Development of India's pharmaceutical industry and medicine exports

Medicines as strategic infrastructure of the global economy

The COVID-19 pandemic elevated the pharmaceutical industry to the level of strategic infrastructure, comparable in importance to energy, transport and digital technologies. Access to medicines, vaccines and medical components was recognised for the first time not as an end product of the healthcare system, but as an independent element of economic infrastructure, directly affecting countries' macroeconomic stability, inflationary pressures and fiscal resilience. The COVID-19 pandemic became the largest shock to the social and economic spheres, requiring a transition to an entirely new approach to healthcare, economic and industrial policy.

The pandemic period demonstrated that disruptions in medicine supplies can result in economic losses comparable in scale to the consequences of energy crises. According to the UN Economic Commission for Latin America and the Caribbean, disruptions in the supply of medical products in 2020–2021 affected the entire region, impacting the healthcare systems of countries with a combined population of around 650 million people.

Data from the Africa Centres for Disease Control and Prevention confirm the critical scale of supply disruptions for countries across the continent. According to the UN Economic Commission for Africa, most African countries purchase up to 94 per cent of pharmaceutical products from outside the continent.

A fundamental change in economic logic has taken place. Medicines have ceased to be an object of social policy and have become part of industrial strategy, investment planning and the state's economic security system.

The development of domestic pharmaceutical production is becoming comparable in strategic importance to the development of energy, transport and digital infrastructure, while the availability of medicines affects inflation and social stability no less than commodity markets.

In recent years, ensuring access to medicines, developing vaccines and advancing medical technologies have become not only part of social policy but also one of the factors underpinning national resilience. Investment in research and development, as well as cooperation with higher education institutions, academia and the private sector, is crucial for ensuring resilience and recovery.

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India's pharmaceutical industry as an export product

India's pharmaceutical sector comprises more than 3,000 companies and over 10,000 manufacturing facilities, a significant proportion of which are certified to international Good Manufacturing Practice (GMP) standards. In the 2023–2024 financial year, India's pharmaceutical exports exceeded US$26 billion. India accounts for around 20 per cent of global generic medicine production and a significant share of global vaccine manufacturing. The Serum Institute of India in Pune is one of the world's largest vaccine manufacturers by physical supply volumes.

India's key competitive advantage lies in its ability to create an interconnected industrial ecosystem in which scientific research, the chemical industry, workforce training, production capacity, government policy and private investment reinforce one another. It is precisely this systemic approach that distinguishes the Indian model from fragmented sectoral structures in other developing economies. In international practice, such a model has become known as the Life Sciences Industry – an integrated ecosystem in which medicine production, biotechnology research and medical technologies develop in close connection with the academic and clinical environment.

The formation of such an ecosystem resulted from a combination of several factors. India's competitive advantage was not created through cheap labour but through a combination of four structural factors. A well-developed tradition of chemical synthesis provided the human resources and technological foundation. A strong chemical sector, historically built around the production of dyes and organic compounds, became the industrial foundation for pharmaceutical manufacturing, providing access to starting reagents and intermediates. A high concentration of manufacturing clusters helped reduce logistics costs and accelerate knowledge exchange. An English-language regulatory environment facilitated access to international markets. A legal system that balanced intellectual property protection with the development of generic medicine production created room for legitimate competition. In addition, private capital played a significant role: Indian pharmaceutical companies grew from family businesses into global players while retaining entrepreneurial flexibility and the ability to rapidly scale up production in response to growing demand.

However, these advantages did not emerge spontaneously. They were preceded by a series of institutional reforms that gradually transformed the structure of India's pharmaceutical industry and created conditions for the development of domestic manufacturers. A turning point in the development of Indian pharmaceuticals came with the adoption of the 1970 Patents Act. Before that, around 75–80 per cent of the domestic market was controlled by major multinational corporations, limiting the development of domestic manufacturers. According to Mansi Kumari, an expert in international studies and geopolitics, BRICS studies, foreign policy and the Indo-Pacific region, and an associate professor and coordinator of the Centre for BRICS Studies at Amity University in Haryana, it was the change in patent legislation that created the conditions for the formation of India's own pharmaceutical industry.

“This act was the real turning point, as it abolished product patents for pharmaceuticals and recognised only process patents, meaning Indian companies could legally reverse-engineer branded foreign drugs and produce them through alternative synthesis routes,” Mansi Kumari says.

