Tag Archives: 2011

Indian Pharmaceutical Landscape: Looking back (2011), Looking Ahead (2012)

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2011 witnessed many interesting developments within the pharmaceutical industry of India. All these developments may not be appreciated by all stakeholders alike, nonetheless had an impact on the industry of varying degree both in the qualitative and quantitative terms.

That said, the list of ‘unfinished agenda’ of the government to improve healthcare access and simultaneously to fuel the growth engine of the industry with reform oriented policy initiatives, kept on increasing staggeringly.

The issue of improving access to modern medicines with comprehensive measures continued to remain unaddressed even in the draft National Pharmaceuticals Pricing Policy 2011. Similarly, the Prime Minister’s dedication of the decade of 2010 as the decade of innovation remained a pipe dream for the pharmaceutical industry of the country.  Policy paralysis of the decision makers during the year failed to translate even this praiseworthy intent into reality.

Increasing consumption of medicines in India: 

Indian Pharmaceutical Market (IPM) continued to grow at a scorching pace of around 15% registering a turnover of Rs 59,621 Crore during the year. (Source: Nov 2011- AIOCD/AWACS).

Fast increasing consumption of medicines in the country continued to position IPM not just as another global success story, but also an emerging pharmaceutical force to reckon with, especially in the development and manufacturing of high quality and low cost generic pharmaceuticals together with its world-class  Contract Research and Manufacturing Services (CRAMS).  Indian pharmaceutical players now cater to about 20% of global requirements of high quality and affordable generic medicines of all types.

Consolidation process continues:

At the same time, ongoing consolidation process within the pharmaceutical industry continued in 2011 with Aventis Pharma (Sanofi) acquiring Universal Medicare and Zydus Cadila shopping for Biochem Pharma.

November 30, 2011: Signaled beginning of the end of the blockbuster drug era:

On November 30, 2011, the patent expiry of the world largest ever brand Lipitor (Pfizer), clocking an annual turnover of over US$ 14 billion and accounting for more than 20% of the company’s sales turnover until recently, I reckon, heralds beginning of the end of the blockbuster drug era.  To equal the turnover of Lipitor with another brand will be a huge challenge not only for Pfizer, but also for any other company in the near to medium term.

Patent expiry of Lipitor will now help opening up the super size Atorvastatin market of the developed world to the Indian generic players.

Launch of innovative products:

Launch of several innovative and patented products in India by the global players during 2011, reconfirmed the attractiveness of the IPM to the global innovator companies. Some of these innovative products are Revolade (Eltrombopag) , Votrient (Pazopanib Hydrochloride) of GlaxoSmithKline, Flexbumin solution of Baxter and BD Ultra-Fine III Nano of Becton Dickinson.

Looking back (2011):

During 2011, the industry witnessed a number of initiatives from the government as an ongoing process, some of which are as follows:

  • Establishment of dedicated Pharma Zones in Mumbai, Hyderabad and Delhi airports, including cold rooms to help achieving world-class cold-chain logistics in India in the medium term.
  • For the first time in 2011, the government initiated steps to put the ‘Biosimilar Guidelines’ in place to ensure high safety standards for follow-on biologics in India. The Department of Biotechnology (DBT) and the Central Drugs Standard Control Organization (CDSCO) prepared these guidelines in consultation with the industry, the effective implementation of which is keenly awaited. This important step will also help Indian biosimilar drug manufacturers to prepare themselves well to explore the opportunity of gradually opening-up biosimilar drugs markets in the western world, like the USA and EU.
  • The Department of Pharmaceuticals (DoP) came out with a draft Uniform Code of Pharmaceutical Marketing Practices (UCPMP) in 2011 to curb alleged unethical practices of ‘bribing doctors’ by pharma companies. The code initially is expected to be of voluntary in nature and its effective implementation will be ensured by the pharmaceutical companies and the industry associations over a period of six months. Thereafter, if the implementation level of UCPMP does not measure up to the expectations of the DoP, it will be made mandatory under strict regulatory control.  However, the final UCPMP has not been announced by the government, as yet.
  • The Ministry of Health and Family Welfare constituted a twelve member task force to evolve a long term strategy to address various issues faced by the Indian Pharmaceutical Industry. Unfortunately, tangible outcome from this committee is still awaited.
  • Following the Supreme Court directive to the government to bring essential drugs under price control, after a very long time, the Government came out hurriedly with a draft National Pharmaceuticals Pricing Policy 2011 (Draft NPPP 2011) by increasing the span of effective price control to over 65% of the IPM. This flawed draft policy, if implemented, could stifle the growth of the industry.
  • During the year the Ministry of Health and Family Welfare finalized the National Vaccine Policy to strengthen the institutional framework required for the universal immunization program. The policy is also expected to streamline the decision-making process on new and underutilized vaccine introduction, besides addressing issues of vaccine security, management, regulatory guidelines and vaccine research and development.
  • The Ministry of Health and Family Welfare also came out with the National Health Research Policy in 2011 to overcome the weaknesses of the publicly funded health structures, which restrict research in the priority health areas. This policy is expected to help maximizing the returns on investments in health research through creation of a robust health research system.
  • New National Manufacturing Policy (NMP), which ultimately saw the light of the day during the year, is expected to promote the productivity of the pharmaceutical sector, as well. The policy will help enhancing the share of total manufacturing of all industrial sectors put together from the current level of 15% to 25% of the GDP within a decade and would also help creating 100 million jobs in the country.
  • 100% FDI in the Pharmaceuticals sector of India remained unchanged, which will attract more foreign investments in this sunrise sector of India.
  • ‘Universal Health Converge’, announced during the year by the Planning Commission of India, will help reducing significantly the ‘out of pocket’ expenses incurred towards healthcare, improving its access to all.

