Tag Archives: Pharmacy

With Covid’s Second Wave ‘A Nation In Distress’ – Why?

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If someone tries to see a silver lining in the disruptive Covid-19 pandemic, besides its vaccine rollout in some countries, there will be at least one. As of April 17, 2021- over 119 million patients (India – over 12 million), reportedly, have recovered out of 141 million (India – over 15 million) of Covid infected patients.

But this can’t mask the grim reality of over 18 million patients remain still infected, with over 3 million deaths (India – 175,673), since the beginning of the Covid menace. In the Indian perspective, this is the highest ever incidence of death – in absolute numbers – for any reason, so far. Now comes the Covid second wave with its more devastation onslaught on human lives and other consequences for the nation.

In this article, I shall explore this area, as apparently a Tsunami-like the second Covid wave starts sweeping across the India states, posing a greater danger than the first one, to the lives and livelihoods of millions of Indians, yet again. Let me start with a perspective, leading to the current situation.

No clinically proven drugs, as yet:

There aren’t any definite or clinically proven drugs after completion of Phase III studies, as yet, for curing patients from Covid infection. Nor are there any such well proven vaccines with fully known efficacy, safety, time interval between two doses, duration of prevention from Covid infection, in the future. All drugs and vaccines are currently being used under ‘emergency use’ approval by country drug regulators, based on interim results.

At the very onset of Covid-19 first wave, other than some attempts of repurposing older drugs, the world did not have any proven drugs to fight against this deadly infection. The old antimalarial drug Hydroxychloroquine – was tried first, followed by other medications, such as, Lopinavir/Ritonavir. Both created a huge global demand and subsequent shortages, including in the pharmacy of the world– India. Subsequently, W.H.O discontinued hydroxychloroquine and lopinavir/ritonavir treatment arms for COVID-19 based on interim clinical trial data. These results showed, hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care.

At the beginning of the second wave of Covid-19, one of the latest repurposed drugs – remdesivir that is being widely used, especially for hospitalized patients, is also facing a shortage, even in the pharmacy of the world. Interestingly, even ‘Remdesivir has little or no impact on survival, WHO trial shows’.

Also – no clinically fully proven Covid-19 vaccines, as yet:

Possibly, the second-best antidote as of date, against rapidly mutating Covid-19 – after Covid-appropriate behavior by all, comes vaccines. All comes with ‘emergency use’ approval, based on interim results only, and with several challenges. These include efficacy against all mutating Covid-19 variants, exact safety profile, dosage interval and duration of protection. Interestingly, on April 16, 2021, Pfizer indicated that ‘Covid-19 vaccine recipients will “likely” need a third dose between six to 12 months after they’re fully vaccinated and suggested vaccinations for coronavirus could be needed every year.’ In this evolving scenario, Indian experts also acknowledge that - abidance to the defined health norms stays as a lifeguard, and will remain so for an indefinite period.

Several countries, including India, are making, and gradually expanding requisite arrangements to vaccinate their population. Whereas a large number of countries – mostly in the developing world, are still awaiting access to Covid vaccines. Meanwhile, another issue has started bothering many, which the April 10, 2021 issue of The Guardian had captured in its headline – ‘Global Covid vaccine rollout is threatened by a shortage of vital components,’ besides manufacturing capacity constraints compared to the current demand.

Global challenges with Covid vaccines in 2021:

As things have progressed with Covid vaccines, thus far, the year 2021 doesn’t seem to be a smooth run to vaccinate people across the world, deriving a significant outcome against the battle of this global menace. This gets vindicated by the following numbers, as published in the ‘Down to Earth’ magazine on April 13, 2021.

  • According to the Johns Hopkins University, United States, as of April 12, 2021, only 773 million Covid-19 vaccines had been administered across the world. This means, only a little more than 2 per cent of the world’s adult population, has been inoculated so far.
  • According to data analytics firm Airfinity, the world will manufacture 9.5 billion doses by the end 2021. Whereas immediate global need exceeds 14 billion doses to vaccinate the entire adult population.
  • According to Gavi – The Vaccine Alliance, this represents almost three times the number of vaccines the world was producing in the pre-pandemic period for other diseases.

