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Karnataka trade bodies find practical problems in govt's 90-day deadline in HPLC tested drug reports
Nandita Vijay, Bengaluru | Friday, November 9, 2012, 08:00 Hrs  [IST]

The Union health ministry’s move to bring in a time-line to complete the tests of drug samples by the state laboratories would allow considerable accountability and an opportunity to improve analysis. However, there are serious practical problems if the reports are issued in 90-days,  opined pharmacy trade associations representing the Bangalore District Chemists and Druggists Association and the Karnataka Chemists’ Druggists Association.
 
For instance, the drugs picked up at random by the drug inspectors are sent in for tests and we are anxious on the ensuing lab test results.   Barring Karnataka, in most of the other state drugs control departments,  the reports are delayed and it most often leads to a situation where the drug of that particular batch number is either exhausted from retail and distributor outlets or crosses the expiry date, said Arun Mehta, administrative secretary, Bangalore District Chemists and Druggists Association (BDCDA).
 
Therefore, for the drugs undergoing not-of-standard quality assessment or picked to be ascertained, if they are spurious or counterfeit, test report analysis needs to be produced at a faster pace.  There is no doubt that a 90-day period is far too lengthy, he added.
 
Though the health ministry’s step is in the right direction, from a pharmacy trade point of view, we cannot put the patient into any sort of problem. The fraternity of chemists are recognized as the health-keepers of the nation and we have a social responsibility because we are a part and parcel of this system of safe drug sale practice. Our basic responsibility to the  patient is to guarantee the standard of quality of the medicines sold. In this background,  the 90-day period for drugs tested using HPLC method which is highly advanced  is a sheer time waste, said Mehta adding that 45 days for drugs tested without HPLC is confusing.
 
Representing as an affiliate of the Karnataka Chemists and Druggists Association,  Ravindra Kumar M, general secretary, Bangalore City Chemists and Druggists Association said that the Union Government’s effort to speed up in getting the lab test report within a stipulated time of 45 to 90 days, on drug samples obtained from the market shall definitely help in curbing the distribution of spurious and sub standard drugs to retail pharmacies and to ailing public at large.
 
Once the circular on spurious or sub-standard drugs reaches our office we immediately inform our members not to sale or distribute such drugs. We ask them to return the drugs to the original supplier along with purchase and sale details. In addition, we also insist that they would need to maintain proper records of such documents for the information of drugs control department’s enforcement officials, he stated.

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