New Delhi, Oct 11 (PTI) There is no change in the rules governing the sale and distribution of emergency contraceptive pill brands like i-Pill or Unwanted 72 and they will continue to be available without a prescription, official sources from national drug controlling authority CDSCO said on Friday.
The Central Drugs Standard Control Organisation(CDSCO) sources said that certain media reports have misinterpreted proposal for change in rules regarding prescription requirement for hormonal contraceptives governed by Schedule H and K of Drug Rules.
There is no change in the status quo regarding the over-the-counter sales and distribution of Emergency Contraceptive Pill (ECP) brands like i-Pill or Unwanted 72, an official source said.
Presently, the contraceptive drugs i.e. Centchroman and Ethinyloestradiol are under Schedule H of Drugs Rules, meaning that they can be sold on the 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 are also covered in Schedule ‘K’ of Drugs Rules, meaning 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,” the official source said.
“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),” the source said. PTI PLB TIR TIR
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