Last week, top Indian drug maker Sun Pharma said the US regulator would lift the import ban on its Mohali manufacturing facility. Investors greeted the news and the development was a big relief for Sun Pharma, which is still fighting to resolve regulatory issues across several of its plants, including the ones acquired from Ranbaxy.
There was similar good news for Cadila Healthcare, part of the Zydus Cadila group, which recently got the green light from the US Food and Drug Administration for its Moraiya plant in Gujarat.
Dr. Reddy’s had a mixed bag. While the company got three “addressable” minor observations for its Miryalaguda plant in Telangana, its two-year remediation work at Vishakhapatnam went in vain as it received 13 observations.
David Keeling is familiar with all these developments. As head of the global quality, compliance and remediation practice at management consulting firm McKinsey and Co, he has been working with these top drug makers and other members of the Indian Pharmaceutical Alliance to help them improve their overall quality.
Speaking to Moneycontrol about these efforts, he feels that while Indian companies have made progress over the past two years, there is still some way to go in terms of bringing in a culture of quality.
Excerpts of the interview:
What has changed in India pharma over the past two to three years that you’ve been working in the sector?
Three years ago, a number of regulatory actions started to occur. The industry hadn’t organized like this to address quality. I think what we have seen over the last 18 months is a concerted action both from individual companies and from the industry.
They addressed operating systems, procedures on the shop floor, they improved the management controls and governance to follow on the shop floor and they actually started to address quality culture.
Is it the first time that competing companies got together to address quality and compliance issues?
Even in the US and Europe, we haven’t seen such an orchestrated action by the industry. It’s remarkable and the IPA is unique as it was able to pull together all these competing companies who were not comfortable sharing information with each other.
Now, at the industry level they are sharing best practices. They are really trying to learn from each other and as a group they are trying to learn from the regulator. As an individual company, it’s more difficult to engage with the British regulator or the (US) FDA and get input on set of standard operating procedures (SOPs) for data integrity.
Also, the commitment from CEO and the next level leadership has been total. Around 30-50 days of CEO time was allocated and the second layer of leadership involvement has been enormous.
How do you measure the outcome so far?
The IPA members are using a tool called POBOS – which is a benchmarking tool around quality. They are using that as a leading indicator of how they improving on a global scale. They are gathering those benchmarks [POBOS includes data of 600 plus plants globally with benchmarks along every step of the value chain].
The public metric will be the outcome of FDA audits. We are going to see over next 2-3 months the results from regulatory standpoint.
How much time do you think Indiam companies will take to catch up?
I think it could be three to 10-year journey. At the end of it, we will know we got it right when no one has to watch an operator on the line or a person in the lab to make sure that they do the right thing. That’s the culture shift for the industry that we have to get. Any culture change will take a lot of time. Even in the US it will take the same time. We have a long way to go.
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