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‘Not enough attention has been paid to quality by the Indian regulatory system’

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GV (REX) Reklaitis, Professor of Industrial and Physical Pharmacy, Purdue University, sheds light on global trends in pharma manufacturing in a discussion with Sachin Jagdale

What are India-specific growth drivers for the pharma industry?

20160331ep23India has a big presence in supplying generic active pharmaceutical ingredients (APIs) and drug products, both to internal markets as well as to developed countries. As shown by IMS Health, the largest growth around the world has been in generic medicines where currently 92 per cent of prescription volume is filled with generic drugs. Indian companies have a significant opportunity to grow with this sector, providing that attention is paid to meet quality requirements and to minimise high visibility recalls and warning letters from regulatory agencies.

On the global front, what are the new developments that have taken place in pharma manufacturing technology? How is the Indian pharma industry responding to these changes?

One of the important developments that is receiving much attention in the US and Europe is the conversion from batch to continuous manufacturing. This spans both small molecule drug substance manufacture as well as solid oral drug product manufacture. Major reductions in capital and operating cost as well as improvements in quality are being reported. Industry meetings such as the FDA-AICHE Workshop on Adopting Continuous Manufacturing (Feb 29-March 2) in which company experiences are being shared are attracting large attendance, indicative of the interest. The Indian industry has not yet pursued these developments.

India is a cost-sensitive market. Are cost concerns restricting big pharma brands from entering this market?

Yes, cost is restricting entry into the Indian market, especially with the speciality drugs, a rapidly growing sector for innovator companies in the US. However, brand-name generics are certainly an opportunity for Big Pharma.

Besides lack of funding, what is hampering the growth of R&D in the Indian pharma industry? What are your suggestions to overcome these problems?

The leading members of the Indian pharma industry have demonstrated the capability to develop generic equivalents of sophisticated drug products, including biosimilars. This requires highly skilled scientific manpower and laboratory infrastructure. Thus, it is proof that the R&D capabilities do exist in the industry. Although the capabilities to develop innovations also exist, this domain is very high risk and managing such R&D portfolios requires taking a long-term view which is challenging for all but the larger companies. For Indian companies to participate in this domain, it would seem prudent in the medium term to seek partnerships with innovator companies abroad for offering development and manufacturing capabilities in which Indian companies would have significant cost advantages. A successful track record in such partnerships would improve the odds of success with in-house innovative products.

In recent times, many big Indian pharma companies received flak from overseas regulatory authorities over quality-related issues. What is the role of the Indian regulatory system in this scenario? Have they done enough till now to address this issue?

The frequency of these quality related events do suggest that not enough attention has been paid to quality by the Indian regulatory system. Of course, there seems to be a growing recognition that more should and can be done to address this issue. In fact, there should be a strong national incentive for doing more since the recurrence of these events does incline risk-averse external entities to seek other suppliers and partners, thus, impeding growth of the Indian sector. A key step would be to have a regulatory framework that does not differentiate between products for internal and external markets. However, development of a culture of quality across the Indian industry will take time given the very large number of companies of various sizes in this sector.

According to you, what are challenges for the Indian and the global pharma industry?

Given the enormous pressures to control the rise in healthcare costs in all countries in the world, the key challenges for the pharma industry in India and the world are in providing drug products of reliable quality at a reasonably low cost. Manufacturing advances such as continuous manufacturing are part of the solution. But, cost control must not only encompass development and manufacturing costs but also the R&D costs associated with the discovery of innovative drugs. Strong industry-university-government partnerships are being viewed as one avenue to make progress in all these areas. This mechanism might be worth developing in India, drawing on the enormous expat talent pool that India has across the global pharma industry.

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