Abstract

The National Pharmaceutical Pricing Authority (NPPA) and the Drug Price Control Order (DPCO) provide distinct regulatory frameworks that the pharmaceutical business in India, which is widely recognized for its size and intricacy, operates in. The study employs the 5C paradigm, which consists of Compliance, Competition, Cost, Consumer, and Consequences, to examine the complex interactions among variables that impact pharmaceutical price decisions. Drug costs are mostly controlled by the regulatory framework, which is anchored by the DPCO. The NPPA is in charge of keeping an eye on compliance and enforcing pricing restrictions. There is ongoing discussion on these measures' efficacy in guaranteeing affordability and promoting innovation. The differentiation between necessary and non-essential pharmaceuticals, in addition to the variations in cost between generic and branded drugs, contributes to the complexity of the pricing environment. This article investigates the competitive environment of the Indian pharmaceutical sector and how it affects pricing tactics by looking at market dynamics. The intricacy of pricing dynamics is influenced by market concentration, entry obstacles, and the power of multinational firms. The practice of international price referencing and its influence on domestic pricing decisions are also covered, emphasizing how interrelated the pharmaceutical markets are on a worldwide scale. The socioeconomic consequences of pharmaceutical pricing are also examined, with a focus on how it affects healthcare affordability and accessibility. The difficulties in managing pricing policies are highlighted by differences in the availability of necessary medications among various socioeconomic groups.

Keywords

Pharmaceutical pricing, Drug price order, 5C framework, Indian pharmaceutical industry, pricing policy management

Introduction

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    Fig 1: 5 C Analysis Frameworks

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Companies:

Indian pharmaceutical companies are vital to meeting healthcare requirements, boosting economic growth, and competing in international pharmaceutical markets. These businesses play a wide range of complex and varied functions in marketing, distribution, manufacturing, R&D, and other areas. The pharmaceutical sector is made up of businesses that create, produce, sell, and distribute both name-brand and generic medications. Typically, corporations concentrate on creating either branded or generic medications due to the significant differences in their different business strategies. For instance, the generic medicine business model necessitates especially strong competency in manufacturing, channel management, and patent disputes, whereas the branded drug business model demands very large investments in R&D and marketing [39]. The pharmaceutical industry has had annual growth of approximately 10 percent, resulting in a total sales value of $602 billion in 2005. Of this amount, the top ten companies accounted for 45 percent (Forbes.com, 2006; IMS Health, 2006). Dollar sales are more heavily skewed toward branded medications and so better reflect prescription spending due to the difference in average price levels between branded and generic drugs, whereas unit sales more accurately reflect actual utilization [40].

R & D

The pharmaceutical industry's significant R&D expenses are a defining feature of product innovation. The process of introducing novel pharmaceuticals to the Indian market is extensive and encompasses several stages, such as research and development, clinical trials, regulatory clearances, and commercialization. It is estimated that the average economic cost of introducing a new medication into the Indian market is between $161 million and $4.5 billion [41]. However, it does highlight the reality that, despite pharmaceutical research potentially being more efficient than ever before due to improved techniques and technologies like high-throughput screening and logical drug design, bringing a new medication to market can still be very costly. The most widely accepted theory for this is that the low-hanging fruit has already been picked, and the recent decline in Food and Drug Administration (FDA) approvals of non-clinical equivalents (NCEs) would seem to corroborate this theory. Alongside these high research expenses are regulatory pressures to conduct progressively larger and more costly clinical studies [42]. The high barrier to entry for new products in the pharmaceutical business affects the pricing dynamics that we see. First, R&D expenses act as a formidable barrier to entry, reducing the level of rivalry that businesses must contend with and enabling market leaders to maintain higher prices. Secondly, companies need to be able to anticipate substantial returns on their investment in innovation because research and development expenses are quite costly. It is commonly known that profitability and innovation go hand in hand. Governments use patents as a key instrument to try and address the innovation issues that occur when reduced expected returns make it less desirable to keep investing in R&D [43].

