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The Drugs Technical Advisory Board (DTAB) of the Union health ministry has given its green signal to the DCGI's proposal to implement 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 within a couple of months.

Once health ministry approves the proposal, a notification will be issued in this regard, said Drug Controller General of India (DCGI) Dr S Eswara Reddy.

The ministry decided to mandate drug manufacturers to introduce a label change for bigger font size of generic names from September 13 this year as well as implement new labelling norms for Schedule H, H1, G and X drugs with effect from November 1 this year. The label change for drug packs in less than two months had given sleepless nights to pharma industry CEOs as it would lead to multiplication of art work and subsequent increase in expense.

The drug industry has been demanding synchronized implementation of labelling changes. Various industry captains have appealed to the health ministry to introduce labelling change for drug packs at one go rather than implementing it in a piecemeal manner.

Implementing new labelling norms for Schedule H, H1, G and X drugs whereas drug makers are required to print warning/caution in red coloured box with black coloured font as well as mention generic name two font bigger than brand name has become a massive challenge for the drug industry.

The industry is looking for leeway from implementation of new labelling norms as it hardly has any use for patients.

Talking about problems faced by the industry in implementing new label changes, Soumyanath Mishra, head-packaging development, Mankind Pharma said “There is a problem with font size. Printing generic names of drugs in a font which is two font size larger than the brand name on small blister packs is a challenge. For this, the pack size needs to be enhanced which in turn leads to production expense. Nowadays pharma companies have started reducing packaging cost to bring down the production cost. The size of drug packs is being optimised.”

The printing of box warning/caution in red colour on Schedule G, H, H1, X drugs is also a challenging task for most of drug companies. The aim of the label is to display patient centric information which helps patients comply with treatment regime. Making cosmetic changes in label such as putting warning statement in red coloured box will hardly improve patient outcomes, he said.

Revealing a lot of information through drug labels will not fulfill purpose unless it is legible. The industry is already displaying a lot of information on drug packs but it hardly has any use for patients as its not legible, he added.

Another packaging expert said, “The pack of certain products has limited space. Its a challenge to increase font size of generic names on the existing drug pack. The manufacturers can comply with the ministry's mandate by decreasing the font size of brand name in the pack which will in turn hamper visibility of brands. The brand invisibility could lead to a lot of prescription errors because certain brand names look like similar. The implementation of label changes containing change in font will increase cost burden of the mid and small sized industry.”

The talks between health ministry officials and industry representatives are going on to withdraw certain changes in new labelling norms. The ministry officials have agreed to withdraw certain changes in the packaging norms, sources said.

“The requirement for same type font for brand and generic name will be removed. A revised notification in this regard is likely to be issued by next month. There will be no change in printing generic names two font size larger than brand name. It will continue as per the notification. The ministry's mandate to label Schedule G drugs as prescription drugs along with earlier cautions or warning is likely to be withdrawn. The proposal to revise Schedule G classification will be presented in the next DTAB meeting,” sources added.

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.
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