Publication


2024

Changing Dynamics of Indian Pharma Supply Chain
Changing Dynamics of Indian Pharma Supply Chain
Guidance on Good Engineering Practices
Guidance on Good Engineering Practices
Guidance on Process Analytical Tools (PAT) in Oral Solids and API
Guidance on Process Analytical Tools (PAT) in Oral Solids and API
Deepening The Responsible Business Agenda
Deepening The Responsible Business Agenda

2023

G20 Side Event – Indian Pharmaceutical Industry: Overview & Way Forward
G20 Side Event – Indian Pharmaceutical Industry: Overview & Way Forward
Market Access Barriers in the Pharmaceutical Sector in India’s Key Export Destinations
Market Access Barriers in the Pharmaceutical Sector in India’s Key Export Destinations
Guidance for Technology Transfer
Guidance for Technology Transfer
Guidance on Nitrosamine Impurities
Guidance on Nitrosamine Impurities
Human Error Reduction
Human Error Reduction
Best Practices on Digital Data Management 21 CFR Part 11 Compliance
Best Practices on Digital Data Management 21 CFR Part 11 Compliance

2022

Draft – Marketing Practices Deck V3
Draft – Marketing Practices Deck V3
5 Key imperatives to build an enabling innovation ecosystem in India
5 Key imperatives to build an enabling innovation ecosystem in India
Innovation index and framework for innovation ecosystem
Innovation index and framework for innovation ecosystem
Funding for innovation and R&D
Funding for innovation and R&D
Global Innovation Summit 2021_Action report
Global Innovation Summit 2021_Action report

2021

IGBA Vision Report
IGBA Vision Report
IPA Submission to RCGM_Regulatory Perspective_Bio Similars_Clean
IPA Submission to RCGM_Regulatory Perspective_Bio Similars_Clean
Pharma Innovation Index
Pharma Innovation Index
Assessment of current innovation ecosystem in India
Assessment of current innovation ecosystem in India
Cleaning Methodology and Validation
Cleaning Methodology and Validation
Best Practices on Media Fill
Best Practices on Media Fill
Opportunities for achieving Vision 2030
Opportunities for achieving Vision 2030
Focus on API manufacturing to reduce the reliance on imports
Focus on API manufacturing to reduce the reliance on imports
Expand and consolidate global footprint and collaborate with international regulatory bodies
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
6 key tailwinds and opportunities to shape the growth of the Generic and Biosimilar Medicines industry
Vaccination – Myths and Facts
Vaccination – Myths and Facts
Opportunities for achieving Vision 2030
Opportunities for achieving Vision 2030
Indian pharmaceutical industry’s contribution to public health and economic growth
Indian pharmaceutical industry’s contribution to public health and economic growth
Vision 2030 – Defining the growth aspiration
Vision 2030 – Defining the growth aspiration
Visual Inspection of Sterile Products
Visual Inspection of Sterile Products
Regulatory Best Practices – Focus on First Cycle Approvals of ANDAs
Regulatory Best Practices – Focus on First Cycle Approvals of ANDAs
Regulatory Best Practices – Focus on Post Approval Changes and Change Control Evaluation
Regulatory Best Practices – Focus on Post Approval Changes and Change Control Evaluation
IPA Submission – USTR Special 301 Report
IPA Submission – USTR Special 301 Report
IPA Employee Safety Initiatives Report
IPA Employee Safety Initiatives Report

