Updated on 25 April 2014
She added that though the number of manufacturers in India is huge, documental evidence suggests that many do not really understand the nuances behind the current Good Manufacturing Practices.
"Further, there is a need for non-biased assessment based on not just understanding of FDA's regulations, but also the regulations in place in other geographies. Each individual market is different," she explained.
Further, Mr Ramzan added that while overall regulatory harmonization is a great idea, it is not practically possible. "The mindset in the US is of having one single body taking care of everything. As per the recent talk on harmonization, what will happen is that the EU will probably hand over the audits and FDA will implement," he said.
Speaking of India, they said that while India has been able to grab the bulls by the horns in the case of generic manufacturing, it has been proactive in BioSimilars too, even though they suggested that there is still a long way to go.
"India is struggling in establishing its own regulatory framework. The system is very hierarchical, you can't tell the higher ups that something is wrong. The Indian board has no teeth. The Indian Patents Act 1970 did away with protection of product patent process. There was no monopoly on product," he explained.