Abstract

The successful introduction of new medicines in today's competitive pharmaceutical market presents significant challenges for companies, particularly in distinguishing their products amidst a myriad of alternatives. This research investigates the complexities of new medicine launches, with a specific focus on Stamlo Beta, a combination medication produced by Dr. Reddy's Laboratories. Stamlo Beta competes within a crowded landscape, where similar combination medications such as Amlokind AT (Mankind Pharma), Amloz AT (Shreya Life Sciences Pvt Ltd), Amlovas AT (MacLeod Company), and Amlip AT (Cipla) command substantial market shares of 22%, 13%, 15%, and 40%, respectively. The aim of this study is to gain comprehensive insights into the strategies and challenges encountered by pharmaceutical companies during the launch and promotion of new medications like Stamlo Beta. This research adopts a mixed-methods approach, combining surveys and interviews with pharmacists and patients, to examine the multifaceted aspects of medicine introduction. Through these methodologies, prevalent challenges at various stages of the medicine launch process will be identified, allowing for the development of effective strategies and solutions. The outcomes of this research are expected to offer practical insights and recommendations forpharmaceutical companies aiming to optimize their approaches to new medicine launches, particularly in competitive market segments. Moreover, this study contributes to the broader understanding of pharmaceutical marketing dynamics, benefiting researchers and scholars interested in the evolving landscape of healthcare product introductions..

Keywords

Introduction

Stamlo Beta, developed by Dr. Reddy's Laboratories, is an antihypertensive medication that combines two active ingredients: atenolol and amlodipine. Atenolol is an example of the beta- blocker medication class, which prevents the heart and blood vessels from being affected by the effects of adrenaline. Blood pressure and heart rate drop as a result of this. As a calcium channel blocker, amlodipine, on the other hand, improves blood flow and lowers blood pressure by relaxing and expanding blood vessels. [1]

An essential component of the entire new product development process is the launch phase. This is particularly the case for the consumer-packaged goods industry, where about 26,000 novel products were released in 1999.[2] In 1986, there were slightly over 12,000 new product launches. The success of product launches is significantly impacted by the level of quality of launch programs given the sharp increase in the quantity of newly introduced products competing for consumers' attention. Furthermore, the number of items existing on the market and line expansions make it more andmore challenging to stand out from the other products every year.[3] Even really clever and well-thought-out products might face commercial failure at times. When a product fails to satisfy the complicated criteria for launch success, as determined by a system of marketing considerations, companies can choose to stop manufacturing a perfect product.[4]

The introduction of a new drug into the pharmaceutical market marks a pivotal moment in the continuum of healthcare innovation. With advancements in medical research and technology, the development of novel therapeutic agents holds the promise of addressing unmet medical needs, improving patient outcomes, and transforming standards of care. However, the successful introduction and promotion of a new drug encompass multifaceted challenges that necessitate a nuanced understanding of the complex interplay between scientific, regulatory, and marketing dynamics.[5] In the contemporary pharmaceutical landscape, characterized by evolving regulatory frameworks, heightened competition, and shifting consumer preferences, the promotional journey of a new drug is fraught with intricacies and uncertainties ethical Regulatory agencies impose stringent guidelines to safeguard patient safety, ensure ethical promotion practices, and maintain the integrity of scientific information disseminated to healthcare professionals and patients. Navigating these regulatory requirements while effectively communicating the benefits and, ensure risks of the new drug presents a formidable challenge for pharmaceutical companies. [6]

This research attempts to clarify the crucial elements impacting the effectiveness of new drug promotions by looking at the main forces, obstacles, and strategies guiding promotional initiatives. Through an interdisciplinary lens encompassing regulatory compliance, marketing innovation, and patient-centricity, this research endeavors to contribute valuable insights to pharmaceutical stakeholders navigating the complex terrain of new drug promotion in the 21st century.

