The sales and distribution of Emergency Contraceptive Pill (ECP) brands, including i-Pill and Unwanted - 72, will remain unchanged, sources with the Central Drugs Standard Control Organisation (CDSCO) said on Friday.
This comes after various media reports suggested a proposed change in rules by the Central Drugs Standard Control Organisation (CDSCO) regarding over-the-counter sale of ECPs. One of the reports had suggested that an "expert panel proposes a prescription requirement for the morning-after pill."
The CDSCO sources said that certain media reports regarding the prescription requirement for Hormonal contraceptives misinterpreted the proposal for change in Rules reg Schedule H and K drugs. The facts related to this subject are as follows:
Presently, contraceptive drugs like Centchroman and Ethinylestradiol are classified under Schedule 'H' of the Drugs Rules, which means they can only be sold with a doctor's prescription. Also, for manufacturers, they are required to these products with the cautionary statement: "To be sold by retail on the prescription of a Registered Medical Practitioner only."
Further, certain 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 mg + Ethinyloestradiol - 0.02 mg) are also also included in Schedule 'K' of the Drugs Rules, meaning 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 need for a prescription as per point 1 and the lack of a prescription requirement in point 2.
The proposed amendment to the rules is intended to clarify these regulations for the benefit of consumers and will not change the status quo. The strengths defined in Schedule 'K' will continue to be available without a prescription, as they are today, while all other remaining strengths will need a prescription, as they do currently.
In view of above facts, the proposed amendment in the Drug Rules, whereby a clarifying statement "Class of drugs mentioned at entry no. 15 of Schedule K shall not be covered by this Schedule" will be added in Schedule H of the Rule. This will remove the ambiguity and simplify the process for sale of such drugs (of selected strengths).
Therefore, media reports on this subject do not accurately interpret the situation.
"There is no proposal to shift the drugs from the non-prescription to the prescription category, and there will be no change in the sales and distribution of Emergency Contraceptives," they added.