In the midst of these, inoculation with, at least, two major Covid-19 vaccines – one from AstraZenecaand other from Johnson & Johnson, have raised safety concern in the United States and many European countries. These ongoing developments complicate Covid vaccine challenges further.

The Indian scenario – ‘a nation in distress?’

Despite building new and a workable emergency health infrastructure by several state governments to combat Covid-19 pandemic, the fierce attack of the second wave with mutating Covid-19 virus, has already made these bursting at the seams. The article - ‘A tsunami of cases’: desperation as Covid second wave batters India, appeared in ‘The Guardian’ on April 14, 2021, captures this desperate struggle of the nation. Another recent report depicted with grim pictures, how India is grappling with the second wave of Covid-19, terming it as ‘a nation in distress.’ There are enough indications that India’s fragile health infrastructure has already collapsed in some places.

According to another news item on April 14, 2021, more than 111 million people has been vaccinated in India, by that time. Notably, this number was achieved after fears of AstraZeneca’s Covishield vaccine shortages, which subsequently prompted the Indian Government to temporarily halt its exports by the Pune-based vaccine manufacturer – Serum Institute of India (SII).

Going by another estimate, if the current momentum continues, India would be able to vaccinate 40% of its population by December 2021, and 60% of the population by May 2022. The report cautions that ‘the non-availability of vaccines may scuttle the pace.’ As per the W.H.O release, three in five Indians need to be vaccinated, to reach herd immunity. For which, the country needs 145 crore doses of vaccine by May 2022. India currently has the capacity to manufacture 100 crore-130 crore doses per year, as per a Rajya Sabha committee report. Another report of April 10, 2021 also highlights, ‘at least 10 states in India have reported a vaccine shortage and many vaccine centers have been reported shut.’

My wife and I also experienced the Covishield vaccine shortage in Mumbai. Our scheduled online appointment for vaccination through Co-Win website of the Government at Sir HN Reliance Hospital,Girgaon, Mumbai, for April 17, 2021, was cancelled. At past 10 pm on April 16, 2021, the hospital rang us up to inform that they have closed their Covid vaccination center till fresh vaccine stocks reach them.

To combat the Covid pandemic – ‘Pharmacy of the World’ goes local:

Yes, to combat the Covid pandemic, the ‘Pharmacy of the World’ goes local for some critical Covid drugs and vaccines, several times in the past. This happened earlier with drugs, like Hydroxychloroquine, when India banned its export to cater to the domestic need for Covid treatment. It happened again now, as ‘Remdesivir, API and formulation were placed under Export ban on 11.04.2021.’

Similarly, India has now, reportedly, put a temporary hold on all major exports of the AstraZeneca’sCoronavirus vaccine (Covishield in India), made by the SII, amid an increase in domestic demand due to a surge in infection. As the news item highlights: ‘It will also affect supplies to Gavi, the W.H.O backed vaccine alliance, through which more than 190 participating economies – 98 higher-income and 92 low and middle-income, are expected to get vaccine doses.’ Such temporary measures are now necessary for India to effectively respond to India’s Covid fight – especially the vaccine crunch.

India’s current vaccine imbroglio, as Covid second wave strikes hard:

Besides the SII, a second Indian company — Hyderabad-based Bharat Biotech, was given permission in January for emergency use of its Covaxin, developed in collaboration with the ICMR. Although, Bharat Biotech can make 12.5 million doses each month, these will be a small proportion of the doses administered in the country, so far.

To effectively respond to the prevailing vaccine crunch, Indian Government already approved the ‘emergency use’ of Sputnik V vaccine, which will be imported till its domestic production commences. Further, the country’s health authorities have now decided to consider the grant of ‘emergency use’ approval of several other internationally developed vaccines, such as, Pfizer – BioNTech double-dose vaccine and Johnson & Johnson’s single-shot vaccine. At least, till then, India’s vaccine imbroglio to vaccinate all adult population in the country, irrespective of age – particularly when Covid second wave is not sparing the young adults, is expected to continue.

Conclusion:

The jaw-dropping pandemic situation, and the pathway to deal with this crisis, especially in India, is getting increasingly complicated in every passing day. As reported on April 16, 2021, Covid-19 is now fooling RT-PCR tests – the most reliable type of Covid test as on date. It is so alarming because: ‘A false negative report is bad for the patient as they might delay consulting a doctor. It’s also bad for others, as the patient might not isolate, and spread the virus around,’ as the report underscores. It has started happening because: ‘Multiple mutations in the coronavirus over 15 months are making parts of it unrecognizable to lab tests.’

