61 medicines, Ayurvedic formulations fail regulator’s quality check

Earlier in February, drugs controller general of India Rajeev Raghuvanshi had directed the state licensing authority (SLA) to keep an eye on drugs in market by routinely analyzing samples

medicines quality check

New Delhi: As many as 61 medicines, cosmetics and Ayurvedic products have failed the quality standards of the Central Drugs Standard Control Organization (CDSCO)–India’s national regulatory body for cosmetics, pharmaceuticals and medical devices.

The drug and other health products that failed the standards include lifesaving formulations for diabetes, cosmetics and ayurveda products, aloevera, glycerin and Vitamin -E soap, jojoba oil and haridrakhandam used to treat skin allergies.

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This puts a question mark on the quality of medicines and other ayurvedic preparations made by Indian pharmaceutical companies and Ayurvedic medicines firms. Credibility of Indian pharmaceutical industries has already suffered after various countries have restricted their use.

The quality of drugs and cosmetic products in India is regulated under the Dugs and Cosmetic Act, 1940 by CDSCO.

CDSCO has stated that medicines including Esomeprazole Gastroresistant tablets IP 40 mg used for gastrointestinal diseases, Amoxycillin & Potassium Clavulanate injections used to manage bacterial infections, Glipizide and Metformin tablets for treating diabetes, Etamsylat tablets 500 mg used in the treatment of bleeding, iron and folic acid syrups, and Albendazole tablets which are used to treat worm infections have failed the quality test.

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Earlier in February, drugs controller general of India Rajeev Raghuvanshi had directed the state licensing authority (SLA) to keep an eye on drugs in the market by routinely analyzing samples. The LSA was asked to act with a view to maintaining a centralized monthly database of spurious and NSQ medicines.

In a drug alert issued in June by the CDSCO, it was stated that Amloheart-AT tablets used to treat cardiovascular diseases, Montor LC tablets which is used to treat respiratory infections, Alpracan 0.5 tablets are used to manage neurological disorders, were sub-standard. The samples were examined at the central and state laboratories.

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According to the drug regulator, different varieties of soaps having aloevera, vitamin E and jojoba oil and Ayurveda products were also found to be substandard. At a meeting to chalk out the Central government’s 100 days agenda, Union health minister JP Nadda had directed officials to ensure the safety and quality of medicines in the country.

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