Central Drugs Standard Control Organization (CDSCO) sources on Friday said the sale and distribution of emergency contraceptive pill (ECP) brands including I-Pill and Unwanted-72 will remain unchanged.
This comes after various media reports suggested a proposed change in rules by the Central Drugs Standard Control Organization (CDSCO) regarding over-the-counter sale of ECPs. One of the reports suggested that “expert panel proposes requiring prescription for the morning-after pill.”
CDSCO sources said that some media reports regarding the requirement of prescription for hormonal contraceptives have misinterpreted the proposal to change the rules for Schedule H and K drugs.
Also Read: Top 6 Contraceptive Myths Debunked: What Every Woman Should Know
Facts regarding the need for a prescription for hormonal contraceptives:
Currently, contraceptive drugs like centromon and ethinyl estradiol are classified under Schedule ‘H’ of the drug regulations, which means they can be sold only with a doctor’s prescription. Additionally, for manufacturers, they require these products to carry a warning statement: “For retail sale only on the prescription of a registered medical practitioner.”
In addition, some strengths of these drugs, including 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) and levonorgestrel ( 0.10) are included. mg Ethinyloestradiol – 0.02 mg) is also included in Schedule ‘K’ of the Medicines Regulations, which means that these specific strengths can be purchased without a doctor’s prescription.
This has led to confusion among consumers, sellers and other stakeholders due to contradictory statements regarding the prescription requirement as per point 1 and the lack of prescription requirement as per point 2.
The proposed amendment to the rules is intended to clarify these rules for the benefit of consumers and will not change the status quo. The strengths defined in Schedule ‘K’ will continue to be available without prescription, as they are today, while all other remaining strengths will require prescription, as they currently are.
Also read: World Contraception Day: Apart from condoms, common types of birth control
Keeping in view the above facts, the proposed amendment to the Drugs Rules, whereby a clear statement “The class of drugs mentioned at Entry No. 15 of Schedule K shall not be included in this Schedule” will be added to Schedule H of the Rules. This will remove ambiguity and simplify the process of sale of such drugs (of selected strengths).
Therefore, media reports on this topic do not accurately explain the situation.
“There is no proposal to transfer the drugs from non-prescription to prescription category, and there will be no change in the sale and distribution of emergency contraceptives,” he said.
Also read: Pregnancy experts on how birth control pills work, how they affect a woman’s body
Disclaimer: This article is for informational purposes only and is not a substitute for professional medical advice. Always seek the advice of your doctor with any questions you may have about a medical condition.
