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The Karnataka Chemists & Druggists Association (KCDA) has termed the recent circular issued by the Karnataka Food and Drugs Administration (FDA) on certificate of analysis as absurd. The FDA has recently issued a circular to the pharmacy distributors asking them to procure ‘Certificate of Analysis’ for every batch of medicines procured. The State FDA sent the circular in its effort to stop infiltration of spurious drugs.
KCDA secretary AK Jeevan said that the circular from the Karnataka FDA was circulated to all the pharmacy wholesalers to adhere to the order of submitting the certificate of analysis. The volume of paper work and the cumbersome task of getting the ‘Certificate of Analysis’ for every purchase of medicines will be difficult.
"We view it as a difficult exercise to get the Certificate of Analysis for every medicine. This is a cumbersome exercise in the wake of the existing jobs that a pharmacy distributor needs to do. It is not easy to key in and check the batch number for every pharmaceutical product. Therefore, we feel that this is not the step in the right direction," said Jeevan.
The reason given by the Karnataka FDA is baseless as it feels it would be right strategy to stop the infiltration of spurious drugs. It is also to be noted that in the communication issued from the state FDA office said that it has empowered to recruit a panel of the department’s enforcement officers who have communicated this via What’sApp. Such a mode of communication is not correct and has never been done using a social media platform, pointed out the KCDA secretary.
"We wish to bring to your notice that in the past when Karnataka drugs control department was led by an IPS officer, a communication which was not relevant led the pharmacy trade fraternity to go to court and win the case, leading to his stepping down from the post," said Jeevan.
With reference to the above issue of pharmacy wholesalers submitting Certificate of Analysis’ for every batch of pharmaceuticals procured is not correct. Also, no state in the country other than Karnataka has come up with such an order. Hence our request is to correspond in the right way of issuing a letter. We also insist that this present circular to be withdrawn, said Jeevan.
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