The National Pharmaceutical Pricing Authority (NPPA) will soon initiate legal action against those pharmaceutical companies which did not register themselves with the Integrated Pharmaceutical Database Management System (IPDMS).

The NPPA had earlier made online submission of data mandatory for all pharma manufacturing/marketing companies under DPCO, 2013 in the IPDMS and the national drug price regulator had issued a notice way back on 18.09.2014, directing all the companies to register themselves online under IPDMS before 31.10.2014. The timeline was extended up to 30.11.2014 and further extended upto 31.12.2014 on the request of the industry.

In spite of repeated warnings, several companies did not register with the IPDMS and the companies sought more time on the plea that there is large volume of data to be entered. Keeping in view the request of various stakeholders, the companies were given a final opportunity to register themselves in IPDMS vide notices issued on 16.11.2015 directing the companies to register themselves in IPDMS and file all the forms as required under the DPCO, 2013 on or before 15.12 2015. The deadline was extended till January 15, 2016 with further extension up to February 15, 2016 and finally up to March 31, 2016.

Even after expiry of two months of the extended period for furnishing information under IPDMS, it is seen that there is a significant gap between the number of products registered under IPDMS and returns filed under Form II, III, and V and the frequency of filing as required under DPCO 2013. NPPA has taken a serious view about the willful violation of DPCO, 2013, by the company. Form II is to be submitted for revised prices for scheduled formulations. Form V is to be filed for all formulations whether scheduled or non-scheduled under IPDMS after registration so that information under IPDMS for PTR and MRP can be incorporated initially. Subsequent changes in price are also to be filed and submitted through IPDMS as and when the change occurs.

NPPA has issued many price notifications, especially during March-June 2016. But many pharma companies have not submitted the forms as required under DPCO, 2013 in IPDMS. “In this regard, NPPA is now constrained to issue show cause notices to individual companies for not having registered their pharmaceutical products under IPDMS and for not having filed the mandatory returns in Form II, Ill and V through IPDMS. NPPA shall also be constrained to take necessary legal action against the companies including the exercise of its powers under Para 29, Para 30 of DPCO, 2013 including the prosecution under EC Act under unavoidable circumstances. Industry associations are requested to sensitize their members on this compliance urgently”, the NPPA warned the companies.

The IPDMS when fully operationalised will be a useful tool for collection of data and information and for monitoring and analysis of data for the industry, the consumer and the regulator, and from which data on production, import and pricing of scheduled and non scheduled formulations can be accessed, analysed and reports generated.