Despite extension of time limit by the National Pharmaceutical Pricing Authority (NPPA) for online registration of Integrated Pharmaceutical Database Management System (IPDMS) for online filing of returns in Form II, III and V under DPCO 2013, the pricing regulator has directed the member companies to register themselves under the IPDMS immediately, failing which NPPA shall be constrained to take appropriate action under the provisions of (Drug Price Control Order -2013 (DPCO-2013) without any further reference on the matter.

It may be noted that NPPA has already provided user ID and password to the registered companies to make online submission of data as required under the provisions of DPCO -2013. It has also been observed that out of top 100 pharma companies, 59 companies have not registered with the system, the NPPA letter stated.

Earlier in September last 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. The IPDMS was developed for 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 had then asked all the pharma companies in the country to register themselves under IPDMS before October 30 for online filing of returns in Form II, III and V under DPCO 2013.

But the NPPA decided to extend the last date of registration by one month i.e. upto 30.11.2014 as all the major pharma industry associations had sought extension of time beyond the stipulated date of 30.10.2014. NPPA further extended the last date for registration of manufacturers under the IPDMS for online filing of returns in Form II, III and V under DPCO 2013 by one month, i.e. upto 31.12.2014.

But, there was demand from the industry to further extend the last date, which the NPPA has now rejected. NPPA had extended the last date by another one month for registration of manufacturers after due consideration.

This is not the first time that the NPPA extended registration time for the industry since the NPPA developed the IPDMS in September last year with the objective of creating an appropriate mechanism of obtaining market-based data related to drugs.

In fact, the NPPA had extended the last date by one month earlier in November also after its directive to the manufacturers to register themselves under the IPDMS evoked poor response from the manufacturers.

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.