Karnataka's paracetamol manufacturers and the drug trade associations are of the view that the warning notice to be carried on paracetamol brands should be of a bigger font size as most cautionary notices indicating the adverse drug reactions failed to catch the attention of the consumers mainly because it is impossible to read.
According to a directive from the Drugs Controller General of India (DCGI) the Karnataka drugs controller has already issued a circular last month to carry a caution note for paracetamol formulations. However, there is no mention about the font size.
Drug manufacturers and drug retail outlets owners expressed that increase in font size was vital in warning notices. But the experts in the area of pharma packaging said that DCGI could only indicate the relative prominence of the fonts for a component of the label claim.
The uniform size of the font cannot be indicated because the print area differs from label to label and from brand to brand even when the active ingredients are the same. For eg. a company can choose to market paracetamol in strips often which can be individually put into a cash cover or ten strips will go into an outer carton which will again go into a shipper, all these packaging entities have a wide variation in their print area. For liquid paracetamol, the print area for a bottle label is much smaller than the bottle's carton.
The drug retailers and wholesalers are of the view that the drug manufacturers should increase the font size as it was crucial for customers to know about the drug reactions and that it was not in their purview to warn patients to read the cautionary note.
Another concern by the drug manufacturers is the growing numbers of over-the-counter misuse of drugs of paracetamol with non-steroidal anti-inflammatory (NSAIDs) formulations prescribed for pain management, which is more dangerous than Benzodiazepine formulations.
But V Hari Krishnan, president, Bangalore District Druggists and Chemists Association said that it was difficult to control the sale of drugs without prescriptions, however the retail outlets are been apprised about the same.
Paracetamol formulations in the state are registering sales to the tune of Rs. 3.2 crore annually. There are over 10 companies engaged in the production of paracetamol formulations, which include Micro Labs, Medibest Pharma, Bentley Remington, Bal Pharma and Sterling Labs.
The paracetamol manufacturers in the State are now in the process of adopting the warning notice on all its brands, which was not required earlier.