Experts are trying to fathom, whether or not more people are dying in India’s Covid second wave, as compared to the equivalent time period of the first wave. This causes an added cause of great concern because, in the six months before the start of the second wave (from September 2020 to January 2021), India’s overall case fatality rate (CFR) was only around 1.1%. This means only 1.1% of cases resulted in deaths. Currently, at the very beginning of the second wave, CFR has already increased to 1.3% and remains below peak levels seen in the first wave – as of date.

Above all, many people – virtually from all social, political, religious and economic strata, are openly flouting the basic norms of Covid appropriate behavior, as daily seen on different TV news channels. Ironically, these are happening at a time, when Indian health care infrastructure is creaking against the enormous and devastating power of the second wave Covid pandemic.

‘Pharmacy of the world’ has also gone local for some critical Covid-19 drugs and vaccines, to save lives and livelihoods of the Indian population, having no other better alternative in sight, at this hour. Isn’t this a sign of ‘A Nation in Distress’ that makes a fervent appeal to all of us, at least, to behave properly – by religiously following the lifesaving Covid guidelines?

By: Tapan J. Ray    

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Shifting Pharma Supply Chain Strategy From Global To Local

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Alongside large-scale disruptions of many critical industrial operations, Covid-19 global pandemic took the wind out of the sail of pharma supply chain, as well, at the very onset of lockdowns. This happened in many countries around the world, including the largest global pharma market – the United States, and also in ‘the pharmacy of the world’ – India.

That there were such disruptions in India, both in procurement and logistics, during the national lockdown, was widely reported in the media. Besides product non-availability, cost of goods also went up significantly in several cases.

From this perspective, I shall deliberate in this article, how different countries are contemplating to respond to any similar crisis in the future, primarily to safeguard patients’ health interest, despite some opposition, though. To drive home the points, I shall cite examples from India and the United States, as specified above.

Supply Chain vulnerability of the ‘largest pharma market of the world’:

There are several examples to vindicate such vulnerability, both for the US and also India. From the US perspective, the country’s supply of generic and branded medicines are, reportedly, heavily rely on emerging markets, like India and China.

This point has now ‘come under close scrutiny of the American policy makers, as COVID-19 sends shockwaves through the industry. According to the US Food and Drug Administration, China and India represent 31 percent of the plants that are registered with the US to supply Active Pharmaceutical Ingredients (API), as of August 2019. The details are as hereunder:

Place

United States

European Union

India

China

Rest of the world

Canada

%

28

26

18

13

13

2

It is worth noting, the number of facilities in China supplying APIs has, reportedly, more than doubled since 2010 – to 13 percent of all those serving the US market.

Examples from India:

The outbreak of Coronavirus had just not shut factories in China - impacting supplies and leading to fears of a shortage of drugs and medicines. It happened in India, too. Several critical supply chain issues were reported during this period. For example,  a major Indian drug manufacturing hub - Baddi,reportedly, was either shut down or operated with reduced capacity, since COVID-19 pandemic related national lockdown.

Its impact also got captured by the twitter handle of the former USFDA Commissioner – Scott Gottlieb. He twitted, “Drug supply chain at risk as Asia’s largest pharmaceutical manufacturing hub in Baddi (an industrial town in southwestern Solan district of Himachal Pradesh, India) is declared a #COVID19 containment zone – forcing many pharma units to slow or stop operations.”

Supply Chain vulnerability of the ‘pharmacy of the world’:

Supply Chain vulnerability related to the domestic issues in India, can possibly be sorted out by the country’s decision-making authorities. However, the country’s vulnerability arising out of the reasons originating in the other countries, needs a greater priority focus of the nation.

As is widely known – India caters to about 20 percent of the world’s generic drug supply. However, according to Bloomberg, 70 percent of the country’s imports of APIs come from China, ‘totaling US$ 2.4 billion of India’s US$ 3.56 billion in import spending for those products each year.

Consequently, ‘pharma companies in the country are dependent on China for two-thirds of the chemical components needed to make them.’ Exposures of such nature are now coming on to the center table – mostly triggered by Covid-19 pandemic, both in India, as well as in the United States.

