Business Standard

Print generic drug names at twice the size of brand: Govt

- ANEESH PHADNIS

The Union health ministry has tightened labelling norms for medicines, making it mandatory for pharmaceut­ical companies to print generic names of drugs in characters that are twice the size of those in brand name. The change in labelling, which is seen as part of the government’s effort to push generic drugs, will come into effect on September 13. A notificati­on amending the Drugs and Cosmetics Rules was issued last week.

The change in font size is mandatory for all formulatio­ns, except combinatio­ns of vitamins and fixed dose combinatio­ns consisting of more than three molecules.

According to the notificati­on for such vitamins and fixed-dose combinatio­ns, the brand name will be written in a bracket below or after the generic name.

Finance Minister Arun Jaitley in his Budget speech last year had announced that the government would introduce rules to promote the use of generic medicines. The government had proposed an amendment to the Drug and Cosmetic Rules to make it mandatory for doctors to prescribe generic medicines. The draft pharmaceut­ical policy of 2017 too proposed sales of single-ingredient drug in generic names only but the policy had remained on paper. This was in line with the government push for affordable medicines, which has included setting up of Jan Aushadhi stores to dispense low-priced medicines.

The proposal to make generic drug prescripti­on mandatory too has not been finalised but experts believe that change in labelling will give generic names greater visibility over the brand name. Earlier, there was a rule that the generic name should be written in a “more conspicuou­s manner” on the package and the rule has now been amended to plug loopholes and for better implementa­tion.

“The government is even proposing that every chemist keep a dedicated shelf for generic drugs. The Drugs Technical Advisory board has recommende­d that chemists keep a separate rack for generic medicines, which is visible to customers,” an expert said.

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