From last 5 years, there has been a continuous issuance of warning letters and frightful regulatory inspections for Indian bio pharma. Still, there doesn’t seem to be a conjunctive put up by the drug companies to handle or deal with this major devastate. True, there has been a lot of buttonholing with the Indian and United States of America government to the USFDA (United States Food and Drug Administration) to bow out. Drug companies who got warning letters or import bans have exploited or functioned to rectify the errors however nothing apparent to bring up the mark on abidance for the drug industry completely.
Thought it is late but right movement for the drug segment to come out from this stage. Bio pharma companies can sound off about elusive regulatory inspections, ever changing regulatory standards and raised expectations. The main thing is that trend of warning letters severely damaged the Indian drug industry. Every drug company gets addressed with same curative mechanisms furthermore everybody has to come together and function together to meet the regulatory standards.
Bio pharma players must take and go for publically that things are not hunky-dory must be securely placed. Should stand unitedly and formulate criterias for demeanors that all members must comply with those procedures. Take educational initiatives for quality assurance professionals; make out list of items of do and don’t, planning so entire drug segment can benefit and gain back the previous positions. This is a great initiative and great chance that can also do well for the Indian patients since traditionally quality and compliance parameters have been the concentration for finished medicines subjected for drug exports. Same parameters must employ to products utilized for the Indian patients.
To conclude, proactive cooperation mechanisms, conjunctive exertions among the industry players to better the abidance expectations will better quality of pharmaceutical medicines also benefit the domestic and global patients, and build again charisma of the Indian bio pharmaceutical and are great for Indian bio pharma business in the long haul.