NPPA asks Pharma Companies to register in IPDMS 2.0

This will also facilitate the ability of the stakeholders to connect with the NPPA from across the country.

February 14, 2023

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NPPA National Pharmaceutical Pricing Authority — Picture: Pixabay

Last Updated on December 31, 2023 by The Health Master

Dr Vinod Kotwal, Member Secretary of the National Pharmaceuticals Pricing Authority (NPPA), has urged Indian pharmaceutical companies to register in the Integrated Pharmaceutical Database Management System (IPDMS 2.0) in order to create a robust database of companies and speed up the regulatory approvals process for drug manufacturing in India.

Speaking at the 61st Annual Day Celebrations of the Indian Drug Manufacturers’ Association (IDMA) in Mumbai under the theme “Indian Pharma – Global Health Care,” Dr. Kotwal emphasized the importance of quality data in making timely regulatory decisions. She was the Chief Guest of the IDMA’s 61st Annual Day Celebrations.

The creation of an authentic database of data on goods, costs, production, and sales of scheduled and non-scheduled formulations as well as active pharmaceutical ingredients (APIs) is one of the goals of IPDMS 2.0.

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By offering a single window for submissions of various forms as required by the Drug Prices Control Order (DPCO) – 2013, it also aims to maximize operational synergies.

As it would allow NPPA to operate without paper, it is also a step toward “paperless governance.”

This will also facilitate the ability of the stakeholders to connect with the NPPA from across the country.

IPDMS 2.0, an integrated responsive cloud-based application created by the NPPA with technical assistance from the Centre for Advanced Computing (C-DAC), was introduced last year by Dr. Mansukh Mandaviya, the Union minister of chemicals and fertilizers.

The IPDMS 1.0 was introduced in 2015 to ensure that data pertaining to DPCO 2013 was updated by the pharmaceutical companies online.

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“IPDMS 2.0 is making steady progress as around 1,150 companies have been registered out of which 1,058 are pharma companies. Around 4,900 manufacturing plants have been brought on to the IPDMS 2.0. Around 5,579 forms have been filed through this platform,” informed Dr Kotwal.

“IPDMS 2.0 is a relevant and significant development for the pharma industry, as good quality data is required to make timely regulatory decisions.” We are also revising the ceiling prices of more scheduled pharma products.”

“NPPA revised the ceiling prices of 400 scheduled drugs in November 2022. “We would like to invite manufacturers to give their feedback and ideas on the same in order to make further progress on the same for affordable drugs based on the principles of essentiality,” Dr Kotwal explained.

Echoing similar views, Special Guest of Honour Dr N Yuvaraj, joint secretary, Department of Pharmaceuticals, Government of India, “Since there is a growing focus on increasing health expenditure from the government to serve the domestic unmet healthcare needs of the country, there is a lot of 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 pharma companies towards making industry friendly policies and regulations.”

In addition, Abhimanyu Kale, Commissioner of the Maharashtra Food and Drug Administration (FDA), stated that pharma manufacturing companies should approach regulators to seek clarity on WHO-GMP compliance and the Certificate of Pharmaceutical Product (CoPP) in order to make safe and efficacious medicines while also maintaining a resilient global pharma supply chain to more than 200 countries.

The CoPP is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country.

The following attended the event among others: