ABOUT US
Introduction
Vision
What We Do
IPA DG Shah Public Policy Award
Organisation
Leadership
Executive Council
Members
Affiliations
Secretariat
UCPMP
Resources
IPA Publications
External Studies
Insight Pharma Newsletter
Blogs and Articles
Videos
About India Pharma Industry
Media Centre
Press Releases
In the News
Interviews
Events
Upcoming Events
Past Events
Contact Us
Publication
2024
Changing Dynamics of Indian Pharma Supply Chain
Event
Guidance on Good Engineering Practices
Quality
Manufacturing
IPA Best Practices
Guidance on Process Analytical Tools (PAT) in Oral Solids and API
Quality
Manufacturing
IPA Best Practices
Deepening The Responsible Business Agenda
IPA_CSR_Report
IPA_Samhita_Report_Launch
2023
G20 Side Event – Indian Pharmaceutical Industry: Overview & Way Forward
Market Access Barriers in the Pharmaceutical Sector in India’s Key Export Destinations
Export
Market
Trade
International Affairs
Guidance for Technology Transfer
Quality
Manufacturing
IPA Best Practices
Guidance on Nitrosamine Impurities
Quality
Manufacturing
IPA Best Practices
Human Error Reduction
Quality
Manufacturing
IPA Best Practices
Best Practices on Digital Data Management 21 CFR Part 11 Compliance
Quality
Manufacturing
IPA Best Practices
2022
Draft – Marketing Practices Deck V3
5 Key imperatives to build an enabling innovation ecosystem in India
Innovation index and framework for innovation ecosystem
Funding for innovation and R&D
Global Innovation Summit 2021_Action report
Event
Innovation
Summit
Report
2021
IGBA Vision Report
IPA Submission to RCGM_Regulatory Perspective_Bio Similars_Clean
Regulatory
Pharma Innovation Index
Innovation
Assessment of current innovation ecosystem in India
Cleaning Methodology and Validation
Quality
Manufacturing
IPA Best Practices
Best Practices on Media Fill
Quality
Manufacturing
IPA Best Practices
Opportunities for achieving Vision 2030
Focus on API manufacturing to reduce the reliance on imports
Expand and consolidate global footprint and collaborate with international regulatory bodies
6 key tailwinds and opportunities to shape the growth of the Generic and Biosimilar Medicines industry
Vaccination – Myths and Facts
Opportunities for achieving Vision 2030
Indian pharmaceutical industry’s contribution to public health and economic growth
Vision 2030 – Defining the growth aspiration
Visual Inspection of Sterile Products
Quality
Manufacturing
IPA Best Practices
Regulatory Best Practices – Focus on First Cycle Approvals of ANDAs
Regulation
Regulatory Affairs
ADAs
Quality
Manufacturing
IPA Best Practices
Regulatory Best Practices – Focus on Post Approval Changes and Change Control Evaluation
Regulation
Regulatory Affairs
Quality
Manufacturing
IPA Best Practices
IPA Submission – USTR Special 301 Report
USTR
Trade
International Affairs
IPA Employee Safety Initiatives Report
CSR
COVID
Safety
2020
Catalyzing Pharma-Medtech innovation ecosystem in India_Committee paper-v2
Innovation
Reviving Pharma Ancillary Industry Roadmap for Resilience with Excellence_ Accenture
Report
Future of work – Quality_IPA-BCG Collaboration
Report
Reviving Indian API industry
Report
Furture of Work – BUILDING THE NEW COMMERCIAL OPERATING MODEL
Appendix 1 Subgroup – Regulatory Annexure 2a
CSR – 1st Report: Beyond Business – Contributions to Social Initiatives (IPA X Samhita)
CSR
Philanthropy
ESG
Manufacturing and safety protocol in response to plant personnel being reported as COVID positive
COVID
Safety
IIMA Case Study_Dealing with Covid19
COVID
Safety
Best Practices Employee Safety In Pharmaceutical Manufacturing – COVID-19
PositionPapers
Handling of Market Complaints
Market
Quality
Policy
IPA Best Practices
Product Robustness and Lifecycle Management
Management
Quality
Manufacturing
IPA Best Practices
Analytical Method Development for Chromatography and Particle Size Distribution
Quality
Manufacturing
USTR: 2020 Special 301 Submission
USTR
Trade
International Affairs
2019
Indian-pharmaceutical-industry-way-forward
Report
The Indian pharmaceutical industry and global market
Presentation
The Indian pharmaceutical industry – the way forward
Indian Pharma
Quality
Manufacturing International Affairs
Export
Report
“Discover in India” – Strengthening the innovation ecosystem for Pharmaceuticals
Innovation
Report
New International Healthcare Policies in Making Perspective from India – Warsaw
Regulatory
Policy
Healthcare International
Presentation On Pharmaceutical Sector in India – Mumbai
Investigations for Non Conformities – Focus on Batch Failure Investigations
Quality
Manufacturing
IPA Best Practices
USTR : 2019 Special 301 Submission, 07February 2019 (Docket No USTR-2018-0037)
USTR
Trade
International Affairs
2018
Comments Relating to Working of Patents, 16 March 2018
Position Papers
Good Documentation Practices
Quality
Manufacturing
IPA Best Practices
Process Validation
Quality
Manufacturing
IPA Best Practices
USTR : 2018 Special 301 Submission, 08 February 2018 (Docket No USTR – 2017 – 0024)
USTR
Trade
International Affairs
2017
Promoting Manufacturing of APIs in India, Invest India – 2017, New Delhi.
