There is no change in the sales and distribution of emergency contraceptive pill brands like i-Pill or Unwanted – 72, an official source with the drug regulatory authority has clarified.

“There is no proposal to move the drugs from non-prescription to prescription category. Also, there is no change in the sales and distribution of Emergency Contraceptive Pill (ECP) brands like i-Pill or Unwanted,” said an official source with the Central Drugs Standard Control Organisation (CDSCO).  

Piramal Pharma makes i-Pill and Mankind Pharma makes Unwanted 72, and the CDSCO clarification was in response to recent reports on a possible ban of over-the-counter sale of  ECPs.

Giving details, the CDSCO source said, contraceptive drugs such as Centchroman and Ethinyloestradiol are under Schedule ‘H’ of the Drugs Rules, so they can only be sold on a doctor’s prescription.  And manufacturers will be required to caution on the label - “To be sold by retail on the prescription of Registered Medical Practitioner only”, the official added.

However, certain strengths of these drugs (DL-Norgestrel - 0.30 mg +Ethinyloestradiol – 0.30 mg, Levonorgestrel – 0.15 mg + Ethinyloestradiol – 0.03mg, Centchroman – 30 mg, Desogestrel – 0.15 mg + Ethinyloestradiol – 0.03 mg and Levonorgestrel – 0.10 + Ethinyloestradiol – 0.02 mg ) are also covered in Schedule ‘K’ of the Drugs Rules –- so these specific strengths would not need a prescription from a doctor for purchase, the source clarified.

Reiterating the point, given the confusion among customers and manufacturers, the official said, “There is no change in status quo, in that some strengths will continue to be available over the counter.  

“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 source added.

Given this backdrop, “the proposed amendment in the Drugs 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.

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