New Delhi: A total of 70 drug samples were found to be Not of Standard Quality (NSQ) by the central drug regulatory body in the latest round of survey.
Further, govt said, one drug sample from the state of West Bengal was identified as a spurious drug, which was manufactured by unauthorised manufacturers using the brand name owned by other companies. The matter is under investigation and action will be taken as per Act & Rules, the source said,
“This action of identifying NSQ and Spurious medicines is taken on a regular basis in collaboration with state regulators to ensure that these drugs are identified and removed from the market,” said a senior health ministry official.
Drug regulatory bodies carry out random sampling and tests on a regular basis to spot and alert the authorities about potential violations of Good Manufacturing Practices (GMP).
Officials said there hasn’t been any significant increase in the number of samples found to be lacking in the desired standards. However, they add, the govt continues to keep up the pressure, so the manufacturing process improves further and there is no violation at all.
Recently, CDSCO introduced new guidelines for the inspections. It stated that all drug inspectors in the country should collect at least 10 samples in a month; nine samples of drugs and one sample of cosmetics/medical device. Also, new guidelines said the drug inspectors must plan the sampling in such a way that samples are forwarded to the laboratory on the same day of sampling.
In the case of rural location or distant location to office, samples shall be forwarded to laboratory by next day and not later than that, according to the guidelines. The new guidelines also provide centralised information on sale outlets where sub-standard or spurious products are reported to keep them under regular vigilance.
