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Pharma Marketing in India: 10 Chain Events to Catalyze a Paradigm Shift

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In the matured markets of the world pharmaceutical marketing is quite different in many respect as compared to India. Besides doctors, different sets of customer groups like, healthcare providers, patient advocacy groups, pharmacy benefit managers, clinical assessment authorities play various critical roles for use and consumption of branded or generic pharmaceutical products and related healthcare services.

Quite in contrast, even today, individual doctors have continued to remain almost the sole target customers for the pharmaceutical players in India. This is mainly because, by and large, they are the only decision makers for usage of medicines and other healthcare facilities for most of the patients in the country.

Heralding a new paradigm:

As indicated above, though the current pharmaceutical marketing strategies continue to revolve mostly around the doctors, a distinct change, albeit slowly though, is now anticipated within the pharmaceutical marketing space in India.

Gradual emergence of healthcare providers with medical insurance and other related products, patient advocacy groups and standard treatment guidelines, just to name a few, are expected to facilitate heralding a new paradigm in the strategy dynamics of the Indian Pharmaceuticals Market (IPM) in the coming years. These changes will not be incremental in any way, but disruptive and radical in nature, as they will fully evolve.

This process of transformation, mainly driven by Government policy reform measures like, ‘Universal Health Coverage (UHC)’, ‘Free distribution of medicines’, mandatory prescriptions in generic names, could make the current pharmaceutical business strategy models of majority of companies irrelevant and obsolete, in not too distant future.

It is worth noting that the Government will spend around Rs.14,000 Crores (US$ 2.60 billion, approximately) from the year 2014 to 2017 just on medicine purchases at highly negotiated/discounted prices for free distribution to all through Government hospitals and dispensaries.

10 Chain events envisaged: 


In the evolving scenario, following chain events, taking place almost in tandem, in my view, will gradually usher in a new pharmaceutical marketing paradigm in India:

1. In addition to ‘Universal Health Coverage’, there will be a rapid increase in the number of other healthcare providers with innovative, tailor-made and value added schemes for various strata of the society.

2. This will trigger emergence of very powerful groups of negotiators for adopting treatment guidelines, pharmaceutical products usage and other healthcare related services.

3. These groups will have the wherewithal to strongly and significantly influence the doctors in their prescription and other treatment choices.

4. A significant proportion of the products that the pharmaceutical companies will market, a tough price negotiation with the healthcare providers/ medical insurance companies will be inevitable.

5. Consequently, doctors will no longer be the sole decision makers for prescribing drugs and also the way they will treat the common diseases.

6. Pharmaco-economics or Health Technology Assessment (HTA) or outcome based pricing will gradually play an important role in pricing a healthcare products. Drug Price Control Order (DPCO 2013) has already signaled to this direction for a class of products.

7. An integrated approach towards disease prevention will emerge as equally important as treating diseases.

8. A shift from just product marketing to marketing a bundle of value added comprehensive disease management processes along with the product would be the order of the day.

9. More regulatory control measures on pharmaceutical sales and marketing are expected to be put in place by the Government to prevent alleged widespread sales and marketing malpractices in the country.

10. Over the counter (OTC) medicines, especially those originated from natural products to treat common and less serious illnesses, will carve out a sizable share of the market, as appropriate regulations would be put in place, adequately supported by AYUSH. This will be fueled by overall increase in general health awareness of the population.

Trapped in an ‘Archaic Strategy Cocoon’:

Over a long period of time, Indian pharmaceutical industry seems to have trapped itself in a difficult to explain ‘Archaic  Strategy Cocoon’. No holds bar sales promotion activities, with very little of marketing, continue to dominate the ball game of hitting the month-end numbers, even today.

It is high time to come out of this cocoon and confront the ‘writing on the wall’ upfront, if not try to hasten the process of the evolving changes, boldly and squarely. This will require a strategic long term vision to be implemented in an orderly way to effectively convert all these challenges into possible high growth business opportunities.

A differentiated composite value delivery system:

Moreover, in today’s post product patent regime in the country, product pipelines of the domestic Indian companies with new ‘copycat’ versions of patented products have almost dwindled into nothing, making price competition in the market place even more ‘cut throat’.

In such type of changing environment, all pharmaceutical companies will be under tremendous pressure to create and deliver additional, well differentiated and composite value offerings, beyond physical products, to attract more patients, doctors, healthcare providers and others, in and around related disease areas, for business excellence.

Thus, ability to create and effectively deliver well-differentiated composite value offerings, along with the physical products, will separate men from the boys in the high growth pharmaceutical market of India, in the long run.

This could also possibly create an ‘Alibaba Effect’ for the successful ones in search of pots of gold in the pharmaceutical space of India.

New leadership and managerial skill set requirements:

In the new environment, required skill sets for both the leaders and the managers of Indian pharmaceutical companies will be quite different from what they are today. This will not happen overnight though, but surely will unfold gradually.

New skills:

Leaders and managers with knowledge in just one functional area like, R&D, manufacturing, marketing, regulatory, finance are unlikely to be successful without a broad-based knowledge in the new paradigm. To really understand and handle new types and groups of customers, they will need to break the operational silos and be proficient in other key areas of business too.

These professionals will require ensuring:

• Multi-functional expertise by rotating right people across the key functional areas, as far as possible, even with a stretch.

• Ability to fathom and correctly interpret patients’ clinical benefits against cost incurred to achieve the targeted clinical outcomes, especially in areas of new products.

• Insight into the trend of thought pattern of healthcare providers and other customers or influencers groups.

• Speed in decision-making and delivery…more importantly ability to take ‘first time right’ decisions, which can make or mar an important initiative or a commercial deal.

IPM growing fast, can grow even faster: 

India is now one of fastest growing emerging pharmaceutical markets of the world with 3rd global ranking in the volume of production and 13th in value terms. Domestic turnover of the industry is over US$ 13.1 billion in 2012 (IMS) representing around 1 percent of the global pharmaceutical industry turnover of US$ 956 billion (IMS 2011).

Since 1970, Indian pharmaceutical Industry has rapidly evolved from almost a non-entity to meeting around 20 percent of the global requirements of high quality and low cost generic medicines.

Financial reforms in the health insurance sector and more public investments (2.5% of the GDP) in the healthcare space during the 12th Five Year Plan Period will have significant catalytic effect to further boost the growth of the industry.

Stringent regulations and guidelines of the Government in various areas of pharmaceutical business in India are expected to be in place soon. Ability to ensure system-based rigid organizational compliance to those changing business demands in a sustainable way. will determine the degree of success for the pharma players in India.

One such area, out of many others, is the professional interaction of the Medical Representatives with the doctors and other customer groups.

