February saw a fairly massive churn in India’s drug regulatory infrastructure. We now have a new Drugs Controller General (India) (DCG(I) with Dr GN Singh handing over charge to Dr S Eswara Reddy. Though the Ministry of Health and Family Welfare circular mentions that he will hold the post for three months, given that he has already been part of the system as Joint Drugs Controller, it is expected that Dr Reddy will continue as DCG(I). On February 20, 22 drug inspectors/ technical officers were transferred out of the CDSCO head quarters to various zones across the states while another 20 had transfers within the states. In addition, four deputy drug controllers also received their transfer orders.
Another top level transition, though not as smooth, was Dr BD Athani’s elevation as Director General of Health Services (DGHS), Union Ministry of Health and Family Welfare. He took over from Dr Jagdish Prasad, who was sent “on a 15-day earned leave” on January 17, with the leave being extended every few days, as there were “disciplinary proceedings for major penalty …. pending,” reportedly in relation to him trying to influence a selection panel in favour of one of his juniors. Even though he was asked to go on leave to allow “the regular departmental action to be conducted …without any prejudice or impartiality,” Dr Prasad reportedly resumed office on February 20 and was given a choice of being suspended or extending his leave. He chose the latter, extending his leave to April 30.
Dr Prasad’s fall from grace is particularly striking, given that he was conferred one of the nation’s highest honours, a Padma Shree, in 1991 in recognition of his pioneering work done to establish and develop the cardio-thoracic and vascular speciality at Safdarjung Hospital, New Delhi and economise the cost of cardiac surgery. However his record has not been without blemish. Media reports refer to his 2009 removal from the post of medical superintendent of Safdarjung Hospital and principal of its medical college. He was accused of administration related mismanagement, though he was later cleared of these charges.
While the general consensus on social media was that the churn in CDSCO was long overdue, one wonders if there was a specific trigger. Or should this be seen as another manifestation of Prime Minister Modi’s anti corruption crusade? And if so, are there more changes in store? Either way, pharma companies in India would do well to further deepen their focus on quality compliance, the key message from this year’s IPA Quality Forum.
Three years ago, the Indian Pharmaceutical Alliance (IPA) Quality Forum (QF), consisting of six founding member pharma companies, and supported by McKinsey & Company as knowledge partner, embarked on a journey to raise the bar and indeed, come clean about quality standards within their companies.
Most of the six companies – Sun Pharma, Cipla, Dr Reddy Laboratories, Lupin, Cadila Healthcare, and Torrent Pharma – have faced varying degrees of quality related regulatory censure. Indeed, even as four CEOs of these six companies discussed the way forward in the CEO Forum, Sun Pharma was issued a 483 notice with three observations. The mood was introspective as Sun Pharma’s Managing Director Dilip Shanghavi described how his company was closely observing the auto industry to understand it’s strategy towards meeting high quality compliance benchmarks.
The journey over the past three years has not been easy, but is there finally light, however dim, at the end of the tunnel? In an update presented at this year’s IPA QF meet, data presented by McKinsey seemed to show that while India accounts for seven per cent of global US FDA approved manufacturing sites, the country’s share of inspections has come down and outcomes improved during 2017. Indeed, the previous inspection of Sun Pharma’s Halol facility had ended with nine observations so the fact that the recent audit, from February 12-23, ended with just three, could be seen as a positive sign.
Are we clutching at straws? Or is this real progress? Over the last three years (with the FY14 taken as October 2013 to September 2014 and similarly for FY15,16 &17), there has been a reduction in data-related errors but gaps in investigations and root cause assessments is now a leading source of non-compliance, according to McKinsey’s analysis of warning letters (WLs) and 483 observations.
The focus of the next year is to scale up IPA QF interventions to other IPA members. The Forum is sharing the learnings as guidance documents and SOPs, with all the presentations made on the two day IPA QF uploaded on the IPA website. Of course, SOPs and guidances, and transfers of drug inspectors for that matter, are not magic bullets and can only be a first step on a long journey.