INDIA. Mumbai: In a major crackdown against the manufacturers of substandard and spurious drugs, the Union Government cancelled the licenses of 18 pharma companies on Tuesday.
The action was taken after an inspection by the Drugs Controller General of India (DCGI) and state agencies at 76 pharmaceutical companies across 20 states and union territories in the past 15 days. The 18 licences were cancelled and 26 firms were given show-cause notices, official sources said.
As part of the special drive, the regulators identified 203 firms. A majority of the companies were from Himachal Pradesh (70), followed by Uttarakhand (45) and Madhya Pradesh (23). The raids came amid reports of deaths and illnesses from Indian drugs in several nations.
In February, all of the eye drops made by Global Pharma Healthcare in Tamil Nadu were recalled because they were said to have caused people in the US to lose their sight. Before, it was said that cough syrups made in India were linked to the deaths of children in the Gambia and Uzbekistan in December of last year. Last week, the Uttar Pradesh Drugs Controlling and Licensing Authority cancelled Marion Biotech’s manufacturing licence after 18 children died in Uzbekistan, allegedly after consuming its cough syrup.
On January 12, the World Health Organization (WHO) also issued a “medical product warning”, relating to two substandard (contaminated) items, detected in Uzbekistan and reported to it on December 22, 2022.
Last month, Zydus Lifesciences, a pharmaceutical company in Gujarat, India, pulled more than 55,000 bottles of a generic medicine used to treat gout from the US market because it didn’t meet standards for impurities.
Similarly, the Noida police detained three Marion Biotech employees from its office in Sector 67, and a lookout notice was issued for two of its directors after an FIR was filed against all of them in the wake of investigations finding that samples of Marion Biotech’s drugs were “not of standard quality.” The production licence of the firm was suspended in January after inspections at its site by the central and state drug authorities.
It may be recalled that the Central Drugs Standard Control Organization (CDS)) had declared 67 samples of drugs, as not being of standard quality in January of this year. Out of 1348 total samples tested, 1281 samples were declared to be of standard quality, and the remaining samples were tested as spurious.
Some of the substandard drugs included: Rabeprazole Gastro Resistant Tablets, IP 20 mg, manufactured by Revat Laboratories, Andhra Pradesh, Ciprofloxacin Hydrochloride Tablets, 500 mg; Karnataka Antibiotics & Pharmaceuticals Limited, Bengaluru, Lvcipro-500 (Ciprofloxacin Hydrochloride Tablets IP), M/s. L V Life Sciences, Solan, Himachal Pradesh, Ciprofloxacin Tablets IP 500 mg, Celebrity Biopharma Ltd, Solan, Himachal Pradesh, Zinc Sulphate Oral Solution I.P., 100ml, Ornate Labs Pvt. Ltd, Muzaffarpur, Bihar, Zinc Sulphate Oral Solution I.P., 100ml, Apple Formulations Pvt. Ltd, Roorkee, Uttarakhand and Budecort Respules 0.5 mg (Budesonide Nebuliser Suspension B.P), Cipla Ltd, Pithampur, Madhya Pradesh.
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