Require a ‘National Regulatory Standard’ for Medical Representatives in India:

Medical Representatives (MRs) currently form the bedrock of business success, especially for the pharmaceutical industry in India. The Job of MRs is a tough and high voltage one, laced with moments of both elation and frustration, while generating prescription demand for selected products in an assigned business territory.

Though educational qualifications, relevant product and disease knowledge, professional conduct and ethical standards vary widely among them, they are usually friendly, mostly wearing a smile even while working in an environment of long and flexible working hours.

There is a huge challenge in India to strike a right balance between the level and quality of sales pitch generated for a brand by the MRs, at times even without being armed with required scientific knowledge and following professional conduct/ ethical standards, while doing their job.

Straying from the right course:

A recent media report highlighted that ‘Indian subsidiary of a Swiss pharma major has run into trouble with some executives allegedly found to be inflating and presenting fabricated sales data for an anti-diabetic drug.’

The report also indicated that officials from mid-management ranks to sales representatives were allegedly involved in those unethical practices. The company has responded to this incidence by saying that the matter is still under investigation.

It is critical for the MRs not just to understand scientific details of the products, their mode of action in disease conditions, precautions and side effects, but also to have a thorough training on how to ‘walk the line’, in order to be fair to the job and be successful.

As MRs are not just salesmen, they must always be properly educated in their respective fields and given opportunities to constantly hone their knowledge and skills to remain competitive. The role of MRs is expected to remain important even in the changing scenario, though with additional specialized skill sets.

Unfortunately, India still does not have a ‘National Code of Conduct or Regulatory Standards’ applicable to the MRs.

Only the clause 4 of ‘The Magic Remedies (Objectionable Advertisement) Act, 1954’ deals with misleading advertisements. It is about time to formulate not only a ‘National Code on Pharmaceutical Marketing Practices’, but also a mandatory ‘Accreditation program’ and transparent qualifying criteria for the MRs for the entire pharmaceutical industry in India, just like many other countries of the world.

‘Central Drugs Standard Control Organization (CDSCO)’ of the Ministry of Health and Family Welfare of the Government of India in its website lists the “Laws Pertaining to Manufacture and Sale of Drugs in India”. However, it does not specify any regulation for the MRs nor does it recommend any standard of qualification and training for them, which is so critical for all concerned.

There are currently no comprehensive national standards for educational qualification, knowledge, ethics and professional conduct for the MRs. In the absence of all these, it is difficult to fathom, whether they are receiving right and uniform inputs to appropriately interact with the medical profession and others in a manner that will benefit the patients and at the same remain within the boundary of professional ethics and conduct.

Thus, a ‘National Regulatory Standard’ for MRs, I reckon, is absolutely necessary in India… sooner the better.

Global pharmaceutical players:

Facing a huge patent cliff, global pharmaceutical companies are now fast gaining expertise in the ball game of generic pharmaceuticals, especially in the developing markets of the world.

In the emerging markets like India, where branded generic business dominates, global pharmaceutical players seem to be increasingly finding it lucrative enough for a sustainable all round business growth.

However, to outpace competition, they too will need to capture the changing dynamics of the market and strategize accordingly without moaning much about the business environment in the country.

On the other hand, if majority of Indian pharmaceutical companies, who are not yet used to handling such changes, are caught unaware of this evolving scenario, the tsunami of changes, as they will come, could spell a commercial disaster, endangering even very survival of their business.

Managing transition:

During ensuing phase of transition in India, pharmaceutical companies would require to:

• Clearly identify, acquire and continuously hone the new skill sets to effectively manage the evolving challenge of change.

• Get engaged, having clarity in the strategic content and intent, with the existing public/private healthcare providers and health insurance companies like, Mediclaim, ICICI Lombard, large corporate hospital chains, retail chain chemists and others, proactively.

• Drive the change, instead of waiting for the change to take place.

• Ensure that appropriate balance is maintained between different types of marketing strategies with innovative ways and means.

Conclusion:

It may not be easy for the local Indian players to adapt to the new paradigm sooner and compete with the global players on equal footing, even in the branded generic space, with strategies not innovative enough and lacking required cutting edges.

In my view, those Indian Pharmaceutical companies, who are already global players in their own rights and relatively well versed with the nuances of this new ball game in other markets, will have a significant competitive edge over most other domestic players.

If it happens, the global-local companies will offer a tough competition to the local-global players, especially, in the branded generic space with greater cost efficiency.

So far as other domestic players are concerned, the fast changing environment could throw a new challenge to many, accelerating the consolidation process further within the Indian pharmaceutical industry.

As the new paradigm will herald, catalyzed by the above 10 chain events, there will be a metamorphosis in the way pharmaceutical marketing is practiced in India. A well-differentiated composite value delivery system would then, in all probability, be the name of the winning game.

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.

 

Does the Landmark Glivec Judgment Discourage Innovation in India?

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No, I do not think so. The 112 pages well articulated judgment of the Supreme Court of India delivered on April 1, 2013, does not even remotely discourage innovation in India, including much talked about ‘incremental innovation’. This landmark judgment reconfirms the rules of the game for pharmaceutical innovation, as captured in the Indian Patents Act 2005.

When one reads the judgment, point 191 in page number 95 very clearly states as follows:

“191. We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment.”

Thus all ‘incremental innovations’, which some people always paint with a general broad brush of ‘evergreening’, should no longer be a taboo in India. The judgment just says that Glivec is not patentable as per Section 3(d) of Indian Patents Act based on the data provided and arguments of Novartis.

To me, the judgment does also not signal that no more Glivec like case will come to the Supreme Court in future. It vindicated inclusion of Section 3(d) in the amended Indian Patents Act 2005.

It is interesting to note that honorable Supreme Court itself used the terminology of ‘incremental innovation’ for such cases.

That said, I find it extremely complex to imagine what would have happened, if the judgment had gone the opposite way.

A critical point to ponder:

The judgment will also mean that all those products, having valid product patents abroad, if fail to meet the requirements of Section 3(d), will not be patentable in India, enabling introduction of their generic equivalents much sooner in the country and at the same time causing a nightmarish situation for their innovators.

However, this again, in no way, is an outcome of this judgement or a new development, as stated above. It is just vindication of the intent behind inclusion of Section 3(d) in the amended Indian Patents Act, when it was enacted by the Parliament of India in 2005.

