CDSCO issues advisory on labelling requirements for Combi Kit of Misoprostol and Mifepristone tablets for Medical Termination of Pregnancy

CDSCO issues advisory on labelling requirements for Combi Kit of Misoprostol and Mifepristone tablets for Medical Termination of Pregnancy

August 23, 2019 Healthcare, OPS, Pharmaceuticals, states 0

The Central Drugs Standard Control Organisation (“CDSCO”) has, in a letter dated 9th August, 2019, instructed that the Combi kit of Misoprostol and Mifepristone tablets (1 uncoated mifepristone 200 mg tablet + 4 uncoated misoprostol 200 meg tablets) (“Combi Kit”) has to be labelled as per the provisions of Drugs and Cosmetics Act and Rules and the Medical Termination of Pregnancy Act and Rules (MTP Act and Rules).

The CDSCO has instructed that such Combi Kit must come with the following warning:

 

“Warning: product is to be used only under the supervision of a service provider and in a medical facility as specified under MTP Act 2002 & MTP Rules 2003”

Background:

The Combi Kit was approved by the CDSCO on 24th December, 2008.

The issue of labelling requirements for the Combi Kit was deliberated in the 56th Drugs Consultative Committee (DCC) meeting.

In the meeting, the DCC stated that

  1. MTP (Medical Termination of Pregnancy) kits, containing Misoprostol and Mifepristone, could be sold by wholesalers only to approved MTP centres having required facilities and services of duly qualified and experienced Registered Medical Practitioner under the MTP Act;
  2. CDSCO has to issue a letter to all State Drugs Controllers about the labelling requirements of such Combi Kits and also to ensure the effective implementation of the labelling requirements as per MTP provisions.

[You can refer to the minutes of the DCC meeting at https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/56thDCCmeeting.pdf. Please refer to page 16 for the decisions of the DCC regarding MTP Kits.]

Hence, the CDSCO has issued this letter.

Source: Central Drugs Standard Control Organisation

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