Looking Ahead (2012):

  • The good news for 2012 is that the Planning Commission has decided to increase the national spending on health to 2.5% of the GDP in the 12th Five Year Plan starting from 2012.
  • In 2012, if the ‘NPPP 2011’ is implemented as in its current draft form, it could seriously impede the court of the vibrant pharmaceutical industry of India.
  • Introductions of DTC and GST: The ‘Discussion Paper’ on the draft ‘Direct Taxes Code Bill, 2009’ highlighted the possibility that the GST regime could have multiple rates based on classification of goods that are to be listed under the exempted category, like goods which would attract lower rate and another category of goods qualifying for standard rate. This concept of multiple rate of tax under GST regime could impact the pharma/health science industry as the business models followed by this industry typically involves import/manufacture and sale of life saving drugs, medical devices and other formulations, which presently attract either NIL rate of duty under central excise/VAT or lower rate of excise duty at 4%. Presently clinical trial services/R&D services attract service tax at 10.30%.
  • The growth trajectory of the IPM is expected to continue to go north despite slowdown in the US and European economies in 2012.

Conclusion:

Like many other sectors, the pharmaceutical industry of India also witnessed the reform oriented policy paralysis of the government in 2011, barring some superficial, half- hearted and incomplete initiatives, as indicated above.

Key areas of general public health interest, encouraging innovation, fostering R&D and improving access to medicines to alleviate healthcare related problems of the common man and at the same time to propel the industry to the inclusive high growth trajectory, have still remained unanswered.

Faster recovery from reform-oriented policy paralysis of the government and effective translation into reality of the seemingly good intent of the policy makers, is now eagerly awaited in 2012.

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.

Draft National Pharmaceutical Pricing Policy 2011: A flawed recipe

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The ‘Drug Price’ has always remained one of the critical factors to ensure greater access to medicines, especially in the developing economies like India, where predominantly individuals are the payers. This point has also been widely accepted by the international community, except perhaps the diehard ‘self-serving’ vested interests.

Just to cite some key examples, in the “ACCESS TO MEDICINES” report, the ‘Swiss Agency for Development and Cooperation (SDC)’ of ‘Swiss Centre for International Health’ has highlighted, “Affordability is one core issue at the center of debates about medicine use in international health.”

An article appeared on “This is Africa”, a new publication from the ‘Financial Times’ dated November 11, 2011 wrote: “The BRIC countries have redefined affordable drugs, making access to medicines possible for millions in low income regions. Yet changing priorities for major generic drug producers, such as India, could reshape the African pharmaceutical landscape. Access to medicines has improved dramatically over the last decade, driven by the rise of cheap pharmaceuticals from Asia, domestic efforts by governments of developing countries, commitment from donors, and price cuts from brand producers.”

Even the Director General Pascal Lamy of the World Trade Organization (WTO) in his address to the 11th Annual International Generic Pharmaceutical Alliance Conference in Geneva on 9 December 2008, said that since the 2001 Doha Declaration on the TRIPS Agreement and Public Health, “access to medicines has been improved through a major reduction of prices, enhanced international funding, a greater recognition of the need to find a balance within the intellectual property system, as well as the use of some of the TRIPS flexibilities by certain WTO Members”.

Similarly, the global pharmaceutical major GlaxoSmithKline (GsK) in its 2010 ‘Corporate Responsibility Report’ indicated: “Pricing is one factor that impacts on access to medicines and vaccines.”

Echoing similar sentiment the Swiss Pharma giant Novartis in its website articulated: “The issue of access to medicines is complex, involving factors such as development and health policies, health system infrastructure and best practices, pricing, rational use of drugs and adequate funding.”

‘Drug Price’ control alone cannot improve access to medicines:

As we have seen above, drug price is indeed one of the critical factors to improve access to modern medicines. It is for this reason, Governments in countries like Germany, Spain, UK, Korea and China have recently mulled strict price control measures in their respective countries.

Thus, I reiterate, drug price is certainly an important factor to improve access to modern medicines, but definitely not the only factor to focus on, as is being done in India by its successive governments.

In India, we have witnessed through almost the past four decades that drug price control alone would do little to improve access to modern medicines to the common man significantly, especially in the current socio-economic and healthcare environment of the country.  Continuation of poor access to modern medicines even after 40 years of stringent drug price control vindicates this point.

Draft NPPP 2011:

A reform-oriented ‘Drug Policy’ of India, was languishing as a ‘prisoner of indecision’ of the policy makers, since quite a  while.

Draft National Pharmaceutical Pricing Policy 2011 (NPPP 2011) has just been announced by the government with the ‘essentiality’ criteria for price control. The stakeholders have been requested to give their views on the same.

The draft policy seems to have taken some bold initiatives in terms of criteria and mechanics of price control, especially, moving away from the age old and non-transparent ‘Cost Based Pricing (CBP)’ to a more transparent ‘Market Based Pricing (MBP)’ model of Pronab Sen Committee of 2005.

However, in my view, NPPP 2011 has failed yet again to go beyond price control by effectively addressing other key issues for inadequate access to modern medicines by the common man, in a comprehensive and holistic way.

HSPH article of 2007 echoes the basis of Draft NPPP 2011:

‘Harvard School of Public Health’ in an article of July 2007 titled, ‘How Effective Is India’s Drug Price control Regime?’ had commented that in the present form, DPCO 1995 is inadequate in its coverage and does not serve the purpose that it had intended to.

The article recommends that there is an urgent need to replace the existing criteria for price control using monopoly and market dominance measures with the criteria of ‘essentiality’ of drugs, which would have a maximum spill-over effect on the entire therapeutic category.

In addition the paper says that this critical change is also ‘likely to prevent the present trend of circumventing price controls through non-standard combinations and at the same time would discourage producers moving away from controlled to non-controlled drugs’.

Just as mentioned in the draft NPPP 2011, the ‘Harvard School of Public Health’ article of 2007 reiterates that direct price control should be applied on formulations rather than basic drugs, which is likely to minimize intra-industry distortion in transaction.