Changes to patent legislation were not the only reform. To consolidate the results achieved, the government simultaneously began changing the conditions in which the market operated, gradually expanding the space for the development of domestic businesses. In 1973, restrictions on foreign capital ownership created additional room for the development of domestic companies.

According to Kumari, in 2005 India amended a number of laws, allowing opportunities for the development of the generic medicine industry to be preserved even after patents were reintroduced.

The scale of the domestic market – the world's largest by population – played a particularly important role. Domestic demand enabled manufacturers to achieve economies of scale, reduce average costs and subsequently compete successfully in international markets.

India's government policy was designed to stimulate the industry. In the 2024–2025 financial year, the Indian government increased pharmaceutical funding by 29.4 per cent. The industry is shifting from low-margin generic medicine production towards more complex products, including biosimilars and specialised medicines.

However, financial support was only one element of this strategy. Equally important was the creation of institutions that for decades supported the industry's development by combining price regulation, industrial policy and workforce training. BRICS countries – India, China, Brazil and Egypt – established scientific schools and production clusters capable, in some cases, of modifying known molecules and adapting them to the needs of national healthcare systems.

However, the reforms did not stop at legislative changes. The next stage was the development of a long-term government policy combining price regulation, the development of state-owned enterprises and support for domestic manufacturers.

"Department of Pharmaceuticals was established in 2008 under the Ministry of Chemicals and Fertilisers to replace the fragmented departmental oversight and have a centralised pharma policy, regulatory oversight and industry promotion. It regulates various complex issues related to pricing and availability of medicines at affordable prices, research & development, protection of intellectual property rights and international commitments related to the pharmaceutical sector, which requires integration of work with other ministries,” the expert said.

In addition to financial incentives, the government consistently invested in scientific and technological infrastructure, without which scaling up pharmaceutical production would have been impossible. According to Mansi Kumari, the gap was helped to be filled by state technical institutions, such as CSIR laboratories, which developed low-cost chemical synthesis methods for use by local companies.

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Localisation of production as the basis of medicine security

The COVID-19 period was a stress test for the entire global pharmaceutical supply chain. Restrictions led to disruptions in the supply of key components, resulting in higher production costs and delays in the release of finished medicines. The main risk lay not simply in import dependence but in the high concentration of critical raw material suppliers outside national jurisdictions.

The response was a new industrial policy. The Indian government launched a programme to stimulate domestic production of active pharmaceutical ingredients through financial support mechanisms and the creation of specialised industrial zones. The next stage was the development of an independent innovative manufacturing base. Modern government support instruments for the sector were designed around this objective.

Mansi Kumari notes that production incentive schemes became another important government policy aimed at supporting the Make in India programme.

“Production Linked Incentive (PLI) 1.0 committed US$730.8 million to reduce import reliance on China by subsidising domestic bulk drug and API production. PLI 2.0 committed US$1.58 billion to incentivise high-value products such as complex generics, biosimilars, gene therapies, and medical devices," the expert said.

This was followed by the launch of the PRIP programme in 2023: 50 billion rupees (US$526.5 million) was allocated to develop cooperation between industry and academia, R&D and clinical trials of innovative treatments. In addition, a programme was launched to establish bulk drug parks in Gujarat, Andhra Pradesh and Himachal Pradesh.

A key instrument is the Production Linked Incentive (PLI) scheme for the pharmaceutical sector, aimed at developing chemical parks and localising the production of active pharmaceutical ingredients. The total amount of support is around US$2 billion.

These measures formed part of a global trend: following the pandemic, countries dependent on imports of active pharmaceutical ingredients began introducing incentives and subsidies to bring the production of pharmaceutical ingredients back to their national territories. As part of this policy, a new industrial structure is gradually taking shape, focused not only on the final production of medicines but also on localising critical stages of chemical synthesis.

For BRICS countries, this situation became a precedent of systemic significance. India's vulnerability does not negate its leadership – on the contrary, it explains why the country is actively investing in the next level of industrial sovereignty. The conclusion for all countries building systems of medicine security is clear: the resilience of the pharmaceutical system is impossible without diversifying sources of active ingredient production and distributing critical links in the supply chain across several jurisdictions.