MATERIAL & METHOD:

1.         Study Design:

The study employed a mixed-methods approach combining quantitative market surveys with qualitative interviews conducted with pharmacists and patients. This approach allowed for a comprehensive investigation into the promotional challenges associated with the launch of Stamlo Beta and provided insights from both industry professionals and end-users. The design was informed by a thorough review of existing literature on pharmaceutical product launches and promotional strategies. [7]

2. Sampling Strategy:

Participants were selected using purposive sampling to ensure representation from diverse demographics and geographic regions. Pharmacists and patients were personally visited at their respective locations (pharmacies and healthcare facilities) to solicit their participation in the study. Inclusion criteria for pharmacists included being actively engaged in dispensing Stamlo Beta and willingness to participate in the survey and interview. Patients prescribed Stamlo Beta were approached during their pharmacy visits, and those meeting inclusion criteria (e.g., recent prescription, willingness to participate) were invited to take part in the study. [8]

3. Data Collection Instruments:

A structured survey questionnaire was developed to gather quantitative data from pharmacists, focusing on their experiences with promoting and dispensing Stamlo Beta, perceptions of promotional materials, and challenges encountered. Qualitative interviews were conducted with a subset of pharmacists and patients using semi-structured interview guides to explore in- depth insights into their experiences, attitudes, and behaviors related to Stamlo Beta promotion and usage. [9]

4. Data Collection Procedures:

Trained interviewers visited pharmacies and healthcare facilities to administer the survey questionnaire to participating pharmacists. Personal interviews with pharmacists and patients were conducted in a private setting to ensure confidentiality and encourage open communication. Data collection sessions were audio-recorded (with consent) to facilitate accurate transcription and analysis of qualitative data. [10]

5. Variables and Measures:

Variables of interest included pharmacists' perceptions of promotional materials, patient adherence to prescribed Stamlo Beta medication, factors influencing prescribing decisions, and challenges faced during Stamlo Beta promotion and dispensing. Measures were developed based on established scales and validated instruments, supplemented by novel items tailored to the specific context of the study. [11]

6. Data Analysis Plan:

Quantitative data collected from market surveys were analyzed using descriptive statistics,

including frequencies, percentages, and measures of central tendency. Qualitative data from interviews were transcribed verbatim and analyzed thematically using a systematic approach to identify recurring themes and patterns. Integration of quantitative and qualitative findings enabled a comprehensive understanding of the promotional challenges and opportunities associated with the Stamlo Beta launch. [12]

7. Ethical Considerations:

Institutional review board (IRB) approval was obtained before data collection, ensuring compliance with ethical guidelines for research involving human subjects. Informed consent was obtained from all participants, and their confidentiality and anonymity were maintained throughout the study. [13]

8. Quality Control and Assurance:

Quality control measures were implemented to ensure data accuracy and reliability, including interviewer training, data validation checks, and regular supervision of data collection activities. Rigorous data analysis procedures were followed to enhance the validity and trustworthiness of study findings. [14]

9. Limitations:

Limitations of the study included the potential for selection bias due to the non-random sampling approach and the reliance on self-report data, which may be subject to social desirability and recall biases. The generalizability of findings may be limited to the specific context of Stamlo Beta promotion and may not apply to other pharmaceutical products or geographic regions. [15]

PLAN OF WORK:

Structured plan outlining the necessary components is as follows:

1.  Refinement of Research Objectives:

Review the findings from the market surveys of pharmacists and patient prescriptions to identify key trends, challenges, and opportunities related to pharmaceutical product launches and promotional activities. Refine your research objectives based on the insights gained from the market surveys, ensuring alignment with the concerns and priorities highlighted by pharmacists and reflected in patient prescription patterns. [16]

2.  Methodology Adaptation:

Modify your research methodology to incorporate data collected from market surveys and patient prescriptions. Consider integrating quantitative data from pharmacist surveys and patient prescriptions with qualitative insights gathered through interviews or focus groups to provide a comprehensive understanding of the promotional challenges faced by pharmaceutical companies. [17]

3. Data Collection Enhancement:

Augment your data collection efforts to include additional information gleaned from pharmacist surveys and patient prescriptions. Expand the scope of your research instruments to capture relevant variables such as pharmacist attitudes toward promotional materials, patient adherence to prescribed medications, factors influencing prescribing decisions, and perceptions of pharmaceutical product effectiveness. [18]

