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 the brand name on drug labels. The Rule will be authorized from September 13, 2018. But, the pharma industry is currently apprehensive about the implementation of the new font as this will clutter the label design and reduce the white space.
This could damage the ease of reviewing the product label. The notice states that the Rules may be known as the Drugs and Cosmetics (First Amendment) Rules, 2018. The industry is given 45 days to give its objections and suggestions if they are impacted or benefited by the new regulations.
The guidance keeps up that in Rule 96, in sub-lead (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 at least three drugs, should be printed or written in a conspicuous manner which might be in a similar font size but at least two font size larger than the brand name or trade name, assuming any, in other cases the brand name or trade name, should be written in brackets below or after the proper name and might be substituted, expressed 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. In any case, the need to print it in a similar font size is going to pose a challenge for most organizations. This is because the brand names are typically designed as a logo and registered with a unique recognizing character and often not even a normal font. In this manner, to write the generic name in with a similar design will be very difficult or companies should change the design of the brand name to a more standard character. This now and again will dissolve the brand image particularly if we move to an OTC regime and differentiating branding will be intense,” Sunil Attavar, president, Karnataka Drugs and Pharmaceutical Manufacturers Association and MD, Group Pharmaceuticals.
The order isn’t sure about the products with more than three active ingredients. This is because the Rule expresses that organizations need to put a section on the brand name. We have sort clarity on the matter so that we can start the process of change for which we have a half year, included the KDPMA president.
As indicated by Kaushik Desai, pharma advisor, this activity will help the consumers to know the generic names of the drug. However, the guidance is vague with respect to FDCs as including the names of multiple generics will be confusing for the doctors, pharmacists, and patients because the brand names are more popular than the generics.
Moreover, it represents a challenge to the imported medications which are re-packaged and labeled in India. Here import takes its own lead time, in this way a half year 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.