New Delhi, Jul 29 (PTI) Drug regulator DCGI has asked drug controllers of all states and Union Territories to direct manufacturers under their jurisdiction to monitor the presence of a potentially carcinogenic chemical — N-Nitrosodimethylamine — in antacid Ranitidine.
Ranitidine is used to reduce the amount of acid the stomach makes and also in the treatment of acid reflux and stomach or intestinal ulcers among others.
The issue related to safety of Ranitidine drug due to presence of N-Nitrosodimethylamine (NDMA) impurity has been under consideration for quite some time now and various measures have been taken from time to time, the Drugs Controller General of India (DCGI) said in a communication on July 24.
An expert-committee was constituted in December last year and the report of the expert committee was placed before the 92nd Drugs Technical Advisory Board (DTAB) meeting in April this year, the communication, which also had minutes of the DTAB meeting as enclosures, said.
The communication said DTAB, after detailed deliberation, recommended that a larger committee is required to be constituted which will look into all the aspects, including the storage conditions of Ranitidine.
Also it suggested that the Indian Council of Medical Research (ICMR) may conduct a study for assessing the safety of Ranitidine drug considering the presence of NDMA impurity.
“The manufacturers should monitor the NDMA levels in the API/formulation and also take risk based measures such as reducing the shelf life etc,” the communication said.
“In view of above, as recommended by DTAB, you are requested to direct the manufacturers under your jurisdiction to monitor the NDMA levels in the API/formulation of Ranitidine and also take risk-based measures such as reducing the shelf life etc,” it added. PTI PLB DV DV
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