Suraj Pharma stands tall as a leading player in the global pharmaceutical landscape. Founded in the 1960s by Dr. Anand Srinivasan, a brilliant…
CA Final · Integrated Business Solutions (Multidisciplinary Case Study) · RTP · November 2024
Suraj Pharma stands tall as a leading player in the global pharmaceutical landscape. Founded in the 1960s by Dr. Anand Srinivasan, a brilliant scientist with a passion for affordable medicine, Suraj Pharma began as a small research lab focused on developing generic alternatives to expensive, brand-name drugs. Despite initial struggles with scarce funding and a nascent market for generics, Dr. Srinivasan's unwavering commitment and the team's innovative spirit fuelled their progress. The company has grown from humble beginnings to become the fourth-largest pharmaceutical company worldwide. Suraj Pharma focuses on developing and manufacturing complex, high-value medications that address specific therapeutic needs. With a global presence in over 100 countries and a diverse patient population, Suraj Pharma holds the top spot in the Indian domestic market, demonstrating their dominance in the region. Suraj Pharma's core strength lies in specialty drugs, which often involve advanced technology and expertise for production. Their product basket caters to a vast array of therapeutic segments, including psychiatry, anti-bacterial, neurology, and diabetes management. This ensures they can address a wide range of medical needs. Furthermore, Suraj Pharma leverages a strong branded presence in India, particularly in high-growth chronic therapy areas, allowing them to cater to specific patient needs within the Indian market. Understanding that quality is paramount in the pharmaceutical industry, Suraj Pharma has established a robust manufacturing infrastructure with over 43 facilities spread across six continents. This global footprint allows them to efficiently produce and distribute their medications. Maintaining high-quality standards throughout the manufacturing process is a top priority, with stringent quality control measures guaranteeing the safety and efficacy of their medicines for patients worldwide. Suraj Pharma actively invests in research and development (R&D) to stay at the forefront of drug development. This commitment to innovation allows them to explore new therapeutic areas and cater to evolving healthcare needs. Their financial performance reflects their success, with global revenue exceeding US$ 80 million. Suraj Pharma holds a leading position within the Indian dermatology segment and ranks highly with several different doctor groups in India. This market leadership, coupled with their focus on innovation, positions them for continued growth and success in the global pharmaceutical industry. Strategic Repositioning and Innovation in Pharmaceutical Development In the drug development value chain, the ultimate valuable product is the drug or vaccine administered to patients. Most promising molecules fail to pass the testing phase. The value chain is defined by research, testing, and delivery, with major pharmaceutical companies typically involved in these activities. They engage either directly or, in the case of research, often through partnerships with research organizations like academic institutions or universities. These activities entail significant costs, ranging from drug discovery and testing to clinical trials, submission of applications to regulatory agencies, and promotion and education for stakeholders. The incentive for bearing these costs is a grace period during which the original manufacturers have exclusive market access through patents. This period allows them to recoup their investments and potentially earn substantial profits. After the patent expires, other manufacturers can produce generic versions of the original product. These generics are crucial for the healthcare system as they ensure the availability of essential drugs at more affordable prices. Since the generic manufacturers did not incur the initial development costs, their manufacturing expenses are much lower, leading to reduced prices. The value they bring lies in creating competition in the market, which can drive down prices and improve accessibility. This competition ensures that price-sensitive consumers have access to necessary medications, contributing to better public health outcomes. One of Suraj Pharma's drugs, Rifmn, is an antibiotic used to treat the contagious disease "Tbis." Rifmn is a patented medicine, but the patent is about to expire, and several competitors are expected to enter the market with similar products. In order to reposition itself, the company is reviewing its pricing policy considering the market change and other threats. Market research for Rifmn indicates that for every 4decrease in price, demand would be expected to increase by 8,000 batches, with maximum demand being one million batches. Each batch of Rifmn is currently made using the following chemical salts: Salt X: 367.50 gm at 0.08 per gmSalt Y: 301.50 gm at 0.40 per gm Each batch of Rifmn requires 30 minutes of machine time to make and the variable running costs for machine time are 40 per hour. The fixed production overhead cost is expected to be 35 per batch for the period, based on a budgeted production level of 3,00,000 batches. The skilled workforce who has been working on Rifmn until now is being shifted to the production of Suraj Pharma's new antiviral drug (injection) for Viral Disease-23. This new drug, costing millions to develop, has been patented by Suraj Pharma and is expected to save millions of lives worldwide. Its launch is eagerly anticipated, although its demand is currently unknown, and no similar specific drug exists. The average labor cost (outsourcing) per batch of Rifmn is 38.60. The management of Suraj Pharma considers that the pricing decision of Rifmn should be based on each batch. In addition to these developments, Suraj Pharma has received a government grant of 80 crores for the research and development (R&D) of a low-cost CN1 vaccine. Existing vaccines are expensive, and the government aims to make them more affordable. The grant agreement stipulates that Suraj Pharma must develop a manufacturing process within two years to reduce production costs by at least 40%. Suraj Pharma also supplies a drug intermediate to its own unit located in another state for the purpose of converting it into formulations. This drug intermediate is unique to the company, and there is no market sale of this drug intermediate in India. Additionally, there are no goods of like kind and quality available in the market. After the conversion process, the finished product is sold directly from the said unit by the company, completing the entire manufacturing and sales cycle internally. This process ensures the company's control over the quality and distribution of the final product. Strategic Moves Amid Legal Setbacks and Acquisitions Suraj Pharma had filed a petition with the National Company Law Tribunal seeking sanction of scheme of arrangement in nature of demerger and transfer of its 'Specified Investment Undertakings' to two overseas companies which were directly and indirectly wholly owned subsidiary of petitioner company. However, the NCLT rejected the said petition. In parallel, Suraj Pharma recently acquired two pharmaceutical companies, Indu Pharma Ltd. and Biraj Lifesciences Ltd. Indu Pharma Ltd. has been conducting in-house research and development activities through its skilled workforce since its inception and has recently obtained intellectual property rights (IPR) in the form of patents over certain drugs. Additionally, Indu Pharma has a production plant that has recently obtained regulatory approvals. However, the company has not earned any revenue so far and does not have any customer contracts for the sale of goods. On the other hand, Biraj Lifesciences Ltd. has incurred significant research costs in connection with two new drugs that have been undergoing clinical trials. Out of the two drugs, one has not been granted the necessary regulatory approvals yet; however, Suraj Pharma expects that approval will be given within two years. The other drug has recently received regulatory approval. The revenue-earning potential of these drugs was one of the principal reasons why Suraj Pharma decided to acquire Biraj Lifesciences Ltd. Compliances and Consolidation Challenges Suraj Pharma has another subsidiary, MKS Ltd. (MKS), in UK. The Company had outstanding trade receivables amounting to 14 crore from MKS. Suraj Pharma observed that there have been some FEMA (Foreign Exchange Management Act) non-compliances on the part of Suraj Pharma, but the management had an action plan which they had initiated and on the basis of which management was sure that the non-compliance would be done good and there would be no penalty on the company. In case the penalty arises in future, the impact would be significant for Suraj Pharma. The auditors of Suraj Pharma also evaluated this matter by involving a regulatory matters expert and agreed with the management's view. Suraj Pharma prepared its consolidated financial statements, but they do not consolidate the financial statements of MKS. This is because the financial year followed by MKS is January to December as against April to March followed by Suraj Pharma.
Suggested Answer and Working Notes:
Correct Answer: Option (B)
Patent protection enables pharmaceutical companies to exclusively capture the benefits from their investment in new drug development for several years
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