formulations listed. Presently under NLEM 2011, there are about 628 unique medicines out of 680 medicines of scheduled formulations covering 27 therapeutic groups are subject to price control. Currently NPPA is scanning the new list of the approved Essential Medicines to compare it with the new list in the NLEM and start fixing the ceiling prices, which would be done in the next three to four months. In additions to medicines listed in the schedule I of the DPCO – NPPA also fixes the retail prices of new medicines for which the pharma companies have to apply specifically to NPPA in the FORM – I of DPCO, 2013, where the retail price is company specific and the medicines of the company’s should satisfy the conditions of para 2(u) of DPCO, 2013 – so that the Drug qualifies to be the new drug under DPCO. So far NPPA has fixed retail prices of 247 new drugs. NPPA also invokes the extraordinary powers under para19 of DPCO 2013 – where the NPPA and Government are given the power to decide on prices in extraordinary circumstance such as public health and other important issues. In July 2014, NPPA fixed the prices of 106 medicines invoking the powers vested in para19, which include anti diabetic and medicines. NPPA also monitors the availability of scheduled and formulations across the country. Along with that, the enforcement wing monitors the selling of medicines at fixed ceiling price for retail prices for company specific, in case of non-compliance it also takes actions against the company for over charging also by invoking the provisions of Essential Commodities Act. DPCO provides for exemptions for the Patented Medicines – if they are developed indigenously through indigenous R & D and this exemption is for a period of five years from the date of commercial production for product or a process Patent. If a new drug involving the drug delivery system is developed through indigenous R & D, it is exempted from price control from the date of
formulations listed. Presently under NLEM 2011, there are about 628 unique medicines out of 680 medicines of scheduled formulations covering 27 therapeutic groups are subject to price control. Currently NPPA is scanning the new list of the approved Essential Medicines to compare it with the new list in the NLEM and start fixing the ceiling prices, which would be done in the next three to four months. In additions to medicines listed in the schedule I of the DPCO – NPPA also fixes the retail prices of new medicines for which the pharma companies have to apply specifically to NPPA in the FORM – I of DPCO, 2013, where the retail price is company specific and the medicines of the company’s should satisfy the conditions of para 2(u) of DPCO, 2013 – so that the Drug qualifies to be the new drug under DPCO. So far NPPA has fixed retail prices of 247 new drugs. NPPA also invokes the extraordinary powers under para19 of DPCO 2013 – where the NPPA and Government are given the power to decide on prices in extraordinary circumstance such as public health and other important issues. In July 2014, NPPA fixed the prices of 106 medicines invoking the powers vested in para19, which include anti diabetic and medicines. NPPA also monitors the availability of scheduled and formulations across the country. Along with that, the enforcement wing monitors the selling of medicines at fixed ceiling price for retail prices for company specific, in case of non-compliance it also takes actions against the company for over charging also by invoking the provisions of Essential Commodities Act. DPCO provides for exemptions for the Patented Medicines – if they are developed indigenously through indigenous R & D and this exemption is for a period of five years from the date of commercial production for product or a process Patent. If a new drug involving the drug delivery system is developed through indigenous R & D, it is exempted from price control from the date of
Activities-of-CIPRA-2015-16.docx