The paper also points out, “Huge trade margins are a rule rather than exceptions in Indian drug industry. In view of this, there is a need to fix ceiling on trade margins which could lead to significant downward influence on medicine prices. Finally, we argue that to ensure drug security in India, a strong regulatory institutions need to be established.”

It is interesting to note that NPPP 2011 draws so much similarity with the ‘Harvard School of Public Health’ article published way back in 2007.

Basic objectives of a Drug Policy:

The ‘Drug Policy 1986’ clearly enunciated the basic policy objectives relating to drugs and pharmaceuticals in India, as follows:

  • Ensuring abundant availability of medicines at reasonable price and quality for mass consumption.
  • Strengthening the domestic capability for cost effective, quality production and exports of pharmaceuticals by reducing barriers to trade in the pharmaceutical sector.
  • Strengthening the system of quality control over drug and pharmaceutical production and distribution.
  • Encouraging R&D in the pharmaceutical industry in a manner compatible with the country’s needs and with particular focus on diseases endemic or relevant to India by creating an conducive environment.
  • Creating an incentive framework for the pharmaceutical and drug industry which promotes new investment into pharmaceutical industry and encourages the introduction of new technologies and new drugs.

After having completed around 25 years since then, it is high time for the government to ponder and assess whether the successive drug policies have delivered to the nation the desirable outcome as enunciated above.

Even the draft NPPP 2011 does not seem to have made any conscious attempt to make any amend in these areas either.

The draft NPPP 2011 offered another opportunity for a robust beginning:

Many of us will know that the 2002 Drug Policy was challenged in the Karnataka High Court, which by its order dated November 12, 2002 issued stay on the implementation of the Policy. This order was challenged by the Government in the Supreme Court, which vacated the stay vide its order dated March 10, 2003 but observed as follows:

“We suspend the operation of the order to the extent it directs that the Policy dated 15.2.2002 shall not be implemented. However we direct that the petitioner shall consider and formulate appropriate criteria for ensuring essential and life saving drugs not to fall out of the price control and further directed to review drugs, which are essential and life saving in nature till 2nd May, 2003”.

When nothing tangible happened thereafter, in October 2011, the honorable Supreme court against another Public Interest Litigation (PIL) asked the Ministry of Health (MoH) and the Department of Pharmaceuticals (DoP) to submit separate affidavits to the court on November 17, 2011 explaining their seriousness to bring the essential drugs under price control.

As a result of the November 17, 2011 order of the Supreme Court, it now appears that to put a new pharmaceutical policy in place in an unprecedented hurry, with the ‘essentiality’ criteria for price control, the Government lost another golden opportunity for a new and robust beginning with a comprehensive and well thought out national drug policy.

Draft NPPP 2011: Is it just to satisfy the Supreme Court of India?

The overall objective of any ‘Drug Policy’ is indeed to help accelerating all-round inclusive growth of the Indian pharmaceutical industry and to make it a force to reckon with, in the global pharmaceutical arena. At the same time, the policy should help creating an appropriate ecosystem to improve access to quality medicines at an affordable price by the entire population of the nation.

As stated above, in NPPP 2011, fixing Ceiling Price (CP) based on ‘Market Based Pricing (MBP)’ approach for 348 drugs falling under National List of Essential Medicines 2011 (NLEM 2011) and not beyond, could make sense, especially keeping in mind the direction given by the honorable Supreme Court of India on March 2003 and October 2011 on the subject, as indicated above.

However, just one pronged approach with the drug price control mechanism to address the issue of improving access to modern medicines in no way can be considered as a holistic approach to achieve objectives of a Drug policy. Isolated and incoherent initiatives of price control (though important) in the draft NPPP 2011, without taking the big picture into consideration, appears to be foolhardy.

A lurking fear creeps in though, has NPPP 2011 been drafted by the Government just to satisfy the Supreme Court of India with the incorporation of ‘essentiality’ criteria for price control medicines?

12th Five Year Plan increases public spending towards health:

In the 12th Five Year Plan of India commencing 2013, the country is expected to spend 2.5% of its GDP for health. Currently, public spending on health as a percentage to the GDP being at 0.9% is among the lowest in the world and against 1.8% of Sri Lanka, 2.3% of China and 3.3% of Thailand, just to name a few.

Recently another expert committee under the chairmanship of Dr. Srinath Reddy suggested that high ‘out of pocket’  healthcare expenditure of the people of India, should be significantly reduced by doubling the public spending on health. The committee also commented, “Increasing public health spending to our recommendations will result in a five-fold increase in real per capita health expenditures by the government from Rs 670 in 2011-12 to Rs 3,432 by 2021-22.”

Health coverage for ‘outpatient treatment’ in India is a necessity:

It is important to note from the above report that outpatient treatment in India accounts for around 78% of the ‘out-of-pocket’ expenses, with medicines accounting for 72% of the total outpatient health expenditure. Unfortunately, there is hardly any cover available to the common man for outpatient treatment in India, even by those holding some form of health insurance coverage.

A comparison of private (out of pocket) health expenditure:

Following is a comparison between ‘out of pocket’ expenses between India and its closer neighbors:

1. Pakistan: 82.5% 2. India: 78% 3. China: 61% 4. Sri Lanka: 53% 5. Thailand: 31% 6. Bhutan: 29% 7. Maldives: 14%

(Source: The Lancet)

Taming drug price inflation has not helped improving access to medicines:

It is quite clear from the following that food prices impact health more than medicine costs:

Year

Pharma Price Increases

Food Inflation

2008

1.1%

5.6%

2009

1.3%

8.0%

2010

0.5%

14.4%

Source: CMIE

Over one third of Indian population can’t afford to spend on medicines:

While framing the draft NPPP 2011, the Government should have kept in mind that a population of around 35% in India, still lives Below the Poverty Line (BPL) and will not be able to afford any expenditure even towards essential medicines.

Adding more drugs in the list of essential medicines and even bringing them all under stringent price control will not help the country to resolve this critical issue.

Why 40 years of stringent price control failed to make medicines ‘affordable’?

