Pharmaceutical Industry needs to reduce dependency on foreign manufacturers

Excerpts from an interaction with Satish Agrawal, President (Technology & Operations), Ajanta Pharma Ltd. Satish Agrawal is a highly motivated and result-oriented professional. He joined Ajanta Pharma in 1988 as production pharmacist after completing his post graduation in pharmacy from University of Pune. He spent over 34 years across production, procurement, project management, information technology and rose through the ranks.

According to Future Market Insights, the overall sales of pharmaceutical formulation grew at a CAGR of 5.1 percent between 2012 and 2021. However, the demand in the pharmaceutical formulation market is anticipated to increase at a CAGR of 5.6 percent, surpassing USD 2.87 trillion by end of 2032. How do you see this market evolving in India? What are the major factors driving the growth of this market?

Indian pharmaceutical formulation market is estimated to be around USD 24 billion. This is expected to grow at 8 to 11% CAGR band for the medium term. In developed nations the growth is largely due to rise in lifestyle ailments. But in developing nations like India while rapid urbanization is leading to rise in lifestyle ailments, the communicable diseases like tuberculosis and malaria are still prevalent.

Moreover, the population growth in India is much higher than developed nations, creating demand for pharmaceutical products. Also, while improving per capita income is making pharma products more affordable, improving healthcare infrastructure and rising penetration of health insurance is enabling greater access of medicine to rural population. All these factors are leading to much higher growth for formulation in India than the expected global growth rate for it globally.

The challenges of developing complex formulations extend to the development of generic drug products. Regulators around the world have recognized the impact of a lack of successful complex generic product introductions on healthcare costs. How can this challenge be addressed?

The need of lowering healthcare cost by offering Generic Drug Products of even complex formulations has to be addressed by active involvement of all stakeholders. Even concern regulators need to come-up with robust policy to provide extra impetus for development of complex generic. The impetus may come in the form of award of extra duration of exclusivity or scientific inputs from specially formed task group of academic-industry professionals.

The government should encourage technology users by offering less taxes or duties on the resources such as equipment or facilities involved in development of complex generics. This will serve as a major boost for companies to offer non-compromised healthcare service to needy patient. Impetus offered to Generic Drug manufacturer will make them put extra efforts for its development to reduce healthcare cost of any particular complex drug product.

Please elaborate on how innovations in excipients as well as advances in processing and manufacturing technologies are impacting formulation development?

Innovations in excipients offer advantages mainly with respect to manufacturing process of pharmaceutical dosage forms. It gives liberty to make lesser number of processing steps. Advancement in processing technology is targeted to have stringent control over critical processing parameters. Tangential & Top Spray Granulation, Hot Melt extrusion Technology, Continuous Coating are the few recent advancements in manufacturing processing technology.

Innovations also allow making the manufacturing process shorter and simpler which is ultimately helping the formulation development activity in way to minimize focus areas. In present scenario, the advanced innovations in excipient manufacturing takes care of traces of impurities such as peroxides, nitrosamines, heavy metals etc., which are required to be controlled in excipients to achieve a quality pharmaceutical products. Overall effect of excipients innovations and advancement in process technology is helping formulation development to focus on much needed attribute of product as efficacy and stability.

Pharmaceutical companies use third parties to share data with collaborators, making data management a crucial area of focus. Please elaborate on how the advancement in analytical techniques is also turning historical and real-time data available with pharmaceutical companies into valuable assets for predictive, diagnostic, prescriptive, and descriptive analytics.

Historical and real time data processing helps to identify root cause of any deviation of process, specifications etc. A cross reference/comparison of real time data to relevant historical data helps to zero down to probable root cause of any problem. The historical data can serve as a standard reference to any real time issue. This serves the diagnostic requirement. Analysis of any data can indicate the behavioral trend of any object in a particular environment.

This can form a basis of prediction of performance of any object in futuristic situation. Apart from that, to keep the situation within predetermined controlled performance space, the analysis of any historical data can form basis for prescriptive purpose. The descriptive analytics of presenting the historical and real time data in more easily conceivable form always helps to take fast, effective and efficient decision.

One should also keep in mind that the data gathered, may need to be protected for its access and reuse because such important data could be misused by third party interveners. The data analytics has redefined the way the data is looked at. It explores the hidden treasure in it.

The structural changes in the pharmaceutical industry and insufficient funding to perform the drug development process through formulation development are the major factors hindering the market growth. How can the industry address these challenges?

This problem is now being addressed by the government with the introduction of PLI schemes. The schemes have potential to ensure greater resilience of the pharma industry from external shocks and contribute significantly to achieving a higher objective of affordable healthcare in the country and globally on a sustainable basis.

The PLI for Pharmaceuticals is designed for product diversification of high value goods in the sector. And specifically, to enhance manufacturing capabilities to diversify product mix to complex generics, patented drugs etc. One additional objective is to create global champions out of India who have the potential to grow in size and scale using cutting edge technology and thereby penetrate the global value chains.

This is motivating companies to invest in new product development which will boost the growth of the industry. Therefore, with this the government is largely addressing the structural issues.

The need for precision medicine is also making pharmaceutical companies rethink the manufacturing process. A lot of research is underway for making advanced 3D printers that print tissues or cells. Please elaborate on how the 3D printing of human tissues having great applications in drug development, organ engineering, and regenerative medicine, and how does this allow the development of age or physiology-dependent medical formulations, as well as precision pills?

The 3D printing technology enables to customize drug development and preparation of pills for considering physiological state of an individual. It offers advantage of preparation of drug delivery system as per individual’s physical/physiological/clinical state.

Even if currently, 3D technology has evolved - focusing its use for individual, a pharmaceutical dosage form manufacturer needs to be abreast with the development in this sector.

The 3D printing technology can be used by Pharmaceutical dosage form manufacturer to develop and manufacture a Drug product customized to meet the need of a particular strata of society as older age group, broadly classified physical state of population or gender specific need etc.

The advances in 3D printing technology are utilized since 2014, for customized engineered livers and kidneys for needy patients. The process of 3D printing typically begins with obtaining a sample of a patient’s own cells to grow and expand outside the body in a sterile incubator or bioreactor.

Keeping track of the development in 3D printing technology will help a Pharmaceutical Dosage Form manufacturer to exploit possibility of its use on large scale.

How do you see the market for Pharmaceutical formulation manufacturing evolving in the near future?

Pharmaceutical Market will see significant above average growth in underdeveloped and developing countries. The overall market will experience growth mainly in chronic disease medicine as Cancer & Diabetes.

Indian Pharma companies need to keep pace with fast changing regulatory requirements. The Indian Pharma companies need to adopt backward working policy to minimize dependency on foreign manufacturers of Active Pharmaceutical Industry.

Indian government has already taken steps to boost Active Pharmaceutical Industry. Post COVID, Indian Pharmaceutical Industry gained more respectable and creditable stature which is likely to attract more foreign investment and as a result industry has to become more professional and efficient.