Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com
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Last Updated on December 3, 2023 by The Health Master
Ranitidine tablets and Injections
Q. What is the status of sale of Ranitidine tablet/ injection in India
Ans:
Ranitidine is a schedule H drug available in the market in the form of tablet and injections.
Govt. of India has not banned it under section 26 A of the Drugs and Cosmetics Act.
As per DCGI office letter dated 13 September 2019 that Ranitidine formulation contains N-Nitrosodimethylamine (NDMA) which is an impurity cause cancer.
Manufacturers / formulators of Ranitidine tablets and Injections should get their products tested for the presence of impurities i.e. N-Nitrosodimethylamine (NDMA).
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