Not only private firms, but the pharmaceutical companies of Central and two state governments — Gujarat and Kerala — have also come under the scanner as their eight medicines were found substandard by drug regulators of four states since March this year.
Many medicines like Paracetamol tablets of Karnataka Antibiotics and Pharmaceuticals Limited (KAPL) were found to be substandard in three different tests by Karnataka’s drug regulator in June. Similarly, Goa Antibiotics’ Gaplex Syrup, which is a Vitamin B-complex syrup, was found to be substandard twice by Goa’s drug regulator in April. Both the firms work for the central government.
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KAPL’s Omeprazole capsules, an important stomach medication, was found to be substandard twice — first time by Karnataka regulator in July and then by Gujarat regulator in August. Stating the reason, Gujarat regulator said the drug failed in its dissolution test. Dissolution test checks the time taken by the medicine to dissolve in the blood stream.
Even an ayurvedic brand of Gujarat State Forest Development Corporation (GSFDC) — Harde Powder — were found to substandard by Gujarat’s drug regulator in April. GSFDC works under the Gujarat government only and Harde powder is used to treat constipation.
Apart from aforementioned companies, drugs manufactured by HLL Life Care and Indian Drugs and Pharmaceuticals (IDPL), which work under the central government, were also found to be substandard. Kerala State Drugs and Pharmaceuticals, a state government company, was also found to be selling substandard diabetes drug Metformin Hydrochloride. The Indian Express asked the companies if they have recalled the drug batches which have been declared substandard; none replied.
HLL Life Care’s Ciprofloxacin, which is an antibiotic, was found to be substandard by Karnataka’s drug regulator in June this year. On the other hand, IDPL’s Glimepiride, which is a diabetes medicine, failed the dissolution test of Maharashtra’s drug regulator in September this year. KAPL’s Getamicin was found to be substandard by Karnataka’s drug regulator in June this year.
‘Emami’s churana drug substandard’
Emami’s Ashwagandha churana was found to be substandard by the Gujarat’s drug regulator in June this year as it had excess amount of “total ash” content and less amount of “alcohol-soluble extractive”.
Once the powdered form of the medicine is mixed in liquid alcohol, various procedures are performed upon it and the remaining content left in the end is called “alcohol-soluble extractive”. The company did not respond to the specific queries mailed by The Indian Express.