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India has become the medical tourism hub of the world, providing cost effective treatments to the general public by adopting the latest technology for drug development. The Indian pharmaceutical sector has emerged as global leaders in research and innovation brought about by adopting a combination of scientific and technological base. The support extended by government agencies has accelerated a strong domestic market and cost competitive manufacturing of quality medicines.
The total market size of the Indian pharma sector is expected to reach US$ 130 billion by 2030 and will touch US$ 450 billion by 2047. The Indian pharma companies are expected to achieve a revenue growth of 9-11 per cent in FY 2025. This growth may be due to robust performances in key markets, which include the US, European union and other emerging areas.
India has the largest number of USFDA compliant pharma firms outside the US. The WHO-GMP approved pharma firms are over 2000 plus, serving demand from more than 150 countries worldwide with more than 10000 plus manufacturing facilities.
Generic drugs, OTC medications, bulk drugs, vaccines, contract manufacturing and research, biologicals and biosimilars are some of the major segments which add to revenue growth. Low price and high quality of Indian medicines have catalysed the industry to become the pharmacy of world.
The access to affordable HIV treatment from India and its role as biggest supplier of low-cost vaccines to the world are some of the success stories of the Indian pharmaceutical sector. The supply of antiretroviral drugs to treat HIV has crossed 80 per cent by Indian pharma industry.
Vikasit Bharat initiative
The Government of India initiative Vikasit Bharat, has created a Vison Pharma 2047 with the following objectives:
- To make India a global leader in manufacturing of affordable, innovative & quality pharmaceuticals & medical devices.
- To become global leaders in innovation & research for delivering health care products to future generations in a sustainable manner, introducing natural products.
- To ensure accessibility & affordability of patient-centric products for better healthcare outcomes for universal health coverage, by building upon partnerships across industry, science and governments departments.
- To contribute to health system for attaining union of equity, efficacy and efficiency towards developing holistic products profile, with focus on NCDs, AMR and rare & neglected
- disease.
- To create equilibrium
- between social, economic & governance aspects through facilitative, balanced & progressive
- policy and regulatory framework.
- To reduce India’s carbon footprint in pharma-MedTech as part of PMs vision of Panchamrita.
- To identify critical suppliers, de-risking & decarbonising the supply chain and promoting local sourcing.
- To promote medical devices as integral part of global supply chains for raw materials, components, spare parts, assemblies/subassemblies etc.
- To digitization and technology upgradation in delivery of services & products under Jan Aushadhi Pariyojana.
Challenges faced by Indian cos
Indian pharma companies have been criticized for lack of quality of medicines, impacting global reputation and acceptance. The contamination of cough syrup, which led to death of children in Gambia, Uzbekistan and Cameroon, lower quality of Indian -labelled drugs sold in different regions in certain African countries compared to those sold in Inda are few examples.
The recurring nature of these quality issues has created severe health consequences and have tarnished the global image of Indian Pharma companies. The critical need for consistent and rigorous quality control measures across all manufacturing units can only maintain the global trust.
The pricing pressures is yet another challenge faced by pharmaceutical firms. India holds a prominent position in generic drug market and is characterized by intense competition. The bargaining power of major markets like the
The US has increased, exerting downward pressure on prices and will squeeze the profit margins of Indian pharma firms.
GOI has imposed price controls a wide range of essential medicines to ensure affordability for consumers which also brings down the profit of pharma firms. The firms are now trying to balance affordability with necessary investments in quality attributes of medicines and research & development.
The investment made by pharma manufacturers in R&D from the total revenue still remains low, despite their status as global leaders in pharma sector. The pharmaceutical firms in India operate within a complex intellectual property and patent law.
The patent law in India allows the manufacturing of generic version of drugs after patent expiry paving the way for legal disputes with multinational pharmaceutical firm over patent right. India is a member of the World Trade Organization and are bound by trade related aspects of intellectual property rights agreement for getting access to affordable medicines with international quality norms.
