In a recent report, the Central Drugs Standards Control Organization (CDSCO) announced that more than 50 drugs are ‘not of standard quality.’ These 50 drugs also include Paracetamol, PanD, and Calcium Supplements. They also raised safety concerns regarding their usage.
Paracetamol Failed Drug Regulatory Quality Test
In its August 2024 report, the CDSCO’s regulator found that some medicines, including Paracetamol, Vitamin D and Calcium supplements, Blood pressure medications, and some diabetes pills, did not meet quality standards. These medicines were labeled as “Not of Standard Quality (NSQ Alert).” NSQ Alerts are created based on random tests done each month by state drug officers.
Other Medicines That Failed Drug Regulatory Tests
- Vitamin C and D3 tablets.
- Shelcal
- Vitamin B complex.
- Vitamin C soft gels.
- Anti-acid Pan-D.
- Paracetamol tablets (IP 500 mg).
- The anti-diabetic drug Glimepiride.
- The high blood pressure medication Telmisartan.
These products were manufactured by several companies, like:
- Hetero Drugs
- Alkem Laboratories
- Hindustan Antibiotics Limited (HAL)
- Karnataka Antibiotics & Pharmaceuticals Ltd
- Pure & Cure Healthcare
- Meg Lifesciences
Metronidazole is a medicine that is commonly used for stomach infection treatment. It is produced by HAL. It also failed quality testing. In the same manner, Shelcal is a popular calcium and vitamin D3 supplement. It has also been flagged in the NSQ Alert Category. A Kolkata drug-testing lab found that antibiotics like Calvam 625 and Pan D were spurious. A children’s infection medicine, Cepodem XP 50 Dry Suspension, also failed the quality test. The CDSCO declared these medicines don’t meet the quality standards.
Central Drug Regulator Released Two Lists
The central drug regulator released two lists based on the results of tests:
- One list includes 48 drugs that failed the quality tests.
- Another list includes 5 drugs under the NSQ Alert category.
They even contacted the manufacturers for the response of these drugs failing the quality tests. If their response is invalid, there could be some consequences that the manufacturers will have to face. These can include product recalls, fines, or even suspension of licenses.
CDSCO conducts random checks on pharmaceutical products monthly. It helps them identify and remove unsafe drugs from the market. The Pulmosil’s drug makers’ responded by saying, “The actual manufacturer (as per the label claim) has informed us that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. The product is purported to be spurious; however, the same is subject to the outcome of the investigation.”
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