Product life cycle

Patents are a tool used by governments to offset the potential dynamic inefficiency brought on by high development costs. By giving companies that create new pharmaceutical items a brief window of market exclusivity, patents promote innovation. This determines the typical life cycle of pharmaceutical items, which, depending on how rapidly generic competitors join the market; can end within months of the patent expiring. The average effective patent life is 11.5 years, despite the fact that patents are active for 20 years from the date of filing since companies register patents prior to starting clinical trials (PhRMA, 2006). A patented molecule must contend with other unique molecules that have been approved to treat the same general ailment in order to avoid direct competition, which means that a patent does not provide monopolistic power [44]. There are several ways in which patent holders can try to prolong the patent life of their medications. If patents were staggered, for instance, so that the patent on the chemical expires at a different period than the patent on the production process or distribution system, generic entry might be delayed. Companies often get patent extensions for non-product-related reasons; two examples are the two-year extension Claritin acquired in an addition to the 1994 GATT treaty, or the fairly common six-month extension for filing a pediatric indication. A new version of an already-existing product may also be presented by well-known firms in the year before the patent expires [45]. As a result, rival companies must either take on greater risk of losing out on possible market share or suffer higher entry costs as they create generic copies of each formulation. Before their patents expire, patent holders may also release their authorized generic products, provide a license to a different generic producer, or lower the cost of their brand product [46].

Competitors:

The pharmaceutical sector in India is characterized by intense competition, since multiple companies operate across multiple segments such as over-the-counter (OTC) medications, active pharmaceutical ingredients (APIs), generic drugs, and biotechnology goods. The Indian pharmaceutical industry's dynamics are significantly shaped by its competitors. Their interactions and tactics have an impact on things like market share, pricing, innovation, and the general evolution of the sector.

For a limited period of time—20 years in India, for example—patents shield pharmaceutical items from direct competition from same-molecule copycats. Nevertheless, since they do not stop rival producers from releasing unique compounds onto the market to cure the same ailment, patents cannot totally eliminate competition. When patents expire, generic producers are free to launch products that are essentially identical to the branded product. This increases competition, lowers the average cost of a molecule, and frequently leads to a market that is contracting as a result of manufacturers' reduced marketing support [47].

Branded Competition

In India, 87% of the pharmaceutical market is made up of branded generics, with generics making up the majority of the market. The prevalence of branded generics in India has an impact on generic competition and medicine pricing, according to a market analysis on the Indian pharmaceutical industry done by the Competition Commission of India (CCI). The survey also highlights the expansion of the generic medication market in India, the country that supplies the most generic drugs worldwide. Despite being secured by a patent, the market conditions that prescription drugs operate in are best characterized as an oligopoly, with multiple unique, patent-protected goods competing for market share within a therapeutic class. Being separate compounds, they could target patients with different risk factors or somewhat different symptoms, they might have various side-effect profiles, and they might operate through different chemical pathways, resulting in varying efficacy. Larger markets typically draw more entrants, although entry into a given therapeutic class is restricted due to the high entry costs associated with generating a unique medicinal molecule [48].

Depending on how much of a therapeutic benefit they offer over other medications in a therapeutic class, brand-name goods are frequently divided into two categories: innovative and "me-too" treatments. This distinction plays a major role in the explanation of drug launch prices. Pharmaceuticals that offer notable therapeutic benefits over currently available medications within a therapeutic class typically come with three times the price tag of other name-brand medications in that class. Conversely, "me-too" medications typically bring slight enhancements over current offerings, which mean they increase some pricing competitiveness in the market [49].

Generic Competition

The prevalence of branded generics in India has an impact on generic competition and medicine pricing, according to a market analysis on the Indian pharmaceutical industry done by the Competition Commission of India (CCI). The survey also highlights the expansion of the generic medication market in India, the country that supplies the most generic drugs worldwide. Legislators in India have determined that the best and most efficient way to lower prescription costs is through generic competition, according to an article published in The Better India. Less patents in India means greater generic competition, which benefits developing country citizens and governments by lowering the cost of medications [50]. Instead of attempting to compete with generic companies, brand name manufacturers concentrate on less elastic market niches once generic businesses enter the market. As a result, volume declines, but pharmaceutical companies can still boost prices to attract the remaining, less flexible clients. Now that most states have generic replacement legislation allowing pharmacists to fill prescriptions with generic medications when available, these segmentation-based pricing patterns are presumably less appealing. The majority of insured patients have plans that use formularies to incentivize switching to generic drugs by raising the co-payment for the branded version of a drug and decreasing the co-payment for the generic version, even in the absence of such rules [51]. When a patent expires, brand name manufacturers can choose to launch their generic products and take direct aim at generic copycats as an alternative to raising the price of their name brands. If the company can make more money during the generic exclusivity period than if they were to concentrate on the inelastic portion of the market, then this is a winning proposal because there would be no entry fees.

