Mumbai : Dr Vinod Kotwal, Member Secretary, National Pharmaceuticals Pricing Authority (NPPA) has urged the Indian pharmaceutical companies to register in Integrated Pharmaceutical Database Management System (IPDMS 2.0) for making a robust database of companies and expediting the process of regulatory approvals for drug manufacturing in India.
Speaking on the occasion of Indian Drug Manufacturers’ Association (IDMA)’s 61st Annual Day Celebrations held in Mumbai under the theme “Indian Pharma – Global Health Care,” Dr Kotwal Emphasized the role of quality data in making timely regulatory decisions. He was the Chief Guest of the IDMA 61st Annual Day Celebrations.
IPDMS 2.0 envisages creating an authentic database of information on products, prices, production and sale of scheduled, non-scheduled formulations and active pharmaceutical ingredients (APIs). It also aims to optimize synergies in operations by providing a single window for submissions of various forms as mandated under the Drug Prices Control Order (DPCO) – 2013.
It is also a step towards ‘Paperless Governance’ as it would also enable paperless functioning of NPPA. This will also facilitate the stakeholders to connect with the NPPA from across the country.
An integrated responsive cloud based application developed by the NPPA with technical support from the Centre for Advanced Computing (C-DAC), the IPDMS 2.0 was launched by the Union minister of chemical and fertilizers Dr. Mansukh Mandaviya last year. The IPDMS 1.0 was introduced in 2015 to ensure that data pertaining to DPCO 2013 was updated by the pharmaceutical companies online.
“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. In order to make further progress on the same for affordable drugs based on the principles of essentiality, we would like to invite the manufacturers to give their feedback and ideas on the same,” 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.”
Further adding on to the point of adherence to norms, Abhimanyu Kale, Maharashtra Food and Drug Administration (FDA) Commissioner said that pharma manufacturing companies should approach the regulators to seek clarity on WHO-GMP compliance and the Certificate of Pharmaceutical Product (CoPP) towards making safe and efficacious medicines and 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 event was attended by IDMA National President Dr. Viranchi Shah, Jyoti Sardesai, Director, FDA, Goa, Dilip Shanghvi, managing director, Sun Pharmaceutical Industries Ltd, IDMA general secretary Mehul Shah, Rehan Khan, managing director, MSD India, Dr H G Koshia, Commissioner, FDA, Gujarat and Parijat Ghosh, partner, Bain & Company among others.
On the occasion, IDMA Appreciation Awards were given to Micro Labs Ltd., Naxpar Pharma Pvt Ltd, Elysium Pharmaceuticals Ltd, Gufic Biosciences Ltd, Onspot Solutions Pvt Ltd, ICEXPO Consults, Marsh India Insurance Brokers Pvt Ltd and TATA AIA Life Insurance Co Ltd.