4. Data Analysis Integration:

Integrate data from pharmacist surveys and patient prescriptions into your analytical framework to explore correlations, patterns, and associations with promotional challenges and product launch outcomes. Conduct comparative analyses to identify differences in perceptions, behaviors, or preferences between pharmacists and patients that may impact promotional strategies and product adoption. [19]

5. Results Synthesis and Interpretation:

Synthesize findings from all data sources, including market surveys of pharmacists and patient prescriptions, to provide a holistic understanding of the promotional challenges and opportunities in pharmaceutical product launches. Interpret the integrated results within the context of existing literature and theoretical frameworks, highlighting insights that can inform promotional strategies and enhance the success of new product introductions. [20]

6. Recommendations and Implications:

Develop evidence-based recommendations for pharmaceutical companies based on the integrated findings, addressing key promotional challenges identified through the market surveys of pharmacists and patient prescriptions. Consider the unique perspectives and needs of pharmacists and patients in crafting targeted strategies to improve promotional effectiveness, enhance communication, and optimize the launch process. [21]

Sales Report Of Stamlo Beta Drug:

Introduction: In our analysis of Stamlo Beta's sales survey performance, we focus on product sales, market penetration, and customer feedback. By examining revenue figures, we gauge its financial impact and identify market trends. Assessing market penetration reveals its reach and potential areas for expansion. Customer feedback helps evaluate its effectiveness and informs future strategies. Additionally, we explore regional distribution and customer segmentation to tailor marketing efforts and enhance engagement.

Sales Performance: The market survey conducted involved querying respondents on various aspects related to antihypertensive drugs. By asking the various questions like –

1) Which antihypertensive drug is mostly preferred by patients?

2)   Why do patients prefer this drug?

3)   Which drug is mostly prescribed by doctors?

4)   Does the cost of the drug affect its sales?

The market survey conducted involved querying respondents on various aspects related to antihypertensive drugs:

1) Which antihypertensive drug is mostly preferred by patients?

- Amlip AT tablets from Cipla emerged as the most preferred antihypertensive drug among patients.

2) Why do patients prefer this drug?

-  Patients cited several reasons for preferring Amlip AT tablets, including its perceived effectiveness in managing hypertension, minimal reported side effects, ease of availability, and trust in Cipla's brand reputation.

3)  Which drug is mostly prescribed by doctors?

-  Doctors predominantly prescribe Amlokind AT tablets from Mankind Pharma. This preference is often due to the medication's proven efficacy, affordability, perceived safety profile, and widespread availability in the market.

4)  Does the cost of the drug affect its sales?

-   Yes, the cost of the drug significantly impacts its sales. Affordable options like Amlokind AT from Mankind Pharma tend to have higher sales volumes due to their accessibility to a broader segment of patients. Conversely, higher-priced medications like Stamlo beta from Dr. Reddy's may experience lower sales unless they offer distinct advantage.

A survey on the sale of antihypertensive drugs revealed a variety of options in the market.Dr. Reddy's offers Stamlo beta tablets at ?14.66 per tablet, providing a potent choice for those managing hypertension. Mankind Pharma's Amlokind AT tablets, priced at a competitive ?3 per tablet, offer an affordable alternative. Shreya Life Sciences Pvt Ltd.’s Amloz AT tablets, priced at ?11.21 per tablet, present another option for patients seeking effective treatment. MacLeod Company's Amlovas AT tablets, priced at ?9.93 per tablet, offer a balance between efficacy and cost. However, the most sought-after option appears to be Cipla's Amlip AT tablets, known for their popularity in the market. With a comprehensive range of options available, individuals managing hypertension have the opportunity to select a medication that suits both their medical needs and budget constraints.

