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Indian pharma industry grows by leaps and bounds

Raheel Shah
Thursday, November 24, 2022, 08:00 Hrs  [IST]

Over the last two decades, the Indian pharmaceutical industry has grown by leaps and bounds, fuelled by its strength in the global generics space, to the point where it has been designated as the world’s pharmacy.

The Indian pharmaceutical industry ranks third in the world in terms of volume production and meets 20 per cent of global demand in the generic market. With a strong network of 3,000 pharmaceutical companies and approximately 10,500 manufacturing units spread across the country, India provides a distinct competitive advantage in the global pharmaceutical industry.

However, in order for Indian pharma to rise in the global pharma order, certain aspects must be prioritised. These include creating a conducive environment for domestic manufacturing and exports, as well as encouraging innovation through increased research and development (R&D) efforts.

The pandemic accelerated the pharmaceutical industry’s reimagination drive, and the industry demonstrated remarkable collaboration across the board in order to reduce the threat to human life. Our industry embraced a data-driven approach and harnessed technology to unlock new growth opportunities and learn critical lessons.

The liberalisation of 1991 had a significant impact on Indian pharmaceutical sector’s export capabilities. The main export destinations are the United States, the United Kingdom, Europe, and various African countries. It meets more than half of global demand for vaccines, 40 per cent of generic demand in the United States, and 25 per cent of total medicine demand in the United Kingdom. Globally, India ranks third in terms of pharmaceutical production by volume and fourteenth in terms of value.

Factors driving growth
India has a large pool of trained pharmaceutical professionals with B Pharmacy, D Pharmacy, and M Pharmacy degrees. The pharmaceutical industry’s ability to develop generic drugs at significantly lower prices is largely due to the industry’s trained professionals.

India has a large pharmaceutical manufacturing base, giving it far more flexibility in producing generic drugs. According to India Briefing, India has 3000 pharmaceutical companies and over 10,000 manufacturing units. 2,000 of them are WHO GMP approved; 253 are EDQM approved; 1,105 have Europe’s Certificate of Suitability (CEPs); and 584 are US FDA approved.

The rise of E-Pharmacy has significant implications for pharmaceutical product penetration across the country. According to research and markets, prescription drugs have a 66 per cent market share, but E-Pharmacy is growing at a rate of 21.28 per cent per year. This is assisting in market penetration because there has been a 45 per cent increase in active rural internet users.

Covid impact on pharma sector
Covid-19 is synonymous with lockdowns, supply chain disruption, and business slowdown. However,
India’s pharmaceutical industry withstood the pandemic. Despite the imposition of lockdowns and restrictions across the country, it was quick to mobilise resources to deal with supply chain disruptions.

The commitment and ability of India to produce high-quality, low-cost drugs on a large scale aided the global fight against the covid-19 pandemic. Contract Service Agreements (CSA) increased from 130 in 2018 to 183 in 2019, according to GlobalData Healthcare, and this trend continued in the following year.

Cases of Covid-19 in 2020 paved the way for large pharmaceutical companies to enter into agreements to outsource clinical research and manufacturing of antiviral therapeutics and vaccines. Aside from CSAs, strategic alliances such as licencing agreements and partnerships increased by 40 per cent between 2019 and 2020.

About 30 per cent of these deals were specifically for Covid-19. With the launch of indigenous testing kits, treatments, and vaccines, Indian pharmaceutical companies also invested in R&D screening, treatment, and prevention of Covid-19.

Pharma industry’s future
The pharmaceutical industry in India is expected to reach US$ 120-130 billion by 2030, according to the Indian Economic Survey 2021. Other pharmaceutical-related industries, such as biopharmaceuticals, bio-services, bio-agriculture, bio-industry, and bioinformatics, are expected to reach US$ 150 billion in 2025, up from US$ 70 billion in 2020.

According to EY and Ficci, the opportunities that will drive growth in the coming years are innovation and R&D, healthcare delivery, manufacturing and supply chain, and market access. In terms of healthcare delivery, India’s rural areas still have enormous potential. In the manufacturing sector, a PLI scheme worth Rs 197,000 crore has been launched in 13 key sectors such as active pharmaceutical ingredients, drug intermediaries, and key starting materials. The medical device market in India is expected to grow to US$ 50 billion by 2025, up from US$ 10.36 billion in FY20.

In terms of exports, India still has a long way to go. The global pharmaceutical trade is expected to reach US$ 1-1.3 trillion by 2030, with the goal of increasing its global share to 6-7 per cent from 2.5 per cent currently. To meet the target, India must expand existing export corridors and create new ones.

The Indian pharmaceutical industry has exercised its authority in a responsible manner. It has made a name for itself, and India is sometimes referred to as “The Pharmacy of the World.” India’s reputation stems primarily from its dominance in the generic pharmaceutical and vaccine industries. The only flaw is a lack of dominance in high-value drugs.

Although India ranks third in terms of volume of exports, it ranks 14th in terms of value of exports. To become the true “Pharmacy of the World,” India must focus on manufacturing high-value pharmaceutical products. It should be noted that China only became known as “The Factory of the World” after producing high-value goods.

