NOT OF STANDARD QUALITY (NSQ) DRUGS
30.09.2024
NOT OF STANDARD QUALITY (NSQ) DRUGS
IN NEWS
- Recently the Central Drugs Standard Control Organisation (CDSCO) has flagged around 53 medicines as being of Not of Standard Quality.
- This includes well-known medications such as paracetamol, metformin and pantoprazole.
ABOUT NSQ DRUGS
- Those drugs that are not of standard quality & they don't meet the quality standards set by national or international authorities.
- Reasons for Drug Failure:
- Spurious Drugs: These are counterfeit medications that mimic well-known brands but are not produced by the original manufacturers. E.g. Certain samples of telmisartan, which is used for hypertension, were found to be falsely branded and were not made by the companies they claimed to represent.
- Poor Quality Drugs: These drugs may not dissolve properly or may contain insufficient amounts of active ingredients, affecting their efficacy. E.g. Metformin, a common diabetes medication, failed a dissolution test. This means it would not work effectively when consumed.
- Adulterated Drugs: These contain harmful contaminants or adulterants that can pose health risks to consumers. Batches of adulterated drugs are often recalled by regulators to protect public health.
ABOUT CDSCO
- It is India's National Regulatory Authority (NRA) for drugs and cosmetics.
- It is headed by Drugs Controller General of India (DCGI).
- It releases a monthly list of drugs that fail quality checks.
- Nodal Ministry: Ministry of health and Family welfare.
- Functions of CDSCO under Drugs & Cosmetics Act (1940):
- Controlling the import of drugs and their quality.
- Approval of new drugs ○ Conduct of Clinical Trials
- Laying down the standards for Drugs
Coordination of activities of the State Drug Control Organizations