• From the above information we prepare the following pie chart

1. Stamlo beta (Dr. Reddy's): 12%
2. Amlokind AT (Mankind Pharma): 26%
3. Amloz AT (Shreya Life Sciences Pvt Ltd): 15%
4. Amlip AT (Cipla): 47%

       
           
       
Fig.1.   Sales of different brands.

• Conclusion from Report:

Based on the comprehensive market survey and data analysis, several key conclusions can be drawn. Firstly, patient preference overwhelmingly Favors Amlip AT tabletsfrom Cipla, owing to factors such as perceived effectiveness, minimal side effects, ease of availability, and trust in Cipla's brand reputation. Secondly, doctor prescription patterns lean towards Amlokind AT tablets from Mankind Pharma, driven by factors including proven efficacy, affordability, perceived safety profile, and widespread availability. Notably, the costof the drug significantly influences sales performance, with affordable options like Amlokind AT experiencing higher sales due to broad accessibility, while higher-priced medications like Stamlo beta may struggle unless offering distinct advantages. Overall, the market boasts a range of antihypertensive drug options, allowing patients to choose based on efficacy, safety, availability, and cost, ensuring alignment with medical needs and budget constraints.

• Result on Report of Survey:

The comprehensive market survey and subsequent data analysis have yielded several key findings that shed light on the dynamics of the antihypertensive drug market such as:

Patient Preference:

The dominant preference among patients is overwhelmingly in favor of Amlip AT tablets from Cipla. This preference is rooted in several factors, including the perceived effectiveness of the medication, minimal reported side effects, ease of availability, and the established trust in Cipla's brand reputation. These aspects collectively contribute to Amlip AT's strong position as the preferred choice among patients managing hypertension.

Doctor Prescription Patterns:

In contrast to patient preference, doctor prescription patterns lean towards Amlokind AT tablets from Mankind Pharma. This inclination is driven by factors such as the medication's proven efficacy, affordability, perceived safety profile, and widespread availability in the market. Doctors prioritize these attributes when prescribing antihypertensive drugs, resulting in a notable preference for Amlokind AT among healthcare professionals.

Cost Influence on Sales Performance:

One significant revelation from the analysis is the substantial impact of drug cost on sales performance. Affordable options like Amlokind AT from Mankind Pharma demonstrate higher sales volumes due to their accessibility to a broader segment of patients. Conversely, higher- priced medications like Stamlo beta from Dr. Reddy's may encounter challenges in sales unless they offer distinct advantages or unique benefits over lower-cost alternatives. This underscores the importance of pricing strategies in determining the market success of antihypertensive medications.

Market Diversity and Patient Choice:

Despite the dominance of certain brands, the market exhibits a diverse range of antihypertensive

drug options. This diversity empowers patients to make informed choices based on various factors such as efficacy, safety, availability, and cost. By offering a variety ofoptions, the market ensures that individuals managing hypertension can find a suitable treatment option that aligns with their specific medical needs and budget constraints.

In summary, the results of the market survey and data analysis provide valuable insights into the preferences of both patients and healthcare professionals regarding antihypertensive medications. Understanding these dynamics is crucial for pharmaceutical companies to develop effective marketing strategies and ensure the continued availability and accessibility of antihypertensive drugs in the market.

Marketing Strategies:

One of India's top pharmaceutical companies, Dr. Reddy's Laboratories, employs various marketing strategies to promote its products and maintain its competitive edge in the global pharmaceutical market. While specific strategies may vary depending on the product, target market, and therapeutic area, here are some overarching marketing strategies often employed by Dr. Reddy's Laboratories:

1. Market Segmentation and Targeting: Dr. Reddy's identifies distinct market segments based on factors such as demographics, geographic locations, and healthcare needs. Knowing the distinct qualities and preferences of every market group enables the business to customize its marketing efforts to effectively target specific patient populations and healthcare professionals. [22]

2. Product Differentiation: Dr. Reddy's focuses on developing innovative pharmaceutical products and generic equivalents that offer unique value propositions compared to competitors. Through research and development efforts, the company seeks to differentiate its products through enhanced efficacy, safety profiles, dosage forms, or patient-centric features. [23]

