53 drugs including paracetamol fail quality test by regulator

Over 50 drugs including paracetamol, Vitamin D supplements, pantoprazole, antibiotics and blood pressure medicines have failed quality tests conducted by India’s drug regulator Central Drugs Standard Control Organisation (CDSCO).

CDSCO in its August alert named 53 drugs of non-standard quality made by different manufacturers.

The list includes Vitamin C and D3 tablets Shelcal, Vitamin B complex and Vitamin C softgels, antiacid Pan-D, paracetamol tablets IP 500 mg, Type-2 diabetic drug Glimepiride, hypertension drug Telmisartan and antibiotics Cepodem as well as Clavam.

Some of these medicines are manufactured by Alkem Health Science, Hetero Labs, HSN International, Pure & Cure Healthcare, Scott -Edil Pharmacia, Digital Vision, Win Cure Pharma and state-owned . Hindustan Antibiotics.

The drug regulator shared two lists: one has 48 drugs, the second list contains additional 5 drugs and replies from the pharmaceutical companies who failed these tests.

“The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufacturer by them and that it is a spurious drug. The product is purported to be spurious, however, the same is subjected to outcome of investigation,” the drug maker’s said in their replies.

Himachal Pradesh-based Digital Vision, whose Klonaz drug was found to be of non-standard quality, was in the news in 2020 when its cough syrups were reportedly found to have high concentrations of the toxin diethylene glycol (DEG), allegedly causing the deaths of 12 children in Ramnagar town of Jammu & Kashmir (J&K). In July 2023, the drug regulator of The Gambia, Medicines Control Agency (MCA), tightened the quality inspection mechanism for imported medicines in the wake of child deaths due to consumption of contaminated cough syrups. The cough syrups were shipped to Gambia from India by Delhi-based Maiden Pharmaceuticals.

In April this year, CDSCO said it will be the sole authority to grant no-objection-certificates to pharmaceutical companies that manufacture drugs that are unapproved, new or banned for the sole purpose of exports in India. In a communication to the drug controllers of all states and Union Territories on April 30, the Central Drugs Standard Control Organisation (CDSCO) said that the powers delegated to the state and UT authorities to grant such NOCs will stand withdrawn from May 15, 2024.

In August 2018, the CDSCO had relaxed the requirement of Central NOCs and permitted state and UT drug licensing authorities to grant permissions to export some specific drugs that are not allowed to be used in India. The state/UT regulators will now have to handover the details of all the approvals they have given during the August 2018-May 2024 period to the central drug regulators.