This opens a window of opportunity for cooperation within BRICS. Brazil has expertise in biotechnology research and vaccine development. South Africa's healthcare system has significant experience in epidemiological monitoring and clinical research. The Gulf countries participating in the BRICS+ format are developing sustainable financial resources for investment in infrastructure and production projects. The combination of these factors creates a basis for moving from national pharmaceutical strategies towards interstate industrial platforms in which risks are distributed and expertise is combined.

It is precisely the vulnerability of individual national models that makes cooperation within BRICS particularly relevant, as different countries possess complementary production and scientific capabilities.

BRICS+ pharmaceuticals

The situation regarding access to medicines in the Global South is uneven, but the pharmaceutical industries of BRICS countries as a whole represent a powerful and rapidly growing sector. The focus across the board is on ensuring pharmaceutical sovereignty and developing advanced vaccines. The member states are building independent production chains and launching joint scientific initiatives.

India is the world's largest producer and supplier of generic medicines, accounting for approximately one-fifth of global supplies. The country also holds a leading position in vaccine production: Indian companies account for around 60 per cent of UNICEF's vaccine supplies.

China has the world's largest capacity for the production of finished vaccines and R&D (research and development of new medicines – Ed.). The country is investing in the development of next-generation medicines against influenza, tuberculosis and dengue fever.

Russia has developed a strong scientific school in virology and epidemiology. Since 2014, the country has implemented programmes to support the pharmaceutical industry, while in 2023 the Pharma-2030 strategy was approved, according to which the share of full-cycle medicines produced in Russia on the domestic market should approach 70 per cent by the end of the decade.

Brazil is actively developing biopharmaceuticals, with a focus on combating tropical diseases. The country is fully self-sufficient in essential immunobiological products and runs large-scale free vaccination programmes.

The UAE's pharmaceutical sector is one of the fastest-growing in the Middle East, serving as a major regional hub with strict quality control and access to advanced technologies.

Egypt is a pharmaceutical leader in the Middle East and North Africa, meeting around 90 per cent of domestic medicine needs. Under the National Vaccine Production Localisation Strategy, which runs until 2030, the country aims to produce 140 million vaccine doses annually and establish supplies to more than 60 countries by 2030, reports Daily News Egypt, a TV BRICS partner.

South Africa has one of the most developed pharmaceutical sectors on the continent, with the market projected to reach US$12.4 billion.

As reported by ENA, a TV BRICS partner, Ethiopia is implementing a national localisation strategy. According to the country's Ministry of Health, local suppliers already account for more than 44 per cent of national procurement. During the pandemic, Ethiopian technology start-ups used 3D printing to produce face shields and valves for ventilators.

Iran has become the only country in its region to independently produce and develop vaccines against polio, tuberculosis and cholera. According to Mehr News Agency, a TV BRICS partner, the country produces more than 90 per cent of the medicines it consumes.

Indonesia is one of the largest and fastest-growing pharmaceutical markets in Southeast Asia, with a strong state-owned vaccine manufacturer producing vaccines against measles, polio and hepatitis B.

BRICS+ countries are building a distributed yet interconnected pharmaceutical ecosystem in which each participant has specialised capabilities. This complementarity creates the basis for moving from national strategies towards interstate industrial platforms. Developing production capacity does not solve all the problems. The economic effect that a state gains from having its own pharmaceutical base is equally important.

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Procurement costs, insurance risks and the economics of pharmaceutical reserves

Experts are increasingly speaking about the formation of so-called pharmaceutical sovereignty – a state's ability to independently provide its population with the necessary medical products, develop vaccine production and maintain a high level of medical training. It is precisely this comprehensive approach that transforms pharmaceuticals from an item of social expenditure into an element of economic security.

The first category is procurement costs. Countries without domestic production are forced to purchase medicines at global market prices, which are subject to sharp fluctuations during crises. According to data from the African Union, the combined expenditure of African countries on pharmaceutical imports exceeds US$16 billion annually, while up to 70 per cent of medicines consumed are supplied through imports.

BRICS countries with domestic production have the ability to establish internal pricing mechanisms that reduce volatility in procurement budgets. Domestic production turns the price of medicines from an externally given one into a manageable parameter of fiscal policy.