Customers:

The final users of pharmaceutical items are called customers. The market is directly impacted by their desire for pharmaceuticals. The demand for particular pharmaceuticals is influenced by a number of factors, including an aging population, a rise in the prevalence of chronic diseases, and changing healthcare needs. Patients, insurance companies, and physicians share the roles of payer, end-user, and decision-maker in the pharmaceutical product market. So, in this section we are going to focus on the different roles of customers and payers and how they affect pricing of pharmaceuticals products [52].

End-users

The main concerns of patients and healthcare professionals are related to the safety, convenience, and efficacy of drugs. Factors such as side effects, convenience of usage, and treatment outcomes impact their decision-making.

Pricing plans need to take the end-user's perception of the drug's value into account. Certain pharmaceuticals may have premium cost due to factors including brand loyalty, special therapeutic qualities, and patient benefits. In situations where out-of-pocket expenses are substantial, patient assistance programs, discounts, or co-pay help may be put into place to increase affordability for end users [53].  Pharmaceuticals that are seen to offer better clinical results or special advantages can be accepted by patients and medical experts, increasing demand and opening up new markets. Pricing policies ought to be in line with how much the patient believe the drug is worth. Premium pricing might be justified by differentiating with cutting-edge features or patient-friendly formulas.Payers

Payers, such as government health organizations and insurance firms, prioritize controlling healthcare costs while guaranteeing that patients have access to affordable treatments. They evaluate the entire economic value of pharmaceuticals when making decisions. Payers frequently bargain with pharmaceutical corporations to obtain rebates or reduced costs, particularly for medications that have therapeutic substitutes. When negotiating prices, the capacity to show value in the real world and cost-effectiveness becomes essential [54]. Drugs with lower costs or better overall value may be preferred or given priority by payers, therefore formulary placement is crucial for market access. Having your product listed in preferred formularies can increase sales. Drugs with a high cost-effectiveness, budget impact, or value for money may be given priority by payers. Providing data from the actual world and positive economic results can help open up new markets. In price negotiations with payers, proving clinical efficacy and cost-effectiveness are frequent requirements. It can be beneficial to offer tiered pricing structures, outcomes-based agreements, or value-based pricing. It is crucial to comprehend the different roles that payers and end users play in the pharmaceutical sector in order to create pricing strategies that work. A well-rounded strategy that takes into account the clinical and financial worth of the product is essential for commercial success and for reaching a large patient base. Pharmaceutical businesses need to manage these intricacies to guarantee that their goods satisfy payers and end users alike while preserving a viable pricing structure [55].

Collaborators:

The healthcare ecosystem's stakeholders are often involved as collaborators in pharmaceutical pricing, with each one having a say in how much pharmaceuticals cost, how they're reimbursed, and how easily they may be obtained. Doctors have an institutionalized role as the key decision-maker, even though they neither pay for nor consume the pharmaceuticals they prescribe for their patients. Upon identifying an issue, doctors not only decide whether medication therapy is necessary, but also the medication and dosage to recommend. It is assumed that doctors' main goal is to provide their patients with care that complies with well recognized best practices, but it is unclear if they are motivated to take cost into account when writing a prescription. Some key collaborators in pharmaceutical industries are pharmaceutical manufacturers, health insurance companies, pharmacy benefit managers (PBMs), government agencies, health providers, pharmacies and retailers, international collaborators, etc [56].  PBMs and insurers have the direct power to persuade doctors to recommend particular medications over others. This strategy works especially well in environments where the pay of physicians is dependent on their cost-effectiveness, such as staff health maintenance organizations. Despite the widespread misconception to the contrary, patients' financial concerns are also taken into account. According to a foundation, when prescribing medication, 53% of doctors regularly talk with patients about their out-of-pocket expenses. Research demonstrating the importance of tiered patient co-payments supports this conclusion. This is particularly noticeable in cases where patients are underfunded or without insurance.

