No proposal to move emergency contraceptive drugs from non-prescription to prescription category, CDSCO clarifies

Manufacturers will be required to mention caution on the label as “to be sold by retail on the prescription of Registered Medical Practitioner only”

There is no change in the status quo regarding sales and distribution of Emergency Contraceptive Pill (ECP) brands like I-Pill or Unwanted-72, said a senior official at Central Drugs Standard Control Organisation (CDSCO), adding that there is no recommendation to move it from an over-the-counter drug to a prescription drug.

CDSCO also refuted recent claims about this proposed move stating that its order has been misinterpreted. CDSCO, under the Health Ministry, is India’s national regulatory body for pharmaceuticals, cosmetics, and medical devices. It is responsible for approving drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of state drug control organisations.

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Emergency contraceptive pills are often considered an essential intervention to prevent unwanted pregnancies. They can prevent pregnancy if taken within 72 hours of unprotected sex. The government’s National Family and Health Survey-5 (2019-2021) revealed that 57% of women obtained ECPs over the counter.

Meanwhile, CDSCO maintained that presently the contraceptive drugs - Centchroman and Ethinyloestradiol are under Schedule ‘H’ of Drugs Rules meaning that the drugs can be sold on doctor’s prescription only. Also, for manufacturers, they will be required to mention caution on the label as “to be sold by retail on the prescription of Registered Medical Practitioner only”.

However, certain strengths of these drugs, [DL-Norgestrel - 0.30 mg + Ethinyloestradiol – 0.30 mg, Levonorgestrel – 0.15 mg + Ethinyloestradiol – 0.03 mg,Centchroman – 30 mg, Desogestrel – 0.15 mg + Ethinyloestradiol – 0.03 mg & Levonorgestrel – 0.10 + Ethinyloestradiol – 0.02 mg] are also covered in Schedule ‘K’ of Drugs Rules, meaning thereby that these specific strengths do not need any prescription from a doctor for purchase.

“The strengths as defined in Schedule K, will be available without prescription, as it is available today. And all other remaining strengths will need a prescription, as it is required today,’’ it maintained adding that there is no proposal to move the drugs from non-prescription to prescription category.

Published - October 12, 2024 07:13 pm IST