NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGES

 

NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGES

Introduction

One of the key determinants of a nation's level of development is its health care system, which also reveals the direction in which a nation is developing.

Pharmaceutical businesses continuously strive to improve the standard of healthcare for people.

One of the key elements of the administration of health care and its costs is pharmaceutical products or medications.

An individual's spending for managing their health is rising as a result of changes in lifestyle and an increase in personal income.

According to research, the cost of pharmaceutical items has grown more rapidly than the cost of all worldwide health care combined.

The pharmaceutical industry not only benefits the nation's health care system but also its economy through fostering job growth, fostering ancillary sectors, generating export revenue, boosting GDP, and other factors.

Thus, the expansion of a nation's pharmaceutical industry is crucial to the expansion of that nation's economy.

Global pharmaceutical industry

The "Triad" (the US, EU, and Japan) is responsible for the majority of global sales of pharmaceutical products.

The global pharmaceutical market was worth approximately USD 1.2 trillion in 2014, and it is anticipated to reach USD 1.4 trillion by 2020.

By 2020, the US is expected to contribute around 41% of the global sales of pharmaceuticals, followed by the EUS and China, who are expected to spend 13% and 11%, respectively. Together, Brazil, Russia, and India account for around 6% of the drug's global usage.

Indian pharmaceutical industry

Evolution of Indian pharmaceutical sector

Phase-I (Before 1970) Early stage

A distinguished scientist and academician named Acharya Prafulla Chandra Roy founded Bengal Chemical and Pharmaceutical Works Ltd (BCPW) in Kolkata in 1901, and in 1907, TK Grajjar, Rajmitra, and BD Amin founded Alembic Chemical Works Co. Ltd. in Vadodara. Hindustan Antibiotics Ltd. (HAL) was founded in 1954 following independence.

Phase-II (1970-1990) Government control and development phase

Private businesses like Sun Pharma, founded in 1983, and Dr. Reddy's Lab, founded in 1984, began to have an effect on the market.

This time period was also characterized by some government regulation of the pharmaceutical industry, including the 1970 passage of the Indian Patent Act and a price cap on medications.

Around this time, the government also took the initiative to export medicinal items.

Phase-III (1990-2010) Growth phase

Leading pharmaceutical corporations raised their R&D spending throughout this Growth Period as well as the number of patents they submitted.

By implementing new sales modules including Channel Management, Key Accounts Management (KAM) and Contract Sales Organization, the pharmaceutical companies launched an aggressive marketing campaign (CSO).

Phase-IV (2010-2015) Acceleration phase

The National Pharmaceutical Pricing Policy 2012 (NPPP-2012) and the Director of Food and Drugs' 2013 New Drug Price Control Order were the two key policy changes made during this time period with the intention of bringing down medicine prices.

In terms of applications for Drug Master Files (DMFs) with the US, India leads the globe.

Around this time, top pharmaceutical businesses raised money for acquisitions and to broaden their product offerings.

Indian Pharmaceutical Market

The Indian pharmaceutical industry is ranked thirteenth in terms of value and third in terms of volume in the global market, according to Equity Master Report.

The pharmaceutical industry in India makes for 2.4% of the global market's value and 10% of its volume. The Indian pharmaceutical industry has a current market size of USD 20 billion and is projected to expand to USD 55 billion by 2020, with a CAGR of 15.92% from 2015 to 2020.

Branded generic medications dominate the Indian pharmaceutical industry, accounting for 70% of market sales.

The US is India's main market for its pharmaceutical exports, which are sent to many other nations.

Branded generic medications make up a significant portion of exports, accounting for 20% of all generic drug exports globally in terms of volume.

Opportunities

The pharmaceutical industry in India provides a wide range of prospects for pharmaceutical businesses to set up shops and sell their goods there.

A further benefit for Indian pharmaceutical companies is the availability of a large number of scientists and experts and a supportive regulatory environment.

India has become one of the preferred locations for pharmaceutical businesses due to the significant infrastructure investment and larger domestic market.

Because to its low production costs and well-developed R&D infrastructure, the Indian pharmaceutical industry sees a bright future.