India is reevaluating its import dependence from China:

To illustrate this point, let me begin with some related recent developments. While reevaluating the import dependence, India has taken both immediate and medium to long term measures – at the policy level.

The immediate reaction of India to Covid-19 outbreak, was to shift focus on local with restricted export of common medicines, such as paracetamol and 25 other pharmaceutical ingredients and drugs made from China. Curiously, prior to the national lockdown, on March 17, 2020 by a written reply the Government had informed the Indian Parliament about the import of APIs /drugs and the extent of the country’s dependence on China for the same.

Be that as it may, to protect the local interest, the above ban was followed by another export ban of the age-old malarial drug - hydroxychloroquine, ‘touted by President Trump as a possible weapon in the fight against Covid-19,’ but has been in short supply, globally. Interestingly, India produces around 47 percent of the U.S. supply of hydroxychloroquine. Thus, understandably, Indian Government had to partially lift this ban after the U.S. President Donald Trump sought supplies for the United States.

For medium longer-term measures, while announcing a ₹20 lakh crore stimulus package, Prime Minister Narendra Modi articulated that Covid-19 pandemic had taught India to ramp up domestic production and create supply chains to meet internal demands. Earlier, for safeguarding ‘national healthcare security’, the Government had allocated US$ 1.2 billion for the pharma industry to be self-reliant, by reducing its import dependence, especially for APIs. The government also wants to finance the construction of three bulk drugs with an investment of ₹300 Crores.

The United States is reevaluating import dependence from one region:

The Fierce Pharma article of June 03, 2020 also reported a shifting focus of supply chain from global to local, as the United States seeks to ‘onshore’ drug production, with the fallout of Covid-19 pandemic looming large on its drug supply chain.

U.S. legislators have argued that ‘U.S. reliance on drugs made or sourced outside the country has created a security issue that could be addressed by erecting parallel supply chains stateside and eliminating reliance on potential bad actors abroad.’ Accordingly, they have put forward ‘a raft of legislation’ that would seek to “onshore” drug manufacturing at the expense of major producers abroad.

Its biggest obstacle could be the pharma industry and its lobbyists:

Nevertheless, the same article also underscores that the biggest obstacle to that plan could be the pharmaceutical industry and its lobbyists on Capitol Hill. This is because, PhRMA - the industry’s biggest lobbying group, has pushed back against Congressional support for a supply chain shake-up. It said, “Policymakers must take a long-term, more holistic look at global pharmaceutical manufacturing supply chains before jumping to rash proposals that may cause significant disruptions to the U.S. supply of medicines.”

Will it happen in India?

My article, published in this blog on February 03, 2020, also focused on this issue. There I had emphasized, about five years back - the Government of India had also announced on February 25, 2015 – terming ‘2015 – Year of Active Pharmaceutical Ingredients’ (API). This came after ascertaining that over-dependence on imports of bulk drugs or API, especially from China, is detrimental to India’s health interest. This decision was also in sync with the freshly announced, and well-publicized government objective regarding ‘Make in India’, I wrote.

Two years down the line from the above date, on July 15, 2017, eHEALTH publication also deliberated on this issue in an article – ‘Why over dependence on APIs imported from China is harmful for India?’ However, not much change has been witnessed till date, in this regard. The same vow is now being taken afresh. Nonetheless, let me hasten to add, Covid-19 has changed the life of all – in several respects. Thus, no one can possibly vouch with a high degree of certainty what can happen hereafter, as we move on.

Conclusion:

As the ‘Lockdown. 05’ or ‘Unlock down. 01’ begins in India – the ‘pharmacy of the world, as on June 02, 2020 morning, the recorded Coronavirus cases in the country reached 247,040 with 6,946 deaths. India is now racing ahead with its number Covid-19 cases, surpassing Italy and Spain, occupying the global fifth rank, in this regard. Whereas, the top ranked pharma market in the world – the United States, where Covid-19 struck hard before India, recorded 1,988,545 cases with 112,096 deaths, on the same day.