Patentability of ‘Incremental Innovations’ in India:

Patentability criteria for any ‘incremental innovations’ has been defined in the Section 3(d) of the Indian statute as follows:

“The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”

Supreme Court interpretation of the term “Efficacy” in Section 3(d): 

The Honorable Supreme Court in page 90 of its above order under point 180 stated that in case of medicines, efficacy can only be “therapeutic efficacy”, which must be judged strictly and narrowly. The interpretation goes as follows:

180. “What is “efficacy”? Efficacy means ‘the ability to produce a desired or intended result’. Hence, the test of efficacy in the context of section 3(d) would be different, depending upon the result the product under consideration is desired or intended to produce. In other words, the test of efficacy would depend upon the function, utility or the purpose of the product under consideration. Therefore, in the case of a medicine that claims to cure a disease, the test of efficacy can only be “therapeutic efficacy”.

The Honorable Court under the same point 180 further elaborated:

“With regard to the genesis of section 3(d), and more particularly the circumstances in which section 3(d) was amended to make it even more constrictive than before, we have no doubt that the “therapeutic efficacy” of a medicine must be judged strictly and narrowly…Further, the explanation requires the derivative to ‘differ significantly in properties with regard to efficacy’. What is evident, therefore, is that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of medicine, as seen above, is its therapeutic efficacy.” 

Based on this interpretation of Section 3(d), the Honorable Supreme Court of India ordered that Glivec does not fulfill the required criteria of the statute.

The rationale behind Section 3(d):

A report on ‘Patentability of the incremental innovation’ indicates that the policy makers keeping the following points in mind formulated the Indian Patents Act 2005:

  • The strict standards of patentability as envisaged by TRIPS pose a challenge to India’s pharmaceutical industry, whose success depended on the ability to produce generic drugs at much cheaper prices than their patented equivalents.
  • A stringent patent system would severely curtail access to expensive life saving drugs to a large number of populations in India.
  • Grant of a product patents should be restricted only to “genuine innovations” and those “incremental innovations” on existing medicines, which will be able to demonstrate significantly increased efficacy over the original drug.

IPA challenges: 86 pharmaceutical patents granted by IPO fall under Section 3(d):

A study by the ‘Indian Pharmaceutical Alliance (IPA)’ indicates that 86 pharmaceutical patents granted by the IPO post 2005 are not breakthrough inventions but only minor variations of existing pharmaceutical products and demanded re-examination of them.

Possible implications to IPA challenge:

If the argument, as expressed above in the IPA study, is true by any stretch of imagination, in that case, there exists a theoretical possibility of at least 86 already granted product patents to get revoked. This will invite again another nightmarish situation for innovators.

Examples of revocation of patents in India:

On November 26, 2012, the Intellectual Property Appellate Board (IPAB) reportedly denied patent protection for AstraZeneca’s anti-cancer drug Gefitinib on the ground that the molecule lacked invention.

The report also states that AstraZeneca suffered its first setback on Gefitinib in June 2006, when the Indian generic company Natco Pharma opposed the initial patent application filed by the global major in a pre-grant opposition. Later on, another local company, GM Pharma, joined Natco in November 2006.

After accepting the pre-grant opposition by the two Indian companies, the Indian Patent office (IPO) in March 2007 rejected the patent application for Gefitinib citing ‘known prior use’ of the drug. AstraZeneca contested the order through a review petition, which was dismissed in May 2011.

Prior to this, on November 2, 2012 the IPAB revoked the patent of Pegasys (Peginterferon alfa-2a) – the hepatitis C drug of the global pharmaceutical giant Roche.

Though Roche was granted a patent for Pegasys by the Indian Patent Office (IPO) in 2006, this was subsequently contested by a post-grant challenge by the large Indian pharma player – Wockhardt and the NGO Sankalp Rehabilitation Trust (SRT) on the ground that Pegasys is neither a “novel” product nor did it demonstrate ‘inventiveness’, as required by Section 3(d) of Patents Act of India 2005.

It is worth noting, although the IPO had rejected the patent challenges by Wockhardt and SRT in 2009, IPAB reversed IPO’s decision revoking the patent of Pegasys.

Similarly the patent for liver and kidney cancer drug of Pfizer – Sutent (Sunitinib) granted by IPO in 2007, was revoked by the IPAB in October, 2012 after a post grant challenge by Cipla and Natco Pharma on the ground that the claimed ‘invention’ does not involve inventive steps.

Patent challenges under section 3(d) may come up even more frequently in future:

Some observers in this field have expressed, although ‘public health interest’ is the primary objective for having Section 3(d) in the Indian Patents Act 2005, many generic companies, both local and global, have already started exploiting this provision as a part of their ‘business strategy’ to improve business performance in India, especially when an  injunction is usually not being granted by the honorable Courts for such cases on public health interest ground.

Thus, as stated above, there is likely to be many more cases like, Glivec coming before the Supreme Court in the years ahead.

Another related development of the last week:

It has been reported that American pharma major MSD has last week filed a suit in the Delhi High Court against Indian pharma major – Glenmark for alleged patent violation of its leading anti-diabetic drugs Januvia and Janumet. In this case also no interim injunction has reportedly been granted to MSD by the Honorable Delhi High Court.

Glenmark has stated through a media report, “It is a responsible company and has launched the products after due diligence and research.” The company has also announced that their version of the molecule named Zita and Zita Met will be available to patients at a 20 percent discount to MSD’s price.

Hence, once again, the Indian court to decide, the balance of justice would now point to which direction.

Government has no role to play – patent challenge is a legal process across the world:

The proponents of ‘no change required in the Section 3(d)’ argue, ‘Patent Challenge’ is a legal process all over the world, the Government has hardly got any role to play in settling such disputes. The law should be allowed to take its own course for all disputes related to the Patents Act of the country, including Section 3(d).

They also opine that India must be allowed to follow the law of justice without casting aspersions on the knowledge and biases of the Indian judiciary for vested interests.

That said, there is certainly an urgent need to add speed to this legal process by setting up ‘Fast-track Courts’ for resolving all Intellectual Property (IP) related disputes in a time bound manner.

Arguments against Section 3(d):

Opposition to the Section 3(d) counter-argues by saying, this is a critical period for India to help fostering an appropriate ecosystem for innovation in the country. This group emphasizes, “Providing the right incentives for incremental pharmaceutical innovation can move India forward on this path and encourage the development of drug products that meet the needs of Indian patients. Reforming Section 3(d) to encourage and protect incremental pharmaceutical innovation would create such incentives and help India become a true powerhouse of innovation.”

Another group says that the main reason in favor of Section 3(d) being the provision will prevent grant of frivolous patents, the ultimate fallout of which will result in limited access to these drugs due to high price, is rather irrelevant today. This, they point out, is mainly because the Government is now actively mulling a structured mechanism of price negotiation for all patented drugs to improve their access to patients in India.

Importance of ‘Incremental Innovation’ in India:

Incremental innovations are indeed very important for the country and have been benefiting the patients immensely over decades, across the world.

