Tag Archives: ministry of health

‘India Taskforce’ takes the first step in an arduous task to bridge the trust deficit.

Posted on by
Reply

To prepare a comprehensive long term strategy to unleash the growth potential of the Pharmaceutical Industry of India considering all its current issues, the Ministry of Health and Family Welfare announced constitution of a taskforce on March 15, 2011 involving all the stakeholders, as mentioned below. As per reports, the first meeting of the committee was held on June 6, 2011 to deliberate on the mandated goals.

Within 3 months the taskforce, under the chairmanship of V.M. Katoch, Secretary, Department of Health Research and Director-General, Indian Council of Medical Research (ICMR), is expected to work out and submit a short, medium and long term strategic path and goals to the Government, highlighting the key and specific policy measures required to achieve these objectives.

The taskforce will have members drawn from:

  1. National Pharmaceutical Pricing Authority,
  2. Department of Industry Policy and Promotion,
  3. Indian Drug Manufacturers Association, Mumbai,
  4. Indian Pharmaceutical Alliance, Mumbai,
  5. Organization of Pharmaceutical Producers of India, Mumbai,
  6. Federation of Pharmaceutical Entrepreneurs, Gurgaon,
  7. Confederation of Indian Pharmaceutical Industry,
  8. Bulk Drug Manufacturers’ Association, Hyderabad,
  9. SME Pharma Industry Confederation, New Delhi
  10. Drug Controller General of India as the Member Secretary.

The focus areas:

The report has been mandated to cover the following critical areas:

  1. Evolving a short, medium and long-term policy and strategy to make India a hub for drug discovery, research and development.
  2. Evolving strategies to further the interests of Indian pharma industry in the light of issues related to intellectual property rights and recommend strategies to capitalize the opportunity of $60 to $80 billion drugs going off-patent over the next five years.
  3. Evolve policy measures to assure national drugs security by promoting indigenous production of bulk drugs, preventing takeover of Indian pharma industry by multi-national corporations, drug pricing, promotion of generic drugs
  4. Recommend measures to assure adequate availability of quality generic drugs at affordable prices.
  5. Recommend measures to tackle the problem of spurious drugs and use of anti-counterfeit technologies.

Estimates and Perspectives:

  • The pharma industry is growing at around 1.5-1.6 times the Gross Domestic Product growth of India
  • Currently, India ranks third in the world of volume of manufacturing pharmaceutical products
  • The Indian pharmaceutical industry is expected to grow at a rate of around 15 % till 2015
  • The retail pharmaceutical market in India is expected to cross US$ 20 billion by 2015
  • According to a study by FICCI-Ernst & Young India will open a probable US$ 8 billion market for MNCs selling patented drugs in India by 2015
  • The number of pharmaceutical retailers is estimated to grow from 5,50,000,  to 7,50,000 by 2015
  • At least 2,00,000 more pharma graduates would be required by the Indian pharmaceutical industry by 2015
  • The Indian drug and pharmaceuticals sector attracted Foreign Direct Investments to the tune of US$ 1.43 billion from April 2000 to December 2008 (Ministry of Commerce and Industry), which is expected to increase significantly along with the policy reform measures and increased Government investment (3%-4%) as a percentage of GDP towards healthcare, by 2015
  • The Minister of Commerce estimates that US$ 6.31 billion will be invested in the domestic pharmaceutical sector
  • Due to low cost of R&D, the Indian pharmaceutical off-shoring industry is expected to be a US$ 2.5 billion opportunity by 2012

Key growth drivers: Local and Global:

Local: • Rapidly growing middle class population of the country with increasing disposable income. • High quality and cost effective domestic generic drug manufacturers are achieving increasing penetration in local, developed and emerging markets. • Rising per capita income of the population and inefficiency of the public healthcare system will encourage private healthcare systems of various types and scales to flourish. • High probability of emergence of a robust healthcare financing/insurance model for all strata of society. • Fast growing Medical Tourism. • Evolving combo-business model of global pharmaceutical companies with both patented and generic drugs is boosting local outsourcing and collaboration opportunities. Global: Global pharmaceutical industry is going through a rapid process of transformation. The moot question to answer now is how the drug discovery process can meet the unmet needs of the patients and yet remain cost effective.

Cost containment pressure due to various factors is further accelerating this process. CRAMS business, an important outcome of this transformation process, will be the key growth driver for many Indian domestic pharmaceutical players in times to come. Bridging the ‘Trust Deficit’ is one of the key Challenges:

Like all other industries, Pharmaceutical Industry in India has its own sets of challenges and opportunities under which it operates. Some of the challenges the industry faces are:

  • Unfortunate “Trust Deficit” between the Government and the Industry to improve access to affordable modern medicines.
  • Regulatory red tape and lack of initiative towards international harmonization.
  • Inadequate infrastructure and abysmal public delivery system.
  • Lack of adequate number of qualified healthcare professionals.
  • Inadequate innovation friendly ecosystem to encourage R&D and other non-product related innovation in the pharmaceutical value chain.
  • Myopic Drug Policies have failed to deliver.
  • Addressing needs of over 350 million BPL families who cannot afford to buy any healthcare products and services.
  • ‘80% out of pocket expenditure’ of the common man towards healthcare.
  • Inadequate Public Private Partnership (PPP) initiatives in most of the critical areas of healthcare.

