Importance of vigilant drug regulation

Source – This post on importance of vigilant drug regulation is based on the article “Random checks find ‘not of standard quality’ drugs in market: Here’s all you need to know” published in “Indian Express” on 28th September 2024.

Why in the News?

The recent discovery of spurious or “not of standard quality” (NSQ) medicines by the Central Drugs Standard Control Organization (CDSCO) highlights the importance of vigilant drug regulation.

About CDSCO

The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.

Major functions of CDSCO

1. Regulatory control over the import of drugs
2. Approval of new drugs and clinical trials
3. Meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB)
4. Approval of certain licenses as Central License Approving Authority is exercised by the CDSCO headquarters.

Overview of Findings

1. Sample Testing: CDSCO conducts routine testing of medicine samples to ensure quality, with recent checks revealing that several common medications, including paracetamol, metformin, and pantoprazole, are not of standard quality (NSQ).
2. Monthly Reports: Each month, CDSCO releases lists of medicines identified as NSQ to inform the public, healthcare professionals, and regulatory bodies.

Categories of Non-Standard Quality Drugs

1. Spurious Drugs: These are counterfeit products pretending to be established brands. For example, Samples of telmisartan and pantoprazole were found not to be manufactured by their branded companies.
2. Poor Quality: These drugs may have incorrect descriptions, inadequate dissolution, or insufficient active ingredients. For example, Metformin failed a dissolution test, meaning it may not dissolve effectively in the body.
3. Adulterated Drugs: These contain harmful contaminants or adulterants. Such drugs are usually recalled by regulators or manufacturers.

Purpose of Testing and Reporting

1. Public Awareness: Monthly lists serve to inform consumers and health authorities about potentially unsafe drugs in the market.
2. Industry Accountability: Random testing acts as a deterrent for manufacturers, ensuring they maintain quality standards.

UPSC Syllabus: Governance