Channels:

The word "channels" in the pharmaceutical industry usually refers to the several distribution channels that pharmaceutical products use to get to customers. These routes are essential for guaranteeing that medications and other medical supplies are supplied to patients effectively and securely [57].

Some channel players in the pharmaceutical industries are;

Pharmaceutical Companies, these are the organizations in charge of doing research, creating goods, and producing pharmaceuticals. To develop and introduce new medications into the market, they spend money on research and development (R&D).

Government Health Agencies, Standards are defined, medication applications are approved, and the safety and effectiveness of pharmaceutical products are ensured by regulatory agencies like the European Medicines Agency (EMA) and the U.S. Food and medication Administration (FDA).

Pharmacy benefit managers (PBMs), Prescription drug coverage is managed by independent companies known as pharmacy benefit managers (PBMs) for the majority of health insurance policies. Even though a lot of PBMs started out as claims processors, they have now grown into full-service organizations that create formularies, bargain with manufacturers over costs, set up pharmacy networks (lists of locations where insured patients can fill prescriptions), and provide mail-order pharmacy services. The majority of the activity in the PBM sector is concentrated in a small number of huge, multi-billion-dollar firms, despite the market being less concentrated than the drug wholesale industry. Businesses and insurers, both private and public, manage pharmacy benefits internally rather than contracting with PBMs. Sometimes self-insured employers band together to increase their negotiating leverage with manufacturers; one example of such a coalition is Rx Collaborative. These entities that carry out the PBM functions internally are also included in our references to PBMs in this chapter.

5Cs in pharmaceutical industries,

These discussion topics offer a place to start when examining the different aspects of the pharmaceutical industry's 5Cs framework. They tackle the industry's dynamic character, taking into account things like evolving consumer expectations, regulatory changes, and technology breakthroughs. The investigation of the 5Cs framework in the pharmaceutical context can also be enhanced by talks about ethical issues, healthcare access, and the role of pharmaceutical companies in addressing societal health challenges.

SWOT Analysis of Indian Pharmaceutical Pricing:

Strengths:

• Low-Cost Manufacturing:

Generic medication is available at reasonable rates thanks to India's competitive edge in low-cost manufacturing. This capacity enables Indian pharmaceutical businesses to manufacture and provide medications at a significantly lower cost in comparison to other nations.

• Robust Generic Drug Market:

One of the world's main suppliers of generic medications, India helps customers both locally and abroad by offering much lower prices for prescription drugs.

• Government Price Controls

In order to guarantee affordability for a wide range of important pharmaceuticals, the National Pharmaceutical Pricing Authority (NPPA) controls the cost of critical drugs in India.

• Sturdy Supply Chain:

India has a large pharmaceutical supply chain that makes drugs widely available and distributed throughout the nation.

Weaknesses

• Regulatory Difficulties:

The complicated regulatory frameworks that the Indian pharmaceutical business operates in can cause inefficiencies and sluggish reactions to changes in price.

• Problems with Quality Control:

There have been instances of poor quality in the Indian pharmaceutical industry, which has damaged customers' and foreign purchasers' confidence.

• Restricted Innovation:

Although India leads the world in the production of generics, there exists a reported deficiency in the country's ability to produce novel, high-value medications. This might have an impact on long-term price.

• Price Control Limitations:

Although price restrictions can guarantee affordability, they can additionally lead pharmaceutical firms to become less profitable, which may have an effect on their capacity to make R&D investments.

Opportunities:

• Growth of the Generic Market:

By concentrating only on generic medications, India can keep growing its market share internationally and offer more reasonably priced options to pricy branded medications.

• Expanding Health Insurance Penetration

Pharmaceutical businesses have a chance to provide creative pricing strategies and take advantage of an expanding customer base as health insurance becomes more widely available in India.

• Collaborations and Partnerships:

Indian pharmaceutical companies can collaborate with foreign businesses to reach new markets and technology, which might result in more affordable prices.

• Innovation and Research Investment:

Indian pharmaceutical businesses may produce high-value medications that enable more flexible pricing and global recognition by making investments in research and development.

Threats:

• International Competition:

India's advantage in low-cost manufacturing could become threatened if other nations strengthen their capacities for producing pharmaceuticals.

• Regulatory Pressure:

Tighter quality standards and more stringent laws may have an impact on pharmaceutical businesses' profit margins and pricing strategies.

