No change in sales, distribution of emergency contraceptive pills: CDSCO

Central Drugs Standard Control Organisation (CDSCO) sources have informed that the sales and distribution of emergency contraceptive pills such as i-Pill and Unwanted – 72 has not changed. These also include the pills of Emergency Contraceptive Pill (ECP) brands.
This follows media reports claiming that the Central Drugs Standard Control Organisation (CDSCO) was considering changes to the rules on over-the-counter sales of emergency contraceptive pills. One of the reports had suggested that an “expert panel proposed 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.
Currently, contraceptive drugs such as Centchroman and Ethinylestradiol are categorized under Schedule ‘H’ of the Drugs Rules, meaning they can only be sold with a prescription from a doctor.
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.” Also Read | Not condoms or pills, but monthly shots
Additionally, 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) – that are listed under Schedule ‘K’ of the Drugs Rules – allows these specific strengths to be purchased without a prescription.
 
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 proposed amendment to the Drug Rules will include a clarifying statement in Schedule H: “The class of drugs listed under entry no. 15 of Schedule K shall not be covered by this Schedule.”
“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,” coureces were quoted as saying by ANI.
(With agency inputs)