HarNeedi - Healthcare & Pharma Job Portal

India is the largest supplier of medicine to US, and pharmaceutical exports from India raise from $3.44 bn in 2013 to $3.76 bn in 2014. ​Country’s pharma sector is likely to grow over three-fold to hit $55 billion in the next five years, even as the exports from the sector may slow down to grow at a CAGR of 7.98% owing to stricter regulations in markets such as the US, Russia and Africa, says a report. “Indian pharmaceutical industry is expected to touch $55 billion by 2020 as against the current size of $18 billion but the exports may slow down to grow at a CAGR of 7.98% in value terms due to tightening of regulatory mechanism in top exports markets of US, Russia and Africa,” a joint report by Assocham and TechSci Research reveals. With 70 percent of market share (in terms of revenues), generic drugs form the largest segment of  the Indian pharmaceutical sector , Consolidation of pharmacy players is leading to an increase in pricing pressures for generic companies existing in...

Before a pharmaceutical product can go to a new market or developing market, filling must be composed and filed with all relevant regulatory agencies to seek a review and finally regulatory approval. Each jurisdiction has its own procedures or procedures to review drug submissions filed to their regulatory authority. These procedures can change considerably with respect to How the drug submission will be managed, The constitution of the review team, Review timelines etc; In spite of the divergences, the procedures to turn over regulatory approval generally follow these stages: Pre filling or Pre-Submission meeting: ​ Even though left to personal choice, a pre filling meeting is often helpful so that any regulatory submission issues can be discussed and settled well in advance to the actual filling. This meeting allows the regulatory authority insight in to the proposed submission and permits them to bring their internal resources in accordance with. Ensure the challenges are...