• Intellectual Property Issues:

The manufacturing and cost of generic medications in India may be impacted by legal disputes pertaining to patents and intellectual property rights.

• Global Economic Factors:

Changes in currency exchange rates, raw material prices, and worldwide market fluctuations can all have an impact on Indian drug prices.

• Competitive Advantage

Reduced costs for pharmaceutical goods originating from India have played a significant role in propelling growth in global sales. How to do it is as follows:

1. Economical Manufacturing

In comparison to their Western competitors, Indian pharmaceutical businesses frequently have cheaper production costs. This is due to a number of factors, including:

• Economies of the Scale:

The abundance of pharmaceutical producers in India results in cost savings.

• Reduced Labour Costs:

In India, salaries for jobs in pharmaceutical production and research are often cheaper.

• Reasonably priced Raw Materials:

Having access to less expensive raw materials and active pharmaceutical ingredients (APIs) helps make production more affordable.

• Infrastructure and technological advances:

India's excellent technology and strong manufacturing infrastructure enable productive output.

2.  Availability of Generic Medicines

India's pharmaceutical industry leads the world in producing generic medications, which are usually less expensive than branded medications. Similar therapeutic benefits are offered by generics at a significantly lower price. There are several benefits to this accessibility:

• Decreased Healthcare Costs:

Lower prices for generic medications save both customers' and governments' healthcare expenses, particularly in developing nations with tight budgets.

• Enhanced Availability:

Generics with lower prices are more widely available to a wider variety of customers, which boosts sales volumes.

• Satisfying Global Need:

There is a significant global need for reasonably priced pharmaceuticals. In order to address this demand and boost sales, Indian generics are essential.

3. Growing Global Markets

India has made a name for itself as a significant pharmaceutical exporter. Indian pharmaceutical businesses may expand their market share and penetrate new foreign markets by offering lower rates. This method helps to enhance sales in the following ways:

• Competitiveness in overseas Markets:

Indian enterprises may build a significant presence in overseas markets by offering competitively priced products.

• Export-Oriented Development:

Businesses in India's pharmaceutical sector export to nations in Africa, Asia, Europe, and the Americas. Increased revenues are supported by this worldwide reach.

• Regulatory Compliance:

Indian businesses can enter regulated markets and increase their reach by adhering to international standards (such as those set down by the FDA and EMA).

4. Getting High-Level Contracts

Indian pharmaceutical firms are able to secure significant contracts from international healthcare organisations, NGOs, and governments because of their lower costs. These agreements considerably boost revenue growth:

• Government Acquisition:

Indian generics are frequently chosen by governments looking to save healthcare expenses due to their affordability, which results in large-scale contracts and higher sales.

• NGO Collaborations:

To provide individuals in need with reasonably priced pharmaceuticals, non-governmental organisations that prioritise healthcare in underdeveloped nations frequently collaborate with Indian businesses.

• Global Health Programmes:

To assist their efforts, organisations such as the World Health Organisation (WHO) and the Global Fund import cheaper drugs from India.

CONCLUSION:

Price policies in the Indian pharmaceutical business are influenced by a variety of factors in an ever-changing and competitive market. With its emphasis on the intricacy of managing business operations, comprehending consumer expectations, competing in a crowded market, working with important stakeholders, and navigating regulatory situations, the 5 C framework offers a thorough grasp of the sector. Regulatory restrictions, cost structures, market rivalry, consumer price sensitivity, brand value, and global market movements all have an impact on pricing policy. Businesses in this sector need to strike a balance between these aspects in order to develop pricing strategies that support corporate goals and guarantee accessibility and legal compliance. Reduced costs for Indian pharmaceutical products provide cost-effective production, easily available generics, larger foreign markets, and the capacity to draw in big contracts, all of which lead to higher sales globally. With this approach, Indian pharmaceutical firms may contribute significantly to the improvement of medicine availability while simultaneously attaining notable worldwide sales growth. It also corresponds with the growing desire for cheap healthcare globally.

ACKNOWLEDGEMENT:

The authors are thankful to Department of Hospital Management and Hospice Studies, Jamia Millia Islamia for providing kind guidance and excellent opportunity as well as necessary facilities for the research.

CONFLICTS OF INTEREST:

The authors confirm that the content of the article has no conflict of interest.

FUNDING:

This research paper received no external funding.

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