Express Pharma

Panel Discussion : Optimising FR&D to expedite regulatory compliance

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The moderator of this panel discussion Dr Vinod Arora, Principal Advisor, Institute of Good Manufacturing Practices India (IGMPI), began the session by saying that FR&D activity can be divided into three parts – prototype development, analytical evaluations and exhibit batches and regulatory filings, etc. On the development part, together, there are almost 3,000 companies in India and about 10,500 manufacturing facilities – API companies or API plus dosage form companies or only dosage form companies. He pointed out that businesses request products for multiple markets, but there are various challenges when it comes to developing formulations for multiple markets because different markets have different Reference Listed Drugs (RLDs) and then there are API sources, DMF sources, non-DMF sources, etc and FR&D resources are limited. The panellists talked about these challenges and the solutions required for such global development programmes.

The panellists also shared their views with the audience on overcoming the challenges with respect to PCS Class-II and Class-IV drugs, and Class-III drugs where the inter-subject variability is high. They threw light on the kind of evaluation that is done to minimise or avoid the failures before initiating the pilot studies in such cases.

Apart from it, the panellists also pondered upon the clinical development programmes, which are time-consuming challenging as well as expensive. They talked about the challenges faced while planning biostudies since the RLD and regulatory requirements are different in different countries. They focussed on the strategies that are worked out during such scenarios. Further, talking about the differentiated products, where unmet needs are there, the panellists also deliberated upon the approaches needed for successful formulation development of generics.

Mentioning about the molecule-based multiple geographies’ simultaneous development, one panellist said that a critical aspect in this regard is IP alignment. In the initial phase itself, the scope of the project needs to be properly defined for all the geographies put together, whatever is of interest. He further said that these days, IP extensions that come in different geographies, while the filing date might be same for the same pattern, but then the pattern extension paradigm that sets in different geographies, actually shift the launch dates, in some cases, by several years. From that perspective, the scope of the project has to be defined keeping in mind IP scenario, packaging requirement and zonal stability requirement. For the formulator, there are challenges of reference products performance being different and all other things. That is something which has to be experimented and taken care of, but then definition scope is crucial for such type of development.

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