Drug regulators cancel licences of drug manufacturing units over quality concerns

New Delhi: The central and state drug regulatory bodies have banned the licences of numerous production facilities and revoked the product approvals of a few others, all on the grounds of quality concerns.

Regulators investigated dozens of medication manufacturing plants in Himachal Pradesh, Uttarakhand, Haryana, Madhya Pradesh, and Maharashtra in response to allegations of the deaths of 19 children in Uzbekistan reportedly brought on by tainted cough syrup produced in India.

As a result, 34 drug production facilities were targeted by state licencing authorities: 17 in Himachal Pradesh, 13 in Uttarakhand, 2 in Madhya Pradesh, 1 in Haryana, and 1 in Maharashtra, as reported by ET.

Earlier, the Medical Dialogues Team had reported that Uzbekistan had arrested four people in an investigation into the deaths of 19 children who consumed cough syrup made by Indian drug maker Marion Biotech. Uzbekistan’s health ministry had said the syrup contained a toxic substance, ethylene glycol, and was administered in doses higher than the standard dose for children, either by their parents, who mistook it for an anti-cold remedy, or on the advice of pharmacists.

The Uzbekistan case follows the deaths of at least 70 children in Gambia that a parliamentary committee had linked to cough and cold syrups manufactured by New Delhi-based Maiden Pharmaceuticals. The company denied any wrongdoing and Indian government inspectors found no contamination in test samples.

In continuation, recently, India’s drug regulator directed drug manufacturers not to use propylene glycol supplied by a Delhi-based company which provided the ingredient to Marion Biotech, whose cough syrups were alleged to have led to the deaths of children in Uzbekistan.

In accordance with the copy of the report on the action taken by the licencing authorities cited by ET, after investigating dozens of medication manufacturing plants, the state licensing authorities cancelled the manufacturing licences of six units, which included Himalaya Meditek, Mascot Health Series (for beta lactam section), SVP Life Sciences, Relief Biotech, and Agron Remedies of Uttarakhand, and Sun Aj Pharma in Madhya Pradesh.

State licencing authorities also issued manufacturing halt orders to some of the companies and halted product permits for some other companies. Pure & Cure Healthcare, Skymap Pharmaceuticals, Anrose Pharma, GNB Medica Lab, Vintochem Pharmaceuticals, Apple Formulations, Relief Biotech, HAB Pharmaceuticals & Research, Rhydburg Pharmaceuticals, Bajaj Formulations, and Trugen Pharmaceuticals are a few of them.

Some units have received show-case notifications and warnings, the article continued. These companies include Nestor Pharmaceuticals, Athens Life Sciences, Life Vision Healthcare, JM Laboratories, Park Pharmaceuticals, ANG Lifesciences India, Laborate Pharmaceuticals India, and Shri Ramesh Industries.

Furthermore, it is also reported that the authorities cancelled the stop-manufacturing orders against Zim Laboratories, T&G Medicare, Medipol Pharmaceutical, Alliaance Biotech, and Shri Sai Balaji Pharmatech.

In response to the above, ZIM Laboratories stated, “We would like to inform that the company has neither received any show-cause notice nor any notice to stop manufacturing from any Drug Authority including DCGI or local drug authority. ZIM Laboratories adheres to current Good Manufacturing Practices as applicable and is accredited by Regulatory Authorities for marketing and distribution of several products in India and abroad”.

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