Central Drugs Standard Control Organisation (CDSCO) notified Regulatory guidelines for sampling of drugs, cosmetics & medical devices

Posted 20 Feb 2024

2 min read

CDSCO has issued new guidelines to ensure quality and efficacy of drugs and cosmetics by adopting uniform drug sampling methodology for drugs inspectors under drug regulatory authorities of state and central.
- Section 22 & 23 of Drugs & Cosmetics Act 1940 prescribes detail procedure for samples to be taken by Drugs Inspectors for routine drugs quality surveillance.

Key highlights
- Establish a centralized database of outlets selling 'not of standard quality' or spurious drugs.
- Each drugs inspector with consultation of controlling authority shall prepare a sampling plan on monthly basis & annual basis for finalizing sampling locations to cover entire jurisdiction/area under their office.

Need for sampling of drugs, cosmetics and medical devices
- Persistent concerns around quality of medicines manufactured in the country. Report of deaths in Gambia and Uzbekistan due to Indian cough syrup.
- Currently, there is no defined methodology for sample selection or location of sampling.
- Sampling was done randomly with individual knowledge of drug inspectors.
- Coverage Gap i.e. existing sampling practices mainly target drugs from big brands in urban or suburban locations, neglecting rural and remote areas.

It is based on Drugs and Cosmetics Act (DC Act), 1940 and Drugs and Cosmetics Rules, 1945.
DC Act 1940 created CDSCO under Ministry of Health and Family Welfare to prescribe standards for ensuring safety, efficacy and quality of drugs, cosmetics, diagnostics and devices in India.
- Drug controller general of India (head of CDSCO) approves licences for specified categories of drugs like blood and blood products, Vaccine etc.

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