Some critical issues still persist which hamper ease of use in operating IPDMS 2.0.

Mumbai, December 12, 2022:

Even though the National Pharmaceutical Pricing Authority (NPPA) has resolved certain critical issues regarding Integrated Pharmaceutical Database Management System (IPDMS) 2.0, some critical issues still persist which hamper the ease of use in operating IPDMS 2.0.  

The unaddressed issues are the lack of visibility and accessibility of old data submitted in IPDMS 1.0. As these are official submissions by the company and in case of any error due to migration of data from IPDMS 1.0 to 2.0, the company should not be held responsible, industry sources said.

NPPA has taken cognizance and has issued an action taken report dated December 7, 2022 on the suggestions of stakeholders regarding IPDMS 2.0.

“With the NPPA playing a proactive role in ironing out operational issues faced by the industry, the persisting issues also look likely to be resolved and a smooth transition from IPDMS 1.0 to 2.0 is on the anvil,” according to industry sources.

Pharma companies have been facing critical issues with IPDMS 2.0 and have sought immediate intervention of national drug pricing regulator NPPA. Among other issues related to IPDMS 2.0 is that the data on the product label contains only MMYYYY format whereas the product label entry in the IPDMS 2.0 is DDMMYYY format which is unnecessary.

Industry sources have also raised the issue that a unique ‘reference number’ used to be generated for every report in IPDMS 1.0 which enabled easy retrieval and saving of reports which is missing and should be restored in IPDMS 2.0. The IPDMS 2.0 makes it mandatory to submit data and documents outside the purview of DPCO (Drug Prices Control Order)- 2013.

DPCO 2013 Para 21 (1) specifies that quarterly submission of data should be made in FORM III but in IPDMS 2.0 month wise data has to be entered for each quarter. The data entered every quarter in IPDMS 1.0 is not visible.

In Form V, entry for Price to Stockist (PTS) including GST has been made mandatory, which was not in IPDMS 1.0, neither is it included in the Form V prescribed under DPCO 2013 nor in paragraph numbers 2, 24,25,26 on which Form V is based. Hence the entry of PTS in Form V should be removed.

The pharma industry faced severe operational issues with IPDMS 2.0 and communicated with the NPPA individually and through pharma industry associations like Indian Drug Manufacturers Association (IDMA), Indian Pharmaceutical Alliance (IP Alliance) and Organisation of Pharmaceutical Producers of India (OPPI). The NPPA conducted a meeting on October 13, 2022 with all the stakeholders regarding teething issues faced by industry with IPDMS 2.0.

The major issues pertained to operational problems in entering and saving data, approvals at every stage that took a long time, lack of visibility of access to data entered in IPDMS 1.0, errors in migration of details from IPDMS 1.0 to 2.0 and inclusion of data and documents outside the purview of DPCO 2013 like manufacturing licenses and facility production data among other related issues.

Through OM dated November 14, 2022, the NPPA conveyed the action taken on the inputs submitted by the stakeholders regarding teething issues faced by industry with IPDMS 2.0, based on the meeting dated October 13, 2022 with the NPPA. The pharmaceutical companies and industry associations subsequently made further representations regarding issues that remained unaddressed.

The IPDMS 1.0 was introduced in 2015 to ensure that data pertaining to DPCO 2013 was updated by the pharmaceutical companies online. The objective was to provide a single window for submissions of various forms as mandated under DPCO- 2013 and create an authentic database of information on products, prices, production and sale of scheduled and non-scheduled formulations as well as API.

In 2022, Union minister of chemical and fertilizers Dr.MansukhMandaviya  launched the IPDMS 2.0 which is an integrated responsive cloud based application developed by the NPPA with technical support from the Centre for Advance Computing (C-DAC).

The IPDMS 2.0 aims to optimize synergies in operations in order to promote Government’s thrust on ‘Ease of Doing Business’. Furthermore, it would provide a single window for submissions of various forms as mandated under the DPCO - 2013.

It is also a step towards ‘Paperless Governance’ as it would also enable paperless functioning of NPPA. In addition to these, it will facilitate the stakeholders to connect with the national drug pricing regulator NPPA from across the country.Pharmabiz