It consists of following points:

Promising domestic market.

Contract Research and Manufacturing Services.

Mergers & Acquisitions.

Government Initiatives to boost the pharmaceutical sector.

Promising domestic market

Increased per capita income, improved health awareness, increased health insurance coverage, higher government spending on health care, a change in illness profiles, and adherence to the Indian Pharmaceutical Association(IPA) are the main growth drivers of the Indian pharmaceutical business.

Drugs that are related to lifestyle, such as cardiovascular, anti-diabetic, gastrointestinal, and respiratory medications, are what are driving the expansion of the domestic formulation market.

It is brought on by an increase in stress levels, dietary changes, and bad eating patterns among people.

In comparison to the conventional acute formulation segment, the predicted increase in the chronic formulation segment is substantially higher.

Contract Research and Manufacturing Services

India is regarded as a hub for global manufacturing due to the availability of a sizable quantity of scientific and professional people resources.

Production expenses will be 40%–50% lower than in the US and other European nations.

India is a good country for outsourcing since it has a sophisticated R&D infrastructure.

Mergers & Acquisitions

For the purpose of expanding their operations in the international market, domestic pharmaceutical businesses are seeking for chances to form strategic alliances with international players.

The domestic firms' distribution network and R&D facilities will be helpful to the international players as they compete in the sizable Indian market.

As a result, the Indian pharmaceutical industry is characterized by win-win circumstances.

Government initiatives to boost the pharmaceutical sector

The Indian government has made numerous efforts to develop the country's pharmaceutical industry.

The time it takes to approve a new facility has been shortened, and the NOC for export licenses will be provided in two weeks.

HIV/AIDS medications and diagnostic tools provided through the National AIDS Control Program supported by the Global Fund to Fight AIDS, TB, and Malaria are exempt from excise taxes and customs fees (GFATM).

Under Pharma Vision 2020, the Indian government's department of pharmaceuticals wants to establish India as a significant center for end-to-end discovery.

Challenges

India is one of the major actors in the global pharmaceutical industry, and India's pharmaceutical businesses are major players in the generic market.

The health care goals, legislative framework, and nature and diversity of the Indian pharmaceutical market present special obstacles for the country's pharmaceutical industry.

The variety of the challenges is quite complicated; thus, the Indian pharmaceutical industry needs to be more courageous in overcoming them if it wants to become one of the top competitors in the global pharmaceutical market and advance healthcare.

It consists of following points:

Intellectual property protection.

Market Access barriers.

Other challenges.

Intellectual property protection (IPP)

The committee constituted by the government under the ministry of health and family welfare believes that the price barriers generated by patents for the drugs needed to treat diseases including HIV/AIDS, Cancer, TB, MDRTB, Diabetes and Hepatitis C are unaffordable.

Sections 92 and 66 of the Indian Patent Statutes have specific provisions that allow the government committee to grant Compulsory Licenses (CL), which make it harder for patent holders to defend their rights.

It is difficult for the government to defend the CL grants, which are an instrument of industrial strategy that can only be utilized in specific situations.

Market Access barriers

According to the Drug Price Control Order (DPCO) 2013, the NPPA is responsible for setting the ceiling price for all essential medications.

This policy is cost-based and takes into account the simple average of all medications with a market share of 1% or more.

The market anticipates that market-based policies are preferable to cost-based policies.

Pharmaceutical businesses anticipate improved public health care administration systems from the government in order to get medicines to those in need and enhance the nation's general health.

The pharmaceutical industry in India must use cutting-edge marketing and sales strategies to target the rural consumer, which is a sizable market.

Other challenges

Clinical trial strategies require simple, well-developed regulations in India.

Pharmaceutical corporations face increased demands as recompense for those hurt during clinical studies.

The legislation governing clinical trials are still unclear, which may negatively affect the clinical research environment in India and the accessibility of novel medications and vaccines for Indian patients.

The Indian pharmaceutical industry's level of ethical concern is deemed to be inadequate.

Many foreign organizations think that there is still need for development in the Indian pharmaceutical industry's ethical climate, particularly in the areas of clinical trials and marketing strategies.