Goregoan, May 14, 2015 – Alliance India has come up for the first time with the regulatory affairs conference exclusively for Emerging Markets. The conference was opened by Chair Person Mrs Hasumati Rahalkar, Founder and Managing Director, Metina PharmConsulting Pvt Limited, with brief market potential about Emerging Markets.
As per METINA, by the year 2016 the global pharmaceutical market will be worth over $1 trillion with generic medicines increasing from $200 billion to around $400 billion within this period. Mature markets are /will face severe cost constraints with reduced number of patent expiring opportunities. Pharmaceutical companies would seek growth in emerging markets where 66% of total growth over the next few years would be expected. Demand for generic medicines will increase as populations increase and live longer.
As per METINA, accessing these markets is not as straightforward and easy as it may first appear. Competition and business models will vary with product portfolios and regulatory frameworks and patent positions will give additional challenges across the regions.
With this brief background about Emerging Markets potential, Alliance India opened conference on Regulatory in Emerging Markets. The esteemed speakers had enlightened regulatory professionals with updated regulatory knowledge and challenges pertaining to these markets.
On Day 1, Mr Nitin Gaikwad, General Manager, Regulatory of Lupin Limited gave detailed information about China markets including China FDA regulations and technical requirements. Mr Gaikwad has given practical knowledge about regulatory challenges to enter into China markets i.e. lengthy approval process, local BE/CT requirements, Analytical Chromatograms requirements as part of submission, and commercial samples to receive final approval. This was followed by Identification of Medicinal Product concept given by Mr JP Reddy of Cognizant Technologies.
Mrs Hasumati Rahalkar, Metina PharmConsulting spoke about latest international concept about Super Generics in Emerging Markets. As per her, mature generic companies are looking for differentiation in product portfolio, better pricing and patient compliance. Super generics give all these opportunities for the companies. The session was full of knowledge about various super generics definition, opportunities and development strategy, regulatory pathway across the globe, technical documentation required and case studies of Absorica, Dymista, Docefrez Injection etc.
Post lunch session was conducted by Mr Rahul Gupta, General Manager, Regulatory Affairs, Piramal Enterprises Limited on “Global Regulatory Requirement and Process for NDDS formulation for smooth and speedy approval”. Apart from regulatory requirements, concern, opportunities for India Pharma Companies, Mr Gupta emphasized on Clinical design for in vivo BA study for NDDS.
Mr Santosh Savarkar, Associate Vice President Regulatory Affairs, Alembic Limited, in his starting discussion about PIC/S and approval, showed very meaningful video about calculation relating with GMP inspection. Mr Savarkar correctly said that GMP inspection remains GMP irrespective of USA, EU or any Emerging Markets. The need and acceptability of PIC/S is revealed in Dr Margaret A Hamburg, Ex FDA Commissioner, quote “Today PIC/S is more important than ever….”. The first day ended well with fruitful panel discussion by esteemed speakers.
The day 2 was opened up by Chair person with brief introduction about the day proceedings. This was followed by detailed presentation on Russia by Mrs Victoria. It says from July 1’2015, the federal law FZ 61 will be implemented and Russian Federation will give clarity about requirement towards end of May 2015. The session was highly informative with New Law update, technical requirements, CTD and eCTD implementation, labeling requirements, normative documents (ND) requirements, variation guidelines, timeframe for approval, Pharmacovigilance and challenges.
Mr Santosh Kasyap, General Manager, Regulatory Affairs of Adcock Ingham gave detailed regulatory knowledge about South Africa technical requirements and ways to make efficient regulatory submission. He briefed about different committees, drug classification, fast track approval and GMP inspection by MCC.
Mrs Meena Shah, General Manager, Regulatory Affairs of Geltec PvtLimited gave in-depth knowledge about GCC and MENA markets. Attendees have learnt about decentralized and centralized process of registration and various market opportunities.
Dr Prasannakumar, General Manager Regulatory Affairs of Dr Reddy Laboratories has given practical knowledge about Fixed Dose Combination Products, how to bring it to market, different challenges, and types of FDCs with clinical and non-clinical requirements.
Mrs Suchitra Tiwari- Head Regulatory and Project Management RPG Life Sciences Ltd spoke about DMF requirements in USA, EU and comparing it with Emerging Markets. She emphasized on Genotoxicity impurities and Elemental impurities.
Mrs Maitrayee Mukherjee, Associate Vice President of Famycare Limited spoke on how to write ASEAN CTD and given comparative information about GCC CTD and SA CTD. She has specified more in detail about writing Module 4 and Module 5 of CTD.
Mr Tulasi Ramu, Deputy General Manager, Regulatory Affiars Wockhardt have spoken on Product Lifecycle Management, giving more detail about PSUR, Stability update, Phase IV study requirements and Re-registration dossier. He emphasized on Pharmaceutical development by QbD approach and Manufacturing compliance as per ICH guideline.
The conference ended with closing remark from Mrs Rahalkar of Metina PharmConsulting and vote of thanks by Mr Brian Nunes of Alliance India. CCI Newswire