Confusion Prevails Over Implementation Of Sept 13 Labelling Norms

Mumbai, 1 Nov 2018: The Union health and family welfare ministry's dilly-dallying to notify implementation of new drug labelling norm from September 13, in which the pharmaceutical companies will have to print the generic names of drugs two fonts bigger than their brand names, has sent drug makers in a tizzy.

As per the draft notification by health 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 rule was supposed to come in force from September 13 but no gazette notification was issued by the ministry in this regard. This has led to confusion among drug makers. 

Meanwhile, a privately circulated draft of the health ministry on August 10, 2018 has extended the deadline of the implementation of above labeling change norms to January 1, 2019 while doing away with requirement of maintaining same font in generic name and brand name. The lack of official notification in this regard has made industry more confused.

According to the current set of rules under the Drugs and Cosmetics Act, the generic name should be written in a more conspicuous manner than the brand name but there is no detailed explanation on it. Taking advantage of it, drug companies prominently display the brand name with bold letters on labels while putting generic name in a lighter way. 

Taking serious note of it, the ministry had come out with a draft notification mandating drug manufacturers to introduce a label change for bigger font size of generic names. The implementation of the said label changes hangs in balance in absence of final notification.

However, in May 2018, the ministry had issued labelling norms for Schedule G, H, H1 and X drugs. The new labelling rules under the Drugs and Cosmetics (Fifth Amendment) Rules, 2018 has come into force from November 1, 2018. 

Earlier Drugs Technical Advisory Board (DTAB) had recommended implementation of both labeling changes together with effect from April 1, 2019 in the interest of industry. The DTAB has sent proposal to this effect to health ministry for approval. The proposal is yet to be approved by the ministry. 

When asked about the ambiguity over notification on implementation of labelling change norms from September 13, Drug Controller General of India (DCGI) Dr S Eswar Reddy said “The final notification on implementation of labelling change norms is likely to be issued in early November. There is nothing to worry about delay in notification as it is not related to quality issue. The DTAB has already given its nod to implement both labelling changes for drug packs at one go from April 1, 2019. We are awaiting health ministry's approval for DTAB's proposal in this regard.”

However, a drug industry representative said since the ministry has not approved DTAB's proposal extending implementation of both labelling changes from April 1 next year before November. The gazette notification on implementation of changes in drug packs with respect to Schedule G, H, H1, X has come into force from November 1. Pharmabiz