With the objective of creating an appropriate mechanism of obtaining market-based data related to drugs, the NPPA in collaboration with the National Informatics Centre (NIC) has developed the Ingredient Pharmaceutical Database Management System (IPDMS), which is aimed at facilitating on-line submission of mandatory returns/reports under the DPCO, 2013 by manufacturers as defined under 2(1) (n) of the DPCO, 2013.

The NPPA has now asked all the pharma companies in the country to register themselves under IPDMS for online filing of returns in Form II, III and V under DPCO 2013.

“The above mentioned reporting obligation on the manufacturers is a legal obligation, which they are required to carry out with full and correct disclosure of information in a timely manner at prescribed intervals. Any default in reporting would be deemed to be an act of contravention of the DPCO 2013 and therefore, attract penalties under the Essential Commodities Act, 1955”, an NPPA order said.

The IPDMS is being launched by the NPPA for the purpose of registration for which a self-contained guide is also being uploaded on the website of NPPA.  All the manufacturers have to register themselves and complete all registration formalities, which include inputting of company details, details of production/procurement sources, and product list. The registration process will be kept open up to 30th October, 2014 after which the data inputting facility shall be made available to all registered users for submission of on-line reports in respect of Form II, III and V under the DPCO 2013.

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.