Urgent need to bridge the ‘Trust Deficit’ and improve public perception of the Industry:

Like many other countries of the world, in India too there is a negative public perception about the pharmaceutical industry. Recent reports on ‘clinical trials related patient’s compensation’ or the government intervention on allegedly gross ‘unethical’ marketing practices by the pharmaceutical companies, further strengthen such belief.  Unfortunately, despite meteoric success of the generic pharmaceutical industry of India in the global arena, public perception of the industry still remains as one, which is being driven by profiteering motive at the cost of the precious lives of ailing common population of the country. This is indeed acting as a strong retarding force. As a result the regulators are also compelled to introduce more of growth stifling measures at a fairly regular pace.

A new ‘Harris Poll’ conducted in the US between November 8 and 15, 2010 reports as follows:

Top industries that largest numbers of people believe should be more regulated

Industry % of respondents
Oil

47
Pharmaceuticals

46
Health Insurance

42
Tobacco

38
Banks

34
Managed Care

34

That an overwhelming 46% respondent in the US feels that the Pharmaceutical Industry should be regulated, only reflects a poor public perception of the industry in the USA.

Industries trusted by the fewest people

Industry % of respondents
Tobacco

2
Oil

4
Telecommunication

7
Managed Care

7
Life Insurance Companies

10
Pharmaceuticals

11

(Source: Harris Poll 2010) 

It is indeed an irony that a miniscule 11% respondents trust pharmaceutical industry in the USA.

Thus in the prevailing scenario globally, the Indian Pharmaceutical Industry should take more demonstrable self-regulatory measures to improve its public perception and make its growth more inclusive, in the best possible way that it can. Without active support of the government, media and other stakeholders, through conscious efforts to improve its image, all the efforts of the taskforce may ultimately get converted into a zero sum game.

Job Creation by the industry is of critical importance: Pharmaceutical sector in India has created employment for approximately 3 million people from 23,000 plus units. Accelerated growth in job creation, will not only open up more opportunities to pharmaceutical professionals, but will also fuel growth opportunities in allied business segments like Laboratory, Scientific instruments, Medical Devices and Pharma machinery manufacturing sectors.

Despite all these, it is worth noting that a major challenge still remains in getting employable workforce with the required skill sets. This issue will grow by manifold, as we move on, if adequate vocational training institutes are not put in place on time to generate employable workforce for the industry.

Government Initiatives, thus far, are still less than adequate: The government of India has started working out some policy and fiscal initiatives, though grossly inadequate, for the growth of the pharmaceutical business in India. Some of the measures adopted by the Government are follows:

  • Pharmaceutical units are eligible for weighted tax reduction at 175% for the research and development expenditure obtained.
  • Two new schemes namely, New Millennium Indian Technology Leadership Initiative and the Drugs and Pharmaceuticals Research Program have been launched by the Government.
  • The Government is contemplating the creation of SRV or special purpose vehicles with an insurance cover to be used for funding new drug research
  • The Department of Pharmaceuticals is mulling the creation of drug research facilities which can be used by private companies for research work on rent

Pharmaceutical Export going North: In recent years, despite economic slowdown in the global economy, pharmaceutical exports in India have registered a commendable growth. Export has emerged as an important growth driver for the domestic pharmaceutical industry with over 50 % of their total revenue coming from the overseas markets. For the financial year 2008-09 the export of drugs is estimated to be around US $8.25 billion as per the Pharmaceutical Export Council of India (Pharmexil). A survey undertaken by FICCI reported 16% growth in India’s pharmaceutical export during 2009-2010.

This trend needs to be encouraged and be given further boost.

Conclusion:

The newly formed taskforce will hopefully be able to address all these issues in an integrated way to guide this life-line industry to a much higher growth trajectory  to compete effectively not only in the global generic space, but also with the global innovator companies, sooner than later.

So the ball game for the taskforce is to recommend strategy and policy measures to improve access to modern medicines by reducing ‘out of pocket’ expenses significantly through public/private health insurance initiatives, protect public health interest and foster a climate for innovation, simultaneously, and certainly not one at the cost of the other.

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.

Deadly ‘Superbugs’: The larger issues

Posted on by
Reply

Every year, April 7 is observed as ‘World Health Day’ across the globe. This year, 2011, is no exception. However, interestingly considering the increasing debate on the antibiotic resistance ‘Superbug’, the theme of this year has been very aptly coined as “No action today, no cure tomorrow”.

