A pill paradigm change

A pill of paradigm change

6:33 AM, 26th December 2017
Kanish Malik, President, Operations, Glenmark Pharmaceuticals
Kanish Malik, President, Operations, Glenmark Pharmaceuticals.

In an interview, Kanish Malik, President, Operations, Glenmark Pharmaceuticals, with Chemical Today Magazine talks in depth about the revolutionary journey that the pharmaceutical industry is in today.

By Shivani Mody

Trends and developments in generic formulations, APIs.

Generics still drive the global pharma growth while representing a volume majority (~55 percent). There has been a tremendous rise in competition in the generics space as blockbusters come off the patent protection. There are multiple other factors at play such as evolving expectations from the regulatory bodies, renewed focus on patient safety, government’s policies to bring the prices down, and approval timelines getting shorter. These are going to test the core ability and speed of all the generic suppliers to provide cost-effective solutions while ensuring that patient safety remains the first and foremost priority.

In addition, the consolidation of trade is redefining the service expectations demanding an upfront commitment on first-time-right capabilities from supply chain with a manufacturing focus.

Focal areas - pharma industry, for business enhancement.

Optimizing the drug life cycle is enhancing the traditional value creation that was largely dependent on intellectual property backed by patents. This optimization would mean expanding the time horizon to realize the overall potential.

Organizations need to be nimble-footed about the development basket. The need for speed, robustness, and first-time-right capabilities that would lead to breaking the fully integrated pharma chain into centers of excellence and a rigour in selecting partners to enable product pipeline.

In addition, the patient safety and adding value to their lives will be the success factors on a global scale. There has to be a significant shift in creating core competency in all areas ahead of the curve to keep pace with the changing needs of the time.

Factors supporting rising trend of outsourcing APIs.

There are largely two factors influencing backward integration – pricing pressures driven by the government policies and increasing number of players in the market, which would call for value engineering. However, given the life cycle of molecules, the long-term financial viability and sustainability are key deciding parameters. Answering this unpredictability demands for a balance between what to produce and outsource.

Thoughts on pharma raw material manufacturers.

Raw material manufacturers are a crucial link in the global pharma supply chain. Any small uncertainty in the supplies from these partners can send ripples across this chain. Driven by the continuous need for patient safety, the robustness of end-to-end chain in development and manufacturing of a drug will always remain a key priority for all the drug manufacturers. The basic expectation is that the partners follow the cGMP standards and embed these principles in the inputs that are going into the finished goods. Some of the molecules involve processes that may have impact on the environment. Any suboptimal processes will no longer be sustainable.

Company’s business expansion plans.  

As we continue our journey, the determination to develop innovative molecules to address needs of patients and make a difference remains our priority. Our strategic roadmap synergizes with our business and the aim is to transition up the value chain and become a speciality, innovation-led company with a solid foundation in the generics business. The therapy areas that we have chosen to focus are Oncology, Respiratory, and Dermatology.

We have been expanding our international manufacturing footprint. Not long ago, we had commissioned facilities in US and Switzerland for the development of injectable and GMP grade biologics. We keep assessing our network to ensure that we are strategically located to fulfil our customers’ demand and have an ecosystem to support innovation.

Paying attention towards R&D & innovation.

Largely, our focus is to develop expertise and capability in the therapy areas characterized by large market size, high entry barriers and high growth with unmet needs. We want to strengthen our current generics base in Dermatology, Respiratory and Oncology.

The company has a pipeline of 7 new molecular entities (NMEs), which includes 2 new chemical entities (NCEs) and 5 new biological entities (NBEs), in various stages of clinical development focused in the therapeutic areas of oncology, respiratory and dermatology. The company also has 3 speciality products in clinical development targeting key indications in the respiratory therapy area. These intellectual assets are already producing results for Glenmark and company expects to launch its speciality business in the US with its first FDA NDA approval in respiratory within 3-5 years.