In my view, there is no ‘one size fits all’ type of definition for affordability of medicines, just like any other essential commodities, especially when around 78% of healthcare expenditure is ‘out of pocket’ in our country. Any particular price point may appear affordable to some, but will still remain unaffordable to many, especially in a country like India.

The initiatives taken by the government for price control of medicines since the last four decades have certainly been able to make the drug prices in India one of the lowest in the world coupled with intense cut throat market competition.

Unfortunately, this solitary measure has failed to improve access to modern medicines to the common man significantly due to various other critical reasons, which we hardly discuss and deliberate upon with as much passion as price control.

Despite so many drug price control orders, even today 47% and 31% of hospitalization in rural and urban areas, respectively, are financed by private loans and selling of assets by individuals.

Multi-dimensional approach to improve access to affordable medicines:

Access to healthcare and affordable medicines can be improved through an integrated and comprehensive approach of better access to doctors, diagnostics and hospitals, along with an efficient price regulatory mechanism for each component of healthcare cost including medicines. We should not forget that in India over 46% of patients travel beyond 100 km to seek medical care even today. (Source: Technopak & Philips (2010) Accessible Healthcare: Joining the Dots Now, New Delhi).

Healthcare infrastructure in India is severely constrained by lack of trained healthcare professionals, limited access to diagnostics/treatment and availability of quality medicines. Consequently, the supply of healthcare services falls significantly short of demand.

The current figure of 9 beds per 10,000 population in India is far from the world average of 40 beds per 10,000 people. Similarly, for every 10,000 Indians, there are just 6 doctors available in the country, while China has 20 doctors for the same number of population. Without proper equipment and doctors to diagnose and treat patients, medicines are of little value to those who need them most.

Thus, drug price control alone, though important, cannot improve access to healthcare without creation of adequate infrastructure required to ensure effective delivery and administration of medicines, together with appropriate financial cover for health.

Encourage healthy competition among healthcare providers:

Effective penetration of various types of innovative health insurance schemes will  be one of the key growth drivers for the inclusive growth of the Indian pharmaceutical industry, as desired by many in India.

Simultaneously, there is a need to promote tough competition within those healthcare providers to make them more and more cost-efficient while providing greater patients’ satisfaction. In that process, all elements of healthcare expenditure like physicians’ fees, diagnostic tests, hospital beds and medicines could be made affordable to the common man.

In such competitive environment, the patients will be the net gainers, as we have seen in other knowledge based industries, like the telecom sector with incredible increase in the tele-density of the country.

The drug policy should also include an equally transparent system to ensure that errant players within the healthcare sector, who will be caught with profiteering motives for manipulation of drug formulations and dosage forms to avoid price control, are brought to justice with exemplary punishments, as will be defined by law.

The Government won’t be able to do it all alone:

The Government needs to partner with the private sector to address India’s acute healthcare challenges through various Public-Private-Partnership (PPPs) initiatives.

Recent examples of successful PPP in the health sector include outsourcing ambulance services, mobile medical units, diagnostics and urban health centers  to private NGOs. PPP should adequately cover both primary and specialty healthcare, including clinical and diagnostic services, insurance, e-healthcare, hospitals and medical equipment.

Conclusion:

‘Drug price’ is universally recognized as one of the important elements, though not the sole element, to improve access to modern medicines. India is no exception.

This time around, the draft NPPP 2011 has come out in the public domain again with a flawed recipe, though the policy makers have tried to include some welcoming changes in it. The authors of the draft policy seem to be still preoccupied and obsessed with addressing the symptoms of ‘affordability of medicines’ rather than focusing on the larger issue of ‘access to modern medicines’ in a holistic way.

By not addressing the all important ‘access’ related critical issues in the draft NPPP 2011 rather comprehensively, dismantling the operational ‘silos’ and inter-ministerial administrative boundaries, the architects of NPPP 2011 seem to have missed the bus, yet again, in their endeavor to help achieving a significant dimension of the long overdue ‘health for all’ objective of the nation.

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.

Tapan Ray in ‘Focus Reports’, March 2011

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FR: Our last report on India dates back to 2006, right after the Patent Law was passed. What developments have you seen happening in the industry since then?

TR: There has been a paradigm shift with the Product Patent Regime coming in place in 2005. The era from 1970 to 2005 has been a very successful era of reverse engineering, when Indian manufacturers were copying and marketing innovative products in India at a fraction of their international price. Nevertheless, this also required talent, for which India had brilliant process chemists. However, the country eventually realized that reverse engineering model would not truly serve the longer term advancement of the economy in creating a conducive ecosystem to foster innovation. This realization process started in 1990 and was reinforced after signing the WTO Agreement in 1995. After the ten-year transition period, the patent law came into force in January 2005.

Since around 2005 Indian companies, which had mainly been relying on cost efficient processes, started investing in the drug discovery research. There are now at least 10 Indian companies engaged in basic research, while around 32 New Chemical Entities (NCEs) are at various stages of development.

This significant step that the country has taken so far, could not have been possible without a conscious decision to move away from the paradigm of replication to the new paradigm of innovation. More importantly, this shift has not happened at the cost of fast growing generic pharmaceutical industry in the country. Branded generics continue to grow rapidly in the new paradigm.

Today, branded generics constitute over 99% of the domestic pharmaceutical market. Of course, according to McKinsey (2007), the share of patented medicines is expected to increase to 10% by 2015. Even in that scenario 90% of the market will still constitute with branded generics in value terms.

FR: At the same time, companies are still only spending some 4% of their revenues on R&D, while internationally these numbers amount up to 12%. Many of the people in the industry seem to still see the future of India for the next 10 years to remain in manufacturing. Is innovation really the story of India right now?

TR: As I mentioned earlier, around 32 NCEs are at various stages of development from pre-clinical to Phase III. Thus, what Indian companies have achieved since 2005, is, indeed remarkable. If you now look at the investments made by the Indian pharmaceutical companies in R&D, as a percentage of turnover, you will notice an ascending trend. Though the R&D ecosystem in India cannot be compared with the developed world just yet, India is catching up.

