The pharmacy traders in Karnataka have called for the inclusion of provisions for fixing accountability on the part of clearing and forwarding (C&F) agents in the Good Distribution Practice (GDP) regulations, for which a draft guideline has been issued by the Union health ministry recently.
“By and large the GDP draft guideline is seen to be a big benefit to pharmacy trade, but we still need to add three key points to the guideline. One is the inclusion of accountability on the part of clearing and forwarding (C&F) agents who are the median points between the pharmaceutical manufacturers and pharmacy trade. The second is the need for a website which could either be a dedicated one or coming under DCGI to provide details of the batch movement from the manufacturers' warehouses to the C&F outlets. Third is the amendment for liability by the C&F agent on manipulative methods”, said Arun Mehta, administrative secretary, Bangalore District Chemists and Druggists Association (BDCDA).
First, GDP should ensure that C&F agents are also responsible for the substandard quality of drugs. This is because most medicines are temperature sensitive. Although the storage units of C&F agents are air conditioned, the commercial transport vehicles are ordinary tempo trucks transporting medicines across chemist outlets. When pharma companies and chemists are held responsible for the not-of-standard quality drugs, the C&F agents are nowhere on the scene or even questioned. More often the drugs lose potency during poor transportation processes. Therefore, the GDP guidelines should include the responsibility of C&F agents too, Mehta pointed out.
Secondly, an online record via a website would help track the batch movement. During an allegation of not-of standard quality or spurious drug, it would be far more simpler to trace the pharma company, C&F agent and chemists for dispatch and delivery of drugs. In most situations of substandard drugs charge, it is the failure of right method of transportation from the C&F depots to the pharmacy outlets which could have led to the drug losing its potency. This is where the Union government mandate for bar code implementation would have also helped to identify the suppliers. More often the chemists are challenged to prove the storage of medicines during substandard drug seizures. We become the scapegoats. The guideline could also look at issuing and renewing pharmacy licenses only if refrigeration and cold storage units are installed at outlets, said Mehta.
Thirdly, in order to put an end to the manipulative moves by C&F agents who allege that payments were not collected from the pharmacy outlets during the delivery of drugs, the GDP guideline should insist that all transaction should be through cheque payment only. The current practice allows identification of chemists by C&F agents with code numbers which is seen to be adopted surreptitiously for bogus billing activity which is rampant, stated Mehta.