Acidity drugs under scrutiny due to presence of cancer agents

The Central Drugs Standard Control Organisation (CDSCO) has asked all state and UT regulators to ensure manufacturers of commonly used acidity medicine ranitidine monitor the levels of NDMA, a potentially cancer-causing impurity.

The move has come following a recommendation by the Drugs Technical Advisory Board (DTAB) to the Indian Council of Medical Research (ICMR) to conduct a study for assessing the safety of ranitidine in view of the NDMA presence.

CDSCO chief Drug Controller General of India Rajeev Raghuvanshi said, “The safety of ranitidine due to the presence of NDMA impurity has been under consideration for quite some time now. This office has taken various measures from time to time.”

Owing to the NDMA concerns, an expert-committee was constituted in 2024, which placed its report of the expert committee was placed before the DTAB meeting held in April this year.

The DTAB, after detailed deliberations, recommended that a larger committee was required to be constituted to look into all aspects, including storage conditions, of the drug.

The board also recommended that the manufacturers should monitor the NDMA levels in the API/formulation and also take risk-based measures such as reducing the shelf life, etc.

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