A report titled, “The Value Of Incremental Pharmaceutical Innovation” highlighted as follows:

  • As per the National Knowledge Commission, while 37.3% of Indian companies introduced breakthrough innovations in recent years, no fewer than 76.4% introduced incremental innovations.
  • 60 percent of the drugs on the World health Organization’s essential Drug list reflect incremental improvements over older drugs.

The report indicates some of the benefits of ‘Incremental Pharmaceutical Innovation’ for India as follows:

  1. Improved quality of drug products, including products that are better suited to India’s climate.
  2. Development of treatments for diseases that are prevalent in India for which new drug discovery is currently limited or otherwise inadequate.
  3. Increasing likelihood that for every therapeutic class, there is a treatment to which an Indian patient will respond.
  4. Development of the R&D capacity and expertise
 of Indian pharmaceutical companies.
  5. Reduction of healthcare and other social costs in India through improved drug quality and selection.
  6. Increased access to medicine as a result of price competition.

The study concluded by saying that Section 3(d) potentially precludes the patenting of hundreds of incremental pharmaceutical innovations that Indian companies are attempting to patent and commercialize outside India.

There are umpteen numbers of examples that can ably demonstrate, ‘incremental innovation’ of the pharmaceutical innovators help significantly improving the efficacy and safety of existing drugs. All such innovations should in no way be considered “frivolous” as they have very substantial and positive impact in improving conditions of the ailing patients.

Be that as it may, the Supreme Court judgment has categorically mentioned that all ‘Incremental innovations’ should conform to the requirement of the Section 3(d) of the statute.

“West should learn from India’s high patent standards”

An article appeared just yesterday written by a well-regarded Indian economist recommended, “West should learn from India’s high patent standards”. It observed that    over-liberal patent system of the West is now broken and it should learn from India’s much tougher patent system.

Patent monopolies needs to be given only for genuine innovations, as defined in the Indian Patents Act 2005, where the public benefits clearly exceed the monopoly cost.

The author concluded by saying, “This means setting a high bar for innovation. High standards are desirable for patents, as for everything else.”

View of the Glivec inventor: 

In another interview titled, “If you erode patents, where will innovations come from?” Dr Brian Druker, whose work resulted in the development of Glivec, re-emphasizing the need for R&D by the pharmaceutical industry, commented,  “I’m going to stay away from the legal judgment … but as a physician, I do recognize that the advances will come from new products, not modifications.”

Are discordant voices out of step with time?

The interpretation of the Section 3(d) of the statute by the Honorable Supreme Court of India is the last word for all, despite a few voices of discord from within and mostly outside India. These voices, many would reckon, could well be out of step with time, especially in relatively fast growing, modern, independent, thinking and assertive young  India.

Conclusion:

In my view, nothing materially has changed on the ground before and after the Supreme Court judgment on the Glivec case so far as the Indian Patents Act is concerned and also in its interpretation.

While encouraging all types of innovations, including incremental ones and protecting them with an effective IPR regime are very important for any country. No nation can afford to just wish away various socioeconomic expectations, demands and requirements not just of the poor, but also of the growing middle class intelligentsia, as gradually getting unfolded in many parts of the globe.

Available indicators do point out that the civil society would continue to expect in return, just, fair, responsible and reasonably affordable prices for the innovative medicines, based on the overall socioeconomic status of the local population.

This critical balancing factor is essential not only for the progress of the pharmaceutical industry, but also to alleviate sufferings of the ailing population of the country, effectively.

For arguments sake, in an ideal scenario, if the Central and State Governments in India decide to buy such drugs to supply to all patients free of cost, just like any ‘welfare state’, will even the Government be able to afford these prices and fund such schemes in India?

It is, therefore, now widely expected that innovator pharmaceutical companies, which play a pivotal role in keeping population of any nation healthy and disease free to the extent possible, should also proactively find out ways to help resolving this critical issue in India, working closely with the Government of 1.2 billion Indians, including other concerned stakeholders.

In that context, the landmark Supreme Court judgment on the Glivec case has vindicated the need of striking a right balance between encouraging and protecting innovation, including incremental ones and the public health interest of India.

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.

A National Regulatory Standard is necessary for MRs of the Indian Pharmaceutical Industry

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Medical Representatives (MR) form the bedrock of business success, especially for the pharmaceutical industry in India. The Job of MRs is tough and high voltage one, laced with moments of elation and sprinkles of frustration, while generating prescription demand for selected products in an assigned business territory. Though educational qualifications, relevant product and disease knowledge, professional conduct and ethical standards vary widely among them, they are usually friendly, mostly wearing a smile even while working in an environment of long and flexible working hours.

Currently, there is a huge challenge in India to strike a right balance between the level and quality of sales pitch generated for a brand by the MRs, at times even without being armed with required scientific knowledge and following professional conduct/ ethical standards, while doing their job.

It is critical for the MRs to understand scientific details of the products, its mode of action in a disease condition, precautions and side-effects in order to be fair to the job and be successful. As MRs are not just salesmen, they must always be properly educated in their respective fields and constantly hone their knowledge and skills to remain competitive.

A qualitative study:

Indian J Med Ethics, 2007 Apr-June; 4(2) reported a qualitative study to determine a wide range of pharmaceutical promotional practices by the MRs influencing prescription of medicines in Mumbai. The study highlighted:

“An unholy alliance: Manufacturers, chemists and doctors conspire to make profits at the expense of consumers and public health, even as they negotiate with each other on their respective shares of profits”.

The paper identified misleading information, incentives and unethical trade practices as methods to increase the prescription and sale of drugs. It reported, besides other points that MRs provide incomplete medical information to influence prescribing practices.

‘Code of Pharmaceutical Marketing Practices’ is necessary, but just not enough:

Gift-giving, ethical vs. unethical promotion, transparency and self-regulation appear to be the main issues in the pharmaceutical industry right across the globe. Owing to inadequate national legislation and the lack of universally accepted self-regulatory codes, the pharmaceutical industry in India has yet to tackle the problem of alleged “Unethical drug marketing practices”.

After a protracted debate on this subject by the pharmaceutical companies, in May 2011, the Department of Pharmaceuticals (DoP) came out with a draft ‘Uniform Code of Pharmaceutical Marketing Practices (UCMP)’ to address this issue squarely and effectively in India.

This decision of the government is the culmination of a series of events, covered widely by the various sections of the media, since 2004. Be that as it may, the UCMP, in my view, is just not enough to address the issue of alleged, “Unethical drug marketing practices” holistically.