2020

Catalyzing Pharma-Medtech innovation ecosystem in India_Committee paper-v2
Catalyzing Pharma-Medtech innovation ecosystem in India_Committee paper-v2
Reviving Pharma Ancillary Industry Roadmap for Resilience with Excellence_ Accenture
Reviving Pharma Ancillary Industry Roadmap for Resilience with Excellence_ Accenture
Future of work – Quality_IPA-BCG Collaboration
Future of work – Quality_IPA-BCG Collaboration
Reviving Indian API industry
Reviving Indian API industry
Furture of Work – BUILDING THE NEW COMMERCIAL OPERATING MODEL
Furture of Work – BUILDING THE NEW COMMERCIAL OPERATING MODEL
Appendix 1 Subgroup – Regulatory Annexure 2a
Appendix 1 Subgroup – Regulatory Annexure 2a
CSR – 1st Report: Beyond Business – Contributions to Social Initiatives (IPA X Samhita)
CSR – 1st Report: Beyond Business – Contributions to Social Initiatives (IPA X Samhita)
Manufacturing and safety protocol in response to plant personnel being reported as COVID positive
Manufacturing and safety protocol in response to plant personnel being reported as COVID positive
IIMA Case Study_Dealing with Covid19
IIMA Case Study_Dealing with Covid19
Best Practices Employee Safety In Pharmaceutical Manufacturing – COVID-19
Best Practices Employee Safety In Pharmaceutical Manufacturing – COVID-19
Handling of Market Complaints
Handling of Market Complaints
Product Robustness and Lifecycle Management
Product Robustness and Lifecycle Management
Analytical Method Development for Chromatography and Particle Size Distribution
Analytical Method Development for Chromatography and Particle Size Distribution
USTR: 2020 Special 301 Submission
USTR: 2020 Special 301 Submission

2019

Indian-pharmaceutical-industry-way-forward
Indian-pharmaceutical-industry-way-forward
The Indian pharmaceutical industry and global market
The Indian pharmaceutical industry and global market
The Indian pharmaceutical industry – the way forward
The Indian pharmaceutical industry – the way forward
“Discover in India” – Strengthening the innovation ecosystem for Pharmaceuticals
“Discover in India” – Strengthening the innovation ecosystem for Pharmaceuticals
New International Healthcare Policies in Making Perspective from India – Warsaw
New International Healthcare Policies in Making Perspective from India – Warsaw
Presentation On Pharmaceutical Sector in India – Mumbai
Presentation On Pharmaceutical Sector in India – Mumbai
Investigations for Non Conformities – Focus on Batch Failure Investigations
Investigations for Non Conformities – Focus on Batch Failure Investigations
USTR : 2019 Special 301 Submission, 07February 2019 (Docket No USTR-2018-0037)
USTR : 2019 Special 301 Submission, 07February 2019 (Docket No USTR-2018-0037)

2018

Comments Relating to Working of Patents, 16 March 2018
Comments Relating to Working of Patents, 16 March 2018
Good Documentation Practices
Good Documentation Practices
Process Validation
Process Validation
USTR : 2018 Special 301 Submission, 08 February 2018 (Docket No USTR – 2017 – 0024)
USTR : 2018 Special 301 Submission, 08 February 2018 (Docket No USTR – 2017 – 0024)

2017

Promoting Manufacturing of APIs in India, Invest India – 2017, New Delhi.
Promoting Manufacturing of APIs in India, Invest India – 2017, New Delhi.
India’s Contribution to Affordable Healthcare in USA, 35th Annual AAPI Convention
India’s Contribution to Affordable Healthcare in USA, 35th Annual AAPI Convention
India’s Contribution to Affordable Healthcare in USA, 35th Annual AAPI Convention.
India’s Contribution to Affordable Healthcare in USA, 35th Annual AAPI Convention.
Unlocking Pharma Growth – Emerging Markets, Joint 23rd Medicines for Europe.
Unlocking Pharma Growth – Emerging Markets, Joint 23rd Medicines for Europe.
Data Reliability
Data Reliability
USTR: 2017 Special 301 Submission, 08 February 2017 (Docket No USTR – 2016 – 0026)
USTR: 2017 Special 301 Submission, 08 February 2017 (Docket No USTR – 2016 – 0026)

2016

IPA Meeting with the FDA: Quality Forum Update, Washington DC.
IPA Meeting with the FDA: Quality Forum Update, Washington DC.
Presentation to IGDRP: Licensing of Generic Products: Needs and Expectation of Industry, Strasbourg.
Presentation to IGDRP: Licensing of Generic Products: Needs and Expectation of Industry, Strasbourg.
USTR: 2016 Special 301 Submission, 05 February 2016 (Docket No. USTR – 2015 – 0022)
USTR: 2016 Special 301 Submission, 05 February 2016 (Docket No. USTR – 2015 – 0022)

