Concerned over the scarcity of certain essential medicines like anti-malarial combination of sulfadoxine + pyrimethamine tablets, rabies vaccine, anti-snake venom, etc in the country, the National Pharmaceutical Pricing Authority (NPPA) has warned the concerned manufacturers and importers of penal action under the relevant provisions of Essential Commodities Act, 1955 if they fail to resolve the issue of shortage of these drugs in the country immediately.
The NPPA has also directed them to maintain the production level and adequate supply of these medicines and also ensure submission of the information in Form- III of the Schedule -II of the DPCO, 2013 quarterly. Besides, the NPPA has directed them to comply with the requirements contained in para 21(1) and provide the month-wise production and sale figures for these drugs for the last 12 months under para 29 of DPCO, 2013.
In a notification, the NPPA said that the scarcity of certain essential medicines, namely, anti-snake venom, rabies vaccine, rabies immunoglobulin, albumin injection and anti-malarial combination of sulfadoxine + pyrimethamine tablets has been reported to the NPPA and in absence of regular reporting under DPCO, 2013 by the manufacturers, it appears that the concerned manufacturers are not maintaining normal supplies of these medicines in domestic market and/or institutions. Hence, the availability of such vital and essential drugs has been affected many parts of the country.
“Now, therefore, in exercise of the powers delegated under para 21(1) and para 29 of the Drugs (Prices Control) Order, 2013 vide S.O. No. 1394(E) dated 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, in exercise of powers conferred by section 3 and 5 of the Essential Commodities Act, 1955, the National Pharmaceutical Pricing Authority after being satisfied that it is necessary in the public interest so to do, hereby direct that all the concerned manufacturers/importers shall comply with the requirements contained in para 21(1) and provide the month-wise production and sale figures for the last 12 months under para 29 of the said Order immediately to the NPPA. All the manufacturers/importers of the essential medicines specified in para 7 above shall also submit a compliance report of resolving the shortage of these drugs in the country immediately but not later than 96 hours from the date of issuance of this notification to NPPA”, the NPPA notification said.
Para 21(1) of DPCO inter alia authorises that the government, shall monitor the production and availability of scheduled formulations and the active pharmaceutical ingredients contained in the scheduled formulation and the manufacturer of scheduled formulations and the active pharmaceutical ingredients contained in the scheduled formulation shall furnish the information as stated in Form-III of Schedule-II of this Order quarterly.
And para 29 of DPCO provides that every manufacturer shall maintain records relating to the sales of individual active pharmaceutical ingredients or bulk drugs manufactured or imported and marketed by him, as the case may be, and the sales of formulations units and packs and also such other records as may be directed from time to time by the government and the government shall have the power to call for any record and to inspect such records at the premises of the manufacturer.
“In case of failure/non-compliance of para 8 above, the manufacturer/marketer/importer shall be liable for penal action under the relevant provisions of Essential Commodities Act, 1955”, the NPPA has warned.
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The NPPA has also directed them to maintain the production level and adequate supply of these medicines and also ensure submission of the information in Form- III of the Schedule -II of the DPCO, 2013 quarterly. Besides, the NPPA has directed them to comply with the requirements contained in para 21(1) and provide the month-wise production and sale figures for these drugs for the last 12 months under para 29 of DPCO, 2013.
In a notification, the NPPA said that the scarcity of certain essential medicines, namely, anti-snake venom, rabies vaccine, rabies immunoglobulin, albumin injection and anti-malarial combination of sulfadoxine + pyrimethamine tablets has been reported to the NPPA and in absence of regular reporting under DPCO, 2013 by the manufacturers, it appears that the concerned manufacturers are not maintaining normal supplies of these medicines in domestic market and/or institutions. Hence, the availability of such vital and essential drugs has been affected many parts of the country.
“Now, therefore, in exercise of the powers delegated under para 21(1) and para 29 of the Drugs (Prices Control) Order, 2013 vide S.O. No. 1394(E) dated 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, in exercise of powers conferred by section 3 and 5 of the Essential Commodities Act, 1955, the National Pharmaceutical Pricing Authority after being satisfied that it is necessary in the public interest so to do, hereby direct that all the concerned manufacturers/importers shall comply with the requirements contained in para 21(1) and provide the month-wise production and sale figures for the last 12 months under para 29 of the said Order immediately to the NPPA. All the manufacturers/importers of the essential medicines specified in para 7 above shall also submit a compliance report of resolving the shortage of these drugs in the country immediately but not later than 96 hours from the date of issuance of this notification to NPPA”, the NPPA notification said.
Para 21(1) of DPCO inter alia authorises that the government, shall monitor the production and availability of scheduled formulations and the active pharmaceutical ingredients contained in the scheduled formulation and the manufacturer of scheduled formulations and the active pharmaceutical ingredients contained in the scheduled formulation shall furnish the information as stated in Form-III of Schedule-II of this Order quarterly.
And para 29 of DPCO provides that every manufacturer shall maintain records relating to the sales of individual active pharmaceutical ingredients or bulk drugs manufactured or imported and marketed by him, as the case may be, and the sales of formulations units and packs and also such other records as may be directed from time to time by the government and the government shall have the power to call for any record and to inspect such records at the premises of the manufacturer.
“In case of failure/non-compliance of para 8 above, the manufacturer/marketer/importer shall be liable for penal action under the relevant provisions of Essential Commodities Act, 1955”, the NPPA has warned.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84006&sid=1
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