Thus, the need to have a fresh look at the strategic design of pharma supply chain is being felt in both these countries. The requirement for becoming less global and more local is attracting a priority focus of Governments in both countries. With an increasing State-push for safeguarding the health security of the country, the need to reshape pharma supply chain – call it transient or otherwise, is now more palpable than ever before.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

A Force Multiplier: An “Armageddon”: A Contender for Supremacy in the Generic Pharma World

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It is very important for any country to ensure access to most appropriate medicines for the patients as and when they require. In many disease areas such access can be remarkably improved through affordable generic drugs, which offer significant savings in cost for absence of monopolistic situation and intense competitive pressures.

In many countries like, India and China to further augment this process, the Government price control on essential medicines is already in force.

A paper titled, “Generic Medicines: Essential contributors to the long-term health of society” highlights the following facts on such drugs:

• Provide an affordable, gold standard medication for many major illnesses

• Allow access to medicines for a greater proportion of the population

• Stimulate healthy competition with the branded sector

• Deliver savings to national health bills

• Are high quality products

Generic companies also innovate:

The same paper also highlights, though innovation has been traditionally perceived as the domain of the research-based originator companies, generic medicine companies often spend significant sums on innovating and improving formulations, enhancing delivery systems and finding solutions to patient compliance issues.

It also says, the generics medicine industry spent 7 percent of revenues on R&D alone, in 2007 and created 150, 000 jobs only in the EU.

Continuous growth of generic drug industry is critical:

Taking all these factors into consideration, continuous growth of the generic drug industry is critical in ensuring broad access to medicines to the population of any country at an affordable price. Nothing else can achieve this objective.

In the developed countries like, Canada, Denmark, Germany, Netherlands, UK and even USA, large volume of generic medicines are prescribed. Most of these countries have put in place appropriate regulations that facilitate market entry of generic drugs soon after patent expiry. All of them, by and large, encourage even more prescriptions of generic medicines.

Of course, there are many instances of deliberate attempts to slow down generic entry, which I shall deal with separately at some other time.

Quality perception for generic drugs:

In many countries the general perception of efficacy and safety standards of generic drugs is still not satisfactory. In many occasions, these are reportedly prompted by well orchestrated campaigns by interested private stakeholders in this area.

However, in markets, like the EU, Canada and the USA Governments do take public awareness measures to dispel such doubt. Unfortunately not enough similar initiatives have been taken in India with tangible results. The reason could probably lie in the existence of a powerful branded generic lobby in the country, unlike many other markets of the world.

The market:

A report of Frost & Sullivan titled, “Generic Pharmaceuticals Market – A Global Analysis” stated, the global generic pharmaceuticals market registered a revenue of US$ 135.85 billion in 2010 with a growth rate of 11 percent. The top eight global markets, namely the United States, Germany, France, the United Kingdom, Canada, Italy, Spain and Japan account for 80 percent of the total generics market. The United States will continue to remain the largest market in the world for generic pharmaceuticals in value terms.

It is estimated, the global generic drug market will grow to US$ 231.02 billion by 2017 with a CAGR 9.3 percent from 2010. The key growth drivers being:

  • Patent expiration of some blockbuster drugs
  • Entry of more biosimilars
  • High growth of emerging markets
  • Cost containment measures of governments and healthcare service providers in various countries

BRIC Countries strongly defend generic drugs:

Allegation of attacks on the generic industry by the patent holders of various drugs is also heard quite frequently.

It was reported that in a TRIPS Council meeting in mid 2012 held at the World Trade Organization (WTO), India, Brazil and China defended the right of access to cheap generic medicines by poor countries, strongly resisting attempts by the US, Japan and some other developed countries to club counterfeits or copies of patented drugs with fake or spurious ones.

They also argued that infringing intellectual property rights should not be confused with sub-standard products.

Many believe that because of the reported ‘clout of India, China and Brazil’ in the WTO, this attempt may not fructify despite such attempts.

