In the wake of massive re-circulation of expiry drugs in the market, the Union government may make it mandatory for the pharma companies embossing of batch number and expiry date on every tablet instead of the present practice of printing the details with ink on each strip which can easily be erased.
All India Chemists and Distributors Federation (AICDF) with its state associations including Karnataka Chemists and Distributors Association and All Kerala Chemists and Distributors Association will be meeting Union health minister Gulam Nabi Azad to present a memorandum to this effect on April 16, 2010.
Currently, the details of batch number and expiry dates are printed with ink on each strip which can be easily erased. Going by the growing number of cases in re-usage of expiry drugs and the absence of a law to curb the same, we are taking this issue to the health minister who is keen to prevent re-circulation and re-claiming expiry drugs, AN Mohan, president, All Kerala Chemists and Distributors Association (AKCDA) told Pharmabiz.
In Karnataka, value of expiry of drugs is Rs 60 crore a month. This is nearly 10 per cent of the total pharmaceutical trade sales which is Rs 600 crore a month and Rs 7,200 crore annually of which Rs 720 crore is the estimated value of expiry dated drugs.
In 1991, National Level Traders Association and its state associations entered into a memorandum of understanding with the Pharmaceutical Industry Associations to handle the problem of expired and breakage drugs. Although all companies adhered to tracking the expired drugs and collect it back from the their respective dealers, fly by night operating fake pharma companies managed to succeed in selling these drugs by chemically erasing the expiry dates on the strips and print fresh dates before re-circulating these in the market. These drugs are usually the fast moving products and mainly included leading branded formulations of vitamins, antibiotics, among others.
Karnataka has drug destroying unit handling all damaged and expiry dated drugs located at Ramanagaram, 40 km off Bangalore. The pharma companies as part of the quality control practices maintain a list of expired/breakage drugs and verify the stocks at the wholesale, collected from retail outlets. The wholesaler and company share a credit note which provides value of the drug on a pack-to-pack basis. This procedure is followed across the country.
Despite the in-house stringent measures to keep expired drugs at bay, there are few retail pharmacy outlets which keep the expired drugs on the shelves. During surprise inspection drives by state drugs control enforcement team notices are issued for violation, said Ravindhera M J, secretary, Karnataka Chemists & Distributors Association.
The alu alu packing used by pharma companies will now need to emboss the batch number and expiry dates on every tablet/capsules of each strip, he added.
According to the pharma industry, expired, defective or rejected drugs should be destroyed or disposed of in accordance with the local regulations and same should be documented.
According to Mohan, the problem of expired drugs prevail mainly because of the permission to manufacture combination of formulations with a single molecule. This had led leading pharma companies including Sun Pharma, Dr Reddy's, GSK and Zydus to float more divisions to promote new drugs in varied combinations. The government will first need to put a blanket ban on these products.
Pharma industry is now vociferous for the need to bring in a concrete move to prevent the circulation of expiry dated drugs and the government is working to provide a regulation, said Ravindhera.