CDSCO issues advisory on Labelling requirements for MTP combo kit of Misoprostol, Mifepristone tablet, Details
New Delhi: The apex drug regulatory body, Central Drugs Standard Control Organisation(CDSCO) has recently issued an advisory on labelling requirements for combi kit of Misoprostol and Mifepristone tablets for Medical Termination of Pregnancy (MTP).
The drugs mifepristone and misoprostol fall under the National List of Essential Medicines. The combo kit of Misoprostol and Mifepristone tablets for abortion is manufactured by various drugmakers including Cipla under the brand name MTprost (200mg/ 200mcg), Zydus Cadila sells it as Mifegest Kit and so on.
The availability of MTP kit has become quite accessible as online pharmacies supply the goods like MTP kits reportedly without confirming the authenticity of the prescription and patient. This paves way for tighter labelling norms to avoid adverse results.
The advisory comes following the deliberation of the issue of labelling requirements for combi kit of Misoprostol and Mifepristone on te matter. The concern was taken up in the 56th Drugs Consultative Committee (DCC) meeting held a couple of months ago.
The combi kit of Misoprostol and Mifepristone tablets (1 uncoated mifepristone 200 mg tablet + 4 uncoated misoprostol 200 meg tablets) for MTP was approved in 2018 by CDSCO 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”
With the advisory, all the State and Union Territory drug controllers are now directed via the CDSCO notice to ensure the effective implementation of labelling requirements for Combi kit of Misoprostol and Mifepristone tablets as per the provisions of Drugs and Cosmetics Act, 1940 & Rules, 1945 and MTP Act, 2002 & MTP Rules, 2003 which intends to safeguard the health of a woman seeking an abortion and prevent sex-selective abortions.