OTC morning-after pills to be sold in varying doses, with warning: Sources

New Delhi: Frequently used morning-after pills will continue to be available Over the Counter (OTC) but will now carry a boxed warning, people in the know told ET.

The drug regulatory authority is planning to add specific strengths of certain contraceptive drugs under Schedule K of the Drugs Rules, meaning they will not require a doctor's prescription and will be available OTC, in its bid to ease access to emergency contraceptives in the country. All emergency contraceptives, including Levonorgestrel and Ulipristal, will however have to include boxed warnings on the primary pack, carton label, and package insert stating: "it does not offer any protection against HIV or any sexually transmitted infections. Do not take this medicine for more than twice in a month and use of alternative methods of contraception is encouraged in consultation with Registered Medical Practitioner".

The package insert of all emergency contraceptives will also include details such as generic name; qualitative and quantitative composition; dosage form and strength; clinical particulars; therapeutic indication; posology and method of administration; contraindications; special warnings and precautions; drug interactions; use in special populations (pregnant women, lactating women, etc.); effects on ability to drive and use machines; undesirable effects; overdose; pharmacological properties; mechanism of action; pharmacodynamic and pharmacokinetic properties; nonclinical properties; animal toxicology/pharmacology; description; pharmaceutical particulars; incompatibilities; shelf life; packaging information; storage and handling instructions; patient counselling information; details of manufacturer; and licence details with date.

The boxed warning and package insert will be accessible via QR code and available in all major regional languages, people in the know said.


The matter was discussed at a meeting held on Monday at the CDSCO. A sub-committee was earlier formed by the CDSCO to suggest changes to the Drugs and Cosmetics Rules, 1945, with regard to morning-after pills. "Barring a few which will be required to be sold with prescription, more strengths have been included under Schedule K which means that there will be no requirement of prescription," said another person.

Emergency contraceptives including Levonorgestrel 0.15 mg + Ethinylestradiol 0.03 mg and Centchroman 30 mg, as well as Levonorgestrel tablets 0.75 mg/1.5 mg, shall be available OTC.

Some drugs including Centchroman and Ethinylestradiol (entry no. 186 of Schedule H of Drugs Rules, 1945) will continue under Schedule H, meaning they will be sold only with prescription. Ulipristal will also remain under Schedule H.