India is surging ahead:      

It is interesting to note that out of top 10 fastest growing generic companies of the world, 4 are of Indian origin namely Glenmark, DRL, Sun Pharma and Taro (owned by Sun Pharma) and 3 definitely are home grown Indian companies, as follows:        

Top 10 Fastest Growing Generic Companies of the World:

No. Company Country Sales US$ Million Growth 2011 (%) Growth 2010 (%)
1. Sagent Pharmaceuticals USA 152 106 153
2. Perrigo USA 620 80 45
3. Nichi-Iko Pharmaceutical Japan 1300 79 25
4. Watson Pharmaceuticals USA 3320 46 38
5. Glenmark India 778 37 17
6. Dr. Reddy’s Laboratories (DRL) India 1480 34 15
7. Taro Pharmaceutical Israel 436 33 11
8. Sun Pharmaceuticals India 1650 29 52
9. Veropharm Russia 156 24 28
10. Polpharma Poland 580 22 20

(Source: FiercePharma)

India the pharmacy of the developing world:

According to a recent report India is now emerging as the ‘Pharmacy of the Developing World’, as it produces a large volume of high-quality, affordable generic medicines.

The study also highlights, “as a result of tough competition from the generic players of India, the price of first-line ARVs dropped from more than US$ 10,000 per person per year in 2000 to around $150 per person per year today. This significant price decrease has helped to facilitate the massive expansion of HIV treatment worldwide: more than 80 percent of the HIV medicines used to treat 6.6 million people in developing countries come from Indian producers, and 90 percent of pediatric HIV medicines are Indian-produced.”

Another study indicates, as a result of phenomenal success of the homegrown pharmaceutical companies:

  • 67 percent of medicines exports from India go to developing countries.
  • Main procurement agencies for developing countries’ health programs purchase their 
medicines in India, where there are quality products at low prices.
  • Approx. 50 percent of the essential medicines that UNICEF distributes in developing countries 
come from India.
  • 75-80 percent of all medicines distributed by the International Dispensary Association (IDA) to 
developing countries are manufactured in India. (IDA is a medical supplier operating on a 
not-for-profit basis for distribution of essential medicines to developing countries.)
  • In Zimbabwe, 75 percent of tenders for medicines for all public sector health facilities come from 
Indian manufacturers,
  • The state procurement agency in Lesotho, NDSO, states it buys nearly 95 percent of all ARVs 
from India.

This situation is going to further improve at a galloping pace in the years ahead with proper encouragement from the Government of India.

India tops the chart for ANDAs:

India, with its rapidly growing homegrown generic players, continues to top the Chart for Abbreviated New Drugs Applications (ANDAs) with USFDA by increasing its share year after year, as follows:

Year

Global

India

India’s Share %

2007

492

133

24.1

2008

483

143

27.9

2009

419

132

31.3

2010

419

142

34.0

2011

431

144

33.4

2012

476

178

37.4

Source: Pharmabiz, January 7, 2013 / US FDA

India tops the Chart in DMFs also:

Similarly, India continues to top the Chart with its Drug Master Files (DMF) for Active Pharmaceutical Ingredients (APIs), as follows:

No. Countries Filing Type II DMF
 1. India 2759
 2. USA 1323
 3. China 870
 4. Italy 644
 5. Japan 270
 6. Spain 268
 7. Germany 266
 8. France 170
 9. Israel 170
 10. Switzerland 136

Source: Pharma Times, August 2012

Moreover, domestic pharmaceutical companies have now between themselves, around 175 USFDA and approximately 90 UK-MHRA approved manufacturing units, to cater to the needs of high quality and affordable pharma products across the world. 

India not loosing its R&D Focus:

Discovery of new drugs being the bedrock for the pharmaceutical industry, domestic Indian companies are also not loosing focus on R&D activities. The New Chemical Entity (NCE) pipeline of the homegrown companies as on 2012 is as follows:

Piramal Healthcare 23
Suven Life Sciences 14
Zydus Cadila 11
Glenmark 8
Biocon 7
Torrent Pharma 6
Sun Pharma 5
Wockhardt 5
Ranbaxy 2
Dr Reddy’s Lab 2
Others 5

Source: Citeline Intelligence Services: Pharma R&D Annual Review 2013

Is the “west pressurizing India to change tack?”

In an interesting article published in ‘The Guardian’, the author observed that the western Pharmaceutical companies are putting health of world’s poor at risk. It commented that India makes cheap medicines for poor people around the world, but the EU, pharmaceutical firms and now the US are pressuring the ‘pharmacy of the developing world’ to change track. The same sentiment was echoed in another article published in Pharma Times.

However, the experts do feel that the Government of India, mostly due to intense public pressure, is well prepared to address any such situation, come what may. Thus, despite any retarding forces coming into play, the incessant march of the home grown pharmaceutical companies in search of excellence, especially in this space, is expected to continue even at a brisker pace.