A mandatory ‘accreditation/certification’ program for MRs is the need of the hour:

Countries like United Kingdom (UK) and Australia with much longer experience of dealing with pharmaceutical industry than India, have appropriate mechanisms, safeguards and legislation in place to deal with the pharmaceutical marketing practices. Even the pharmaceutical industry in the UK and Australia have controlling authorities with comprehensive standards in place to deal with proper education, professional conducts and ethics for the MRs. Similar mandatory ‘accreditation/certification’ program for MRs, in my view, is also necessary in India without any further delay.

India should learn from others to work out a robust process:

Even with such systems and regulations in place, both in the UK and Australia, some ethical issues still remain unresolved. In Australia the largest consumer organization highlights, “that it is a conflict of interest for the Code to be administered by the industry peak body.” and “it is also concerned that the sanctions available in the Code do little to prevent breaches”. United Kingdom is no exception in this regard.

Other markets are fast catching up:

Very recently in Turkey, Turkish Ministry of Health published a new pharmaceutical promotion regulation, which specifies for the first time a certification obligation for the MRs.

In Philippines, ‘MR Accreditation Program (MRAP)’ started about 8 to10 years ago. MRAP is administered by the Pharmaceutical and Healthcare Association of Philippines. The certifying examination is accredited by the Professional Regulation Commission (PRC) under its Board of Pharmacy of the Government of Philippines.

In Japan there is a certification program for the MR since 1997, which is administered by the MR Education and Accreditation Center of Japan, a public service corporation. One has to receive over 450 hours education and training in Japan to be qualified for the examination. Even after being qualified in the certification examination, at least 50 hours of continuing education is required every year to keep the certification updated that expires after 5 years.

In Germany, under German law and practice, MRs have either the status of “pharma advisors” (“Pharmaberater”) as specified in German Drugs Act or they have to pass the examination for certified MRs (“Pharmareferent”), which is accessible online.

“Pharma Advisors” have science background as a pharmacist, chemist, physician, veterinarian etc. whereas other MRs are required to obtain scientific and medicinal knowledge through suitable education and training program, which will lead to an examination for certification by the German authorities. All MRs are required to start the program within 6 months of employment in the industry and complete the five modules within 2 years.

In Canada ‘the Code of Ethical Practices’ requires the MRs to complete an accreditation course offered by the Council for Continuing Pharmaceutical Education within two years of commencing their employment.

In USA, there is no official MR certification program.

In Hungary, the MR certification program is administered officially by the Health Authority of the country.

In Indonesia, this is administered officially by the state/ governmental bodies or by the industry through an outside consulting organization, which issues certificates after successful completion of the examination.

In Argentina, MR Certification Program is required by the law of the land. In order to include the name in the ‘Registry of MR’, a qualifying degree as medical sales representative, issued by a tertiary educational institution and/or officially acknowledged training institutions, is essential.

In South Africa, they have certification only for marketing code training, which is administered by an independent Marketing Code Authority.

In Sweden, this course is administered by an external course organizer on behalf of LIF Sweden.

However, Swedish companies nowadays prefer to employ pharmacists, who do not need to take the examination.

A National regulatory standard for MRs is necessary in India:

India is now one of fastest growing emerging pharmaceutical markets of the world with 3rd global ranking in volume of production and 13th in value terms. Domestic turnover of the industry is around US$ 12.1 billion in June 2011 (IMS) representing just over 1% of the global pharmaceutical industry turnover of US$ 850 billion (IMS). Since 1970, Indian pharmaceutical Industry has rapidly evolved from almost a non-entity to meeting around 20% of the global requirements for high quality and low cost generic medicines.

Unfortunately, despite a fast evolving scenario, appropriate regulations in various areas of the industry in India have not been worked out, as yet, to derive the best mileage out of this scorching pace of growth of the industry. India still does not have a national code of conduct or regulatory standards applicable to MRs.

Only the clause 4 of ‘The Magic Remedies (Objectionable Advertisement) Act, 1954’ deals with misleading advertisements. It is about time to formulate not just a national code on pharmaceutical marketing practices, but also a mandatory accreditation program and qualifying criteria for the MRs for entire pharmaceutical industry in India, like many other countries of the world.

Central Drugs Standard Control Organization (CDSCO) of the Ministry of Health and Family Welfare of the Government of India in its website lists the “Laws Pertaining to Manufacture and Sale of Drugs in India”. However, it does not specify any regulation for the MRs nor does it recommend any standard of qualification and training for them, which is so critical for all concerned.

Conclusion:

In the above scenario, the moot question is without any comprehensive and formalized uniform national standards of educational qualification, knowledge, ethics and professional conduct being in place for the MRs, are they getting right uniform inputs, across the board, to appropriately interact with the medical profession in a manner that will benefit the patients and at the same remain within the boundary of professional conduct and medical ethics?

Thus, a National regulatory standard for MRs, I reckon, is absolutely necessary in India… sooner the better.

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.

NRHM of India: Yet to ‘Tick all the Right Boxes’

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‘National Rural Health Mission (NRHM)’, one of the largest and a very ambitious healthcare initiative for the rural population of India, was launched by the Government of India on April 12, 2005.

The primary purpose of NRHM, as announced by the Government, was to ensure universal access to affordable and quality healthcare for the rural poor of 18 states of India, namely, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Himachal Pradesh, Jharkhand, Jammu and Kashmir, Manipur, Mizoram, Meghalaya, Madhya Pradesh, Nagaland, Orissa, Rajasthan, Sikkim, Tripura, Uttarakhand and Uttar Pradesh, to start with.
During the launch of NRHM, the then Health Minister of India announced that the nation would see the results of these efforts in three years’ time.

The key objectives of NRHM:

• Decrease the infant and maternal mortality rate • Provide access to public health services for every citizen • Prevent and control communicable and non-communicable diseases • Control population as well as ensure gender and demographic balance • Encourage a healthy lifestyle and alternative systems of medicine through AYUSH

As announced by the government NRHM envisages achieving its objective by strengthening “Panchayati Raj Institutions” and promoting access to improved healthcare through the “Accredited Social Health Activist” (ASHA). It also plans on strengthening existing Primary Health Centers, Community Health Centers and District Health Missions, in addition to making maximum use of Non-Governmental Organizations.

NRHM was to improve access to healthcare by 20 to 25% in 3 years’ time:
To many the National Rural Health Mission (NRHM) has made a significant difference to the rural health care system in India. It now appears that many more state governments are envisaging to come out with innovative ideas to attract and retain public healthcare professionals in rural areas.
On January 11, 2010, the Health Minister of India Mr. Ghulam Nabi Azad, while inaugurating the FDA headquarters of the Western Zone located in Mumbai, clearly articulated that the NRHM initiative will help improving access to affordable healthcare and modern medicines by around 20 to 25 percent during the next three years. This means that during this period access to modern medicines will increase from the current 35 percent to 60 percent of the population.
If this good intention of the minister ultimately gets translated into reality, India will make tremendous progress in the space of healthcare, confirming the remarks made by Professor Sir Andrew Haines, Director, London School of Hygiene and Tropical Medicine, as quoted above.

