Failure to do so will invite penal action
NPPA has given a final chance to pharmaceutical companies to register themselves with pharma data bank by December 15 and said failure to do so will invite penal action.
“The companies are hereby given a final opportunity to register themselves in IPDMS and fill all forms as required… on or before December 15, 2015,” National Pharmaceutical Pricing Authority (NPPA) said in a notice on its website.
Failure to submit mandatory data in IPDMS — also known as pharma data bank — or returns prescribed under Drugs (Prices Control) Order, 2013, through the IPDMS “will attract penal action under the provisions of the DPCO 2013 read with EC Act 1955,” it added.
The regulator said it may be constrained to initiate prosecution proceedings under the provisions of the Essential Commodities Act, 1955, against companies which fail to submit requisite and mandatory form under the DPCO 2013, through Integrated Pharmaceutical Database Management System (IPDMS).
When fully operationalised, IPDMS will be a useful tool for collection of data and information and for monitoring and analysis of data for industry, the consumer and the regulator, NPPA said.
Through IPDMS, data on production, import and pricing of scheduled and non-scheduled formulations can be assessed, analysed and used to generate reports, it added.
“The pharma companies are legally bound to report information through IPDMS under the provisions of DPCO, 2013, issued under Section 3 of the Essential Commodities Act, 1955.
“It is emphasised that online information regarding price, production, import and sales of formulations and discontinuation of scheduled formulations provides consumers with information on different price points, facilitating informed decision making for efficacious and cost-effective treatment,” NPPA said.
Non-submission of mandatory information will therefore harm public interest, it added.
Making online submission of data mandatory for all the pharmaceutical manufacturing and marketing companies under DPCO 2013 in IPDMS is an initiative of Department of Pharmaceuticals and NPPA.