Glenmark’s research centers are based in Navi Mumbai, India and Neuchâtel, Switzerland. Spread over 125,000 square feet the R&D centre in India has end-to-end capabilities for discovery and development of NCEs from target selection to clinical development. Glenmark’s dedicated R&D centre for biologics in Switzerland has end-to-end capabilities to discover NBE’s and to support clinical development. It is also fully equipped to manufacture and supply clinical trial material. The research facility is equipped with state-of-the-art infrastructure required to carry out research activities like medicinal chemistry, process and analytical chemistry, in vitro and in vivo studies and project management.

Adopting sustainability.

At Glenmark, taking proactive steps to minimize and mitigate our impact on the environment is integral to our vision of enriching lives. Our actions are guided not only by the regulatory requirements and business risk mitigation but also by our commitment to give back and contribute to the well-being of our stakeholders, community and the nature. As a responsible corporate citizen, we give a high degree of importance to EHS considerations in every business decision and operational activity.

Eleven of our facilities are ISO 14001 certified, complying with environmental management standards. We have been able to achieve ‘Zero Liquid Discharge’ status for eleven of our facilities through our own initiatives. On our journey toward environment sustainability, we have been able to reduce the waste generation and conserve water, electricity and fuel through our resource management and recycling focus.

Challenges faced by pharma manufacturers.

Continuously evolving regulatory expectations coupled with high pace of growth have been pressing the industry to quickly sync their systems, processes, and culture with new standards. While the large business houses may be able to meet this demand with the rigour and automation they possess, other players of this highly fragmented industry still face challenges in adapting to the environment. Unifying the quality standards across the industry will address the debate between cost efficiency and safety.

Changing government policies can bring unpredictability in the business. The sector needs a long-term stable policy environment for a sustainable growth. 

Trends in pharma supply chain and packaging industry.

There is an evolving trend of consolidation of trade that is happening in developed markets and the same pattern is catching up with the other parts of the world where the service expectation lines are blurring between pharma and other consumer industries. This is leading to value engineering and SCM optimization through pharmacy solutions, automation, and ability to enable faster response time.

The packaging of pharma products is being seen from a fresh perspective. These are now more aesthetic and appealing to consumers besides being more informative. The solutions are now becoming more and more user-friendly. OTC products, in particular, are no less than FMCG products when it comes to packaging. Among other factors, concern about environment has given rise to alternatives to plastic packaging.

Packaging solutions are now embedding product tracing features. This has been enforced by the regulatory agencies and governments. This addresses the concern of counterfeit drugs entering the supply chain.

GST in pharmaceuticals.

GST has transformed the way business transactions are made. This will break the boundaries between states, and smoothen the entire supply chain flow that will ultimately elevate the service levels benefitting the end consumer.

Lack of infrastructure has often been cited as an impediment in business growth. GST should be able to improve upon this situation as the implementation solidifies and businesses become more comfortable with this change.

Pharma Vision 2020 - Ways companies are striving for it.

India is a leading pharma producer accounting for 20 percent of global exports in generics with a CAGR of 12 percent. Currently, India’s strength is being cost efficient and competent. India’s cost of production is around 40 percent of US. We have a competent workforce possessing high managerial and technical skills. This is coupled with manufacturing capability - We have the second largest number of USFDA plants outside US. India is also a leader in the clinical trial markets. R&D is an area where we have lot to cover. Typically India pharma companies spend around 8 to 11 percent of their total turnover on R&D.

While we have organizations excelling in individual areas, there are only few companies having end-to-end manufacturing - covering R&D, clinical trials, Manufacturing, Regulatory access, and marketing. Government’s support on basic research, discovery, and pre-clinical research will certainly help the industry boost their efforts. Also, the policies regarding promotion of localization of key input material for pharma industry are welcome. The government’s proposal to rationalize and harmonize the quality standards across the country and running frequent checks on compliance will help in enhancing the image of the industry.

© Chemical Today Magazine

 

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https://www.worldofchemicals.com/digitalissue/chemical-today-december-2017/26

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