From a global perspective, looking into India, how do you view the changes on the clinical trials regulatory front? Industry bemoans the slowdown in approvals, and the increased stringency as far as patient safety is concerned. Your comments.
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| Dr Alexandra Pearce |
Clearly, there has been a lot of change in the way clinical trial applications are evaluated in India as a consequence of the Parliamentary Standing Committee Report. There was a need for it to become much more rigorous to improve the standards both in terms of the quality of the data and more importantly safeguarding patient welfare. A number of measures have been taken by the Government to ensure these aspects – like increasing the number of specialists taking part in investigations, limiting the number of clinical trials investigators can participate in at one time as well as taking steps to ensure that the patient understands the informed consent process correctly.
Proper implementations of these measures will ensure that the regulations and processes will be broadly in line with developed markets. But there is no denying the fact that the process has become extremely bureaucratic with multiple layers of review from different committees. So, there needs to be a way of streamlining the process so that not only the goal of patient welfare is maintained, but it also allows for valid scientific questions to be answered through clinical trials.
How does the Pharmacovigilance Programme of India (PvPI) measure up to global PV regulations?
I am of the opinion that the standards of reporting of PV in India, in light of the recent measures, brings the country broadly in line with developed markets. In some cases, I feel the reporting requirements and the timelines are actually more stringent than even some developed markets.
The area which needs to be addressed is under reporting of adverse events both for marketed and investigative products. The system is there to handle adverse events, but the authorities in the first place need to receive the reports to act on them. So, in India there needs to be greater efforts by the authorities to educate physicians and investigators to report adverse events.
On the manufacturing side, India-based manufacturers who export to different geographies find it extremely difficult to cope with differing GMP regulations and standards. There are increasing efforts to share inspection findings between global regulators so how should such manufacturers cope with these challenges?
As we aware, approximately 40 per cent of generic drugs sold in the US are from India. Regulatory authority expectations have been increasing exponentially globally in recent years putting pressure on India-based manufacturers to comply with national cGMP requirements, including FDA, whilst remaining competitive.
A challenge for India-based manufacturers undertaking global pharma supply is there is no single standard for GMP. Different approaches may be taken by different national authorities and a single facility may be inspected by multiple authorities. This results in a single facility holding multiple GMP licenses including:
- FDA, EMA
- WHO
- National Regulators who are not PIC/S members
- National Regulators who are PIC/S members, but who may or may not perform their own inspections regardless
There are a number of collaborative exercises between FDA and EMA, including information sharing to increase monitoring and reduce duplication in the fields of:
- API
- Finished product manufacture where the facilities are located on each other’s territories leading to deferment or waiving of some inspections.
- GCP inspections of information in generic applications
In January, 2014 the Drug Controller General (India) DCG(I) asked India-based manufacturers to inform him instantly of alerts and restrictions by other countries regulatory authorities and also instructed the state licensing authorities (SLAs) to hold inspections in such cases. In addition, it has recently been announced that unannounced inspections will be conducted by SLAs of domestic and overseas facilities with the aim of achieving a level playing field.
In addition, it was announced in January that the Indian Government is considering revising the Indian good manufacturing practices guidelines (Schedule M) at par with WHO-GMP which is the mandatory requirement for global market entry and specifically for countries with no dedicated regulatory authority.
So, clearly absence of a single standard for GMP is clearly a road block for Indian manufacturers supplying to the global markets.
Is setting up manufacturing plants in overseas locations the only solution to meeting global GMP standards?
Absolutely not. There are excellent manufacturers based out of India who are manufacturing for the entire world. I am of the opinion that quality is a philosophy regardless of geographies. It’s about how you approach GMP and apply those standards.
As the programme co-chair of the upcoming DIA India Conference 2014 (October 16-18, Mumbai) how does the theme, ‘The Future of Indian Health Care: Patients, Access and Innovation’, tie in with these concerns?
India’s life expectancy has increased considerably in the last two decades or so. So, the healthcare policies pursued by the Government have been effective and they have been able to make medicines and treatment available to large sections of the population. However, there are still challenges. The most critical aspect among these is ensuring safety, efficacy, quality, affordability and accessibility of medicines and treatment to patients at all times. The key imperatives to overcome these continual challenges and catalyse the transformation include putting patients first, fostering innovation, and enhancing access. The 9th Annual DIA India Conference will bring together leading local and global experts in healthcare, pharma industry members, academia, researchers, regulators and patients under one roof to deliberate on the emerging trends, opportunities and challenges.
I along with my programme Co Chair Professor Ranjit Roy Chaudhury, Chairman for the Task force for research at Apollo Hospital are really excited that that we have the commitment of experts who will be discussing the ‘patient first’ approach that will cover innovation and access of Indian healthcare. In addition, important topics such as clinical trials, quality and manufacturing, health economics, healthcare delivery, public-private partnership in innovation and healthcare access, and case studies on Indian innovation will be shared. A true demonstration of opportunities that lie before us here in India. So, I invite all stakeholders in the pharma and healthcare industry to be a part of the conversation at DIA India Conference 2014 in Mumbai.
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