Unlocking Potential

A transforming landscape

Experts and influencers reflect on the many milestones achieved by our pharma industry to become ‘Pharmacy of the World’ and explore strategies to enable India Pharma Inc embark on its next phase of growth

The future of pharma is expected to be driven by digital transformation

Given the recent price control on essential drugs, stringent regulatory requirements and focus on affordable healthcare by the government, managing cost is a big driver for the pharma industry. Recent trends indicate that companies have started collaborating in the value chain, especially in the back end supply chain to drive efficiencies and sustain a profitable growth.

Driving collaboration requires a connected ecosystem and there is thrust towards enhancing digital capabilities in the sector, therefore driving new areas of strength. This is seen to have led to many non-traditional players, especially tech giants participating in the value chain right from drug discovery to drug delivery changes in the healthcare industry are expected to lead to large scale disruptions over the next 15-20 years, especially when moving towards a solution for affordable health for all. For example, care today is retrospective and reactive, and in the future, care is likely to be prospective and predictive, adapting to the needs of the empowered consumer/patient. Consumers will not wait until symptoms force them to go to a physician – in the future, technology and an ‘always on’ environment is expected to provide continuous insight into an individual’s well-being and help in deciding proactively while addressing a potential disease. In this context, today’s biopharma approach is unlikely to sustain 15-20 years down the line – the modern research process is too expensive and time consuming, and treatments typically adopt the one size fits all approach.

Biopharma must prepare for a future that will focus on personalised treatments. Mass marketed therapies are unlikely to cut it when we can map a human genome in under an hour at low cost, and then tailor drugs to individuals’ biology and underlying needs. Therefore the future of pharma is expected to be driven by digital transformation enabled by radically interoperable data and open, secure platforms, when moving to more personalised drugs and treatments.

Implement quality culture at all levels to rebuild image and credibility

The Indian pharma industry has achieved several milestones in the past 25 years. Some of them are as
follows:

• Moving away from manually operated/semi-automated manufacturing plants and machines to automat

  ed manufacturing machines and building management system/software based operations.

• Moving towards total global regulatory compliance.
• Record high ANDA/DMF submissions to US FDA. India ranks 2nd largest globally.
• High level of trained and knowledgeable working force.
• Learnt the hard way, paid a heavy price to improve and meet compliance challenges, especially meeting data integrity requirements.
• Realised the need to ensure quality culture.
• Implementation of ‘quality by design’ process for API/product development.
• Better infrastructure in R&D, manufacturing, quality monitoring and supply chain.
• Focus on niche products development and expanding global markets.

Steps to sustain the growth in next 25 years must include:

• Focus on biosimilars, genetics, vaccines, nanotechnology products as biologics offers opportunities for
  explosive growth.
• Develop horizontal and vertical digitalisation of pharma processes.
• Utilise AI/Machine Learning in development and manufacturing besides big data analytics to witness drastic changes in the way we diagnose/treat diseases.
• Use emerging technologies like continuous manufacturing and 3D printing.
• Implement ‘Quality Culture’ at all levels to rebuild image and credibility.
• Build and operate fully automated labs for inline testing and monitoring.
• Business focus should be patients-oriented.

Innovation in operating models, patient outreach and payment models will be as important as the science of pharma itself

The Indian pharma industry is truly one of the success stories of modern India. It also reflects entrepreneurship to capitalise on a market driven opportunity and fulfil an economic need at very competitive prices. The industry has been able to adopt innovative both, innovative process development coupled with modern manufacturing processes, while adhering to global compliance standards. The number of manufacturing plants in India that meet manufacturing standards across a wide gamut of regulatory standards reflects its maturity.

As we stare at the horizon, in terms of what lies ahead, questions must be asked whether the engines that propelled us to achieve the success we enjoyed, will continue to serve us in an ever-changing environment.

As personalised medicine becomes a reality, the target audience will translate into a more sharply concentrated and smaller population, which seeks targeted cures as opposed to broad spectrum cures. Personalised medicine at its peak will challenge the traditional bulk manufacturing model. Add to this, innovations such as 3D printing and dispersed manufacturing, the rationale for large manufacturing plants, except for basic building blocks will be challenged.

Innovation in operating models, patient outreach and payment models will be as important as the science of pharma itself. A fundamental question to be asked is whether the basis on which we compete remains the same. The industry has achieved great success in emerging as a manufacturer of low-cost products. To remain a low cost producer, it would be imperative to have a stringent controls over all elements of costs. As is apparent, this is becoming increasingly difficult. The problem is compounded with the concentration of buying power in markets like the US.

Some of the imperatives for the industry are:
1. Rebranding itself
The industry is recognised as a low cost manufacturer. It would be essential to convey high quality at competitive costs, rather than only low cost.
The industry is represented by a large number of trade associations, perhaps one for every segment. It is time that it comes together and speaks in one voice. The success achieved by NASSCOM for the software industry needs to see a parallel in the pharma sector.
2. Innovation partnerships
The experience with partnering with universities and institutions such as NIPER has at best been a limited success. The industry needs to forge a new partnership with academia setting up chairs and programs for future oriented, industry focussed research. Accountability for results must rest equally with the industry and academia. Merely giving grants will not resolve this.
3. One standard for quality
We cannot have a domestic standard for quality, which is in any manner not equal to the highest standard adopted in any geography. Cost and quality need not be opposing ends. The cost of low quality will far exceed the price for being the hallmark of dependability.

Emerge as leader in innovation with an aim of launching three to four NMEs annually by 2030

M&As in pharma industry have been increasing at a very fast rate. Big MNCs have been acquiring small companies with niche products to increase their own footprint. The other opportunities for MNCs lie in the areas of CROs, high-end products, and clinical trials owing to the availability of skilled doctors and other medical and paramedical personnel. This also also resulted in a change in the spending pattern of Indian pharma companies. Today, it is estimated that the industry spends around 18 per cent of its revenue on R&D which is further expected to reach 25 per cent.

But, the industry is also facing a number of challenges such as:

• Frequent and unexpected changes in prices.
• Constrained talent pool who possess advanced skills.
• Low collaboration between academia – industry on innovative R&D
• Moderating growth in US market due to price erosion
• Limited presence in other markets like China, Japan
• Greater scrutiny from global regulators on quality norms, requires continuous investment in upgrading quality standards
• >80 per cent API requirement along with KSMs are imported, vulnerability to supply disruptions and price movements
• Lack of a cost-competitive domestic API manufacturing base So, the following steps will be needed to ensure India Pharma Inc’s continued progress:
• Take bold strategic moves into uncharted territories (like making big bets on markets like China, Japan)
• Protect the core through extensive adoption of new-age digital and advanced analytics techniques to drive newer
  efficiencies across front-end and back-end operations.
• Drive capability building, especially on the quality front, with regular and deeper engagement with regulators like the US FDA and other drug authorities.
• Emerge as leader in innovation with an aim of launching three to four new molecular  entities (NMEs) and 10-15 incremental innovation launches annually by 2030.
• Create research ecosystem supported by incentives, state-mandated academia-industry collaborations, streamlined regulations and create enabling environment for encouraging start-ups.
• Focus on driving innovation at scale by easing regulations on technological development
• Collaborate to create an independent Ministry for Pharmaceuticals.
• Increase government expenditure on healthcare from 1.2 per cent to 2.5- 3 percent of GDP by 2022 and five per cent by 2030, in line with the European and North American economies.
• Provide infrastructural and investment support needed to bring India’s doctor-patient ratio in line with WHO’s global benchmark e.g., support innovative digital technologies to increase access.