emergency contraceptives should not be used more than twice a month and do not protect against HIV or other sexually transmitted infections (STIs).

Also Read | Centre tightens blood safety protocols post Jharkhand HIV sc

The measure follows similar government mandates for vaccines, antibiotics, and other essential medicines.

The new QR-linked packaging will enhance traceability, curb misuse, and bridge the information gap, said Dr. Archana Dhawan Bajaj, a gynaecologist and IVF expert at Nurture in Delhi.

“A major issue witnessed in clinical practice is that most women tend to take 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 suggested QR code can help explain safe usage."

“Many women mistakenly believe these pills protect against STIs. QR-linked warnings can correct this and empower users with verified information," she added.

Queries sent to the health ministry spokesperson, DCGI on Monday remained unanswered. Cipla Ltd, Mankind Pharma, Piramal Pharma, and Hindustan Lifecare Ltd declined to comment.

Also Read | Govt moves to rein in online advertisements of high-risk medici

In 2023, a government sub-committee was constituted to recommend amendments to the Drug Rules, 1945, governing the retail sale of Levonorgestrel 0.75mg/1.5mg tablets.

According to the sub-committee's report, new package inserts for emergency contraceptives must be comprehensive, detailing the drug's composition, dosage, pharmacological properties, contraindications, side effects, storage instructions, and patient counselling information.

“All emergency contraceptives (Levonorgestrol / Ulipristol) should include the following boxed warnings on the primary & carton label and in package insert: a. Does not offer any protection against HIV or any sexually transmitted infections. b. Do not take this medicine for more than twice in a month. c. Use of alternative methods of contraception is encouraged in consultation with registered medical practitioners," it said.

The 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).

Also Read | No more free pass: Govt plans to regulate cough syrup sales in villa

Poonam Muttreja, executive director at the Population Foundation of India, welcomed the move.

“Emergency contraceptives play an important role in preventing unintended pregnancies, but to better advance India's family planning goals, we also need better counselling, comprehensive sexuality education, and far greater engagement with men as informed partners in contraception, so responsibility for their reproductive health does not continue to fall disproportionately on women alone," she said.

Muttreja added that public awareness, easy access, and clear guidance from pharmacists and health-care providers, including ANMs and ASHAs, is also important.

MENAFN05122025007365015876ID1110442709