Monitor presence of potentially carcinogenic chemical in Ranitidine: DCGI to drug controllers
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.
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