Batches of Combiflam substandard, drug controller issues notice

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Batches of Combiflam substandard, drug controller issues notice

India’s most popular “pain-killer” with the brand name Combiflam, is under fire for being “substandard” and that many batches of the medicine failed to pass a critical test of the Central Drugs Standard Control Organisation (CDSCO).

According to media reports, many batches of this ibuprofen-paracetamol combination drug which controls 50 percent of the Indian market, earning revenues upwards of Rs 169 crore, failed to pass CDSCO’s disintegration test. This is a test that checks how long it takes for a tablet to completely disintegrate in the bloodstream and whether it is within a prescribed limit.

With certain batches failing the test, the CDSCO has notified all its sub-offices to keep a “strong vigil” on the “movement” of Combiflam. If needed the offices will take “necessary action”.

It has been revealed that the drug’s batch number A151195, manufactured in October 2015 failed the test on March 10.

India Legal Bureau