The second category is insurance risks. Dependence on a single supplier or a limited number of suppliers creates a situation in which any disruption to the supply chain automatically turns pharmaceutical risk into a budgetary risk. For national finance ministries, this means that they must build a risk premium into budget planning: either invest in supply diversification and contingency mechanisms or face significantly higher costs in the event of a crisis – including direct losses for the healthcare system.

As noted by Margarita Isaakova, an expert in academic and scientific diplomacy, the export of Russian education, international healthcare cooperation and international medical research, “the very concept of ‘availability’ is not limited to the physical presence of a vaccine at the point of care. The economic aspect is equally important – the possibility of purchasing or obtaining the medicine regardless of the end consumer's income level. Availability is inseparably linked to the readiness of infrastructure to receive, store and distribute a particular type of vaccine, which is far from always achievable outside major urban centres.” This means that even when a medicine is formally available on the market, actual access for the population may remain critically low – and this gap becomes a direct budgetary risk.

The Indian model, with its diversified production base and export orientation, effectively serves as a market insurance mechanism: the multiplicity of manufacturers and high level of competition within India's pharmaceutical cluster reduce the likelihood of a complete halt in supplies even under force majeure circumstances.

The third category is the cost of reserves. States that recognise the vulnerability of supply chains are forced to create and maintain strategic reserves of medicines, which requires significant capital and operational expenditure. This ties up budgetary funds that, under an alternative scenario, could be directed towards developing healthcare infrastructure. A strategic reserve is a frozen budget. Integration into a production chain is a working asset. Countries integrated into resilient production chains can afford to maintain smaller reserves, relying on predictable and regular supplies.

The economics of trust and BRICS regulatory integration

In addition to production capacity, there is another factor explaining India's strong position in the global pharmaceutical market. For decades, Indian companies have ensured stable supplies of medicines to healthcare systems in Africa, Asia and Latin America. This has created a robust reputational infrastructure based on predictable quality and cost.

India's pharmaceutical model has effectively evolved into a risk management system in which the key product is not only the medicine itself but also reduced uncertainty for national healthcare systems.

As a result, a particular form of reputational capital has emerged, based on many years of predictable quality and supplies. Unlike short-term price advantages, such capital cannot be created through one-off incentive measures. This is what transforms India's pharmaceutical industry from a major sectoral player into a systemic supplier for a significant share of the global healthcare market.

However, full integration of the pharmaceutical markets of BRICS countries remains limited. National medicines control systems operate independently despite comparable basic quality and safety standards. A medicine that has already undergone registration and inspection in one jurisdiction must go through another full regulatory assessment when entering another country's market. The average delay in bringing medicines to market can reach two to three years and involves duplication of clinical documentation, repeated inspections of manufacturing facilities and additional requirements for local trials. Regulatory fragmentation is a factor directly affecting access to healthcare in real time.

Overburdened regulatory procedures complicate and significantly increase the cost of producing biotechnology medicines, preventing their timely market entry. At the same time, while reducing barriers, it is necessary to increase confidence in regulatory procedures in order to counter criticism from international pharmaceutical holdings that promote the view that medicines from BRICS countries are of poor quality.

This is why healthcare international cooperation expert Margarita Isaakova calls regulatory convergence the most effective tool for accelerating development:

“At present, manufacturers spend years registering a single medicine in five countries. If an agreement is reached on mutual recognition of assessments, this will reduce the time needed to bring medicines to market several times over. The main thing is to ensure that this does not turn into a race at the expense of quality,” she stated.

The solution lies in functional convergence rather than the creation of a supranational regulator or the harmonisation of legislation. The idea is to establish a model in which the regulator of one state can rely on the results of inspections and assessments conducted by the regulator of another state, provided that the quality standards and procedures are equivalent.

The first level of integration is the mutual recognition of Good Manufacturing Practice inspections, eliminating duplication of inspections at already certified facilities. This creates a direct effect by reducing costs and accelerating the production cycle without lowering product safety requirements.

The second level is the creation of a single digital register of manufacturers and active pharmaceutical ingredients as a distributed database shared among national regulators. Such a system ensures supply chain transparency, reduces the risk of counterfeit products and improves the management of pharmaceutical markets across the entire group.

The third element is the development of digital infrastructure for regulatory exchange, including standardised electronic registration dossiers and digital certificates of origin for medicines. In the long term, such a system could be integrated with distributed ledger technologies, ensuring the immutability and traceability of data on a medicine's life cycle – from development to final consumption.

