18 Pharma Giants Blacklist by Government for Cheating with Spurious Medicines

New Delhi: The Union Government has taken a firm stance against the production of substandard and counterfeit medicines. On Tuesday, it announced that the licenses of 18 pharmaceutical companies have been revoked as a part of a major crackdown. This decision was taken following a rigorous inspection carried out by the Drugs Controller General of India (DCGI) and state agencies at 76 pharmaceutical companies across 20 states and union territories over the past two weeks. According to official sources, apart from the cancelled licenses, show-cause notices have been issued to 26 other firms.

Recently, regulators carried out a special drive where they identified 203 companies, with most of them being from Himachal Pradesh (70), Uttarakhand (45) and Madhya Pradesh (23). The raids reportedly took place due to the rising number of deaths and illnesses linked to Indian drugs in various countries.

In February, Global Pharma Healthcare in Tamil Nadu had to recall all eye drops due to reports of people losing sight in the US. Prior to this, cough syrups manufactured in India were supposedly responsible for the deaths of children in the Gambia and Uzbekistan in December 2020. Just last week, Uttar Pradesh Drugs Controlling and Licensing Authority revoked Marion Biotech’s manufacturing license following reports of 18 children dying in Uzbekistan after consuming their cough syrup.

The World Health Organization (WHO) has recently issued a warning regarding two subpar medical products discovered in Uzbekistan and reported on December 22, 2022. Additionally, Zydus Lifesciences, a pharmaceutical company in Gujarat, India, removed over 55,000 bottles of a generic gout medicine from the US market last month due to impurities that did not meet the required standards.

In the aftermath of investigative findings indicating that samples of Marion Biotech's drugs did not meet standard quality, an FIR was filed against three of the company's employees, who were subsequently detained by Noida police from the firm's Sector 67 office. Following this development, lookout notices were issued for two of its directors. It should be noted that Marion Biotech's production license was suspended in January following an inspection by both central and state drug regulatory bodies.

As previously reported, in January, the Central Drugs Standard Control Organization (CDS) found that out of 1348 tested drug samples, 67 were of non-standard quality, and the remaining 1281 samples were declared of standard quality.

The findings of a recent report indicate that multiple drugs have been found to be below acceptable standards. These include Rabeprazole Gastro Resistant Tablets, IP 20 mg produced by Revat Laboratories in Andhra Pradesh, Ciprofloxacin Hydrochloride Tablets 500 mg made by Karnataka Antibiotics & Pharmaceuticals Limited in Bengaluru, and Lvcipro-500 by M/s. L V Life Sciences in Solan, Himachal Pradesh. Additionally, the list comprises of Ciprofloxacin Tablets IP 500 mg from Celebrity Biopharma Ltd in Solan, Himachal Pradesh, Zinc Sulphate Oral Solution I.P., 100ml from Ornate Labs Pvt. Ltd in Muzaffarpur, Bihar, Zinc Sulphate Oral Solution I.P., 100ml produced by Apple Formulations Pvt. Ltd in Roorkee, Uttarakhand and Budecort. It is important to note that these drugs have been deemed substandard.