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Nandita Vijayasimha, Bengaluru February 19 , 2024
The recent regulatory guidelines on sampling of drugs, cosmetics & medical devices by drug inspectors of the central and state drugs control department will bring in the much-needed accountability. It is a positive step and the best that could happen for India, said Dr BR Jagashetty, former National Adviser (Drugs Control) to Union health ministry and former Karnataka State Drugs Controller.
In similar way, exhaustive guidelines were formulated and issued by me during 2009 for Karnataka based on number of retailers, wholesalers, government pharmacies, etc., including veterinary products & cosmetics, said Dr Jagashetty.
This present DCGI circular mandates all data on not-of-standard quality (NSQ) and spurious drugs, to be uploaded on the CDSCO website along with analysis reports issued by state government analysts. This will provide the extent of work put in by enforcement teams, he added.
However, the big challenge in the wake of these regulatory guidelines is the paucity of officers and funds, though CDSCO has appointed drugs inspectors. For instance, Karnataka has several vacancies for drug inspectors. The situation is same in other states too, he noted.
The guidelines indicate each Drug Inspector will collect at least 10 samples in a month comprising 9 samples of APIs, excipients and formulations, besides one sample of cosmetics and medical device with no mention of veterinary drugs. Further, it has been mentioned about establishing supply chain up-to manufacturer for every sample taken which is a tedious exercise involving huge workforce of enforcement officers which is currently lacking, Dr Jagashetty told Pharmabiz.
Another point observed is that the NSQ reports with copy of test reports in excel sheet format need to be uploaded before 10th of every month on CDSCO website as per Para 9 but does not indicate the need for loading on state DC department websites, wherever available, which is odd, he said.
Also the regulatory guidelines fail to mention ‘marketers’ in the NSQ alert chart though during March 2021 itself rules have been amended making marketers also equally responsible for quality This information need to be furnished in test reports of Form 13 besides Form 17 and 18, said Dr Jagashetty.
Though the government analyst has been mandated to submit a test report within 60 days as per Rule 45 which is too long for simple analysis and may require only around 48 to 72 hours, the said guidelines do not provide suitable accountability to the government analyst, he noted.
Section 23 (3) of the Act provides to divide the sample into four portions from any outlet and into three portions from manufacturer’s premises. However under para 6 mentions dividing the samples taken into four equal portions which may lead to confusion for drug inspectors while drawing samples.
Raising an objection to 7 (d), calling drug inspectors to obtain the method of analysis from manufacturer instead from concerned SLAs who needs to obtain the same from the manufacturer before grant of license, Dr Jagashetty said, “The government analyst can evolve a method of analysis which must be mentioned in the report in Form13 as per explanation 5 of Rule 46. Also CDSCO officers should help to get the same from concerned SLA.
It is strange to observe that as per para 7 addressing CDSCO drug inspectors to use the Sugam lab portal for generation of Form 17, 17A, 18 to forwarded online to concerned labs instead of making this portal available to all state labs, to bring in uniformity pan-India, said Dr Jagashetty.

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