The fourth and most complex level is the harmonisation of approaches to the registration of biosimilars and innovative biological medicines. This segment has the greatest regulatory complexity, as it requires assessment not only of chemical equivalence but also of clinical comparability across different populations.

As practice shows, for pharmaceutical exporters the key barriers are not transport or customs costs but regulatory restrictions: the need for repeated clinical trials, duplication of registration procedures and the absence of mutual recognition of GMP standards (a set of rules and requirements governing the group of medicine production and quality control – Ed.). Eliminating these barriers could produce a greater economic effect than direct subsidies.

The development of joint clinical research platforms among BRICS countries is particularly important here. Data on patients, diseases and therapeutic outcomes become part of a common research ecosystem, making it possible to improve the quality of medical decisions by expanding the statistical base and taking regional specificities into account.

Regulatory integration is becoming a systemic institutional project. Its implementation creates the conditions for moving from fragmented national pharmaceutical markets towards a single space of regulated trust, in which the speed of access to medicines is determined not by administrative barriers but by the actual readiness of production and scientific systems to implement them. In the long term, this level will become a key factor in the competitiveness of the BRICS pharmaceutical system.

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From generics to the technologies of the future

Competition in the global pharmaceutical industry is shifting to a different level. While India previously won the price competition against most developing manufacturers with confidence, it now faces the challenge of winning the technological competition.

One of the main drivers is the expiry of patent protection for a range of expensive biological medicines. The combined sales of prescription medicines at risk due to the expiry of patent exclusivity by 2030 exceed US$400 billion, half of which is accounted for by biological medicines – precisely the segment that offers the greatest opportunities for biosimilar production. In the coming years, the market will shift from a regime of patent protection to one of price competition. The first to enter it will gain not a temporary advantage but a structural position for decades.

The global biosimilars market will exceed US$60 billion by 2030, and India plans to secure a share of at least 10 per cent. China's biosimilars market is forecast to reach US$7.77 billion by 2028. The impact of introducing biosimilars to the market is demonstrated by a multiple reduction in prices.

The market is opening up to biosimilars – medicines that reproduce the efficacy of original biological products at a significantly more affordable cost. India is steadily changing its development model by increasing investment in biosimilars, high-tech medicines, contract research and the development of new molecules.

The priority is to move higher up the value chain – from serial production to proprietary scientific research and technology platforms. Under its Biotechnology Development Strategy, India has increased the size of its bioeconomy to US$150 billion, financing the construction of research centres, project subsidies and specialist training.

At the same time, the organisation of pharmaceutical research is changing. Technologies based on artificial intelligence, machine learning and big data analysis are being used increasingly widely, making it possible to accelerate the search for promising compounds and optimise clinical trials. The introduction of multimodal AI systems could drive growth in the pharmaceutical and biotechnology market in this segment from US$1.8 billion in 2023 to US$13 billion by 2034, with average annual growth of almost 19 per cent.

More than half of medicines are expected to be developed using AI technologies by 2030. Machine learning algorithms are already being used to analyse molecular structures, identify promising compounds and model interactions between medicines and the human body, significantly shortening research timelines.

The Indian government is also funding initiatives for the practical application of AI, including seminars to train specialists from academic and business communities. Industrial and technological policy plays a decisive role in the transition to a new development model, while cooperation between governments, universities and research centres is becoming a key factor in strengthening domestic capacity. At the intersection of pharmaceuticals, bioengineering and digital healthcare, a range of related high-tech industries is emerging, linked to personalised medicine and new diagnostic platforms.

If just a few years ago the main competitive advantage was considered to be the cost of individual production operations, the coming decade will be a period of competition between technology platforms, research capabilities and the ability to rapidly adapt scientific advances to the needs of healthcare systems. This transformation will determine the position of India and BRICS countries in the new architecture of the global health economy.

Exporting standards and a new model of integration

Modern pharmaceutical exports are no longer limited to the supply of finished medicines. Alongside medicines, manufacturing technologies, specialist training programmes, clinical research practices, digital supply management solutions and models of interaction between governments, academia and private business are also being shared. Joint educational programmes to train pharmacists, chemical engineers and regulatory specialists are becoming just as important an element of cooperation as the transfer of production technologies.

