March 25, 2017

27 medicines sold by top firms ‘fail’ quality tests in seven states: Drug Regulation Authority

27 medicines sold by top firms ‘fail’ quality tests in seven states: Drug Regulation Authority

In a major crackdown since March this year, the drug regulators of seven states have alleged that 27 medicines — sold by 18 major drug companies in India including Abbott India, GSK India, Sun Pharma, Cipla and Glenmark Pharma are of “substandard” quality, citing grounds such as false labelling, wrong quantity of ingredients, discolouration, moisture formation, failing dissolution test and failing disintegration test.

These include key drug brands of eight top-tier companies, which are the leaders in their respective molecule categories (pharma companies sell the same molecule under different brand names) with a market share ranging from 47 % to 92 %. 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 from the market.

Some of the key brands which were alleged to be substandard are: antipsychotic drug Stemetil and antibiotic drug Pentids from Abbott India, anti-bacterial medicine Althrocin by Alembic Pharma, migraine medication Vasograin by Cadila Pharma, popular cough syrup Ascoril by Glenmark Pharma, worm infection drug Zentel by GSK India, arthritis medication Hydroxychloroquine (HCQS) by Ipca Labs, anti-inflammatory medication Myoril by Sanofi Synthelabo, and Torrent Pharma’s hypertension drug Dilzem.

The tests on the 27 medicines were done by drug regulators of Maharashtra, Karnataka, West Bengal, Goa, Gujarat, Kerala and Andhra Pradesh. The 10 other companies that were alleged to be selling substandard drugs are Alkem Labs, Cadila Healthcare, Cipla, Emcure Pharma, Hetero Labs, Morepen Labs, Macleods Pharma, Sun Pharma, Wockhardt Pharma and Zydus Healthcare


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