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P A Francis
Wednesday, September 20, 2017, 08:00 Hrs  [IST]

National Pharmaceutical Pricing Authority had set up an Ingredient Pharmaceutical Database Management System (IPDMS) in the country in September 2014 aimed at facilitating online submission of mandatory cost data by all pharmaceutical companies in the country. A directive was issued at that time to all pharma companies to comply with the requirements with a deadline of one month. The objective of this initiative was to create an appropriate mechanism for obtaining market-based data related to all drugs marketed in the country. The launch of IPDMS was also felt necessary in the context of the transition from a cost based price fixing of controlled drugs followed until DPCO 1995 to a market data based price fixation under the DPCO 2013. NPPA initially has been sourcing the required market data from IMS Health subject to necessary validation for fixing prices under the DPCO. Even after three years of issuing direction for submitting data to IPDMS, several pharmaceutical companies are yet to provide the same to NPPA. Only very few companies have provided data so far despite quite a few extensions for the deadline during 2015 and 2016. Now the latest deadline for compliance was in last week this year. Concerned over the poor response from the manufacturers, the NPPA has warned the companies of action for non compliance some time back.
So far not many companies have registered with NPPA and even the registered companies have not filed all mandatory forms for all their products including Form-V for coronary stents.  As per the records with NPPA, only marketing companies are filing the requisite forms, whereas the forms are to be filed by 'manufacturers' as defined under para 2(n) of DPCO 2013. As the response from companies was not very encouraging despite various notices and warnings, NPPA once again issued an order making compliance with IPDMS a pre-requisite for consideration of representations of companies for retail price approvals and discontinuation of drugs. In view of the poor compliance of IPDMS, NPPA once again warned all the pharma companies of appropriate action under the provisions of Essential Commodities Act and DPCO 2013. NPPA should not be granting any more extensions for the compliance of this order. Unless punitive actions are initiated against the non compliant companies, the goal of developing a pharma Data Bank can never be achieved in the near future. NPPA should not be having any more hesitation in this regard. Cooperation of industry bodies should also be sought to make their members cooperate with NPPA in this regard.


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Pradeep Awasthi Sep 20, 2017 4:38 PM
The new concept of Ingredient pharmaceutical database management system which is set by National pharmaceutical price fixing authority is the smart move for accessing comprehensive datas about cost of several drugs marketed by different pharma companies.It will equally enable NPPA to have better idea for fixing prices of drugs under DPCO category.

But looking to the slowness of pharmaceutical companies in registering themselves and comply with IPDMS objectives,for submitting database information of prices of drugs marketed and manufactured by them in designed time line is the need of hour for NPPA.

In this matter Drug control general of India,has to discontinue license of different drugs marketed by companies which are unable to submit their drugs and cost based information to NPPA.
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