Pharma producers welcome USFDA move to incentivize quality

Jayarama Emani | The Dollar Business The pharmaceutical industry appreciated the recent move by US Food and Drug Administration (USFDA) to incentivize those adopting a culture of quality in addition to its usual practice of pulling up those for manufacturing lapses. Speaking to The Dollar Business, Krishna Prasad, CEO & Director, Cito Healthcare (P) Ltd; said “I am glad the agency is taking pro-active and positive steps in encouraging compliance across the industry. In the past, we have the UK MHRA (Medicines and Healthcare Products Regulatory Agency) being appreciative of some of the GCP (Good Clinical Practice) measures adopted by a sponsor or a contract research location. USFDA too have been complementing more from the CFR (Code of Federal Regulations) point of view.” “As much as an auditee organization is told where it needs to pull up its socks, placing the credit where it matters for better compliance is a welcome step,” he said and added, “I am sure such steps towards giving credit where it is due would make the stakeholders not only to comply but far exceed the expectations.” More than any country, it is India which would be at the positive receiving end for good; at a time when there are many issues plaguing the pharma industry especially in the research process on quality and compliance. India is the location USFDA frequents in terms of inspections, approvals more than any other location outside of US. In spite of what is all said and done, more than 40% of what Americas consume as medicines are from India. Not for nothing it is a preferred location and placing the credits at the rightly deserving places would improve India's place, prestige, business volumes against its competitors such as China, Prasad said. Dr AVS Suresh, Director, ClinSync Clinical Research Pvt Ltd, whose company is in the midst of a USFDA audit, while welcoming the USFDA initiative expressed reservations too. He said, “The appreciation of the better systems by the agency should be shared in confidence as a note letter to the audit location. This could be carried on the Website in a generic way (masking the audit location identity). The objective is to see that if a location is specified in such note publicly, others in the trade may show such compliance on paper and not in deed (which does not serve the purpose of good practices implementation) just to garner the possible project/business which is not their due." "While it is great to be optimistic and positive on such recognition of credit, the flip sides resulting in fake claimants should always be prevented. For the specific location, it would be a matter to show their confidential note of appreciation while quoting the generic one made on agency's site would help both their existing and prospective clients.” This recent change in the US regulator's approach comes as a breather to Indian pharma companies, many of which have seen their facilities getting blacklisted since 2012 after the USFDA intensified its scrutiny in India. In 2013 alone, the USFDA had banned 21 Indian manufacturing facilities from shipping drugs to the US, the highest ever for India in any single year. India also constituted half of all such import alerts the US drug regulator issued globally that year. But that is mainly because outside of the US, India has the largest number of facilities (523 as of March 2014) registered with the USFDA and is source to 40% of generic drugs consumed there.  

This article was published on March 18, 2015.