Need to target rare molecules
Prioritizing rare molecules is necessary for the Indian population. Since India is such a diverse country, with various lifestyles and geographical conditions, the illness pattern likewise has a variety of symptoms when viewed from the Indian perspective. In comparison to people in any other nation, the illnesses and diseases that are reported in Indian populations are highly diverse. One thing that pharmaceutical manufacturers and researchers have noticed is that the Indian population has a disproportionately high prevalence of numerous diseases that are extremely rare elsewhere in the globe. One of the classic examples is Leishmaniasis.

Due to the low emphasis given to research on these diseases in developed nations, there is very little treatment readily available in developing nations. So, there is a clear lead for finding a cure for these disorders. Apart from that a country with a population where the poverty line is very high and based upon which the affordability criteria become a major challenge when it comes to the treatment cost or pharmaceuticals.

Life science industries in India have greatly contributed to improving health outcomes both in India and around the world. This is due to the nation’s natural advantages in the creation of vaccines, generic medications, and more recently, biopharmaceuticals. We have only focused on non-patent drugs for a very long period.  A noteworthy effort has been made by India on behalf of the international healthcare sector with the focus being on accessibility and affordability.

India has made significant progress in producing generic drugs and vaccines for the rest of the globe, which is without a doubt beneficial for the global healthcare system. The focus has always been on reengineering a patented medication. It has always been about finding new ways to innovate while remaining cost-effective.

We are aware that in many adverse nations, the cost of treatment is primarily covered by the government or insurance. However, in India, the majority of it is self-care taken by the patient, or in a very limited number of cases, insurance companies do take care of it, but this kind of population is very less. We need to develop medicines that treat the rare diseases that are prevalent in India and at the same time make the products more affordable to the people, because the treatment costs for complicated diseases like diabetes, cancer, Alzheimer’s, etc., are very high.

As a result, the main focus has been on comprehending the types of molecules that can be targeted in order to explore potential treatments that are not now available. The treatment of diseases like leishmaniasis has been a priority for the Indian government, they have funded a significant amount of funding for the research in this area. Many manufacturers and researchers are also working on its direction.

It is crucial that the pharmaceutical industry utilizes the skills it has developed throughout the years and transforms them into high-value innovations in order to transition to patented medications and capture the value from patents.  India has everything it takes to make the switch from volume to value, whether it’s the pool of researchers, scientists, medical professionals, and everyone else needed in the innovation ecosystem, or the capacity to come up with new ideas or discover unique pathways through translational research. In order to produce high-value IP that will move India from 14th to among the top three or five in terms of value, it is necessary to fund it, carry out those ideas, and deliver on the science.

For the treatment of uncommon diseases or in situations when there are few therapy options, there is a special category of medications called orphan drugs. Unfortunately, there is no such medication as an orphan drug in India. Instead, we mainly rely on the US and European orphan drug lists, which are extremely difficult to completely rely upon because the disease patterns in India and western countries are very different. As a result, it is crucial to identify and develop molecules for rare diseases.

In fact, Indian Government has a list called as essential drug list which was published in 1970 along with the first Indian patent act in 1970 but following the wars, several changes took place through the list that was regularly updated, which focused on the more concerning diseases, such as malaria. Many of the medications used to treat malaria at that time were regarded as being on the list of essential medications since it was a serious disease.

However, now malaria is in the stage of eradication as we have very positive and effective options available to treat malaria. However, diseases like tuberculosis were also treated with a long list of essential drugs. We can observe a pattern similar to that of a snake and ladder game, whereby the treatment is successful until a certain point, but after that point, the disease is taken over by tuberculosis macro-organisms due to resistance, and the overall course of treatment returns to the point where it first began. In these types of attempts, where multi-drug resistance is still a cause for concern, attention must be paid.

There are certain developments that are taking place in the world market which need to be brought to the Indian population but unfortunately patents prevailing prevent the generic manufacturers to bring them to the Indian population to benefit them. Whatever the originators they are providing it in India as of now are doing so with an exorbitant cost which makes the treatment highly unaffordable once again. Therefore, this specific necessity for uncommon compounds also includes the need for working for the molecules that are not readily available and economical.

This type of situation can occur in many different contexts, including the treatment of cancer. It has a significant role in Alzheimer’s disease as well. The scientific community in India has therefore been making an attempt to deal with domestically with situations of this nature. In India, there has been a lot of incremental innovation that is undoubtedly focused on improvements that can help patients. For instance, there has been a lot of incremental innovation to increase patient compliance; this kind of patient compliance advancement to reduce toxicity and advancement to reduce hypersensitivity reaction has been the name of the game in many of the researches conducted by the Indian researchers.

In order to make a few of the existing therapies like monacolin antibodies more affordable to the Indian population. In order to understand a very clear-cut strategy to develop the alternative medicines to the existing drugs themselves. Therefore, the development of drugs for uncommon diseases requires a concentrated strategy. Governmental initiatives may also help the pharmaceutical industry by helping to focus resources on such compounds and disorders.     

(The author is Director of BDR Pharmaceuticals Pvt Ltd)


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