According to the drug pricing regulator, creating a database is necessary for monitoring production and availability of scheduled formulations and the active pharmaceutical ingredients in the scheduled formulations, and monitoring the prices of non-scheduled formulations

The National Pharmaceutical Pricing Authority (NPPA) has asked all pharmaceutical companies to register themselves under its integrated pharmaceutical database management system (IPDMS) for online filing of returns for monitoring, fixing and revision of drug prices.

In a notice on its portal, the drug pricing regulator said, “Availability of reliable database is a necessary pre-requisite for carrying out the functions of price fixation and price revision in respect of scheduled drugs; price fixation in respect of new drugs.”

It further said such a step was also necessary for monitoring production and availability of scheduled formulations and the active pharmaceutical ingredients contained in the scheduled formulations, and monitoring the prices of non-scheduled formulations.

The registration process will be kept open till 30 October 2014 after which that data inputting facility shall be made available to all registered users for submission of online reports in respect of form II, III and V under drug price control order (DPCO) 2013.

Online filing of returns has to be done under the DPCO 2013, it added.

This is being done as “the objective of the DPCO 2013 is that the government should in due course come out with an appropriate mechanism of obtaining market-based data related to drugs,” NPPA said.

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, it added.

The IPDMS is being launched with immediate effect for the purpose of registration, NPPA said.

The 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, the regulator said.

“Any default in the reporting would be deemed to be an act of contravention of the DPCO 2013 and therefore attracts penalties under the Essential Commodities Act, 1955,” it added.

NPPA was established to fix or revise prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in the country, under the Drugs (Prices Control) Order, 1995.

The organisation is also entrusted with the task of recovering amounts overcharged by manufacturers for the controlled drugs from the consumers and also monitors the prices of decontrolled drugs in order to keep them at reasonable levels.