Vineet Laboratories Ltd Management Discussions

a) Industry structure and developments.

The Indian Pharmaceuticals industry plays a prominent role in the global pharmaceuticals industry. Transformed over the years as a vibrant sector, presently Indian Pharma ranks third in pharmaceutical production by volume and the thirteenth largest by value in the world, producing more than 60,000 generic drugs across 60 therapeutic categories.

Indian pharmaceutical industry plays significant role globally, supplying affordable and low cost generic drugs to millions of people across the globe. The sector offers lower cost without compromising on quality as is reflected by the fact India has the highest number of United States Food and Drug Administration (USFDA) approved pharmaceutical plants outside the US and also a significant number of World Health Organization (WHO) Good Manufacturing Practices (GMP)-compliant plants as well as plants approved by regulatory authority of other countries. Indias pharmaceutical sector forms a major component of the countrys foreign trade and has been consistently making trade surplus.

Indias pharmaceutical exports have demonstrated robust and consistent growth in recent years, underscoring the countrys prominent role as the "Pharmacy of the World." During the financial year 2023-24, the exports of drugs and pharmaceuticals reached approximately $27.85 billion, marking a significant growth of 9.67% compared to the previous years $25.39 billion, which itself was a moderate 3.25% increase over the $24.59 billion recorded in FY 2022-23. This upward trajectory continued into FY 2024-25, when Indias pharmaceutical exports surged further to about $30.47 billion, reflecting a strong growth rate of around 9.4% year-over-year. In currency terms, the exports in FY 2023-24 stood at Rs. 2.30 lakh crore, representing a 13% increase over the Rs. 2.04 lakh crore posted in FY 2022-23. The month of March witnessed particularly strong export performance, with March 2024 exports totalling $2.80 billion (a 12.73% increase over March 2023), followed by an even more impressive 31.2% growth in March 2025, reaching approximately $3.68 billion. These exports span over 200 countries, with the United States remaining the largest market, accounting for nearly 30% of total exports, followed by the UK, South Africa, Brazil, and the Netherlands among others. The bulk of the export value derives from drug formulations and biologicals, which constitute roughly 75% of total pharma exports, followed by active pharmaceutical ingredients (APIs) and vaccines. Indias pharmaceutical sector benefits from its extensive network of US FDA-compliant manufacturing plants, high-quality and affordable generic medicines, and its leadership role in global vaccine supply. This sustained export growth reflects Indias strategic focus on maintaining high quality, regulatory compliance, and expanding market reach to highly regulated economies, positioning it for continued expansion and a growing share of the global pharmaceutical market.

During the fiscal year 2023-24, Indias imports of medicinal and pharmaceutical products grew modestly by 2.02 percent to reach $8.27 billion, up from $8.10 billion in the previous fiscal year. However, the month of March 2024 saw a decline in imports by 2.85 percent, dropping to $681.18 million compared to $701.19 million in March 2023. Despite this dip in imports, the export side exhibited strong growth, with pharmaceutical exports in February 2024 increasing significantly by 22.24 percent to $2.51 billion from $2.05 billion in the same month the previous year. This positive export trend continued into FY 2024-25, with Indias pharmaceutical exports surpassing $30.47 billion, marking an impressive growth of about 9.4 percent over the previous year. The March 2025 exports especially highlighted the sectors strength, surging by over 31 percent to $3.68 billion. These figures underscore Indias growing dominance as a global pharmaceutical supplier, sustained by its cost-efficient production, high-quality generic drugs, and a skilled workforce, even as import growth remains relatively modest and volatile in specific months.

The top five export markets, for the sector during the last fiscal, are the US, the UK, the Netherlands, the United Kingdom, South Africa and Brazil. In 2024-25, the outbound shipments also entered new geographies like Montenegro, South Sudan, Chad, Comoros, Brunei, Latvia, Ireland, Chad, Sweden, Haiti and Ethiopia. An industry expert said that increasing market opportunities and healthy demand in countries like the US are helping exports to record healthy growth rates month after month. Experts have said that Indias pharmaceutical business may exceed USD 130 billion by 2030, supported by expanding market opportunities and heightened demand in the overseas markets.