The triggering factor:

Experts opine that the reason for excellence of the domestic Indian pharmaceutical industry, especially in the generic pharma landscape, is due to the amendment of the Indian Patents Act in 1970 allowing only process patents for drugs and pharmaceuticals.

The Government of India reportedly had taken such a path-breaking decision in the 70’s to lay the foundation of a vibrant domestic pharmaceutical industry capable of manufacturing low cost and high quality modern medicines for the health security of the country leveraging latest technology, including IT.

This decision was also directed towards creation of ‘drug security’ for the country as in the 70’s India was very heavily dependent on drug imports and the domestic pharmaceutical industry was virtually non-existent. 

Conclusion:

Paying kudos to the pharmaceutical ‘Crown Jewels’ of India, many industry watchers feel that the global pharma players are now keener than ever before to work with the domestic pharma industry, in various areas of business. This augurs well for all, as it will help creating a win-win situation to add further momentum to the growth of the pharmaceutical industry of India.

Be that as it may, taken in entirety and strengthened by its well-balanced patent laws, India  will continue to have a significant force multiplier effect to emerge as a global force to reckon with, particularly in this important space.

In tandem, with other significant cutting edges, as mentioned above, India is now well poised to be an “armageddon” – a contender of supremacy as a “pharmacy of the developing economies” despite selective allegations and  detrimental efforts by some vested interests.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

 

‘The Pharmacy of the Developing World’ keeps its eye on the ball to emerge as ‘The Pharmacy of the World’

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The incessant march of the home grown pharmaceutical companies of India in search of excellence, especially in the space of high quality low cost generic medicines for almost all disease areas, continues at a scorching space, probably more than ever before.

It has been recently reported  that among the top 10 fastest-growing generic companies globally, three are now from India with Sagent Pharma of the U.S topping the league table. These ‘Crown Jewels’ of India are as follows:

Company Global rank Growth %
Glenmark pharmaceuticals 5 37
Dr. Reddy’s Laboratories (DRL) 6 34
Sun Pharma 8 29

In terms of country ranking, currently India is among the top 20 pharmaceutical exporting countries of the world. It exports high quality and very reasonably priced generic drugs to around 220 countries across the world, including highly regulated markets like USA and EU.

Today India contributes around 20 percent of the total volume of global generic formulations and has registered a CAGR of 21 percent between 2005 and 2011. It is, therefore, no wonder that India is popularly called ‘The Pharmacy of the Developing World’, despite many formidable challenges from various corners.

Focus on opportunities and less of moaning:

It is worth noting that Indian pharmaceutical players have been keeping their eyes on the ball always as they keep expanding their market access globally and do not seem to let go any opportunities untried, like:

  • Large number of blockbuster drugs going off- patent
  • Product portfolio strategy with many first-to-file products.

Unlike many others, these winners do not also seem to get engaged much in moaning, which could significantly dilute their operational focus. 

Aiming the top: 

Currently, more than a third of the Abbreviated New Drug Applications (ANDA) in the U.S is being filed by the domestic Indian players.  Another industry estimate indicates that the Indian companies are filling on an average around 1000 ANDAs every year to reap a rich harvest out of the available opportunity, which will increase by manifold as about US$150 billion worth of drugs go off-patent between 2010 and 2015 as reported by the Crisil Research.

Similarly, India accounted for 45 percent in 2009 and 49 percent in 2010 of the total Drug Master Filing (DMF) for bulk drug in the US, which has reportedly increased to 51 percent in 2011. 

The key trigger factor:

Experts opine that the reason for the domestic Indian pharmaceutical industry being able to be recognized as a global force to reckon with, especially in the generic pharma landscape, is due to the amendment of the Indian Patents Act in 1970 allowing only process patents for drugs and pharmaceuticals.

The Government of India had taken such a path-breaking decision in the 70’s to lay the foundation of a vibrant domestic pharmaceutical industry capable of manufacturing low cost and high quality modern medicines for the people of the country leveraging latest technology, including IT.

This decision was also directed towards creation of ‘drug security’ for the country as in the 70’s the country was very heavily dependent on drug imports and the domestic pharmaceutical industry was virtually non-existent. 