The Indian pharmaceutical firms under SMEs lack necessary infrastructure and capital investment to scaleup operations and to adhere with international standards. This will create a setback in overall growth and quality standards of industry. The low investment will restrict the industry’s ability to move beyond generics and implement latest technologies to manufacture quality medicine with international standards.
Overcoming challenges
Though India is a global player in pharma sector, focus on innovation and discovery of new drugs are still limited. The focus on biopharmaceuticals and biosimilars by Indian firms can improve India’s competitive edge in global market. The collaboration with academia, government agencies and other private sectors in research and development will improve fostering innovation to develop next generation therapies.
The shortage of skilled professionals/researchers for driving innovation is another challenge faced by many pharma firms. India produces large number of pharma professionals, but lack in practical’s/hands on experience, which is essential for advanced research and development.
This challenge could be overcome only by active industry- institute partnership to fill the gap. To sustain the global competition, Indian pharmaceutical industry should invest in upskilling its work force and fostering collaborations with academic institutions for filling the gap.
The key trends which Indian pharmaceutical Industry must focus is supply chain resilience, contract manufacture and development, contract research, enhanced focus on research and innovations and increased regulatory harmonization.
The India pharmaceutical firms should make use of the opportunity for exports within specific geographical clusters or countries. The pharma firms should also focus on several key segments like generic drugs, biosimilars, API export, vaccine export to high income countries and CDMO services. This will enhance the growth by 10 to 15-fold, reaching $350 billion by 2047.The end-to-end traceability has become the non-negotiable part of the pharma supply chain.
AI technology in digital healthcare
The AI technology in digital healthcare has significantly influences pharmaceutical companies by enhancing data analysis across the supply chain. This has helped firms to better equip themselves to meet the rising market demands and increase their resilience to potential disruptions. With AI it is now possible to optimize production and stream logistics.
The pricing fluctuations, decarbonisation initiatives, technological advancement, novel healthcare delivery models and personalized therapies have added layers of complexity to manufacturing and supply chain operations. These trends have prompted a re-evaluation of priorities that pharma firms have to adopt for better growth.
The future of pharma firms lies in AI, which can revolutionize the drug development process. AI accelerates identification of lead compounds from vast datasets and predicting the changes in molecular structure for improved safety and efficacy. This can significantly reduce development costs making medications more affordable for the general public.
AI is also transforming clinical trials through real -time data tracking and allowing researchers to monitor patient responses and drug effectiveness. Rapid progress in genomics is paving way for personalized medicine which is based on treatment on individual genetic makeup. Personalized medicine allows the modification of genes and promises improved patient compliance and therapeutic outcomes.
Novel drug delivery system
Another promising frontier is the development of novel drug delivery system. The digital transformation is also reshaping healthcare and drug delivery systems. One example is the use of digital twins in trial simulations-virtual models of patients that permit researchers to test variables without impacting real individuals.
This leads to safer more efficient trials with fewer errors. Moreover, digital tools are increasingly being integrated into patient-centric care. Wearables and remote diagnostic devices collect and transmit health data directly to healthcare providers. This real-time monitoring enables treatment adjustments for patient to remain at home, reducing costs and improving satisfaction.
The real-world evidence, a new approach to obtain clinical data beyond traditional clinical trials by using information provided by portable devices, conducting patient surveys and medical records. These methods help to assess treatment accuracy and provide opportunity for personalized medical care.
Digital technology
Finally, as pharma firms embrace digital technology, they are better equipped to comply with stringent regulatory standards while driving innovation. The virtual healthcare has gained a lot of traction over the past few years and is expected to grow further.
The wearable devices and mobile apps will play a key role in chronic disease to monitor and improve medication adherence. The telehealth platforms will also get integrated with pharma services for direct delivery of medications to patients and create opportunity to have virtual consultations.
The digitalization of pharmaceutical firms includes adoption of robotics, automation solutions and computerization for bringing down cost and improve production efficiency.
(The author is Professor & Principal, National College of Pharmacy, Manassery, Kozhikode, Kerala)
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