CDSCO believes that the guidelines will use available information and identified risks for selecting samples and locations to cover a variety of drugs, cosmetic and medical devices from across India
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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, notified last week, it said that interior locations or rural distributions are not covered and thereby the quality of drugs at distant users or last users 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.
Cosmetics samples were not collected in some regions. There is no centralised database of sale outlets where “not-of-standard” quality (NSQ) or spurious products were reported, the new guidelines stated, adding that such identified outlets are to be kept for regular vigilance.
“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.
Currently, the list of “not-of-standard quality” and spurious drugs shared by the CDSCO is not updated every month. Also, the information on distributors from where samples are drawn is not shared. This guidelines will be useful for effective surveillance for quality and efficacy of drugs and cosmetics available in the market by adopting uniform drug sampling methodology for drug inspectors under drug regulatory authorities of state and central governments, the document said.
New guidelines
According to the new norms, each drugs inspector with consultation of his controlling authority shall prepare a sampling plan on a monthly and annual basis for finalising the sampling locations to cover the entire jurisdiction/ area under their office.
This will avoid the communication gap between the officers and optimum utilization of resources to cover the maximum territory and all kinds of product categories with identified risks and approached under this guidance document.
Sampling plan shall include rural and tribal areas and drugs used in areas of endemic for certain diseases, drugs for seasonal diseases, etc.
The annual sampling plan shall be shared with the headquarters of their offices for review to avoid any repetitive sampling of one brand and to cover the maximum variety of brand/category in the proposed sampling schedule.
It is important to avoid any procedural delay in testing and obtaining the test reports from the laboratories, so that further use of identified NSQ products is stopped by issuing drug alerts and product recall notices at the earliest for public awareness, irrespective of the proceeding of drugs inspector as per provision under the Drugs and Cosmetic Act and Rules thereunder.
Each drug controlling office shall prepare a list monthly for wholesale/retail outlets with the name of the registered pharmacist and owner where spurious products are reported/distribution chain is broken for the provided invoice.
The above list shall be shared with their head office for preparation of a centralised list of wholesale and retail outlets revealed in the sale and distribution of spurious products and to give wide publicity for the public to avoid use of purchased medicine from these outlets, the guidelines stated.