FR: In some previous interviews we have conducted, concerns were raised over the Indian industry, saying that the local companies are selling off to international players. What is your take on this?

TR: In India, we all express a lot of sentiments and are generally emotional in nature. These are not bad qualities by any standard. However, such expressions should ideally be supported by hard facts. Otherwise these expressions cannot be justified.

Consolidation process within the industry is a worldwide phenomenon and is also taking place in India. One of the apprehensions of such consolidation process in India is that drug prices would go up, as a consequence. In my view, all such apprehensions should be judged by what has already happened in our country by now, in this area.

One example we can cite is the Ranbaxy-Daiichi-Sankyo deal, an acquisition which has not at all led to an increase in Ranbaxy’s product prices. Similarly, the acquisition of India-based Shantha Biotech by the French pharmaceutical major, Sanofi-Aventis did not lead to any increase in product prices either. It is difficult to make out how could possibly the drug prices go up when we have an effective national price regulator called National Pharmaceutical Pricing Authority (NPPA) in India? Currently, 100% of the pharmaceutical market in the country is regulated by NPPA in one way or the other.

India is currently having a drug policy which came into force way back in 1995. As per this drug policy, any company which increases its product price which are outside price control, by more than 10% in a year, will be called for an explanation by the NPPA. Without a satisfactory explanation, the concerned product – not the product category – will be brought under price control, that too for good. In addition, intensive cut-throat competition has made pharmaceutical product prices in India the cheapest in the world, even lower than in the neighboring countries such as Bangladesh, Pakistan and Sri Lanka. Moreover, if the potential to increase prices exists, why would any company wait for an acquisition in a highly fragmented pharmaceutical market in India?

Many of the concerns are, therefore, difficult to justify due to lack of factual data. In fact, on the contrary, the presence of multinational pharmaceutical companies in India is good for the country. These companies with their international expertise and resources would help India to build capacity in terms of training and creating a world-class talent pool. Indian companies, therefore, should consider to take more and more initiatives to partner and collaborate with these MNCs to create a win-win situation for India.

Another key advantage is in the area of market penetration. Market penetration through value-added innovative marketing has happened and has been happening all over the world; India should not let go this opportunity.

FR: In that case, how do you feel about some of the proposed protectionist measures such as a 49% cap on Foreign Direct Investment (FDI)?

TR: This may, once again, be related to the strong local sentiments. India needs financial reforms and wants to attract more and more FDI. The country wants to liberalize the process of FDI and, to the best of my knowledge, any step to move backward in this area should not be contemplated.

It is also worth mentioning that the acquisitions that have taken place were not of any hostile nature. Both Indian companies and MNCs have their own sets of skills, competencies and best practices. Both cost revenue and value synergy through such consolidation process could be made beneficial for the country.

Without commenting on any specific cases, I believe India has taken significant steps to encourage and protect innovation by putting in place the product patent Act in 2005. However, there are some additional steps that the Government should take to further strengthen the process, such as fast-track courts that can quickly decide on the cases of patent infringements. Another example is that when any company will apply for marketing approval for a product, the regulator will upload the same on its website. This is an easy way for other players to detect patent infringement and start taking counter-measures at an early stage. These are examples of steps that can be taken to create a proper ecosystem without amending the law.

FR: You mentioned the paradigm shift towards innovation earlier, to some extent a similar path as China. How innovative has India become in this respect and is it sufficient in terms of clinical trials and other related aspects of the sector?

TR: With regards to attracting FDI in areas such as R&D and clinical trials, India at present is far behind China. The reason for this, as said earlier, is that the country should try to analyse why the innovator companies are not preferring India to China in these areas. Simultaneously, there is a need to assess the expectations of the innovative companies from India in various areas of IPR. One such factor that is bothering the global innovative companies is the absence of regulatory data protection in India. The Government should seriously ponder over this need and take active steps towards this direction as was proposed by ” Satwant Reddy Committee in 2007.”

FR: In your view, what is the industry going to look like in the coming years?

TR: I do not expect a radical shift in the way the Pharmaceutical Industry will be operating in the next few years. Changes will take place gradually and, perhaps, less radically. The increase of the share of patented medicines to 10% of the market share by 2015 as was forecasted by McKinsey in 2007, in my opinion, is rather ambitious. We will certainly see more and more patented products in the market, but it will be slow and gradual unless corrective measures are taken to tighten the loose knots in the Patent Amendment Act 2005, as stated earlier. As more and more Indian companies will start embracing an innovation-driven business model, the strengths and the international experience of the MNCs in this area should be leveraged to catapult the Indian pharmaceutical industry to a much higher growth trajectory.

The interview is available at the following link:

http://www.pharma.focusreports.net/#state=Interview&id=0

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 time to keep our nose to the Grindstone – Competition Act will take care of M&As, come June 2011

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Full control of powers on Mergers and Acquisitions of the Competition Commission of India (CCI) effective June 1, 2011, has now been notified.

In this evolving scenario, it is indeed difficult to understand, why is the FDI issue on M&A in the Pharmaceutical space of India is still catching headlines of both national and international media. Instead, should we not now keep our nose to the grindstone and take strategic measures to accelerate the inclusive growth of this life-line industry of the nation?

Stipulations for M&As under the Competition Act:

Section 6(1) of the Act prohibits any person or enterprise from entering into a combination which has an “appreciable adverse effect” on competition in India. It also stipulates that any enterprise which intends to enter into such M&A, shall give notice to the CCI furnishing details of the proposed M&A within thirty days of:

(i)  Approval of the merger by the Board of Directors of the concerned enterprise

or

(ii) Execution of any agreement relating to acquisitions referred to in clause 5(a) & (b) of the Act. S.6(2A) provides a period of 210 days to the CCI to complete the investigation relating to such combinations (if the CCI is unable to come to any conclusion within this period then the combination is deemed to be approved)

S.5 of the Act lays down the transactions which will qualify as combinations for the purposes of the Act. The following is the threshold limit for Mergers and Acquisitions:
• Transactions among Indian companies with combined assets of Rs. 1000 Crores or Rs 3000 Crores in turnover of the merged entity
• Cross-border transactions involving both Indian and foreign companies with combined assets of US $500 million or US $1.5 billion in turnover

• Transactions that have a territorial nexus with India, where the acquirer has US $125 million in assets or US $375 million in turnover in India.