3. Global Expansion and Market Penetration: Dr. Reddy's has a strong presence in both domestic and international markets, leveraging its global distribution network to expand its reach and penetrate new markets. The company strategically enters partnerships, alliances, and licensing agreements to access new territories and expand its product portfolio. [24]

4. Brand Building and Promotion: Dr. Reddy invests in brand-building initiatives toenhance brand awareness, credibility, and reputation among healthcare professionals,patients, and stakeholders. The company employs various promotional channels, including medical conferences, seminars, digital marketing, and advertising campaigns, to effectively communicate the value proposition of its products. [25]

5. Key Opinion Leader (KOL) Engagement: Dr. Reddy collaborates with key opinion leaders, healthcare experts, and medical associations to gain insights, build credibility, and foster relationships within the medical community. Engaging KOLs through advisory boards, educational programs, and scientific forums helps validate the efficacy and safety of Dr. Reddy's products and influences prescribing behavior. [26]

6. Patient Education and Support Programs: Dr. Reddy recognizes the importance of patient education and support in promoting medication adherence and improving health outcomes. The company develops patient education materials, online resources, and adherence programs to empower patients with information and resources to manage their health effectively. [27]

7. Regulatory Compliance and Quality Assurance: Dr. Reddy adheres to stringent regulatory standards and quality assurance protocols to ensure the safety, efficacy, and quality of its products. Compliance with regulatory requirements and adherence to Good Manufacturing Practices (GMP) are integral to maintaining regulatory approvals and building trust with healthcare stakeholders. [28]

8. Investment in Research and Development: Dr. Reddy allocates significant resources to research and development activities to drive innovation, develop novel therapies, and address unmet medical needs. By investing in R&D, the company sustains its pipeline of new products, enhances its competitive position, and delivers value to patients and healthcare providers. [29]

Regulatory Compliance For New Drug Launch:

Regulatory compliance for launching a new drug involves adherence to various guidelines and regulations set forth by regulatory bodies including the European Medicines Agency (EMA) in Europe, Food and Drug Administration (FDA) in the United States, and other regulatory bodies depending on the region. key aspects of regulatory compliance for new drug launches. [30]

1. Clinical Trials: Before a new drug can be launched, it must undergo thorough clinical studies are conducted to demonstrate quality, safety, and efficacy. These trials must adhere to Good Clinical Practice (GCP) guidelines, which outline ethical and scientific standards for conducting clinical research. [31]

2. Marketing Authorization: Obtaining marketing authorization or approval from the regulatory agency is a prerequisite for launching a new drug. This involves completing a Marketing Authorization Application (MAA) or New Drug Application (NDA) containing

comprehensive details about the labeling, manufacturing process, safety. [32]

3. Labeling and Packaging: The medication's packaging and labeling must conform to legal regulations including precise representation of indications, dosage instructions, contraindications, warnings, precautions, and adverse reactions. Labeling must be clear, concise, and scientifically accurate to ensure medication usage that is both safe and efficient. [33]

4. Post-Marketing Surveillance: After launch, post-marketing surveillance is obligated by law for pharmaceutical firms to ensure the safety and efficacy of their products in their actual applications. Adverse events and other safety concerns must be promptly reported to regulatory authorities as part of pharmacovigilance efforts. [34]

5. Promotional Activities: Promotional materials and activities related to the new drug must comply with regulations governing drug promotion, advertising, and marketing. These regulations include guidelines on fair balance, substantiation of claims, disclosure of risks, and appropriate targeting of healthcare professionals and consumers. [35]

6. Quality Assurance and Manufacturing Standards: Pharmaceutical companies must adhere to Guidelines for Good Production Practices (GMP) are designed to guarantee the uniformity, quality, and purity of the medication manufacturing process. To deal with deviations or non-compliance, this involves implementing strict quality control procedures, conducting routine inspections, and putting remedial measures in action. [36]

7. Risk Management Plans: Some drugs may require Risk Management Plans (RMPs) or Risk Evaluation and Mitigation Strategies (REMS) implementation to mitigate known or potential risks associated with the drug's use. These plans may involve additional monitoring, education, or distribution restrictions to ensure safe use. [37]

8. Compliance Reporting: Pharmaceutical companies are required to maintain comprehensive records and documentation related to regulatory compliance activities, including submissions, approvals, inspections, and adverse event reporting. Timely and accurate reporting of compliance-related information is essential for demonstrating adherence to regulatory requirements. [38]

By making certain conformation to these legal requirements and specifications, pharmaceutical companies can navigate the complexities of the regulatory landscape and launch new drugs in a manner that prioritizes patient safety, public health, and regulatory integrity.

