Lupin gets employees to take ‘ownership’ of quality at its manufacturing plants

PT Jyothi Datta Mumbai | Updated on June 26, 2019 Published on June 25, 2019

Nilesh Gupta, MD, Lupin Ltd   -  BUSINESS LINE

Four of drugmaker’s sites are facing USFDA regulatory actions

Drugmaker Lupin is embarking on a quality transformation initiative at its manufacturing plants, to train employees to take greater ownership, says Managing Director Nilesh Gupta.

Recounting a recent discussion with sister and Chief Executive Officer Vinita Gupta, Nilesh told BusinessLine that they felt “ownership of quality has to be at site, has to be owned by the site, that’s what we have to drive.” The quality initiative starts in July.

Interestingly, Nilesh is clear that the transformation programme will not involve consultants. “Ownership has to happen, that is a core fundamental we are driving in this project. This is something we are starting now, as I see it, it is a three-year project. We will do a lot of good stuff in the first year itself,” he said.

USFDA action

Many Indian companies when faced with regulatory action from the United States Food and Drug Administration (USFDA) have appointed consultants, often foreign ones, to help navigate turbulent waters. Four of Lupin’s sites (Mandideep, Goa, Indore and Somerset) are facing different levels of USFDA regulatory action.

Nilesh explains why appointing a consultant was a mistake the industry was making “over and over again”. Consultants have a role to play, he agrees, however “this has to be a company owned.” Giving an insight on how it works, he says, “We had an Aurangabad inspection. We didn’t have any consultant coming there. We had a dozen people from other Lupin sites who came into Aurangabad to say, what does this look like, just to challenge the site. That is infinitely-better and infinitely more sustainable than having somebody else step in.”

Years ago when Lupin’s Mandideep plant faced USFDA action, insiders recounted how Nilesh had taken personal interest in sorting out the problem. “It’s still my responsibility. There’s no difference in that quality and technical operations report directly to me, it is all my responsibility,” he says, narrating how they were up till midnight recently responding to FDA observations.

“One of the things I had stepped back a little bit (from) was on participating in the FDA audits. We changed that this year. We were very clear, whenever FDA comes to plants like Indore and Goa I would be there. To me that was a big eye-opener, I was there through the entire inspection in Indore and Goa. It didn’t change the fate of the outcome by being there, it was a lot of learning,” he says.

Earlier, on receiving regulatory observations or warning letters, “the lens have always been, what do I need to do to fix that,” says Nilesh. While there is nothing inherently wrong in the way things are done, he says, a lot needs to be done to have the confidence that “yes, all plants are fine.”

The focus of the quality transformation initiative is on all sites and on a sustainable basis, he says and “not something that we do as an episode in Goa or Pithampur. It has to be each and every site. And it has to be multi-year programme where we constantly challenge and make sure that we are where FDA expects us to be.”

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Published on June 25, 2019
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