The Central Drugs Standard Control Organisation (CDSCO) recently flagged over 50 drug samples, including commonly used as Not of standard quality drugs in its latest report.
Key Points from the Report:
- The list includes popular medications such as Shelcal, vitamin supplements, and antibiotics like Amoxicillin and Potassium Clavulanate tablets.
- High blood pressure medications, including Telmisartan and Atropine Sulphate, were also flagged.
- Common medications like paracetamol, anti-diabetes pills, and calcium and vitamin D3 supplements.
- Many batches failed critical tests, such as the ‘dissolution test’ and ‘Assay’ test as per the Indian Pharmacopoeia.
- Some drugs were identified as spurious or had issues with uniformity of volume.
- The CDSCO conducts monthly random testing of drug samples to ensure safety and quality.
- The list of “not of standard quality” drugs is released each month, and actions are taken against manufacturers accordingly.
- Several states, including Andhra Pradesh, Assam, and Tamil Nadu, did not submit data regarding the NSQ alert for August 2024, indicating potential lapses in monitoring at the state level.
About Central Drugs Standard Control Organisation (CDSCO):
- The CDSCO is the national regulatory authority for pharmaceuticals and medical devices in India.
- It operates under the Ministry of Health and Family Welfare and is primarily responsible for ensuring the safety, efficacy, and quality of drugs and medical products in the country.
- CDSCO formulates policies and regulations regarding the approval, manufacture, import, and distribution of drugs and medical devices.
- It evaluates and approves new drugs for use in India, ensuring they meet established safety and efficacy standards.
- The organization regulates and monitors clinical trials conducted in India to ensure compliance with ethical standards and good clinical practices.
- The organization oversees the reporting and analysis of adverse drug reactions to improve drug safety.
- CDSCO plays a role in public health by addressing issues related to drug availability, pricing, and accessibility.
Structure
- The CDSCO is headed by the Drug Controller General of India (DCGI).
- It operates through a network of offices at the central and state levels, with various divisions responsible for specific areas of drug regulation.
Ref: Source
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Frequently Asked Question:
What is the Central Drugs Standard Control Organisation (CDSCO)?
CDSCO is the national regulatory authority for pharmaceuticals and medical devices in India, operating under the Ministry of Health and Family Welfare.
What are “not of standard quality” (NSQ) drugs?
NSQ drugs are medications that fail to meet the quality standards set by the Indian Pharmacopoeia, often due to issues like inadequate dissolution or assay test results, or being identified as spurious.
What types of medications were flagged as NSQ?
The list includes popular medications like Shelcal, vitamin supplements, antibiotics such as Amoxicillin and Potassium Clavulanate tablets, high blood pressure medications like Telmisartan, and common medications like paracetamol and anti-diabetes pills.