Once any transaction reaches the threshold limit as specified in S.5, the enterprise has to take recourse to the procedure as specified in the Competition Act.

A time to keep our nose to the Grindstone:

Last year, though the growth of the Global Pharmaceutical Industry with a turnover of US$ 752 billion significantly slowed down to just 6.7% due to various contributing factors, the Indian Pharmaceutical Industry continued to maintain a robust of growth of 19% with a turnover of US$ 10.1 billion (IMS October, 2010).

R&D will fuel future growth:

However, on a longer term perspective, the domestic industry growth will be significantly driven by the newer products, which will be the outcome of painstaking innovative research and development initiatives. Keeping this point in mind, the fact that today India accounts less than one per cent of over US$130 billion of the worldwide spending on research and development for pharmaceuticals, despite its known strength in process chemistry and abundant talent pool, has started attracting attention of the government.

Government taking appropriate measures:

It is encouraging to note that the Department of Pharmaceuticals of the Government of India through its ‘Vision 2020’ initiatives is planning to create a new echo-system in the country to promote new drug discovery platforms. This is expected to catapult the country as one of the top five global pharmaceutical hubs, by 2020 attracting additional investments of around US$ 20 billion to the GDP of the country.

Primary role of the industry:

The Primary role of the Research based Pharmaceutical Industry in India, like in many other countries of the world, is to make significant contribution to the healthcare objectives of the nation by meeting the unmet needs of the ailing patients, with innovative medicines. This role can be fulfilled by developing newer medicines through painstaking, time-consuming, risky and expensive basic research initiatives. The research based Pharmaceutical Industry in India is committed to its prime function of discovering and developing new medicines not only for the patients in India but all over the world.

Encouraging innovation will be critical:

Despite immense progress made over the past decades in developing new medicines for numerous acute and chronic illnesses, innovation still remains critically important in the continuous and ever complex battle between disease and good health. Ongoing efforts in Research & Development (R&D) would require a robust national policy environment that would encourage, protect and reward innovation. Improving healthcare environment in partnership with the Government remains a priority for the Research based Pharmaceutical Companies in India, both global and local.

Continuous improvement in ‘Access to Medicines’ is critical:

Therefore, improving access to healthcare in general and medicines in particular should be on the top priority agenda of the policy makers in our country. High incidence of mortality and morbidity burden in a country like ours can only be addressed by improving Access to healthcare through a concerted partnership oriented strategy.

Some concerns still linger:

However, in the new paradigm, which has been designed to foster innovation in the country, there are still some loose knots to be tightened up to achieve the set objectives for the inclusive growth of the nation, in the longer term perspective.

These measures, in turn, will help improving the competitiveness of India vis-à-vis countries like China to attract appreciable investments towards R&D related to pharmaceutical and bio-pharmaceutical products. The Government has already initiated measures to expand the capacity of Indian judiciary and setting- up of fast-track specialized courts that can more effectively enforce Pharmaceutical patents with requisite technical expertise.

Industry should set examples in ‘Good Corporate Governance’ and ‘Global Good Manufacturing Practices’:

Another area of focus should be on corporate good governance. This encompasses adherence to high ethical standards in clinical trials, regulatory and legal compliance, working to prevent corrupt practices, high ethical standard in promotion of medicines and addressing all other issues that support good healthcare policies of the Government. In addition, Pharmaceutical Industry should take active measures to involve all concerned to fight the growing menace of counterfeit and spurious medicines, which significantly affect the lives of the ailing patients, all over the country.

All stakeholders should work in tandem:

It is obvious that the Pharmaceutical Industry alone will have a limited role to address key healthcare issues of our nation, especially when around 400 million Below the Poverty Line (BPL) population will not be able to afford any expenses towards healthcare, at all. All stakeholders like the government, corporate and the civil society in general, must work together according to their respective abilities, obligations and enlightened societal interests to effectively address such pressing issues.

Let us move ahead from ‘Price Control’ to ‘Price Monitoring’:

Despite Medicine Prices in India being one of the lowest in the world, mainly because of stiff competition within the industry and watchful eye of an effective price regulator, 100% of the Pharmaceutical market in the country is currently being price regulated by the Government even with the growth restrictive and ‘draconian’ ‘Third Schedule’ of the DPCO 95.

To enable the Industry to be globally competitive in all aspects of its operations, the government should move ahead from ‘Price Control’ to effective ‘Price monitoring’ mechanism and scrap the growth restrictive measures like, ‘third schedule’ of the current DPCO.

Transaction costs of medicines are too high:

Current transaction costs (all taxes) on medicines in India including trade margins is as high as over 50% of the ex-factory cost of a product.

This cost has been further increased in 2011-12 Union Budget proposal. The government should reduce exorbitantly high transaction costs to make medicines even more economical to the common man.

Conclusion:

I am confident, the entire Pharmaceutical Industry in India would continue to act responsibly with demonstrable commitment to help achieving the healthcare objectives of the nation.

Global players will keep on searching for their suitable targets in the emerging markets like India, just as Indian players are searching for the same in the global markets. This is a process of consolidation in any industry and will continue to take place across the world. Adverse impact of M&A on competition, if any, will now be effectively taken care of by the CCI.

So far as the ‘Financial Reform’ process is concerned, India has always been a slow starter, but it never walked backwards. This tradition, I reckon, will continue in the vibrant democracy of the country, in future too.

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.

