National drug price regulator has sought comments from the pharma industry, health experts and other stakeholders on recommendations of Tata Memorial Centre to add 12 drugs in the National List of Essential Medicines (NLEM) while asking for deletion of 3 drugs.
The comments are invited from pharmaceutical industry and trade, consumer organisations, public health experts and other stakeholders on the recommendations of Tata Memorial Centre under Dept of Atomic Energy.
"(this is) on revision of NLEM 2011 with respect to addition/ deletion of drugs relating to oncology from price control and affordability angle, NPPA said.
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It has asked for addition of twelve drugs -- All Trans Retinoic Acid (ATRA), Bendamustine, Rituximab, Lenalidomide, Trastuzumab, Capecitabine, Temozolomide (TMZ), Irinotecan, Erlotinib, palliative and supportive medicines such as Zoledronic acid and hormonal therapy drug Megestrol acetate and Letrozole, NPPA said.
The centre has asked for deletion of three drugs Busulphan, Raloxifene and Danazol from the NLEM list due to their restricted use or not common usage in oncology at present.
The recommendations are based on careful review of the list of medications included in the NLEM, taking into consideration factors such as unequivocal proof of benefit versus previous comparator, the number of patients potentially impacted in India and price of the drug to patients and the differential in price between various brands, NPPA said.
National Pharmaceutical Pricing Authority (NPPA) has been assigned with the task of evaluating the impact of NLEM 2011 in making essential and lifesaving drugs both affordable and available to all, NPPA said.
It has also been asked to make necessary recommendations with respect to updating the list of scheduled drugs in order to ensure that all essential and lifesaving drugs of mass consumption are under price control for safeguarding public interest, it added.
"Comments, if any, on the above draft recommendations for addition/ deletion from NLEM 2011 may be submitted to NPPA within a period of two weeks from the date of the notice," NPPA said.