MoH Notifies Uniform Implementation Of New Labelling Norms From April 1, 2019

Mumbai, 24 Dec 2018: The Union health ministry has come out with draft notification implementing labelling change for drug packs uniformly from April 1, 2019 thus bringing the much needed respite to pharmaceutical industry from complying with changes in drug label twice.

The notification was issued by the ministry after consultation with the Drugs Technical Advisory Board (DTAB). 

The ministry in a circular on December 3, 2018 had extended the deadline of the implementation of March 13 notification to April 1 next year while omitting the requirement of maintaining same font in generic name and brand name. 

As per the notification by the ministry on March 13, 2018, the proper name of the drug or fixed dose combination drug other than fixed dose combinations of vitamin and other fixed dose combinations containing three or more drugs, shall be printed or written in a conspicuous manner which shall be in the same font but at least two font size larger than the brand name or the trade name, if any, and in other cases the brand name or the trade name, if any, shall be written in brackets below or after the proper name.

The circular was supposed to come into force from September 13. Meanwhile on August 10, 2018 the ministry had come out with a notification removing the need for maintaining same font in generic name and brand name following a slew of representations from the drug industry who found it difficult to comply with labeling norms mandating to print generic names of drugs in a same font but at least two font size larger than the brand name. It had invited suggestions from stakeholders in this regard. 

Industry sources said the March 13 circular, if implemented, would potentially affect visibility of brands. The brand invisibility could lead to a lot of prescription errors because certain brand names look like similar.

In another draft notification on December 7, the ministry had extended the deadline of the implementation of April 26 notification to April 1 next year. 

On April 26, 2018, the ministry had come out with a notification on labelling norms for Schedule G, H, H1 and X drugs. It had made printing of box warning/caution in red colour on Schedule G, H, H1, X drugs mandatory with effect from November 1, 2018.

Though the ministry has considered industry's concern over implementation of March 13 circular, it is yet to look into grey areas of April 26 notification posing a greater challenge for compliance. No effort has been made in the December 7 circular to address the grey areas. 

A drug industry representative said “The printing of box warning/caution in red colour on Schedule drugs with legible black coloured font needs clarity. To bring transparency, the ministry needs to come out with samples of label mentioning warning in red coloured box with legible black coloured font.”

He said “The ministry's mandate to label Schedule G drugs as prescription drugs along with earlier cautions or warning needs to be withdrawn. Schedule G drugs are non prescription drugs but are taken under the guidance of doctors. The conversion of caution statement into prescription warning has become cause of concern for the industry.”

He further pointed out that the ministry has not yet clarified the fact that in case of drugs uncovered in Schedule G, H, H1 and X, drug companies would comply with Form 45 mandates or April 26 notification. Form 45 mandates drug companies selling drugs, left uncovered in above schedules to print warning--  to be sold by retail on the prescription of a specialist doctor. For instance, cancer drugs uncovered in any of above schedules will carry warning, to be sold by retail on prescription of oncologists. While April 26 notification directed the companies to print warning on packs, “To be sold by retail on the prescription of a registered medical practitioner only.” Pharmabiz