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Since the state has four drug testing laboratories and one more in the pipeline, the drug control administration (DCA) in Kerala has prepared new guidelines to drug inspectors for drawing drug samples from industry and retail shops.
As per the new guidelines, one drug inspector has to collect 23 samples per month and this will likely increase when the fifth lab becomes operational. Kerala DCA is the only drug regulator in India having this much number of drug testing laboratories and large collection of drug samples.
Sources said the department wants that the quality of all the medicinal products circulated in the market, whether locally manufactured or imported, should be free from all sorts of defects, deficiencies and variations. The DCA is fully committed to standards and measures are taken accordingly to ensure that all the drugs of every batch marketed in Kerala should have the same quality standards and not even a single NSQ will be allowed to remain in the market, says Dr. K Sujith Kumar, drug controller, Kerala.
“Unlike in other states in the country, Kerala DCA has four drug testing labs (DTL), out of which two are NABL accredited. One more laboratory is being constructed at Kannur. The labs and the drug control wing have sufficient staff including drug inspectors and they need jobs. So, the number of sample collections has been increased from 10 to 23 per month. With the increase in the number of laboratories, the time for analysis and test report has been reduced to three weeks from the earlier two months or three months time”, said the DC over telephone.
He said once the Kannur lab becomes functional the state will have a total five DTLs and each one will be notified for specialization like one facility for Ayurveda, one for cosmetics, one for medical devices and the remaining for pharmaceuticals. The department has recommended to the government for increasing the number of drug inspectors and analysts for the smooth operation of the laboratories. Five retirement vacancies of drug inspectors will be filled up this month and some new posts are expected in another few months' time. Then sample collection will automatically increase further, said Dr. Sujith by adding that all other states are drawing less than 10 samples in a month.
Upholding Kerala DC’s comment, the Tamil Nadu drug controller M N Sreedhar said the inspectors in the state are drawing only less than ten drug samples in a month’s time as there are only two laboratories. Madurai DTL, the latest one, is receiving samples from 13 districts in the south, whereas the Chennai lab which is NABL accredited is getting samples from 20 districts. Sreedhar said the drug control wing has given two months time to the analyst to release the test report.
Sumanta Kumar Tiwari, joint drug controller of Jharkhand and national secretary of drug control officers association, said the laboratory in Ranchi is also NABL accredited and the drug inspectors in the state collect ten samples per month. The department has given an annual target of 120 samples to a drug inspector. The department gives 60 days to the laboratory to issue the test report from the day of dispatching.
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