New Delhi: Despite concerns over presence of cancer causing agents in popular antacid Ranitidine and a recent recommendation by an expert panel for suspension of the drug, India's top drug advisory body has decided to ignore and form another "larger committee" to look into all aspects of the drug.
It is widely sold in India under brand names like Aciloc, Rantac and Zinetac.
After a meeting held last week, the Drugs Technical Advisory Body (DTAB) also recommended that the Indian Council of Medical Research (ICMR) should conduct a study to assess the safety of the drug. The drug was withdrawn/suspended by regulatory bodies including the USFDA, European Medicines Agency (EMA), and Australia among others,
Last year a committee was constituted to examine the safety issue of Ranitidine in the light of the nitrosodimethylamine (NDMA) impurity.
The experts got samples of Ranitidine tested at a government run laboratory. Of the 42 Ranitidine samples tested at the Central Drug Laboratory in Kolkata, 21 were found to contain NDMA impurities exceeding 0.32 PPM. This level surpasses the globally acceptable limit for the impurity, which is linked to an increased risk of cancer over a lifetime.
After evaluating the global regulatory status of the drug and having found some of the samples in India exceeding the safety limit, the expert committee recommended for the "suspension of the drug Ranitidine for manufacture, sale and distribution in the country," it said. The committee also recommended that the people taking Ranitidine should consult their health care professional for other treatment options.
It is widely sold in India under brand names like Aciloc, Rantac and Zinetac.
After a meeting held last week, the Drugs Technical Advisory Body (DTAB) also recommended that the Indian Council of Medical Research (ICMR) should conduct a study to assess the safety of the drug. The drug was withdrawn/suspended by regulatory bodies including the USFDA, European Medicines Agency (EMA), and Australia among others,
Last year a committee was constituted to examine the safety issue of Ranitidine in the light of the nitrosodimethylamine (NDMA) impurity.
The experts got samples of Ranitidine tested at a government run laboratory. Of the 42 Ranitidine samples tested at the Central Drug Laboratory in Kolkata, 21 were found to contain NDMA impurities exceeding 0.32 PPM. This level surpasses the globally acceptable limit for the impurity, which is linked to an increased risk of cancer over a lifetime.
After evaluating the global regulatory status of the drug and having found some of the samples in India exceeding the safety limit, the expert committee recommended for the "suspension of the drug Ranitidine for manufacture, sale and distribution in the country," it said. The committee also recommended that the people taking Ranitidine should consult their health care professional for other treatment options.
You may also like
RSS cautions caste census survey should not be used as 'political tool'
Households with no time urged to plant these 'neglect thriving' flowers
Liverpool given reality check over transfer plan for Mo Salah successor
Pahalgam attack fallout: Border on the edge as wary Pak ups offensive
Will bet big on growth, even at cost of margins: Rohit Jawa, Hindustan Unilever
