Kerala’s drug regulator has found three drugs of major companies – Sanofi India, Macleods Pharmaceuticals and Cadila Healthcare – to be of substandard quality during the testing done since June this year. Kerala drug control department found in September that the batch number 2118031 of Sanofi India’s drug “Lasix” is not of standard quality as it did not pass the “assay” test.
Sanofi India spokesperson told The Indian Express: “Sanofi India Limited has recalled stocks of one batch of Lasix from the market based on the directive issued by Kerala Drug Control department. Our control samples are in line with defined quality parameters and do not show any deviation. We are investigating the matter and have no further details to add at this stage.” Lasix is the brand name given by Sanofi India to the drug Furosemide, which is taken to remove excess fluid from the body and lower blood pressure.
In “assay” test, the analyst checks if the ingredients in the molecule are in proper amount and of good quality.
“Each ml of the given sample contains Furosemide 9.01 mg against the label claim of Furosemide IP 10 mg,” the test results of Kerala drug control department stated. “MacFast-500”, which is the brand name under which Macleods Pharmaceuticals sells it Paracetamol drug, has been found to substandard by Kerala drug regulator in July this year as it failed the dissolution test, which checks the time taken by the medicine to dissolve in the blood stream.
Kerala drug regulator found sample from batch number KMB705A of MacFast-500 to be substandard. However, it is not clear if this batch has been recalled from the market or not. Macleods Pharmaceuticals did not respond to the queries sent by The Indian Express.
Zipcet is the brand name under which Cadila Healthcare sells its drug Levocetirizine, which is used to treat allergy symptoms such as itching, swelling and rashes. Zipcet was found to be substandard by Kerala drug control department in June this year as it failed the dissolution test.
Cadila Healthcare did not respond to the queries sent by The Indian Express. It is not clear if batch number BRT1273 – sample of this batch was found to be substandard by Kerala drug regulator — of Zipcet has been recalled from the market as yet.
According to a report dated November 28, 2016, of The Indian Express, in a major crackdown since March, 2016, the drug regulators of seven states found that 27 medicines — sold by 18 major drug companies in India — were of ‘substandard’ quality, citing grounds such as false labelling, wrong quantity of ingredients, discolouration, moisture formation, failing dissolution test and failing disintegration test.
Of the 18 companies, only two said they had stopped sale of the affected drug batches and just one said the affected batch had been recalled. The tests on the 27 medicines were done by regulators of Maharashtra, Karnataka, West Bengal, Goa, Gujarat, Kerala and Andhra Pradesh.
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