As a result, a long-term ecosystem of cooperation is emerging, significantly exceeding traditional export operations in its economic impact. For BRICS, this is an opportunity to move from the logic of trade to the logic of distributed cooperation, in which each country performs a specialised function and resilience is ensured not through concentration but through diversification.

The group is creating its own space for technological exchange, in which knowledge, expertise and production solutions are becoming as significant an object of cooperation as trade in goods or the movement of capital. Pharmaceutical cooperation is moving beyond sectoral policy and becoming a mechanism for shaping a new model of economic integration.

Unlike traditional export-import relations, this model involves distributing production functions among several countries of the group. Some participants have developed chemical industries, others have expertise in biotechnology, others have investment resources, while others have rapidly growing healthcare markets.

The expansion of BRICS+ plays a particularly important role in this model. The accession of states with significant financial resources creates additional opportunities for implementing capital-intensive projects in pharmaceuticals, biotechnology and medical infrastructure. As a result, a system is emerging in which industrial cooperation is complemented by investment integration, while production capacity gains long-term sources of financing.

The creation of a common scientific space is becoming equally important. The development of joint research projects between universities, research centres and pharmaceutical companies can significantly shorten the development cycle for new medicines and accelerate the introduction of technologies into industrial production. Knowledge exchange is no longer a supplementary element of cooperation and is becoming an independent driver of economic growth. It is precisely the concentration of scientific potential that can enable BRICS countries to move from predominantly producing generics to creating their own innovative medicines.

As Margarita Isaakova emphasises, “for a wide range of neglected tropical diseases, multinational pharmaceutical companies do not develop new medicines at all due to a lack of commercial incentives. The Global South relies on its own resources or humanitarian initiatives rather than multinational corporations.” This is precisely where BRICS cooperation acquires not only an economic but also a direct humanitarian dimension: the group can fill niches that the global market leaves empty.

Within this system, medicine exports cease to be the ultimate goal. They become a tool for building a common market for technologies, knowledge and industrial cooperation capable of providing BRICS countries with greater economic resilience amid the transformation of the global economy.

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Pharmaceutical sovereignty as a new development architecture for the Global South

The development of the global pharmaceutical industry is gradually moving beyond the sectoral agenda and becoming one of the key factors in shaping a new model of international economic cooperation. The new stage is linked to competition for the resilience of healthcare systems.

In this architecture, the winner is not the one that produces the largest quantity of medicines but the one capable of bringing together production capacity, regulatory mechanisms, scientific expertise and investment capital. This is the main lesson of the Indian model.

India's experience shows that achieving pharmaceutical sovereignty is not solely the result of large-scale government investment or the availability of cheap labour. Its foundation is the consistent development of all elements of the pharmaceutical ecosystem capable of operating as a single system. This systemic approach became the key factor enabling the country to transform its pharmaceutical industry into one of the most dynamic high-tech sectors of the economy.

For BRICS and BRICS+ countries, the significance of India's experience extends far beyond the successful development of a single national industry. It is about the possibility of creating a distributed model of pharmaceutical production based on cooperation between production facilities, research centres, investment resources and regulatory mechanisms across several states simultaneously. Such an architecture can significantly increase supply chain resilience, reduce dependence on individual producers of critical products and create conditions for long-term technological development.

As Vittoria Davi Marzola, an expert in medicine and public health, emphasises, countries of the Global South are no longer simply buyers of vaccines and medicines and are beginning to participate in the entire chain: research, clinical trials, production, regulation, distribution and monitoring. It is precisely this transition from the role of buyer to that of co-developer that lies at the heart of the new type of pharmaceutical sovereignty.

The health economy is an economy of shared security. As a new architecture of the global economy takes shape, this model could become one of the foundations for strengthening the pharmaceutical sovereignty of BRICS and BRICS+ countries, ensuring not only access to medicines but also the creation of resilient infrastructure for economic development for many years to come.

India is emerging as a systemic architect of a new healthcare model for the Global South – a model in which accessibility, resilience and technological independence form a single economic logic. India today exports not only medicines but also a model for organising a modern pharmaceutical economy based on a combination of industrial cooperation, technological development and long-term institutional partnerships.

Article prepared by Vakhit Niyazov.