Indian Drugs Manufacturers Association (IDMA) has approached National Pharmaceutical Pricing Authority (NPPA) to withdraw the draft proposal on distinguishing mark and ceiling price for scheduled drugs as it could lead to price hikes and confusion among the consumers.

As per the draft proposal of NPPA, the product pack is supposed to carry the information on ceiling price per unit additionally along with the MRP already printed as per DPCO 2013 Rules.

IDMA in a letter to the NPPA has pointed out that this would be totally confusing to the consumers as they are not aware of the state-wise VAT taxes (local taxes) added to the ceiling prices. This could also create ill-will and chaos among the consumers, as they naturally would prefer to pay the lesser printed price, i.e. the ceiling price and not the MRP, which they need to pay.    

Proposal for a distinguishing mark (a bold strip with the words "DPCO Scheduled Drug" printed on it in black ink) would mean that the scheduled drugs will need to carry two red lines.

Questions an IDMA official, "Also when the Supreme Court has ruled that no pack should be available at two different prices at the same time to avoid confusion, how is it mandatory to print the ceiling price and MRP on the same pack and expect the consumer to understand the working of DPCO to calculate the MRP to be paid?"

IDMA is also concerned about the fact that all the packs and labels of scheduled drugs will have to be changed and artworks redesigned and printed reprinting of labels/cartons/foils etc to incorporate the new suggestions, entailing additional costs running into hundreds of crores, which are not covered under DPCO -2013. In addition to preparation of art work, which is a one time cost, the cost of packing material will also go up.

Another point of contention pointed in the submission states that for all packs which are very small, it would not be possible to add any additional field or lines. The size of the packs of ampoules, strips etc are very small and the requirements under the Drugs and Cosmetics Rules 96 and 97 regarding declarations to be made on each pack of drug is mandatory.  And this distinguishing mark would not be able to fit in, in addition to all the declarations already required to be displayed on each such pack.

It is also been highlighted by IDMA that drugs are exempted for the provision of the rules under Rule 26 (c) with reference to invoking Legal Metrology Act 2009 and the Legal Metrology (Packaged Commodities (Rules), 2011. And this exemption stems from the very fact that there already exists under the Drugs and Cosmetics Act more than adequate labelling provisions so that the labelling provisions under the Packaged Commodities Rules would be redundant.

If the exemption is removed, then all drugs available in the market will have to additionally comply with these rules and be governed by the size of fonts and principal display concepts etc embodied in the Legal Metrology (Packaged Commodities) Rules for declarations.

"A drug which falls under the scheduled category for one manufacturer as a new drug may not necessarily be a scheduled drug for another manufacturer. This will have some drugs with red line and the same drugs without the red line and will only add to the confusion among the consumers and medical doctors," IDMA in its letter sent to the NPPA concluded.