The National Pharmaceutical Pricing Authority (NPPA)'s recent directive to the manufacturers to register themselves under the Integrated Pharmaceutical Database Management System (IPDMS) has so far evoked poor response from the manufacturers as only 90 companies have registered under the IPDMS till October 10. The registration process will be open upto October 30, 2014. 

Concerned over the poor response from the manufacturers, the NPPA has warned the companies of action for non-compliance of the directive.   “In view of the fact that the registration process is open upto 30.10.2014 and only 90 companies have so far registered themselves till date, all the manufacturers are once again requested to extend their cooperation by registering themselves with IPDMS and enable NPPA in effective and timely implementation of the various provisions of DPCO, 2013.  It may be noted that non-compliance in this regard would attract appropriate action under the Essential Commodities Act, 1955”, NPPA chairman Injeti Srinivas in his reminder order said.

Earlier in September this year, the NPPA in collaboration with the National Informatics Centre (NIC) had developed the IPDMS with the objective of creating an appropriate mechanism of obtaining market-based data related to drugs as availability of reliable database is a necessary pre-requisite for carrying out various functions such as price fixation/revision, monitoring the production/availability of scheduled formulations and monitoring of prices of medicines. 

All the manufacturers were requested by the NPPA to register themselves under IPDMS for online filing of returns in Form-II, III and V under DPCO, 2013 by placing a notice on NPPA’s website on 18.09.2014.

The launch of IPDMS is of significance because with the transition from DPCO 1995, which followed cost-based mechanism for price fixation, to the DPCO 2013, which follows market-based mechanism for price fixation, reference data and source of market-based data has assumed critical importance. Through this effort, the NPPA in due course wanted to come out with an appropriate mechanism of obtaining market-based data related to drugs.

So far, due to the absence of a robust in-house data base in this regard, the DPCO 2013 has permitted that initially the required market-based data may be sourced from IMS Health subject to necessary validation exercise by the NPPA wherever considered necessary. Whenever the data of IMS Health is not available or found to be inadequate, it would be supplemented by sourcing market based data from Pharma Trac, which like IMS Health is another specialised pharmaceutical market-based data source. In addition to that, data is also obtained from manufacturers directly and from several other secondary published sources.