The risks associated with any slippage in maintaining high quality while manufacturing medicines can be too high. Leading Indian pharmaceutical companies who eschew the thought of being labelled makers of poor quality copycat drugs should be knowing this only too well by now. Having spent years coping with warning letters, import alerts and observations by the US Food and Drug Administration (USFDA), the drug regulator in their biggest global market, the US - at least 40 per cent of revenues, if not more, for most big Indian players is from the US -they all, at least know the costs involved. Most have after all spent huge sums hiring US-based consultants who charge $350-400 an hour and subsequently, based on their inputs, set aside men and money to revamp and automate their production systems and retraining people.
In what seems an effort at trying to showcase what to expect on automation and what the company was doing to strengthen its quality governance, Lupin, the eighth largest generic company globally and India's third largest pharma company (by sales) invited a few journalists to visit its Nagpur facility that manufactures oral solid dosage forms and injectables.
This plant, which sent out its first commercial batch as late as October 2017, has had five USFDA inspections between March 2015 and September 2018 with no observations and receiving an EIR (inspection closure report) after each inspection visit. The plant had a lot to convey on good manufacturing practises as you walk past the epoxy coated floors and peer into the glass wall to look at some of the latest equipment imported from Germany like the vial filling line or the aseptic isolator from Switzerland or the Lypophilizer with automatic loading/ unloading system from Spain.
With all aspects looked at from warehouse management to packaging and material handling, Lupin arguably had a good story to tell in Nagpur. But for a company with 18 manufacturing sites - 12 in India, one in the US, three in Japan and two in Latin America, what happens elsewhere is equally important.
Our concern, therefore, was more about facilities where Lupin had still regulatory challenges to deal with. Lupin has four plants that have OAIs (Official Action Indicated) and is meant to convey that there is an unacceptable state of compliance. These are Pithampur (unit 2), Goa, Mandideep (unit 1) and Somerset in the US. Business Today spoke to Rajiv Desai, Executive Vice President, corporate quality assurance and Rajendra Chunodkar, president, manufacturing operations at Lupin. They talked of measures being taken and how there were top-level involvement and strict vigil to ensure USFDA is constantly updated on measures being put in place to address concerns and to work towards creating conditions for a re-inspection by the regulator.
These could be around the change or replacing equipment - in one case for instance, an older Korean machine was being replaced by a modern German machine (apparently, this process has been on for the last two years to constantly review machines and given their life, either upgrade or replace), the root-cause analysis, process improvements, approach to preventive actions, structural changes in terms of talent addition.
Starting June last year, in what seems a complete revamp of quality governance, the core leadership team has been devoting time each month reviewing progress and keeping track of developments in the industry and looking to warning letters and 483s issues to other companies and seeing if there is any learning for Lupin at any of its facilities. There is a heat chart with different colours with red indicating urgent attention and a dashboard on each of the parameters where progress is required to be reported to the regulator. For the moment, all eyes now on how the regulator responds.