Major segments of Indian Pharmaceutical Industry include generic drugs, OTC medicines, bulk drugs, vaccines, contract research & manufacturing, biosimilars and biologics.

The Pharma sector has seen a lot of investments and developments in the recent past.:

Up to 100%, FDI has been allowed through automatic route for Greenfield pharmaceuticals projects. For Brownfield pharmaceuticals projects, FDI allowed is up to 74% through automatic route and beyond that through government approval. The cumulative FDI equity inflow in the Drugs and Pharmaceuticals industry is US$ 22.38 billion during the period April 2000-December 2025, constituting almost 3.4% of the total inflow received across sectors. In August 2024, Union Minister for Labour & Employment and Environment, Forest and Climate Change Bhupender Yadav launched Chemotherapy Services in 30 ESIC Hospitals across the country. An MoU was signed on June 4, 2023, between the Indian Pharmacopoeia Commission (IPC), Ministry of Health & Family Welfare, Government of India and Ministry of Health, Government of Suriname for Recognition of Indian Pharmacopoeia (IP) in Suriname. The Department of Pharmaceuticals will soon launch the Scheme for the Promotion of Research and Innovation in Pharma (PRIP) MedTech Sector. The scheme has been approved by the Union Cabinet for a period of five years starting from 2023-24 to 2027-28 with a total outlay of Rs. 5,000 crore (US$ 604.5 million). Implementation of Production Linked Incentive (PLI) schemes with a total outlay of over 15,000 crore to boost high-value drug manufacturing, including cancer and diabetes treatments, and reduce import dependence on critical raw materials like Penicillin G. Promotion of Bulk Drug Parks scheme allocating 3,000 crore to develop mega pharma manufacturing hubs in Gujarat, Himachal Pradesh, and Andhra Pradesh to enhance production efficiency and cost-effectiveness. Strengthening of Pharmaceuticals Industry (SPI) scheme with 500 crore funding for upgrading labs, boosting research and development (R&D), and improving productivity and global competitiveness across pharma MSMEs and clusters. Liberalization of Foreign Direct Investment (FDI) policies allowing 100% FDI through the automatic route for greenfield pharma projects, boosting foreign investments that reached 12,822 crore in FY 2023-24 alone. Significant focus on innovation with increased R&D spending by top Indian pharma companies, advancing pipelines in biosimilars, biologics, CAR-T therapies, and mRNA vaccines, shifting towards high-value, specialty drugs. Expansion of Contract Development and Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs) to leverage Indias skilled workforce and technology adoption in drug discovery and development. Governments Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) scheme operating 15,479 Kendras, providing affordable generic medicines up to 80% cheaper than branded drugs, enhancing domestic healthcare accessibility. Indias pharma exports continuing strong growth, with incentives supporting diversification and reducing geographic and product concentration risks. Strategic partnerships and global alliances expanding Indias market reach in the US, Europe, and emerging markets.

Some of the initiatives taken by the Government to promote the pharmaceutical sector in India are as follows:

In the Interim Budget 2025-26:

Exemption of customs duties on three critical cancer medicines Trastuzumab Deruxtecan, Osimertinib, and Durvalumab reducing costs and improving patient access to these life-saving drugs. Extension of customs duty waiver on drugs and medicines imported under Patient Assistance Programmes (PAP) till March 31, 2029, supporting wider availability of essential medicines. Operationalisation of the Anusandhan National Research Fund and a financing pool of Rs. 1 lakh crore to spur private sector-driven pharmaceutical research and innovation in India. Increase in allocation to the Department of Pharmaceuticals to Rs. 5,268.72 crore (approximately $603 million), a 28.8% increase over the previous fiscal year, aimed at supporting various schemes for pharma clusters, MSMEs, and R&D.