The Achievements:

More than five years are over now. Let us have a look at the key achievements of this ambitious health scheme as on January 2010, as available from the Ministry of Health:

  • 71.6% (10.86 million) institutional deliveries across India as compared to only 41%
  • 78.8% (19.82 million) children across the country fully immunized
  • A total of 23,458 primary health centers (PHC) have been set up against NRHM goals of 27,000 during the same period.
  • 5,907 community health centers were upgraded against 7,000 as was planned under the NRHM.
  • 462,000 Associated Social Health Activists were trained
  • 177,924 villages have sanitation committees functional
  • 323 district hospitals have been taken for up gradation

Free Care to Mothers and Children: A new initiative

In the recent publication of the Ministry of Health and Family Welfare (MoHFW) titled, ‘Two years (2009-2011): Achievements & New Initiatives’, the ministry has highlighted another commendable initiative to provide free care to the mothers and children, which includes as follows:

Provision of free drugs,

  • Free Consumables and Diagnostics,
  • Free Diet during stay and
  • Free transport to health facility and drop back home. 

Still to ‘Tick all the Right Boxes’:

Despite all these, a recent study done by ‘Chronic Care Foundation’ indicates that in India about 86% of highly populated rural districts still do not have provisions for basic diagnostic tests for chronic ailments.

The study also highlights that in rural areas, as a percentage of total healthcare expenses, out of pocket costs are more than the urban areas, with hospitalization expenses contributing the most to the total costs. In many rural areas the healthcare costs have been reported to be as high as around 80% of the total expenses. Such a high out of pocket expenses have mainly been attributed to the lack of facilities in these rural areas, requiring patients to travel to distant areas for medical treatment. It was also reported that even in rural areas due to inefficient and inadequate services at the Government healthcare units there has been a very high dependence on more expensive private healthcare facilities.

Obvious questions:

Thus even after over five years from the inception of NRHM, the current status of rural public healthcare system, poses the following obvious questions:
• How is the huge money allocated for NRHM being utilized? • Who all are accountable for the current state of affairs of this great scheme?
Even our Prime Minister Mr. Manmohan Singh has admitted recently that “the shortage of human resources was becoming an impediment in strengthening the public health delivery system through the National Rural Health Mission (NRHM)”.

Economic Survey 2010 did raise a flag:

The Economic Survey 2010 highlighted that ‘several glitches in the flagship NRHM needed to be ironed out to improve health infrastructure’, some of these are the following:

  • Shortage of over 6,800 more hospitals in rural areas to provide basic health facilities to people
  • Shortage of 4,477 primary healthcare centers and 2,337 community healthcare centers as per the 2001 population norms.
  • Almost 29% of the existing health infrastructure is in rented buildings.
  • Poor upkeep and maintenance, and high absenteeism of manpower in the rural areas are the main problems in the health delivery system.
  • Basic facilities are still absent in many Primary Health Centers (PHCs) and Community Health Centers (CHCs) to provide guaranteed services such as in-patient care, operation theatres, labor rooms, pathological tests, X-ray facilities and emergency care.

The Economic Survey further highlighted that “An assessment of the health related indicators would suggest that significant gains have been made over the years. However, India fares poorly in most of the indicators in comparison to the developing countries like China and Sri Lanka. The progress in health has been quite uneven, across regions, gender, as well as space.”

It now appears that this great initiative of the government of India called the NRHM, has made, if at all, only marginal impact on the healthcare needs and systems of the nation.

Leveraging capacity of the Private Healthcare sector is critical:

Though the private sector contributes over 70% in healthcare space, unfortunately NRHM has not yet been successful to leverage this key strength.  Participation of the private healthcare players through Public Private Partnership (PPP) initiatives could be one of the key determinants of success of NRHM of India. Electronic Media outreach program, though quite sporadic, has started creating some awareness about this project within the general population.

Role of the State Governments:

In the federal governance structure of India, health being a state subject, respective state governments should play more creative and proactive role with requisite allocation of fund, freedom of operation and accountability to make NRHM successful across the country.

Who will bell the cat?

To make NRHM deliver desired results the Government should at the very outset significantly increase in health expenditure to around 3% to 5% of GDP and simultaneously outline, decide and announce the key measurable success parameters for performance evaluation of the scheme. This is to be done by uploading for public scrutiny in the respective Health Ministry websites of both the Central and State Governments the names and designations of the responsible senior Government officials who will be held accountable for the success or failure to deliver the deliverables for NRHM. All these details should be updated at least half yearly.

With tax-payers money being utilized for this important and critical public health arena, no non-performance should escape attention and go unpunished.
Moreover, with the help of experts, the Government should decide which elements of each identified success parameters the Government will be able to deliver better with its own internal resources and what are those areas where the Government should outsource from the private players.
Such an approach when worked out in great details will be able to ensure whether through NHRM the country is making progress to improve access to affordable and quality healthcare for a vast majority of its rural population. Otherwise this scheme may well be treated just as one of those which failed to deliver and over a period of time vanished in the oblivion.

Conclusion:

Thus, in my view, despite publication of all the details done for NRHM by the MoHFW in its latest publication titled, ‘‘Two years (2009-2011): Achievements & New Initiatives’ and witnessing some sporadic flashes of brilliance here or there, I reckon, the overall implementation of this excellent healthcare project called NRHM has failed to tick many of the important boxes as was eagerly expected by the common man of India.

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.

Hype on “Superbug” – national pride – rational mind

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Since around last fortnight Indian media of all types and forms, have been fiercely competing with each other to attract the ‘eye balls’ of the viewer/readers through ‘alarming’ news items starting from the situation in the J&K to the ‘rampant corruption’ involving the Commonwealth Games, with of course their usual (over)dose of sensationalism.

In a situation like this to prove ‘enough is JUST NOT enough’, as it were, on August 11, 2010, the well-known medical journal of repute “The Lancet” published a routine article, which further added to the ‘media sensationalism’ in India. The report highlighted that a new ALL antibiotics-resistant “Superbug” originating from Pakistan, appears to have taken its first life. This happened when a patient who was brought to a hospital in Belgium and died in June this year after having met with a car accident in Pakistan, where the diseased was infected by this ‘Superbug”.

