The Central Drugs Standard Control Organisation (“CDSCO”) has, in a letter dated 9th August, 2019, issued an advisory on labelling requirements for combi kit of Misoprostol and Mifepristone tablets for medical termination of pregnancy (MTP).
The drugs Misoprostol and Mifepristone fall under the National List of essential medicines. The combo kit of Misoprostol and Mifepristone tablets for abortion is manufactured by various drug makers, The availability of MTP kit has become quite accessible as online pharmacies supply the goods like MTP kit reportedly without confirming the authenticity of the prescription and patient this paves way for tighter labelling norms to avoid adverse results.
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”
Therefore now all the state and union territory drug controller are now directed via this CDSCO letter to ensure the effective implemtitaion of labelling requirement 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 indent to safequard the health of women seeking an abortion and prevent sex-selective abortions
Click here to read the notification.