Continued implementation and increased disbursement under the Production Linked Incentive (PLI) scheme for pharmaceuticals with a total outlay of Rs. 15,000 crores to boost domestic drug manufacturing capacity and investment. Increased budget allocation for biotechnology research and development from Rs. 500 crores in 2023-24 to Rs. 1,100 crores in 2024-25 to enhance innovation capabilities. Initiatives to streamline regulatory processes including proposals for a single-window clearance system for pharmaceuticals and medical devices to improve ease of doing business. Proposed multi-year transfer pricing assessments and expanded safe harbour rules to reduce litigation and provide clarity in cross-border pharma transactions and collaborations. Increased funding to healthcare schemes such as Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY), with a 7% increase in budget allocation for better healthcare coverage. Promotion of research and development focusing on novel drugs, biosimilars, bio-pharmaceuticals, and enhanced support for contract research organizations (CROs) and contract manufacturing organizations (CMOs). Emphasis on improving medical infrastructure, expanding medical education, and boosting medical tourism through campaigns like “Heal in India” in partnership with the private sector.

As per the Union Budget 2024-25: o A mission to eliminate sickle cell anaemia by 2047 will be launched. It would involve raising awareness, conducting a comprehensive screening of seven crore individuals in the impacted tribal regions between the ages of 0 and 40, and providing counselling through coordinated efforts. o For innovation in the pharmaceutical sector, through centres of excellence, a new initiative to encourage pharmaceutical research and innovation will be implemented. T he g overnment persuades business to spend money on R&D in a few chosen priority fields. At the grassroots level, government has also announced on building 157 nursing colleges in co-location with government medical colleges.

b) Opportunities and Threats.

Opportunities:

Market Size: Often hailed as the pharmacy of the world, the Indian pharmaceutical industry is booming. According to the Indian Economic Survey 2021, the domestic market is expected to grow fix in the next decade. Indias domestic pharmaceutical market expected to reach US$ 120-130 billion by 2030. Indias biotechnology industry comprises biopharmaceuticals, bio-services, bio-agriculture, bio-industry, and bioinformatics. Beyond just keeping up with the demand at home, the Indian pharma industry commands over 20% of the global pharma supply chain and addresses approximately 60% of the worldwide demand for vaccines. It meets 40% of the generic demand in the US and provides a quarter of all medicines in the UK.

Financially speaking, the pharma sector is expected to grow. A report by EY and FICCI recently stated that the Indian Pharmaceutical market is expected to reach a value of USD 130 billion by the end of 2030. The global Pharmaceutical market is estimated at an astronomical USD 1 trillion in value.

In the Pharmaceutical industry, AI and big data technologies will allow companies to restructure their business models. They will rationalize biopharma manufacturing, improve financial decisions, reduce human error, increase performance and accelerate time-to-market. The power of AI is already being leveraged to create pipelines of precision-engineered oncological and immunological treatments. Overall, the pharma and healthcare industry in India presents tremendous potential for growth especially in innovation, research, early detection, and futuristic solutions like robotics-assisted surgery. By leveraging its strengths, embracing technological advancements, and fostering collaboration, the Indian pharmaceutical industry can continue to play a pivotal role in shaping the future of healthcare delivery both domestically and internationally.

Exports: India is the 12^th largest exporter of medical goods in the world. Indian drugs are exported to more than 200 countries in the world, with US being the key market. Generic drugs account for 20% of the global export in terms of volume, making the country the largest provider of generic medicines globally. Indian drug & pharmaceutical exports stood at US$ 24.60 billion in FY22 and US$ 24.44 billion in FY21.

Road Ahead: Medicine spending in India is projected to grow 9-12% over the next five years, leading India to become one of the top 10 countries in terms of medicine spending. Going forward, better growth in domestic sales would also depend on the ability of companies to align their product portfolio towards chronic therapies for diseases such as such as cardiovascular, anti-diabetes, anti-depressants and anti-cancers, which are on the rise. The Indian Government has taken many steps to reduce costs and bring down healthcare expenses. Speedy introduction of generic drugs into the market has remained in focus and is expected to benefit the Indian pharmaceutical companies. In addition, the thrust on rural health programmes, lifesaving drugs and preventive vaccines also augurs well for the pharmaceutical companies.

Threats:

The issue that Indian Pharma is facing today is the govt. stringent control over the pricing of drugs. If one can see the other perspective then it seems fine as Citizens are getting good quality drugs at cheaper prices but it becomes a hurdle in the innovation capabilities of Pharma companies. If there is not much of the surety of getting the investment back that is already spent on R&D then the pharma companies will hesitate to invest respectable amounts in their R&D departments for drug discovery.

