CDSCO, US FDA, MHRA, EMA, EDQM officials share updates in regulatory guidances, identify weak spots and suggest ways to bridge these gaps
The India Pharmaceutical Forum 2017 saw the release of Data Reliability Guidelines, in the presence of drug regulatory authorities from India, the US and the European Union.
This year’s conference had the theme, Towards Excellence in Quality. As in previous years, the Indian Pharmaceutical Alliance (IPA) with knowledge partner McKinsey & Company, had speakers from the US FDA, MHRA, EMA and EDQM expanding on their initiatives and taking questions from the audience.
The two-day meet saw global regulators explain the rationale behind their procedures and take questions from the audience asking for more clarity.
Gerald Heddell, Director of Inspection, Enforcement and Standards, MHRA urged Indian regulators to join regulatory harmonisation efforts like PIC/S, ICH and also cautioned that there are many (countries and companies) who are competing for a slice of the same pie that India is targeting.
Brendan Cuddy, Head of Manufacturing and Quality Compliance, EMA, emphasised that with 40-60 per cent of generic medicines in the EU market made in India, the country is considered a strategic partner of high importance to the EU. His observation was that API sites consistently showed increased levels of non-compliance relative to the finished products sector.
Responding to these observations, India’s regulators, led by Dr GN Singh, DCG(I), CDSCO and KL Sharma, Jt Secretary Department of Health and Family Welfare, reviewed India’s drug regulatory reform process over the past year with the Jt Secretary hinting that the year ahead would see more such reform in the sector. Singh summed up his approach saying, “The whole world is changing but India is changing faster, so we need to work harder. We are going to revisit many rules. We are on the path to simplification without compromising on safety or quality.”
Reflecting on the journey of the past year, Vikas Bhadoria, Director (Senior Partner), McKinsey & Company, summarised the work of the Quality Forum – the IPA’s initiative to address all quality related issues of the pharma industry- over the past year. The IPA Report on Data Reliability Guidelines was prepared after a pilot study of 12 plants, six API and six formulation manufacturing sites, two each from six of the 20 member companies of the IPA.
Speaking on EMA’s guidance on data integrity, Cuddy, said, “Data integrity is ultimately about the integrity of your company. Once lost, trust cannot be easily restored. And there are no standard CAPAs to heal the breach of trust.“
Dr VG Somani, New Drug Approval and Post Marketing Surveillance, CDSCO took this thought further saying, “Our integrity should be ultimately to the patient. Data integrity is ultimately the person’s integrity.”
Another session on building a strong quality culture and line ownership had presentations from McKinsey elaborating on the steps towards building such a culture.
Most representatives of regulators who spoke at the conference seemed open to listen and understand the concerns. There is also a realisation that stringent enforcement is not sustainable in the long term.
Alicia Mozzachio, Senior Advisor, International Activities (OPPQ), US FDA, urged companies to expand quality assurance (QA) roles and requiring QA to be involved in improving the quality culture and part of the drug research and development process. She also talked about the cost of poor quality, summing up with an apt visual in which ‘quality’ was the visible tip of the iceberg, while ‘culture’ was the larger invisible part of the iceberg.
The conference also threw up differences in the approach of the US, the UK and the EU regulators. Non compliances were high with the EMA as its inspection process was risk based, choosing to focus on high-risk sites in contrast to the US FDA which follows a routine inspection process. Inspections by the US FDA have also increased as the Agency gears up for GDUFA II, explained Paula Katz, Director, Manufacturing Quality Guidance And Policy, (CDER), US FDA.
But there is a move to become “more educators than regulators”, in the words of Mark Birse, Group Manager Inspectorate, MHRA. US FDA’s Mozzachio too spoke of not wanting to be seen as an ‘inspector’ and urging QA professionals, who are usually seen as inspectors to the rest of their colleagues, to become part of the quality initiative across functions as early as possible.
The highlight of the two-day event was a panel discussion between the CEOs of the six IPA member companies who were part of the pilot study. Moderated by Gautam Kumra, MD, McKinsey & Company, the panelists discussed the way forward and ways to unlock the potential.
Sharing their perspectives on the journey so far, Nilesh Gupta, MD, Lupin; Satish Reddy, Chairman, Dr Reddy’s Laboratories; Dilip Shanghvi, MD, Sun Pharmaceuticals; Pankaj Patel, CMD, Cadila Healthcare and Umang Vohra, MD and CEO, Cipla also spoke about their shared vision to become the global benchmark of quality.
Patel also spoke about the need to upgrade curriculum in pharmacy colleges. Reddy requested the global regulators to share more detailed feedback and give advance information of future areas of regulatory focus.
The meet ended with a vote of thanks from DG Shah, Secretary General, IPA.
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