CDSCO issues sampling guidelines to ensuring quality and efficacy of drugs, cosmetics
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The Central Drugs Standard Control Organisation (CDSCO) has issued new guidelines for effective surveillance for quality and efficacy of drugs and cosmetics available in the market by adopting uniform drug sampling methodology.
The apex drug regulator, functioning under the Union Health Ministry, said that currently most sampled drugs are from big brands and collected from urban or suburban locations only.
In the new guidelines for sampling of drugs, cosmetics and medical devices, notified last week, it said that interior locations or rural distributions are not covered and thereby quality of drugs at distant user or last user was not being assessed.
“From the past trends it is observed that there is no defined methodology for sample selection and location of sampling etc and was done randomly with the individual knowledge of drug inspectors,” the document stated.
“This guideline is mainly focused to utilize available information and identified risks for selection of sample and location to cover vast variety of drugs, cosmetic and medical devices moving in the market from manufacturing facility, wholesale outlet, retail outlet, government distribution channel etc. In urban, sub-urban, and rural locations,” it stated.
This will also ensure maintaining a centralised monthly NSQ/spurious drug list and publishing on CDSCO website to avoid their further use.
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