Trade
International Affairs
Report
API
India’s Contribution to Affordable Healthcare in USA, 35th Annual AAPI Convention
Report
India’s Contribution to Affordable Healthcare in USA, 35th Annual AAPI Convention.
Unlocking Pharma Growth – Emerging Markets, Joint 23rd Medicines for Europe.
Presentation
Data Reliability
Quality
Manufacturing
IPA Best Practices
USTR: 2017 Special 301 Submission, 08 February 2017 (Docket No USTR – 2016 – 0026)
USTR
Trade
International Affairs
2016
IPA Meeting with the FDA: Quality Forum Update, Washington DC.
Presentation
Presentation to IGDRP: Licensing of Generic Products: Needs and Expectation of Industry, Strasbourg.
Presentation
USTR: 2016 Special 301 Submission, 05 February 2016 (Docket No. USTR – 2015 – 0022)
USTR
Trade
International Affairs
2015
IPA Meeting with the FDA: Quality Forum, Washington DC.
Presentation
Presentation to Health Secretary: TRIPS article 39.3 & Data Exclusivity, New Delhi.
Presentation
IPA Meeting with the FDA: Desire to Work Together, Washington DC.
Presentation
Presentation at Carnegie Endowment for International Peace, Washington DC.
PositionPapers
Comments on National IPR Policy
National
Policy
2014
CII-12th National Pharmaceutical Conclave 2014: Industry Perspective, New Delhi.
National
2014 Special 301 Out-of-Cycle Review of India:USTR-OCR Docket No.USTR 2014-0020
USTR
Trade
International Affairs
Improving Access; Promoting Innovation: Access to Medicines & Universal Health Coverage, Chennai.
Innovation
IPA-FDA Workshop – May 2014 Effective Quality Systems: Participants’ Feedback, Mumbai.
Event
Quality
USITC: Written Submission – Investigation No.332-543.
Trade
International Affairs
National Conference on Pharmaceutical Policies in India Balancing Industrial and Public Health Interests Drug Pricing: Implication of DPCO 2013, New Delhi
Policy
Drug Pricing
2014 Special 301 Review – Response to Hearing Testimony on India – Docket No. USTR 2013-0040.
Legal
USITC: Pre Hearing Statement – Investigation No.332-543.
Legal
2013
GoM: Impact Assessment of NPPP 2012, New Delhi.
Policy
Role and Contribution of National Pharmaceutical Industry
Trade
International Affairs
2012
GoM_NPPP 2011: Road Map for Carefully Calibrated Policy to Avoid Adverse Trade Offs, New Delhi
Policy
Trade
International Affairs
Backgrounder on IP Rights
PositionPapers
Roundtable Symposium on The Emerging Legal & Policy Landscape of IP Protection for Pharmaceuticals in India: NPPP 2011, Jodhpur.
Policy
Legal
Roundtable Meeting with Secretary – US Department of HHS: Indian Pharmaceutical Industry, Mumbai.
Presentation
2011
Comments on Discussion Paper on Organizational Structure of the IPO
PositionPapers
2nd Annual SCM Pharma India 2011: Overcoming Counterfeiting to Protect the Quality and Integrity of Product, Mumbai.
Event
Quality
Comments on Discussion Paper on the Utility Model
PositionPapers
BioSpectrum Technology Forum 2011: Changing Face of Indian Pharmaceutical Industry Road to Success, Bangalore.
Event
2010
Comments on Discussion Paper on Compulsory Licensing.
PositionPapers
Comments on Discussion Paper on IPR Regime.
PositionPapers
Data Protection vis-a-vis Data Exclusivity
PositionPapers