RESULT & DISCUSSION:

The dynamics of the antihypertensive drug market are shaped by a complex interplay of patient preferences, doctor prescription patterns, and the influence of cost on sales performance. Patient preference tends to Favor medications such as Amlip AT tablets from Cipla, driven byperceived effectiveness, minimal side effects, and trust in the brand's reputation. Conversely, doctors often prescribe Amlokind AT tablets from Mankind Pharma due to proven efficacy, affordability, and widespread availability. This dichotomy highlights the importance of understanding both patient and healthcare professional perspectives in guiding treatment decisions and shaping market demand. Cost also plays a significant role in driving sales performance within the antihypertensive drug market. Affordable options like Amlokind AT tend to demonstrate higher sales volumes compared to higher-priced alternatives. This underscores the economic considerations faced by patients managing hypertension, who prioritize access to cost-effective treatment options. Pharmaceutical companies must carefully consider pricing strategies to balance revenue generation with ensuring affordability for patients, thereby maximizing market penetration and revenue generation while maintaining competitive advantage.

Despite brand dominance, the market offers a diverse range of antihypertensive options, empowering patients to make informed choices based on factors such as efficacy, safety, availability, and cost. This diversity reflects the heterogeneity of hypertension as a medical condition and underscores the importance of providing tailored treatment options to meet individual patient needs. By fostering competition and innovation, the market encourages pharmaceutical companies to continually improve drug efficacy, safety, and affordability, ultimately benefiting patients and healthcare systems alike.

CONCLUSION:

The research delves into the intricate realm of pharmaceutical product launches, with a specific focus on Stamlo Beta developed by Dr. Reddy's Laboratories. This medication, blending atenolol and amlodipine, stands as a testament to the multifaceted challenges inherent in introducing new pharmaceuticals to the market. Regulatory landscapes wield substantial influence over product launches, emphasizing the importance of understanding pricing negotiations, reimbursement dynamics, and health technology assessments. Furthermore, the evolution of traditional marketing paradigms within the pharmaceutical sector, catalysed by shifts in prescribing habits and digitalization, introduces novel promotional challenges that necessitate innovative solutions while upholding ethical standards.

The research objectives were meticulously crafted to dissect the nuances of pharmaceutical product launches and the associated promotional hurdles. Employing a mixed-methods approach, the study seamlessly integrated quantitative market surveys with qualitative interviews to illuminate the promotional landscape surrounding Stamlo Beta's introduction. Methodological robustness, including purposive sampling and stringent ethical protocols, fortified the credibility of findings despite inherent limitations such as selection bias and reliance on self-report data.

The scrutiny of Stamlo Beta's sales performance unearthed invaluable insights into its market impact, penetration, and customer feedback. Leveraging regional distribution and customer segmentation data, tailored marketing strategies can be sculpted to optimize engagement and drive sustained growth. Additionally, the pull system operational within the chronic therapy sector underscores the paramount importance of fostering robust relationships with core stakeholders, particularly physicians, and orchestrating seamless communication across the pharmaceutical ecosystem to maximize product uptake and solidify market share.

In essence, this research serves as a beacon illuminating the convoluted landscape of pharmaceutical product launches and promotional endeavors. By confronting these complexities with strategic acumen, innovative prowess, and collaborative synergy across stakeholders, pharmaceutical entities can navigate the labyrinth of product launches with aplomb, realizing their market potential while steadfastly upholding patient welfare and ethical consideration.

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