CDSCO releases regulatory guidelines for sampling of drugs, cosmetics and medical devices
 In its efforts to streamline and rationalise the sampling procedure and maintain a centralised monthly database the Central Drugs Standard Control Organisation (CDSCO) has released the final version of the regulatory guidelines for sampling of drugs, cosmetics and medical devices by drugs inspectors of the Central and State drug authorities.The guideline is mainly focused to utilize available information and identified risks for selection of sample & location to cover vast variety of drugs, cosmetics 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 is also to maintain a centralised monthly NSQ/Spurious drug list and publish on CDSCO website to avoid their further use. “The guideline will be useful for effective surveillance for quality & efficacy of drugs & cosmetics available in the market by adopting uniform drug sampling methodology for drug inspectors under drug regulatory authorities of state and central,” said the drug regulator. The guideline stipulates that the drug inspectors should prepare a sampling plan on monthly and annual basis, select samples applying certain identified risks, select the sampling locations based on certain criteria, and complete the process within a timeline prescribed by the Central drug regulator. The drug inspector, in consultation with the controlling authority, shall prepare a sampling plan on monthly basis and annual basis covering the entire jurisdiction or area under their office. The sampling plan shall include rural and tribal areas and drugs used in areas of endemic for certain diseases, drugs for seasonal diseases etc., as the regulator has observed that the interior locations or rural distributions are not covered and thereby quality of drugs at distant users or the last user was not being assessed. The annual sampling plan shall be shared with the headquarters of their offices for review and to avoid any repetitive sampling of one brand and to cover a maximum variety of brands or categories in the proposed sampling schedule. The selection of a sample has to depend on various factors, which may indicate possible higher risk to the quality of the drug. The Drugs Inspectors shall draw samples of different therapeutic categories, different formulations, and different manufacturers from a one sales outlet by applying identified risks including around 20 listed in the guideline such as the feedback from the stakeholders including healthcare professionals and citizens, sampling scheduled provided by the CDSCO for specific therapeutic category drugs in specific months, use of drugs alert of CDSCO and state drug authorities for detail of frequent Not of Standard Quality or spurious drugs and their manufacturing and sales outlets, among others. The Drugs Inspector shall ensure that at least all the above identified risks are utilized in his sampling activities of six months. Further, not more than three samples are collected from one sale outlet and excess sampling, if any reasons shall be recorded and approved by the controlling authority. The guideline also specifies the criteria to select the sampling location. Each drug inspector shall collect at least 10- samples in a month, including nine samples of drugs – active ingredients, excipients and formulations, and one sample of cosmetics or medical devices. The inspector may ensure that the quantity of samples is sufficient for testing and re-testing of all parameters, it says, adding a list detailing the quantity required for testing of various sample product categories. If the retail outlets or rural sale outlet does not have sufficient quantity for complete testing, priority shall be given for identification and assay tests, to rule out spurious products. In such cases the sample portion can be divided in two equal portions preferably both with primary/secondary labels (one portion for government analyst and other for producing in the court) and remaining two portions sufficient for performing reduced testing. This information shall be recorded in respective forms under Drugs, Cosmetics & Medical Devices Rules and covering letter to respective Government Analyst, where sample is sent for testing for reduced testing i.e. identification and assay only due to non-availability of full quantity, it added. The guideline also stipulates that the drug inspector shall plan the sampling in such a way that the samples are forwarded to the laboratory on the same day of sampling or by next day in case of delay due to transit from rural or distant location. The Drugs Inspector shall obtain the method of analysis and reference/working standards from the manufacturer for samples belonging to patent and proprietary drugs or new drugs, without waiting for communication from the laboratory and shall provide to the laboratory for timely testing of the product. The NSQ and spurious drug reports shall be sent to the CDSCO before 10th of every month for uploading in its website. Each Drugs Inspector shall maintain data of sampling including the number of samples drawn and their process completion up to test report, number of NSQs reported by laboratory and their action taken, and the cases of spurious products reported by the laboratory in test report. The inspector shall submit the data to their controlling authority on a monthly basis for execution of the sampling plan. The inputs from the monthly data of sampling shall be used for planning of next month’s sampling plan. “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 wholesaler/retailer outlets revealed in sale/distribution of spurious products and to give wide publicity for the public to avoid use of purchased medicine from these outlets,” said the guideline. From the past trends, the drug regulator observes 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. “Often it was seen that sampled drugs are from big brands and collected from urban locations or sub urban locations only. The interior locations or rural distributions are not covered and thereby quality of drugs at distant users/last user was not being assessed. Cosmetics samples were not collected in some regions. There is no centralised database of sale outlets where NSQ/spurious products were reported, such identified outlets are to be kept for regular vigilance,” it added. The Section 22 & 23 of the Drugs & Cosmetics Act 1940 prescribes the detailed procedure for samples to be taken by Drugs Inspectors of Central and State drugs control as a part of routine drugs quality surveillance. Drug sampling is a costly task and limitations of resources may restrict the number of samples collected, parameters tested, techniques to be used for analysis or number of Drugs Inspector & Laboratory available to conduct the sampling and analysis respectively. Therefore, it is important to optimize the use of resources by focusing on parameters that pose a higher risk to patients and apply risk analysis during planning of the sampling, said the guideline. It may be noted that the 62nd meeting of the Drugs Consultative Committee (DCC) has called for a uniform system in the country for quick actions in connection to the dissemination of information and suspension or cancellation of license for sale of spurious products. During the meeting, all States agreed to share the data related to the not of standard quality (NSQ) products and spurious products identified on a monthly basis preferably before 10th of every month. |
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