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.
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.
According to the new norms, each drugs inspector with consultation of his controlling authority shall prepare a sampling plan on monthly basis and annual basis for finalizing the sampling locations to cover the entire jurisdiction/ area under their office.
This will avoid communication gap between the officers and optimum utilization of resource to cover the maximum territory and all kinds of product category with identified risk 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 their headquarters of their offices for review and to avoid any repetitive sampling of one brand and to cover maximum variety of brand/category in the proposed sampling schedule.
It is important that sufficient quantity of samples are collected and forwarded to laboratory so that all the parameters are tested and re-tested, if any required by laboratory before issuing of NSQ test report, the guidelines.
It is important to avoid any procedure delay in testing and obtaining of test report from the laboratory, so that further use of identified NSQ products are stopped by issuing drug alert and product recall notice at the earliest for public awareness, irrespective of proceeding of drugs inspector as per provision under the Drugs and Cosmetic Act and Rules thereunder.
Each drug controlling office shall prepare a list on monthly basis for wholesale/retail outlet with name of registered pharmacist and owner where spurious products are reported/distribution chain is broken for the provided invoice.
The above list shall be shared to their head office for preparation of a centralised list of wholesale and retail outlets revealed in 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.
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