Pharma companies will stand to gain by registering in IPDMS 2.0
On duly completing all registration formalities, manufacturers will help create a single window data source
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With the objective of creating an appropriate mechanism to obtain market-based data related to drugs, national drug pricing regulator, the National Pharmaceuticals Pricing Authority (NPPA), in collaboration with the National Informatics Centre (NIC) had developed the Ingredient Pharmaceutical Database Management System (IPDMS). This was to facilitate on-line submission of mandatory returns/reports under the drug price control order (DPCO), 2013 by pharmaceutical manufacturers as defined under 2(1) (n) of the DPCO, 2013.
The transition from DPCO 1995 (which followed cost-based mechanism for price fixation) to DPCO 2013 (market-based mechanism for price fixation), reference data and source of market-based data assumed critical importance, thanks to IPDMS. NPPA intended to come up with an appropriate mechanism to obtain market-based data pertaining to drugs. IPDMS entails registration for which a self-contained guide was also uploaded on the NPPA website. All the manufacturers have to register themselves and complete all registration formalities, including company details, details of production and procurement sources and the product list.
In the absence of a robust in-house data base, IPDMS comes across as a timely measure given that DPCO 2013 had permitted market-based data to be sourced from IMS Health subject to necessary validation by the NPPA. Whenever the data of IMS Health was not available or found to be inadequate, it would be supplemented by sourcing market based data from Pharma Trac, which like IMS Health, was another specialised pharmaceutical market-based data source. In addition to that, data was also obtained from manufacturers directly and from several other secondary published sources. Since its launch in 2014, NPPA asked all pharmaceutical companies to register themselves under IPDMS for online filing of returns in Form II, III and V under DPCO 2013.
However, the response from the industry was poor, forcing the NPPA to extend the last day of registration with IPDMS, which has proved to be hugely resourceful. This is especially with regard to collection of data, monitoring and analysis of data for the industry, consumer and the regulator. Data on production, import and pricing of scheduled and non-scheduled formulations can be accessed, analysed and reports generated.
After the success of IPDMS, the IPDMS 2.0 was launched last year. It was an integrated responsive cloud-based application developed by NPPA with technical support from the Centre for Advanced Computing (C-DAC). It was envisaged to optimize synergies in operations in order to promote government’s thrust on ‘Ease of Doing Business’ as it could provide a single window for submissions of various forms as mandated under Drug Price Control Order (DPCO), 2013. It would also enable paperless functioning of NPPA and facilitate the stakeholders to connect with the national drug pricing regulator from anywhere in the country.
On that count, IPDMS 2.0 is a relevant and significant development for the pharmaceutical industry given that quality and genuine data is required for regulatory decisions. Since there is a growing focus on increasing health expenditure to serve the domestic unmet healthcare needs of the country, there is tremendous scope for drug development, innovation, research and manufacturing in the country. Besides this, the government needs data on the installed capacity of drug manufacturing units or pharmaceutical companies for coming up with industry-friendly policies and regulations. But, there were several operational issues because of which the pharmaceutical companies were not forthcoming to register in it. It was against this background that Dr. Vinod Kotwal, member-Secretary, NPPA, urged the Indian pharmaceutical companies to register in IPDMS 2.0 for making a robust database of companies and expediting the process of regulatory approvals for drug manufacturing in India. Dr Kotwal also emphasised the role of quality data in making timely regulatory decisions.
The onus is now on the pharmaceutical industry to come forward and register in IPDMS 2.0 as it will go a long way in creating an authentic database of information on products, prices, production and sale of scheduled, non-scheduled formulations and Active Pharmaceutical Ingredients (APIs).
