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Viveka Roychowdhury – Mumbai
Coming on the heels of the visit of the Dr Margaret Hamburg, US FDA Commissioner, the recently held 2nd Healthcare & Pharma Expansion Summit 2014, Mumbai was an excellent opportunity for top industry professionals and service providers to discuss the learnings and move forward.
In his keynote address in the morning session, as well as while moderating the panel discussion later, TS Jaishankar, Managing Director, Quest Life Sciences, spoke about how regulatory issues are proving to be a challenge in the Indian pharma sector.
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Jamila Joseph, Vice President and Head, Clinical Research Services, Reliance Life Sciences, spoke about the need for business process transformation to deal with regulatory challenges. The business model should be economically viable as well as compliant, and we need to improve infrastructure and the talent pool along with regulatory reform so that these reforms are implementable on the ground, was her solution.
Dr Anil Pareek, President, Medical Affairs & Clinical Research, Ipca Labs said that of all the many regulatory changes on the clinical research front, industry was most concerned about delayed approval timelines.
SV Veeramani, Founder and Chairman, Fourrts (India) Laboratories and President, Indian Drug manufacturers’ Association (IDMA) reassured the audience that India’s regulatory chief, the Drug Controller General (India), had in a recent meeting with association members and senior industry personnel, promised to clear the backlog in the next three-six months. He made the point that India’s pharma products had a wider reach than the country’s IT services, if one considers that the former are exported to around 250 countries while the latter reach 150 countries. Be that as it may, on the compliance front, Veeramani opined that continuous technical upgradation calls for continuous training.
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In her concluding statement, Joseph stressed on the need to have a more practical roll out of regulatory reform. Pareek too touched on this refrain saying that while new requirements like AV recording of the informed consent process might be an issue initially, with time, they will become part of the process. Jaishankar summed up concluding that while our laws were good, implementation is difficult; partly due to the democratic process.
Winding up the pharma track of the event, Dr Rashmi Hegde, Director Medical & Regulatory Affairs, Abbott India, in her presentation on the best practices for improving risk management and compliance in the healthcare sector, spoke about the need for harmonisation of regulations to avoid duplication of efforts.
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