Counterfeiting is viewed as a serious public health menace promoted by criminals with little regard for the health and safety of patients which requires a combined public private sector response. The counterfeit medicine market is more lucrative than the narcotics business with the World Health Organization estimating that counterfeiting costs the global pharma industry $75 billion USD a year. The Criminal Intelligence Service Canada says that “Most estimates range in the billions annually for global losses.”

With that in mind, its unsurprising that the majority of pharmaceutical companies believe that the illegal use of their brand name on these counterfeit products threatens the integrity of the company that they are trying to represent. In addition to lost revenue, counterfeiting imposes other costs including increased costs to secure the supply chain, investments in anti-counterfeiting technologies, potential reputational damage and risk of liability.

Indian Pharma market is heavily dependent on China for its API needs. Currently, about 80% of the Indian Pharma Market APIs requirement is fulfilled by the Chinese Pharma Market. Occasionally there is an increase in API pricing due to policy changes & geo-political reasons. For example, to Curb pollution, China closed many of the API manufacturing units which led to a shortage of API supply. Ultimately the prices of APIs were increased.

Pharma companies also need to be aware of threats from their employees. This often occurs because of disgruntled employees trying to disrupt day-to-day operations or sell customer data to a third party or competitor. Threats can also be caused by well-intentioned users not following corporate policies or through human error.

c) Segment wise or product-wise performance.

Pharmaceutical Intermediates Market - Segment wise performance:

The Pharmaceutical Intermediates Market is Segmented by Type (Chemical Intermediate, Bulk Drug Intermediate, and Others), Application (Analgesics, Anti-Infective Drugs, Cardiovascular Drugs, Oral Antidiabetic Drugs, Antimicrobial Drugs, and Others), End-User (Biotech and Pharma Companies, Research Institutions, and Others), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America).

The pharmaceutical intermediates market studied is anticipated to grow with a CAGR of nearly 5.3%, during the forecast period (2022 - 2027).

According to a study that was published in the American Chemical Society Pharmacology and Translational Science, 2020, new potential therapeutics for COVID-19 were discovered using a combined virtual and experimental screening strategy. Furthermore, they choose among the medications that were already in use and were examined to check for structural similarity against a library of almost 4,000 medications that were already in use, with hydroxychloroquine (HCQ) serving as a reference medication. The study suggested remdesivir and favipiravir therapies as prospective adjuvants in COVID-19 treatment and zuclopenthixol, nebivolol, and amodiaquine as potential candidates f or clinical t rials against the early phase of t he SARS-CoV-2 infection. Thus, the pharmaceutical intermediates market is likely to increase both during and after a covid pandemic. As a result, market growth is anticipated in the coming years.

Given that these pharma intermediates are used in the treatment for cancer detection and a variety of chronic diseases, the rise in the prevalence of chronic diseases is projected to propel market expansion in the area under study. For instance, chronic diseases account for around 41 million annual fatalities, or 71% of all fatalities worldwide, according to the World Health Organizations key facts on non-communicable diseases published in April 2021. The high fatality rate from these diseases increases the demand for early intervention, which in turn propels the markets expansion.

There has been an upsurge in the usage of advanced technologies, such as high throughput, bioinformatics, and combinatorial chemistry for better drug candidate identification. The discovery and development of novel drugs to treat, prevent, or cure a number of diseases, including cancer, diabetes, cardiovascular disorders, and chronic kidney disease, has been hampered by the significant rise in disease incidence rates around the world.

Additionally, increased investments in R&D are a significant driver of market expansion. Hence, owing to the rising R&D activities in the pharmaceutical industry, the usage of pharmaceutical intermediates is expected to observe a steady growth as well.

Product-Wise Performance

Our Company Vineet Laboratories has been involved in developing and manufacturing of API Intermediates through innovative technology. We are an expert in designing, developing, and manufacturing API Intermediates which are key ingredients for manufacturing drugs for saving human race. Our products are cost-effective, and they cater to customers across the nation and overseas.