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Drug trade bodies have sought direction from the government to pharmaceutical companies to demarcate generics to help chemists comply with Drugs Controller General of India (DCGI)'s recent circular mandating all drug stores to display generics on a separate shelf.
Joydeep Sarkar, general secretary of the All India Chemists and Distributors Federation (AICDF) said keeping a separate shelf for generic drugs is not an issue for chemists but there is no demarcation of generics on drug pack. The domestic market is dominated by branded generics. There is no way for a chemist to identify pure generics. Unlike US and Europe, where brand name is not printed on generic drug packs, there is no such provision in drugs and cosmetics rules in India. Indian drug companies are required to submit brand name along with drug master file to get product approval.
The drug controller should direct pharma firms to demarcate generics before making provision for a separate rack for them in stores, said Sarkar.
“We urge the Union health ministry to frame directions with stipulated clauses towards the manufacturers to keep separate ‘identity marks’ for different kinds of formulations like ‘Schedule H’, Schedule H1’, ‘TB drugs’, ‘dietary supplement’, ‘NLEM’ products etc to create awareness among the consumers which can only help the mission of CDSCO which they are aiming through this initiative,” he added.
“Demarcation is helpful while a normal retail outlet used to deal in a minimum of 20,000 brands of different schedules and categories to serve the variations of advice memos of the prescribers or medical practitioners,” said Kaushik Saradar, secretary of Progressive Chemists and Druggists Association (PCDA), an associate of AICDF.
Members of PCDA governing body are very much confused with the directive with a note that following the definition of ‘generic’, so mentioned in different laws and acts the retail outlets hardly deal in 1 per cent of the generic formulations yearly, since ‘brand name’ is compulsory for the registration of any medicine produced by any manufacturer in India.
“The clarity is missing here to describe the ‘generic medicine’ since formulations available in the ‘fair price shops’ of the government hospitals also carry a brand name at every conspicuous place though with a smaller font than its generic name. PCDA seldom finds so called ‘generic medicine’ with the ‘pharmacies’ like Dey’s Medical Stores, Kolkata where ‘dispensing’ is still allowed,” opined Saradar.
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