Generating value in generics

Utkarsh Palnitkar, Partner and Head, Infrastructure, Government and Healthcare, Life Sciences, KPMG in India, gives an insight on the importance to develop NDDS by Indian pharma companies

While active pharmaceutical ingredient (API) is a critical component of any drug formulation, the mechanism by which a drug is delivered plays an important role in the efficacy and safety of a drug. Many large and medium-sized Indian pharma companies are launching and investing in Novel Drug Delivery Systems (NDDS) products, as they have realised that it is a major differentiating factor in the competitive generic industry. Besides, there are various clinical advantages that can drive NDDS, such as, increase in safety, efficacy; a controlled and predictable release; decrease in dosing frequency; minimisation of side effects; and increase in patient compliance. Further, NDDS-based generic product development is more economical and less risky for Indian pharmaceutical companies, as compared with developing a new drug that is far costlier and more time consuming.

Product differentiation, emergence of new complex therapies and increasing NCDs burden driving NDDS

Drug delivery technologies can help drug manufacturers differentiate their products from existing ones and enable novel treatments. It can also help tackle the growing non-communicable disease (NCD) burden, which requires a patient to take medicines over a longer term. NDDS can further help in supporting new therapy areas based on new age complex molecules, such as proteins, nucleic acid, interferon, and antibodies.

There is a thus a dire need to develop a safe and effective drug delivery system and Indian pharma companies are trying to meet this gap by increasing research and development (R&D) spend towards NDDS development in the last few years.

Scenario in India

Slower launch of new innovative drugs and growing competition in generics is driving the growth of niche segments, such as NDDS, in India. Large as well as medium-sized pharma companies are progressing remarkably in NDDS development by focussing on R&D activities and consequently launching various new and controlled drug delivery systems.

Indian pharma companies are riding the tide of advancement and availability of technology in order to deliver conventional drugs using NDDS. The key is to develop formulations that circumvent invasive administration; deliver complex biologics and protein/ peptide drugs while minimising side effects and increasing precision.

While market potential is attractive for NDDS, limited clinical data availability to prove its superiority over conventional drugs; lack of specific guidelines and existing patents for new drug delivery systems, collectively, hinder the growth of this niche segment. Despite these challenges, pharma companies are using India’s inherent strengths such as low cost scientific manpower, low cost of clinical trials and low production cost to boost NDDS development.

Way forward

The Indian pharma industry could provide value-added offerings with ‘super generics’. Continuous investment in R&D to innovate and adoption of technology will also play a larger role in drug delivery and help add value, improve margins, extend product lifecycles and, more importantly, allow differentiation in a cluttered generic market.

• Harness potential of nanotechnology: While nano-formulations and nano-particles have been used to successfully deliver drugs, the nanotechnology platform has greater potential for many applications, including gene therapy, cancer therapy, delivery of proteins, antibodies, vaccines, and antibiotics. A Mumbai-based pharma company has successfully developed a nanotechnology-based platform that targets cancer cells through higher drug localisation with lesser excipient and higher dose
• Continuous effort in R&D: Pharma companies need to continuously invest more in R&D for NDDS development. It is crucial to constantly differentiate in a saturated generic market as competitors could potentially launch similar technology-based NDDS products rapidly. A Delhi-based pharma company has designed its entire strategy around NDDS, in order to differentiate itself in the generic market
• Embrace innovation and adopt technology: Technology adoption can play an important role in NDDS development as combining drugs with devices and delivery systems is likely to drive success in future. Moreover, technology and innovation can also help deliver complex biologics (many Indian companies are focussing on biologics (including biosimilars and bio-betters for future growth)
• Combine medical devices and chemistry expertise: Pharma companies can combine their expertise in chemistry with the expertise from medical device manufacturers to develop innovative drug delivery device technologies. For example, to manage diabetes, several companies are providing continuous glucose monitoring by integrating the insulin pump and a monitor to provide the right dose of insulin at the right time
• Increase industry–academia linkage: Strengthening the industry–academia linkage can help advance the understanding of this niche and emerging field. Pharma companies can fund or jointly work with academic research teams to design and evaluate new NDDS platforms and decrease time to market. For example, a French multinational pharmaceutical company’s India entity has recently collaborated with NIPER Kolkata for their expertise in novel small molecules for anti-diabetics and drug resistant tuberculosis (TB).