This article in ‘The Lancet’ written by a team of international researchers including an Indian, elaborated that a new variety of enzyme named after India’s national capital New Delhi, called, “New Delhi Metallo beta lactamase” in short “NDM 1” turns any bacteria into a deadly “Superbug”, making it resistant to ALL types of antibiotics, leaving virtually no cure in sight.

It was also reported that this deadly “Superbug” has already reached the United Kingdom through patients who acquired it from the hospitals in India. The article reported that the deadly “Superbug” originated from the hospitals of Pakistan and India has the potential to precipitate serious health issues across the world.

“The New Delhi Superbug” was discovered even earlier:

This report generated a sharp reaction in India and from some of its authors regarding its authenticity. Some experts even termed this study as the ‘Western plot to undermine medical tourism in India’.

A leading daily of India reported, “Indian medical journal first documented Superbug”. It stated that that the first ever formal documentation of this ‘Superbug’ was made last year at the P.D. Hinduja National Hospital and Medical Research Centre located in Mumbai. This finding was published in the ‘Journal of the Association of Physicians in India (JAPI’) in March 2010. The reason for the emergence of the ‘Superbug’ was attributed to the ‘worrisome outcome of the indiscriminate use of antibiotics’.

“Unfair to blame the country for the ‘New Delhi’ superbug”:

Reacting to this article, Indian health authorities opined, “It is unfortunate that this new bug, which is an environmental thing, has been attached to a particular country.” The reasons being, “Several superbugs are surviving in nature and they have been reported from countries like Greece, Israel, the U.S., Britain, Brazil and there is no public health threat and no need to unnecessarily sensationalize it”. Some experts, however, feel, “such drug resistant bacteria is a matter of chance, is a global phenomenon and is preventable by sound infection prevention strategies which are followed in any good hospital.”

It has been reported that the ‘National Center for Disease Control of India’ is working on guidelines for appropriately recording these types of nosocomial (hospital acquired) infections.

“Superbug” Hype and Medical Tourism:
Many people of both India and Pakistan have felt since then that in absence of an effective response by the health authorities, especially, in India the fast evolving Medical Tourism initiatives, providing medical services ranging from complicated cardiovascular, orthopedic and cerebrovascular surgery to other life-threatening illnesses, may get adversely impacted.

The root cause and the ‘blame game’:

Experts have opined that overuse and imprudent or irrational use of antibiotics without any surveillance protocol are the root cause for emergence of such ‘Superbugs”, though some Indian parliamentarians have termed this article as the propaganda by some vested interests. It has been alleged that the study was funded by the Wellcome Trust and Wyeth, the two global pharmaceutical companies who produce antibiotics to treat such conditions, together with the European Union.

In this context it is worth mentioning that ‘The Lancet’ article in its disclosures says:

“Kartikeyan K Kumarasamy has received a travel grant from Wyeth… David M Livermore has received conference support from numerous pharmaceutical companies, and also holds shares in AstraZeneca, Merck, Pfizer, Dechra, and GlaxoSmithKline, and, as Enduring Attorney, manages further holdings in GlaxoSmithKline and Eco Animal Health. All other authors declare that they have no conflicts of interest.”

Such a situation has not been reported for the first time:

This type of situation has indeed some precedents. When ‘MRSA’ was reported for the first time, it caused similar scare. However, this time many experts feel that it is too early to conclude whether or not ‘NDM-1’ will eventually prove to be more dangerous than ‘MRSA’.

Several such “Superbugs”, as stated earlier, have already been reported from countries like Greece, Israel, USA, UK, and Brazil. However, as I know, in the battle against infectious diseases involving both the scientists and the bacteria, the later had always to succumb, in the long run.

‘NDM-1′, as well, perhaps will be no exception. All concerned MUST continue to make it happen, not by mere wishful thinking but by establishing a strong procedural mechanism to keep a careful vigil on the reasons for emergence of drug resistant bacterial strains in the country.

The World Health Organization (WHO) perspective:

On Saturday, August 21, 2010 the WHO commented, “while multi-drug resistant bacteria are not new and will continue to appear, this development requires monitoring and further study to understand the extent and modes of transmission, and to define the most effective measures for control”.
Conclusion:

The hype created and motives attributed by the media and the politicians over one such routine scientific papers published in a medical journal of international repute, in my view are unwarranted. There are built in systems within the scientific discourse for raising questions and even challenge any findings. Remarks made by one of the authors of the article to the media, perhaps added more fuel to the fire. Politicians seem to have joined the bandwagon to politicize even a benign medical issue captured in the said article. In an era where news items mean “sensationalism” and ‘politicization’ of most such news items is the order of the day, the civil society should be helped to understand the core issues behind all such raging debates.

Besides the reasons, as discussed earlier, attributed to repeated emergence of such “Superbugs”, one more issue I could foresee in today’s environment compared to the same in the past. This issue possibly lies in the shift in focus of pharmaceutical R&D from discovery of novel drugs for infectious diseases to discovery of drugs for non-infectious chronic illnesses like, metabolic disorders (diabetes), hypertension, cardiovascular diseases, psychiatric disorders, cancer, vaccines etc. This shift in the R&D focus has obviously been prompted by the tilt in the prevalence of the disease pattern towards the same direction.

Perhaps for this reason, one notices hardly any significant and novel molecules in the research pipelines of either global or local pharmaceutical companies to treat such antibiotic-resistant infections. It is understandebly not an ‘either/or’ situation. However, as we all know, in life-threatening conditions both types of drugs have their respective places to save precious lives. Let us ponder over it.

By Tapan 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 First Pharmaceuticals Census of India – a commendable initiative by the National Pharmaceutical Pricing Authority (NPPA)

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Currently there is indeed a crying need for the pharmaceutical industry to generate a robust data base to formulate not only various healthcare related policies, but also to measure the level of their effective implementation. In the absence of such dependable and credible facts, most of the arguments, which take place between the government and other stakeholders, are mainly based on ‘your views’ versus ‘our views’.

An admirable initiative:

To address this critical need, more than a couple of years ago in February 2008, the National Pharmaceutical Pricing Authority (NPPA) announced their intent to initiate the first pharmaceuticals census of India (FPCI). The main purpose of this census is to create a structured, comprehensive and dependable pharmaceutical industry related database in the country to capture valuable information, which could be prudently used by the government towards effective planning, policy making and good governance. NPPA is also expected to publish this census data for all stakeholders and other ministries within the government for appropriate actions.

Create a ‘Common Thread’:

This ‘Pharmaceutical Map’, I guess, will be able to create a common thread for the Ministry of Health, Departments of Pharmaceuticals and Biotechnology, Ministry of Commerce & Industries and the Ministry of Finance based on which each of them will frame their respective healthcare related policies targeting the needs of a vast majority of the population of the country, for inclusive growth.

