Union government has now amended Rule 96 of D&C Rules making it mandatory to print/write the generic name in double the font size making it bigger than brand name on drug labels. The Rule will be enforced from September 13, 2018. But, the pharma industry is now apprehensive on the implementation of new font as this will clutter the label design and decrease the white space. This could mar the ease of viewing the product label.  
 
The notification states that the Rules may be called the Drugs and Cosmetics (First Amendment) Rules, 2018. The industry is given 45 days to provide its objections and suggestions if they are impacted or benefited from the new regulations.
 
The guidance maintains that in Rule 96, in sub-rule (1), in clause (i), in sub-clause (A), the proper name of the drug or FDC drug other than fixed dose combinations of vitamin and other FDCs containing three or more drugs, shall be printed or written in a conspicuous manner which shall be in the same font size but at least two font size larger than the brand name or trade name, if any, in other cases the brand name or trade name, shall be written in brackets below or after the proper name and shall be substituted, stated Sunil Sharma, joint secretary of Ministry of Health and Family Welfare in his communication.
 
“We appreciate the initiative of the government to make the generic name more prominent on the pack with a directive to have it 2 font size bigger than the brand. However, the need to print it in the same font style is going to pose a challenge for most companies. This is because the brand names are usually designed as a logo and registered with a unique distinguishing character and often not even a regular font. Therefore, to write the generic name in with the same design will be very difficult or companies will have to change the design of the brand name to a more standard character. This in some cases will erode the brand image especially if we move to an OTC regime and differentiating branding will be tough,” Sunil Attavar, president, Karnataka Drugs and Pharmaceutical Manufacturers Association and MD, Group Pharmaceuticals, told Pharmabiz.
 
The order is not very clear on the products with more than three active ingredients. This is because the Rule states that companies need to put a bracket around the brand name. We have sort clarity on the matter so that we can initiate the process for change for which we have six months, added the KDPMA president.
 
According to Kaushik Desai, pharma consultant, this initiative will help the consumers to know the generic names of the drug. But, the guidance is unclear with regards to FDCs as adding the names of multiple generics will be confusing for the physicians, pharmacists and patients because the brand names are more popular than the generics. Furthermore, it poses a challenge to the imported medicines which are re-packaged and labelled in India. Here import takes its own lead time, therefore six months is too short a time to execute the same. In wake of drug price control, industry views additional expenditure in terms of new label artworks and inventory management.