2015

IPA Meeting with the FDA: Quality Forum, Washington DC.
IPA Meeting with the FDA: Quality Forum, Washington DC.
Presentation to Health Secretary: TRIPS article 39.3 & Data Exclusivity, New Delhi.
Presentation to Health Secretary: TRIPS article 39.3 & Data Exclusivity, New Delhi.
IPA Meeting with the FDA: Desire to Work Together, Washington DC.
IPA Meeting with the FDA: Desire to Work Together, Washington DC.
Presentation at Carnegie Endowment for International Peace, Washington DC.
Presentation at Carnegie Endowment for International Peace, Washington DC.
Comments on National IPR Policy
Comments on National IPR Policy

2014

CII-12th National Pharmaceutical Conclave 2014: Industry Perspective, New Delhi.
CII-12th National Pharmaceutical Conclave 2014: Industry Perspective, New Delhi.
2014 Special 301 Out-of-Cycle Review of India:USTR-OCR Docket No.USTR 2014-0020
2014 Special 301 Out-of-Cycle Review of India:USTR-OCR Docket No.USTR 2014-0020
Improving Access; Promoting Innovation: Access to Medicines & Universal Health Coverage, Chennai.
Improving Access; Promoting Innovation: Access to Medicines & Universal Health Coverage, Chennai.
IPA-FDA Workshop – May 2014 Effective Quality Systems: Participants’ Feedback, Mumbai.
IPA-FDA Workshop – May 2014 Effective Quality Systems: Participants’ Feedback, Mumbai.
USITC: Written Submission – Investigation No.332-543.
USITC: Written Submission – Investigation No.332-543.
National Conference on Pharmaceutical Policies in India Balancing Industrial and Public Health Interests Drug Pricing: Implication of DPCO 2013, New Delhi
National Conference on Pharmaceutical Policies in India Balancing Industrial and Public Health Interests Drug Pricing: Implication of DPCO 2013, New Delhi
2014 Special 301 Review – Response to Hearing Testimony on India – Docket No. USTR 2013-0040.
2014 Special 301 Review – Response to Hearing Testimony on India – Docket No. USTR 2013-0040.
USITC: Pre Hearing Statement – Investigation No.332-543.
USITC: Pre Hearing Statement – Investigation No.332-543.

2013

GoM: Impact Assessment of NPPP 2012, New Delhi.
GoM: Impact Assessment of NPPP 2012, New Delhi.
Role and Contribution of National Pharmaceutical Industry
Role and Contribution of National Pharmaceutical Industry

2012

GoM_NPPP 2011: Road Map for Carefully Calibrated Policy to Avoid Adverse Trade Offs, New Delhi
GoM_NPPP 2011: Road Map for Carefully Calibrated Policy to Avoid Adverse Trade Offs, New Delhi
Backgrounder on IP Rights
Backgrounder on IP Rights
Roundtable Symposium on The Emerging Legal & Policy Landscape of IP Protection for Pharmaceuticals in India: NPPP 2011, Jodhpur.
Roundtable Symposium on The Emerging Legal & Policy Landscape of IP Protection for Pharmaceuticals in India: NPPP 2011, Jodhpur.
Roundtable Meeting with Secretary – US Department of HHS: Indian Pharmaceutical Industry, Mumbai.
Roundtable Meeting with Secretary – US Department of HHS: Indian Pharmaceutical Industry, Mumbai.

2011

Comments on Discussion Paper on Organizational Structure of the IPO
Comments on Discussion Paper on Organizational Structure of the IPO
2nd Annual SCM Pharma India 2011: Overcoming Counterfeiting to Protect the Quality and Integrity of Product, Mumbai.
2nd Annual SCM Pharma India 2011: Overcoming Counterfeiting to Protect the Quality and Integrity of Product, Mumbai.
Comments on Discussion Paper on the Utility Model
Comments on Discussion Paper on the Utility Model
BioSpectrum Technology Forum 2011: Changing Face of Indian Pharmaceutical Industry Road to Success, Bangalore.
BioSpectrum Technology Forum 2011: Changing Face of Indian Pharmaceutical Industry Road to Success, Bangalore.

2010

Comments on Discussion Paper on Compulsory Licensing.
Comments on Discussion Paper on Compulsory Licensing.
Comments on Discussion Paper on IPR Regime.
Comments on Discussion Paper on IPR Regime.
Data Protection vis-a-vis Data Exclusivity
Data Protection vis-a-vis Data Exclusivity