The ‘Methodology’ will be very important:

I understand that the FPCI is expected to cover over 10,000 manufacturing units in the country in a well-structured manner to produce an elaborate healthcare related credible data bank for India. The methodology that will be followed for this census will determine the credibility of the data thus generated.

My expectation from the FPCI is that, as announced, this will be able to provide credible details, among others, on the following ten key areas of the Pharmaceutical Manufacturing Units (PMUs) to enable the policy makers to frame policies based on the ground realities and at the same time measure the level of their effective implementations:

• Turnover by types and class (Micro, Small, Medium, and Large)
• Locations with separate details of Export Oriented Units (EOUs)
• Capacity installed, capacity utilized by major products
• Number of ‘own’ and ‘loan’ licenses units and by type of units, license issued by the respective state
drug controllers
• Types, class and pattern (plant & machinery, land & building) of investments
• Consumption of indigenous and imported inputs and utilities
• Adherence to GMP
• Product types and pricing
• Pattern of expenditure on R&D, clinical trials and quality control
• Employment generated in the country by the pharma sector

All these data will be available state-wise and district-wise by class and types of industry (API, formulations), among others.

It has been reported that NPPA has by now progressed quite a lot with the FPCI and the Final Report may be published soon.

Conclusion:

It would have been excellent, if FPCI would also have generated data on ‘Access to Modern Medicines’ in India.

Be that as it may, this is an admirable initiative by the NPPA. Data thus generated will be immensely useful to all stakeholders, if updated in every 3 to 5 years to maintain their relevance.

By Tapan 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.

National Non-Communicable Disease (NCD) prevention program of the government needs a new thrust to contain the burden of disease in India.

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The disease pattern in India is showing a perceptible shift from the age old ‘Infectious Diseases’ to ‘Non-infectious Chronic Illnesses’. As reported by IMS, incidence of chronic ailments in India has increased from 23 percent in 2005 to 26 percent in 2009. It is estimated that chronic illnesses will be the leading cause of both morbidity and mortality by the next decade.As a consequence of such changing disease pattern, healthcare needs and related systems of the country should undergo a paradigm shift together with the emergence of a carefully planned concept of ‘Preventive Healthcare’ for the entire population of the nation.
It is a myth that non-infectious illnesses are more prevalent in higher socio-economic strata:

There is a common perception that non-communicable diseases are more prevalent within higher socio-economic strata of the society. However, a national survey done in India shows that diseases related to misuse of alcohol and tobacco are higher in the poorest 20 percent quintile of our society.

Current healthcare system in India:

Currently with appropriate disease treatment measures, alleviation of acute symptoms of the disease that a particular patient is suffering from, is the key concern of all concerned starting from the doctors to the patients and their family. The process of the medical intervention revolves round treatment protocols and procedures based on the diagnosis of the current ailments and not so much on preventive measures for other underlying diseases, except with the use of vaccines for some specific diseases.

Developing a protocol for ‘Preventive Healthcare’ for non-communicable diseases is very important:

In the above process, while addressing the acute problems of the patients’ current ailments is very important, proper risk assessment of other underlying diseases, if any, which the patient could suffer from in future, for various reasons, do not attract any organized attention. As a result the important advice on preventive healthcare from the doctors, properly highlighting its importance, is not available to most of the patients to enable them to significantly reduce, if not eliminate, their future burden of disease.

Keeping such common practices in view and noting that ‘Preventive Healthcare’ is significantly different from ‘Curative Healthcare’, developing an appropriate protocol for ‘Preventive Healthcare’ has become a crying need of the hour.

‘Preventive Healthcare’ in India should attract high priority of the healthcare policy makers with a care vigil on its effective implementation at the ground level:

All said and done, the ‘Preventive Healthcare’ system in India is in its very nascent stage. If appropriate measures are taken in this area, like learning to reduce the impact of mental and physical stress, avoiding sedentary life style, taking healthy diet, avoidance of tobacco and alcohol consumption, leading healthy sex life etc., it can in turn immensely help the population to remain disease free and healthy, thereby contributing to improvement of their respective work productivity in a very substantial way.

The Medical Council of India should also step in:

Thus the role of medical professionals in the disease prevention process is also very important. The interaction of the patients with the doctors when they meet to address any ailment provides huge opportunity to the doctors to advise those patients about various measures of underlying disease prevention, for which different patients have different types of exposures.

Keeping all these points in view, through regulatory initiatives, the Medical Council of India (MCI) should consider making ‘Preventive Healthcare’ an integral part of each interaction of a patient with a doctor.

Include the civil society in the healthcare improvement process of the nation:

The risk factors of many of the diseases like, cancer, chronic respiratory disorders, cardiovascular, diabetes, and hypertension can be identified well in advance and appropriately assessed. Therefore, such diseases can be prevented effectively, to a great extent, provided the healthcare policy of the country supports the ‘Disease Prevention’ process, program and initiatives through adequate resource allocation, improving awareness of the civil society and above all including them in this healthcare improvement process of the nation.

Need to raise general awareness towards ‘Preventive Healthcare’:

Raising the level of awareness of ‘Preventive Healthcare’ is indeed very important. It requires a change in the mindset of the community in general, together with the healthcare policy makers, medical profession, employers, patients and their families.

National Non-Communicable Disease (NCD) prevention program of the government:

As per the planning commission, the government of India has initiated the following structured measures for the prevention of NCD:

• “Health education for primary and secondary prevention of NCDs through mobilizing community action;
• Development of treatment protocols for education and training of physicians in the prevention and management of NCDs:
• Strengthening/creation of facilities for the diagnosis and treatment of CVD and stroke, and the establishment of referral linkages;
• Promotion of the production of affordable drugs to combat diabetes, hypertension, and myocardial infarction;
• Development and support of institutions for the rehabilitation of people with disabilities;
• Research support for: Multispectral population-based interventions to reduce risk factors;
• The role of nutrition and lifestyle-related factors;
• The development of cost effective interventions at each level of care”.

Conclusion:

Many diseases in India, with proper ‘Disease Prevention’ measures can be effectively averted. It is worth repeating that some common measures which can be easily practiced through community initiatives are maintenance of proper hygiene, sanitation, adequate physical activities, moderation in alcohol and tobacco consumption, healthy sexual activities, avoidance of unhealthy food etc.

Besides, the government should spearhead the paradigm change towards ‘Preventive healthcare’ by including the civil society as a part of this process along with appropriate regulations wherever necessary, generating increased awareness within all concerned and through mobilization of adequate resources. All these will ultimately help all of us to translate the well-known dictum into reality, ‘Prevention is better than cure’.

By Tapan 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.