The rich pay-off:

Though the country reverted to the product patent regime again in January 1, 2005, the critical mass that the home grown pharma industry had developed during almost thirty five years’ time in between, had catapulted India towards achieving today’s self-sufficiency in meeting the needs of affordable drugs for the ailing population of the country and perhaps including even those living beyond the shores of India.

The above ‘trigger factor’ has indeed paid a rich dividend to the country, by any yardstick. Currently India ranks third globally in terms of manufacturing of pharmaceutical products in volume.

Moreover, domestic pharmaceutical companies have now between themselves around 175 USFDA and approximately 90 UK-MHRA approved manufacturing units to cater to the needs of high quality and affordable pharma products across the world. 

The Leading Indian Pharmaceutical ‘Crown Jewels’:

The following are the leading Indian Pharmaceutical players in terms of sales:

Company Sales in US $Mn Year End
Cipla 6,368.06 March 2011
Ranbaxy Lab 5,687.33 December 2010
Dr Reddy’s Labs 5,285.80 March 2011
Sun Pharma 1,985.78 March 2011
LupinLtd 4,527.12 March 2011
Aurobindo Pharma 4,229.99 March 2011
Piramal Health 1,619.74 March 2011
Cadila Health 2,213.70 March 2011
Matrix Labs 1,894.30 March 2010
Wockhardt 651.72 December 2011

(Source: India Biz News: April 13, 2012)

Domestic Indian pharmaceutical companies currently control not only over 75 percent of the total domestic market, but also export low cost and high quality drugs to over 220 countries, as mentioned above, including  US, EU, Kenya, Malaysia, Nigeria, Russia, Singapore, South Africa, North Africa, Ukraine, Vietnam, and now Japan.

US accounts for 22 percent of the total Indian pharmaceutical exports, with Africa accounting for 16 percent and the Commonwealth of Independent States (CIS) eight percent, as reported by India Biz News: April 13, 2012.

Incessant growth story:

As reported by Dolat Capital, US generic market currently estimated at US $350 billion, is expected to grow by around 12 to13 per cent over 2011to15 period keeping the Indian pharmaceutical growth story intact, adding albeit more shin to it.

After the new healthcare reform brought in by President Barrack Obama, generic drugs now play a critical role in the US healthcare system, predominantly driven by the cost containment pressure of the government.

According to the Generic Pharmaceutical Association of US, generic medicines saved the healthcare system of the country over US$734 billion during 1999 to 2008 period. Expenditure on patented medicines being one of the fastest-growing components of healthcare costs, over a period of time, has now become a prime target for cost reduction by the US government.

‘The Guardian’ guards:

Some international experts do contemplate that potentially retarding global forces may attempt to cast their dark shadows over the well hyped ‘India Pharma Shining Story’ in the generic space of the industry from time to time, which needs to carefully guarded against and more importantly effectively negated.

In an interesting article, though in a different context, titled “Pharmaceutical companies putting health of world’s poor at risk: India makes cheap medicines for poor people around the world”, recently published in ‘The Guardian’, the author Hans Lofgren, an associate professor in politics at Deakin University, Melbourne articulates as follows:

“The EU, pharmaceutical firms and now the US are pressuring the ‘pharmacy of the developing world’ to change tack”.

Lofgren further commented: “We ought to be asking why governments in the rich world still seem happy to checkmate the lives of poor people to save their political skins. And why the pharmaceutical industry sees India as such a threat. Could it be that they detect the whiff of real competition?”

Conclusion: 

Be that as it may, after gaining the required critical mass, the shining story of the home grown pharmaceutical industry of India seems to be irreversible now, despite possible challenges as they will emerge.

Paying kudos to the pharmaceutical ‘Crown Jewels’ of India, many industry watchers feel that the global industry is now keener than ever before to take extra steps to keep the domestic pharma industry, enjoying a mind boggling over 75 percent share of the Indian Pharmaceutical Market, in the forefront and in a good humor to achieve their India objectives.

‘The Pharmacy of the Developing World’ should, therefore, continue to keep its eye on the ball keeping the flocks together and try to effectively translate it into the ‘The Pharmacy of the World’, as the global community keeps looking at this great transformation as a ‘miracle’ with much admiration and probably blended with a dash of awe and envy.

By: Tapan J Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.