Gone 2010…Comes 2011: Looking Back…Looking Ahead at the Healthcare Space of India

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Our country, especially the media and the politicians (perhaps not so much the ‘Aam Aadmi’), appears to be totally engrossed now in uprooting the issue of corruption from the soil of India, once and for all. Politicians of all hues are not showing any sign of respite to let go this opportunity, without squeezing out the last drop of ‘political elixir’, out of the current high level of self-created cynicism. This is very important for them in the run-up to the next general and state elections for ultimate win in the political power-game. The ‘common man’, like you and me, on the contrary, is perhaps thinking about job creation, financial progress, infrastructure development, education and health.

The Fourth Estate of the country, especially the Electronic Media, seems to be lapping up any news, which could even remotely help the TRPs of their respective news channels going north.

In a chaotic situation like this, when even the country’s parliament is defunct, it appears, by and large the entire nation is currently being encouraged to get deeply engaged in ‘self-flagellation’, as it were. There seems to be a desperate need to prove to the world, time and again, how bad the Indians are. The ‘Brand India’ after taking so many powerful blows on its chin, is in tears now.

Be that as it may, has India achieved anything in the year 2010 with a public spend of just around 1% of the GDP towards healthcare? Let me try to capture some of those hard facts, which could appear as a laundry list though, at the very onset of the brand New Year. I have collated these details from various published sources.

Some doomsayers with ever ‘pontifying’ mind-set would nevertheless keep brushing all these aside. However, acknowledging these achievements, I would rather say, “all these are too little even for too few”.

Whatever it is, I am trying to put these details in one place for a comprehensive record of the year, just gone by.

Here it goes:

I. Healthcare Indicators:

I. The number of polio cases has sharply declined during the year. Only 41 polio cases have been reported as on November 30, 2010, against 633 in the corresponding period of 2009.

II. Adult HIV prevalence has declined from 0.41% in 2000 to 0.31% in 2009. The number of new annual HIV infections has declined by more than 50% from 2000 to 2010.(Source: National AIDS Control Organization )

III. Leprosy Prevalence Rate has declined to 0.71/10,000 in March, 2010. 32 State/UTs have achieved elimination by March 2010, leaving only Bihar, Chhattisgarh and Dadra & Nagar Haveli.

IV.TB mortality in has gone down from over 42/lakh population in 1990 to 23/lakh population in 2009 as per the WHO global report 2010. The prevalence of the disease in the country has reduced from 338/lakh population in 1990 to 249/lakh population by the year 2009 (Source: WHO global TB report, 2010).

II. New Initiatives:

  1. A bivalent oral polio vaccine (bOPV) was launched in the country in Bihar on January 9, 2010.
  2. A ‘Sports Injury Centre’ was dedicated to the nation at the Safdarjung Hospital, Delhi, with an inpatient capacity of 35 beds with all modern facilities.
  3. The Indian Pharmacopeia Commission published the 2010 version of Indian Pharmacopeia.
  4. Upgradation of the National Centre for Disease Control (NCDC), Delhi with an estimated cost of Rs 382.41. Crore.
  5. A scheme to support the State Government Medical Colleges for conducting paramedical courses with a total proposed project cost of Rs.1156.43 Crore.
  6. Setting up of 132 Auxiliary Nurse Midwives training schools at an estimated cost of Rs.5.00 Crores per school and 137 General Nursing and Midwifery training schools at an estimated cost of Rs.10.00 Crores per school.
  7. Ministry of Health and Family Welfare and Ministry of Railways signed a memorandum of Understanding for development of healthcare infrastructure along the railway network of the country.
  8. A new ‘National Program for Health Care of the Elderly’ (NPHCE) was approved with an outlay of Rs. 288.00 Crore for 2010-11 & 2011-12.
  9. Urban Slum Health Check-up Scheme for Diabetes and Blood pressure was launched in New Delhi on November 14, 2010. Pilot project is in progress in Bangalore, Hyderabad, Kolkata, Mumbai, Chennai and Ahmedabad.
  10. The revised National Program for Prevention & Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) was approved with a budgetary provision of Rs. 1230.90 Crore
  11. Under Central Government Health Scheme (CGHS), a pilot project of a standalone hemodialysis center has started at Sadiq Nagar CGHS Wellness center in collaboration with M/S Alliance Medicorp (India) Limited, Chennai, under Public Private Partnership (PPP).

III. National Rural Health Mission (NRHM)

  1. Healthcare Infrastructure:

I. New construction and upgradation of 433 District Hospitals, 2921 Community Health Centers (CHCs), 4165 Primary Health Centers (PHCs) and 11856 Health Sub-Centers.

II. 9120 PHCs became functional for 24 hours, as compared to only 1262 in 2005.

  1.                III.  2426 health facilities which include District Hospitals, Sub-District Hospitals and Community Health Centers started functioning as First Referral Units (FRUs) as compared to 955 in 2005.

 

  1.                IV.  1653 Mobile Medical Units are operating in different States providing services in the interior areas.
  2. Human Resource:

I. 2394 Specialists, 8284 MBBS doctors, 9578 AYUSH doctors, 26734 staff nurses, 53552 ANMs and 18272 other Para-medical staff were added to the health system to improve the services.

II. Over 8.33 lakh trained ASHA/community workers were engaged to link the households with the health facility.

 

3.  Healthcare System:

 

I. State and District Health Societies were set up in all the States and Union Territories (UTs).

  1.                               II.  Planning capacity at the district level was strengthened and Integrated District Health Action Plan prepared by 540 districts.

4. Community Engagement:

Effective and efficient decentralized management of health system is being achieved through communalization of facilities, adequate and flexible financing with community accountability, monitoring progress against Indian Public Health Standards, innovations in human resources, together with engagement and building of capacity at all levels.

I. 29904 ‘Rogi Kalyan Samitis’ were registered in the health facilities up to PHC level.

  1.                               II.  4.93 lakh Village Health and Sanitation Committees (VHSCs) were constituted and 4.82 lakh joint accounts at the Village Health and Sanitation Committees and Health Sub-Centers were opened.
  2.                            III.  23.61 million Village Health & Nutrition Days were held at village level over the last three years to provide immunization, maternal and child healthcare and other public health related services at ‘Anganwadi’ centers.