April 2011 issue of ‘The Lancet’ reported again the presence of drug-resistant bacteria NDM-1 in the public water system of Delhi.

Some observers in this area commented that this report is clearly aimed at raising alarm by recycling an old claim that has been found to be contentious, clearly suggesting indirectly that foreigners who visit India for medical and cosmetic treatments may carry back the deadly microbes with them to their respective countries.

The new report attempts to establish that the ‘Superbug NDM-1′ is no longer a hospital-born infection but can also spread through contaminated water and food. Understandably, this has raised a hue and cry in India.

Ministry of Health ridicules ‘The Lancet’ April study:

Last week the Ministry of Health rejected the above study observing that it was not only conducted with “motivated intentions”, but is illegal too. As transport of  water samples for such study out of the country requires prior permission from regulatory authorities. The authenticity of the samples also appears to be questionable, as these were reportedly to have been collected by a TV reporter.

However, just a day after the government rejected ‘The Lancet’ report, it formed a committee to look into the findings of the study, as announced by Dr R K Srivastava, Director General of Health Services, Government of India.

However, ‘The Lancet’ stands by this study report.

August 2010 report of ‘The Lancet’:

One will perhaps recall that on August 11, 2010, “The Lancet” published similar article highlighting that a new antibiotics-resistant “Superbug” originating from Pakistan has taken its first life. This happened when a patient brought to a hospital in Belgium died in June 2010 after having met with a car accident in Pakistan, where from the person got infected with this “Superbug”.

The above article was written by a team of international researchers including an Indian. The study 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. This deadly “Superbug” was reported to have already reached the United Kingdom through patients who acquired it from the hospitals in India and has the potential to precipitate serious health issues across the world. “The New Delhi Superbug” was discovered even earlier: The ‘The Lancet’ 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 in 2009 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 the August article, Indian health authorities opined at that time, “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 pathogens, is a global phenomenon and is preventable by sound infection prevention strategies which are followed in any good hospital.”

Based on this report the ‘National Center for Disease Control of India’ started 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 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 ‘blame game’: Experts have opined that overuse, imprudent or irrational use of antibiotics without any surveillance protocol is the root cause for emergence of “Superbugs”, though some Indian parliamentarians had termed the August 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 of August 2010 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.” Not a first time reported incidence: 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. As I know, in the battle against infectious diseases involving both the scientists and the bacteria, the later had  to succumb mostly, in the long run. ‘NDM-1′ 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”.

International Cooperation:

US based Center for Disease Control and Prevention (CDC), which is known as one of the world’s best-known institute for handling ‘Superbugs’, will help India in its capacity building efforts to better detect pathogens like NDM-1.

In India, the National Center for Disease Control (NCDC) with state of art facilities is expected to commence working from the next year. The facility is expected to be equipped with highly-advanced bio-safety level-II and BSL-III laboratories and would cost around Rs 382.41 Crore.

The larger issue:

The larger issue is that antibiotic resistance is fast becoming a global health concern as drug-resistant bacteria can turn a simple infection life threatening. According to the World Health Organization, ‘some 440,000 new cases of tuberculosis resistant to different types of drugs were detected last year in 60 countries across the world.’

Thus the emergence of drug-resistant ‘Superbug’ is being seen by many experts as a natural process of evolution of organisms. However, it goes without saying that indiscriminate use of antibiotics is hastening this deadly process.

R&D focus shifted more towards chronic illnesses:

Besides the reasons attributed to emergence of such “Superbugs”, as discussed earlier, one more important issue I could foresee in today’s environment compared to the past decades.

This issue possibly lies in the drastic shift in focus of pharmaceutical R&D from discovery of novel drugs for short term treatment of infectious diseases to discovery of potentially greater money spinner drugs for life-long treatment of 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. As a consequence, one notices hardly any significant and novel molecules in the research pipelines of either global or local pharmaceutical companies to treat  antibiotic-resistant infections.

As reported by the ‘Infectious Diseases Society of America’ between 1983 and 1987 sixteen new patented antibiotics were approved by the US FDA, while from 2003 to March 2011 only seven patented antibiotics were launched in the international market.

It is understandably not an ‘either/or’ situation so far as R&D target molecules are concerned. However, as we all know, in life-threatening conditions both types of drugs have their respective places to save precious lives.

Conclusion:

Let the global innovators ponder over the issue for newer antibiotics to counter the emerging ‘Superbugs’.

In India, the Ministry of Health should consider strictly implementing the measures suggested by the task force set up last year to prevent indiscriminate use of antibiotics. Such measures include a ban on sale of antibiotics without prescriptions and simultaneously regular audits of prescriptions of the doctors to stop irrational use of such drugs.

The need of the hour is a well-orchestrated effort by the Government, members of the civil society and the medical fraternity to have full control on this growing menace, through tangible, prudent and truly patient-friendly action .

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.