Even as the government has brought coronary stents under the scheduled drugs category to control the skyrocketing prices of these life-saving medical devices, the national drug price regulator National Pharmaceutical Pricing Authority (NPPA) has asked all the manufacturers, importers and marketers of coronary stents to register themselves on  the Integrated Pharmaceutical Database Management System (IPDMS), also referred to as Pharma Data Bank, for collection of data.

“As coronary stents have been notified by the Department of Pharmaceuticals (DoP) as scheduled formulations, it is mandatory for all manufacturers/importers/marketers of coronary stents to file Form V as prescribed in the DPCO, 2013, through the Integrated Pharmaceutical Database Management System (IPDMS)”, the NPPA said.  

“As the software of IPDMS is being updated/modified in this regard, I am directed to request all manufacturers/importers/marketers of coronary stents that the information in the attached format may be sent to this office in hard copy and also in soft version on email id nppa.nic.in, dir.me.nppa@gmail.com, and me.nppa2015@gmail.com latest by 31st January, 2017, failing which action will be initiated as per provisions of DPCO, 2013, against the company”, the NPPA further said.

Earlier, the Union health ministry through a notification on July 19, 2016 had included coronary stents in the National List of Essential Medicines (NLEM). Later on December 21, 2016, the DoP has notified the coronary stents in Schedule-I of DPCO, 2013.

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.

The launch of IPDMS was 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.