IPA’s 3rd Technical Conference talks on Global Regulatory Compliance Challenges of APIs

Indian Pharmaceuticals Association (IPA) recently organised 3rd Technical Conference in Mumbai. The main participants were from European Directorate for Quality of Medicine (EDQM) and WHO. The title of the conference was Global Regulatory Compliance Challenges of Active Pharmaceuticals Ingredients (APIs). Present on the occasion were SD Joag, General Secretary, IPA and Dr JAS Giri, President, IPA along with Dr Florence Benoit – Gubod – EDQM and Dr Milan Smid – WHO. An august audience comprising pharmaceutical technical personnel attended the meet.

Dr P Khadgapathi, Director and Chairman, Hetero Group, delivered the key note address pertaining to Quality Assurance and Manufacturers’ Perspectives of APIs.

Following eminent speakers of the first session moderated by Dr Venugopal Somani, Deputy DCGI, spoke on assurance of API quality and its implication for the Global API manufacturers. Benoit spoke on ‘Assurance of API Quality and its Implication for the Global API manufacturers’; Ian Thrussel – (WHO) – spoke on Application Quality By Design (QBD) Concept in Production of APIs. SM Mudda – Executive Director Technical and Operations –Micro Labs, conveyed his concerns on EU Falsified Medicine directives and implementing these directives will lead to protectionist measure possibilities by the EU regulators.

Mudda added, “The fact that key speakers from the major leading Regulatory Agencies such as UK MHRA, WHO, EDQM, French Regulatory Agency and US FDA participated actively and shared their expectations from the Indian industry confirmed that India is considered as one of the important global suppliers of API. However, the presentations made and the deliberations brought to the fore the concern that the Indian API industry has to adopt the quality systems and risk-based approaches to face the future regulatory challenges and remain in the state of on-going compliance.”

Parallel sessions followed where Dr Nandkumar Chodankar moderated the session on GMP Compliance in Production of APIs along with Benoit and Thrussel. Dr Albinas D’sa -US FDA Country Manager spoke on inspections conducted by US FDA of API manufacturing sites in details where a lot of insights were highlighted.

Thrussel drew the audience to international collaboration of api programme and inspection aimed at arriving at successful quality global supply chain.

The second parallel programme was on Documentation of API Quality as required for regulatory purposes. This was moderated by Dr Jagashetty – Drug controller of State of Karnataka. The speakers were Dr Vishwanath Malkar-Consultant. He Spoke on quality of the APIs followed by Dr Maryam Mehmandoust. She gave an authentic details of EU requirements on Quality of APIs

Dr Anthony Fake – (WHO) discussed on API Documentation from the perspective of WHO- Prequalification Programme.

The first session on the second day was an Update on Pharmacopoeia Development. This session was chaired by Dr Ajit Dangi – President and CEO -Danssen Consulting with Dr Pascale Poukens – Renwart; DrViany Nayak – President, Alembic Pharmaceuticals and Dr Anthony Fake -WHO. They all spoke and gave updates on European International and Indian Pharmacopoeias respectively.

Nayak highlighted the important areas in the Pharmacopoeal harmonisation and the initiatives taken and to be taken in the days to come.

The last session was on API Certification & Prequalification Scheme. This session was moderated by Dr Devinder Pal- Head Catalyst Pharma. The session saw Dr Pascale Poukens and Dr Anthony Fake gave details about EDQM Certification and WHO programme respectively.

EP News Bureau