Random checks find ‘not of standard quality’ drugs in market

Sub: Polity

SEC: National body

Context:

CDSCO, the country’s top drug regulator has found around 50 medicines, including common ones like paracetamol (used for fever), metformin (first line of treatment for diabetes), and pantoprazole (used for acidity), to be spurious or substandard.
These findings are from a routine quality testing exercise where samples were tested randomly.

About Routine quality checks:

The Central Drugs Standard Control Organisation (CDSCO) publishes a monthly list of drugs deemed “not of standard quality” (NSQ), highlighting the parameters in which they fall short.
This is done to inform the public, health departments, industry, and regulators about substandard drugs in the market, while also reminding manufacturers that their products are under constant scrutiny.
Central and state regulators randomly collect samples from the market for testing to ensure drug quality and safety.

Drugs that fail quality checks (NSQ) fall into three categories:

Spurious Drugs: Fake products mimicking popular brands, often without the correct active ingredients. For example, telmisartan (used for the treatment of hypertension) and pantoprazole samples falsely carried Glenmark and Sun Pharma branding.
Poor Quality: Medicines that do not dissolve properly, contain a faulty description, or lack the correct amount of active ingredient, leading to reduced effectiveness. For instance, metformin recently failed a dissolution test, affecting its intended function.
Adulterated Drugs: Contain contaminants or adulterants that can cause direct harm to the person who consumes them, often leading to product recalls initiated by regulators or companies.

Central Drugs Standard Control Organisation (CDSCO):

CDSCO is the national regulatory authority for pharmaceuticals and medical devices in India.
CDSCO was established in 1966 and is headquartered in New Delhi.
The Drugs Controller General of India (DCGI) heads CDSCO.
It operates under the Directorate General of Health Services, Ministry of Health and Family Welfare.

Major functions of CDSCO:

Responsible for ensuring the safety, efficacy, and quality of drugs and medical devices under the provisions of Drugs and Cosmetics Act, 1940.
Responsible for the approval of vaccines and managing the regulatory framework for the medical devices sector.
Approves new drugs and clinical trials.
Works with state drug regulators and other health authorities to ensure compliance with regulations.
Controls the quality of imported drugs in the country.