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Vide a notification F. No. 12-03/19/DC (Safety-007), the DCGI has issued a directive to all the States and UT Drug controllers regarding a nitrosamine impurity, N-nitrosodimethylamine (NDMA) in ranitidine.
Ranitidine is an OTC drug. It is also one of the most commonly prescribed drugs for heartburn and GERD.
The DCGI has asked all Drug controllers of states and UTs to communicate to the manufacturers of ranitidine API & formulations under their jurisdiction “to verify their products and take appropriate measures to ensure patient safety”.
As a precautionary measure, this is a welcome step. But, the safety alert issued by the office of DCGI is a serious matter. It shows that even the DCGI is concerned about this issue.
However, it should not have left it upon the states and UTs to take necessary action. Instead, the DCGI should have put a country-wide temporary hold on the drug till it had been certified safe.
In view of the current situation, all patients taking ranitidine should shift to or consider another group of acid blockers after discussing with their doctor. The most affordable alternative is omeprazole.
Dr KK Aggarwal
Padma Shri Awardee
President Confederation of Medical Associations in Asia and Oceania (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA