Earlier On 27th February, 2019, National Pharmaceuticals Pricing Authority (the 'NPPA') listed 42 anti-cancer drugs under 30% Trade Margin rationalization. In this view, drug manufacturers and Hospitals were asked to convey revised MRP of these drugs on the basis of revise Trade Margin (TM) formula.

Now therefore, the NPPA listed out the MRP price of 3901 non-scheduled anti-cancer medicines based on the data received till March 07, 2019. The revised prices made effective from March 08, 20192. In addition to this NPPA on March 19, 2019 listed out 543 more branded anti-cancer drugs under this price revision, making it effective from March 08, 2019. Prices of more brands are expected to show downward reduction in near future, as data is received from other manufacturers.

The MRP reduction of 390 anti-cancer non-scheduled medicines were recorded up to 87%. 390 brands i.e. 91% of the 426 brands reported by manufacturers, showed downward price movement as described below:

Range No. of Brands
75% & above 38
50% to <75% 124
25% to <50% 121
Below 25% 107
Total 390

The price so fixed shall be valid for one year from the date of notification. The price computed for non-scheduled formulations (all strengths and doses form) (whether individual or in combination, irrespective of dosage strength, dosage form and /or route of administration) under this Order containing any of the drugs listed in 42 drugs shall be applicable even if the formulation is being used for other therapeutic uses.

The manufacturers of the formulations are required to maintain the present production levels. Any manufacturer intending to lower the average monthly production levels will seek prior permission from NPPA. Further, any manufacturer intending to discontinue production of above said formulations shall furnish information to the NPPA, in respect of discontinuation of production and / or import of said formulation in Form-IV of Schedule-II of the Drugs Price Control Order, 2013 at least six months prior to the intended date of discontinuation.

State Drug Controllers shall monitor the compliance of this Order by the manufacturers / dealers / Hospitals / Medical Institutions and the manufacturers / dealers / Hospitals / Medical Institutions shall assist the State Drug Controllers in verifying the compliance to this order. Any violation of this Order is required to be brought to the notice of NPPA.

Conclusion:

The average out of pocket expenditure for cancer patients is 2.5 times that for other diseases. This move is expected to benefit 22 lakh cancer patients in the country and would result in annual savings of approx. INR 800 crores to the consumers. The Trade Margin rationalizations for these 42 anti-cancer drugs was rolled out as Proof of Concept, stressing on the new paradigm of self-regulation by the Industry.

Footnotes

1. http://www.nppaindia.nic.in/wp-content/uploads/2019/03/Brands-List-for-OM.pdf

2. http://pib.nic.in/PressReleaseIframePage.aspx?PRID=1568297

3. http://www.nppaindia.nic.in/wp-content/uploads/2019/03/Annexure-Z.pdf

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