CDSCO says 52 medicines, including Paracetamol, failed quality check in May

The widespread nature of the issue stretches across different regions of the country, including Himachal Pradesh, Hyderabad, Waghodia, Vadodara, Andhra Pradesh, and Indore

India’s top drug regulatory body, the Central Drugs Standard Control Organisation (CDSCO), has flagged around 50 drugs, including popular medications like paracetamol, pantoprazole, and several antibiotics, for failing to meet quality standards. Of these, 22 were produced in Himachal Pradesh, as detailed in the CDSCO’s May 2024 alert.

Samples from other locations such as Jaipur, Hyderabad, Waghodia, Vadodara, Andhra Pradesh, and Indore were also found to be substandard.

A total of 52 samples did not pass the quality tests conducted by the CDSCO, according to the drug alert released on June 20.

The CDSCO’s recent findings, identifying 50 medications including substandard paracetamol, have alarmed the medical community. Paracetamol, a commonly prescribed drug for pain and fever relief, failing to meet quality standards is particularly concerning.

The substandard 500 mg paracetamol tablets were produced by Askon Healthcare, based in Ujjain, Madhya Pradesh. Askon Healthcare’s official website states that the company manufactures final pharmaceutical dosage forms.

Concerns mount over substandard drugs

The list of substandard drugs includes Clonazepam tablets for seizures and anxiety disorders, the pain reliever Diclofenac, the anti-hypertension drug Telmisartan, Ambroxol for respiratory diseases, the antifungal Fluconazole, and various multivitamin and calcium tablets.

This revelation comes at a time when India’s pharmaceutical industry is under scrutiny following links between Indian-made cough syrups and child deaths overseas.

Cough syrup containing Terbutaline Sulphate, Bromhexine Hydrochloride, Guaiphenesin and Menthol Syrup produced in Ambala was also flagged by the drug regulator.

Concerns over henna mehndi

Moreover, the drug regulator also flagged that the commonly applied Henna mehndi is misbranded and of poor quality as per the standards set for the cosmetics category.

The CDSCO’s May alert indicated that drug samples were collected from Waghodia (Gujarat), Solan (Himachal Pradesh), Jaipur (Rajasthan), Haridwar (Uttarakhand), Ambala, Indore, Hyderabad, and Andhra Pradesh.

Last year, around 120 drug samples manufactured in Himachal Pradesh did not meet test parameters.

In February, Drug Controller General of India (DCGI) Rajeev Raghuvanshi directed states and Union Territories to maintain strict vigilance and surveillance on drug quality through random sampling.

Nepal bans Indian antibiotic drug

Additionally, Nepal’s Department of Drug Administration (DDA) recently banned the sale of the Indian antibiotic injection Biotax 1 gm due to quality issues. The suspension was based on failed lab tests, which did not comply with production standards, posing potential health risks. Despite the ban, alternative medications are available, so treatment disruptions are not anticipated.

In response to Business Standard inquiries, Zydus Lifesciences stated that the reports about their product were ‘misleading and erroneous’, asserting that their product meets all quality specifications and that the DDA's concerns were limited to the quantity of sterile water provided with the medication.