The Union health and family welfare ministry's decision to introduce change in drug label twice in less than a span of two months between September and November this year has become a cause of concern for pharmaceutical companies as it will result in multiplication of art work and subsequently increase cost.

The industry captains are of the view that the labelling change for drug packs should be implemented at one go rather than introducing it in a piecemeal manner. The repeated changes could affect sales and lead to temporary shortfall in drug supply thereby posing serious risk to patients.

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.

DG Shah, secretary general of Indian Pharmaceutical Alliance, said, “All companies carry certain inventory on the label. Frequent changes in labelling norms will impact production cost. Implementation of all label changes should be synchronized in a manner that industry should not get affected. We have time and again appealed to the ministry to introduce label changes which are not related to drug quality and patient safety altogether. It should be implemented by month end as batches are under production in mid-month.”

As per the notification issued by the ministry, pharma units are required to change the label with the generic name printed on it in double the font size making it bigger than brand name with effect from September 13. They have to recall products again to comply with new labelling norms for Schedule G, H, H1, X drugs which will be effective from November 1. Putting in place different labels of same product at interval of one and half months will enhance packaging cost. If both the labelling norms will be implemented on a single day, it will save time and money to be spent on re-doing the task, said Nipun Jain, chairman of Small and Medium Pharma Manufacturers Association (SMPMA).

The ministry issued a notification in March this year amending Rule 96 of Drugs and Cosmetics Rules mandating pharmaceutical companies to have bigger font size of generic names on labels.

Earlier this month, the ministry issued labelling norms for Schedule H, H1 and X drugs. The new labelling rules will be effected through the Drugs and Cosmetics (Fifth Amendment) Rules, 2018. It has made it mandatory to label Schedule G, H, H1 and X drugs as prescription drugs along with earlier cautions or warning. The colour of printing of box warning/caution is also prescribed now and should be in black whereas box linings in red colour.

Deepnath Roy Chowdhury, national president of industry body Indian Drug Manufacturers Association (IDMA) said, “We definitely have issues with said notifications. We will make further representation shortly in this regard.”