Centre acts against 34 pharma firms

Pharma

HT Correspondent

Ref: Hindustan Times Chandigarh Friday April 14, 2023

HT Correspondent

NEW DELHI: The Centre has taken action against at least 34 companies so far in the biggest crackdown against pharmaceutical companies manufacturing substandard drugs, according to people familiar with the matter.

The second round of inspections on this aspect is under- way across the country. Central and state drugs regulators began conducting joint inspections earlier this year as part of a special drive to check the production of substandard medicines in the country. As part of this special drugs inspection drive, 203 pharmaceutical companies were identified for joint inspection. A majority of the companies are from Himachal Pradesh, followed by Uttarakhand, and Madhya Pradesh.

In the first phase, the inspection was conducted of 76 pharma companies across 20 states, and 18 were reportedly found to be producing spurious and adulterated drugs.

According to the “action taken list by state licensing authorities”, a copy of which has been seen by HT, among the companies whose manufacturing licence was suspended or which were asked to stop production are included Himalaya Meditek Pvt Ltd registered in Dehradun, Sun AJ pharma, Indore (MP), Vintochem, Ujjain (MP), Om Biomedic, Haridwar (Uttarakhand), SVP Life Sciences, Dehradun, Uttarakhand, Apple Formulations, Roorkee, Uttarakhand, Relief Biotech, Roorkee, Uttarakhand, Agron Remedies, Kashipur, Uttarakhand, and Bajaj Formulations, Roorkee, Uttarakhand.

HT reached out to the companies but did not get a response immediately. In addition, regulators issued show cause notices to Athens Life Sciences, Laborate Pharmaceuticals, Life Vision Healthcare, and JM Laboratories in Himachal Pradesh.

According to people familiar with the matter, the joint inspections are a part of heightened pharma surveillance measures that the government decided to adopt after three incidents involving India-made completed products.

The Uttar Pradesh Drugs Controlling and Licensing Authority recently cancelled the manufacturing license of Noida-based pharmaceutical company Marion Biotech, whose cough syrup was allegedly linked to the death of  18 children in Uzbekistan in December last year.

In February, the Tamil Nadu based Global Pharma Health care recalled its entire lot of eye drop allegedly linked to vision loss in the US.

However, a joint inspection was carried out at its manufacturing unit, and samples that were tested were found to be ‘free of contamination, as per officials familiar with the matter.

And on October 5, WHO Issued an alert over four cough syrups – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup manufactured and exported by Maiden Pharmaceuticals and likely linked to the deaths of 70 children in The Gambia.

While the Haryana government’s investigation found violations in Maiden’s manufacturing processes, the samples p tested of its drugs did not find any kind of contamination. The regulator asked the company to stop manufacturing until the investigation was completed.

In February, the Union health ministry conducted a two-day “Chintan Shivir” (deliberation camp) with a focus on drug quality, regulation, and enforcement.

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