5. Service Delivery:

I. Under the ‘Janani Suraksha Yojana (JSY)’, which is cash transfer scheme to promote institutional delivery, over 100.78 lakh pregnant mothers were covered in 2009-10 as against 7.39 lakh in 2005-06.

  1.                               II.  53500 male health workers were hired for all the Sub Health Centers (SHC) in 235 high focus districts for disease control with a total costs of Rs. 385.52 Crores per year.

6. Family Planning:

  1.                                 I.  Fixed day Fixed Place Family Planning Services round the year through PHCs
  2.                               II.  ‘Santushti’ strategy was implemented through ‘Janasankhya Sthrirata Kosh’, to provide private sector gynecologists and vasectomy surgeons an opportunity to conduct sterilization operations through Public Private Partnership (PPP) initiatives.

7. Disease Control:

  • National Tuberculosis Control Program:

I. Treatment success rates increased from 25% to 87% in 2010.

II. Death rates have declined from 29% to 4% in 2010

III. Treatment success rate is now >85% and new sputum positive (NSP) case detection rate is currently more than the global target of 70%.

  • The National Program for Control of Blindness started providing financial assistance to NGOs for cataract operations and treatment of other eye diseases.
  • 75 districts were added to the National Program for Prevention and Control of Deafness (NPPCD), making it a total of 176 districts of 15 States and 4 UTs. Rs.11.50 Crore has been provided for the current year.
  • Phase–I of ‘Pradhan Mantri Swasthya Suraksha Yojana’ projects commenced with an allocation of Rs 9307.60 Crore.

IV. Healthcare Legislation:

1. The Indian Medical Council (Amendment) Bill 2010 was introduced in the ‘Lok Sabha’ to give effect to amendments to the IMC Act 1956 by which in certain specified situations Government can dissolve the elected Medical Council and replace it, for a period not exceeding one year with a nominated Board of governors.

2. The “National Institute of Mental Health and Neuro Sciences Bangalore Bill, 2010” was introduced in the ‘Rajya Sabha’ to facilitate NIMHANS to develop as an Institute of National Importance on the lines of All India Institute of Medical Sciences, New Delhi,

3. The Clinical Establishments (Registration & Regulation) Bill, 2010 was passed by both Houses of Parliament and notified. The Act aims at providing registration & regulation of clinical establishments in the country with a view to prescribing minimum standards of facilities and services.

V. International Cooperation:

  • A MoU on the Establishment and Operation of Global Disease Detection (GDD) – India Centre, between National Centre for Disease Control, New Delhi and Centre of Disease Control and Prevention, Atlanta, USA, was signed during the recent visit of the US President Mr. Barack Obama in November 2010.
  • India raised the issue of counterfeit medicines and “urged countries to steer clear from the commercially motivated debates over the ‘counterfeit’ issue which have hampered public health by preventing access to good quality and low cost generic drugs”. As a result WHA adopted a resolution establishing a time limited and result oriented working group on substandard / spurious / falsely-labeled / falsified / counterfeit medical products comprised of and open to all Member States.

VI. Health Research:

I. Draft National Health Research Policy prepared during the year, is being debated across the country.

II. Draft Policy for Knowledge Management Policy for Health – services, education and research prepared and debates completed.

III. Based on guidelines for use of assisted reproductive technologies a draft Bill has been prepared.

IV. Guidelines for management of cancers of buccal mucosa, stomach & cervix has been developed.

My wish-list for 2011:

In my view, the following 5 important issues, if addressed effectively in 2011,could make a significant impact on the Healthcare space of India:

1. Announcement of a robust, reform oriented long overdue pharmaceutical ‘Drug Policy’ in India.

2. More budgetary allocation and a transparent delivery system for the National Rural Health Mission (NRHM) and the Rashtriya Bima Yojana (RBY) to improve access to healthcare and ensure inclusive growth in the healthcare sector, covering majority of the population of the country.

  1.               3.  A strong healthcare financing model covering all strata of  society to reduce  the burden of huge ‘out of pocket’ healthcare expenses and make healthcare more accessible and affordable to all.

- The 2010 ‘World Health Report’ of the ‘World Health Organization (WHO)’ “provided governments of various countries with practical guidance on ways to finance healthcare expenses. Taking evidence from all over the world, the report showed how all countries, rich and poor, can adjust their health financing mechanisms so more people get the healthcare they need.” I reckon, policy makers in India will exert enough efforts in 2011 for speedy implementation of such reform oriented healthcare initiatives in the country in its endeavor to fulfill the long overdue promise – ‘health for all.’

4. Progressive policy and fiscal measures to encourage innovation and pharmaceutical R&D within the country

5. Speedy resolution of all Intellectual Property related disputes through ‘Fast Track IP Courts’ to create appropriate innovation oriented ‘Echo System’ in the country.

Conclusion: 

All the achievements of the year just gone by, are good… but are these enough? India in its ‘Healthcare Policy’ statement, way back in mid-1980 promised, ‘health for all’ by the year 2000. We are not there, not just yet.

Though the country is trying hard to achieve the ‘Millennium Development Goals (MDG)’ by 2015, as the situation stands today, it appears a remote possibility, in many areas.

Non-communicable diseases are now posing a major threat to the country, significantly increasing the burden of disease. The World Health Organization (WHO) has cautioned that India would be the ‘diabetic capital’ of the world with a population of around 80 million diabetic patients by 2030. Further, the ‘Cardiological Society of India’ predicts that there would be around 100 million cardiac patients in the country by 2020, which roughly works out to be around 60% of the total cardiac patient population of the world.

Keeping all these in view, the achievements made by the country in the year 2010, though should be taken note of… but the moot question still remains, ‘aren’t all these too little even for too few?’

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.