Tag Archives: Forbes

Two Paintings on the Same Canvas: ‘Truth About Drug Companies’ and ‘Protecting Access to Medicines’

Posted on by
Reply

As the saying goes, “Great people think alike”, many thought leaders of very high credibility across the globe, seem to think almost in similar lines when it comes to improving access to medicines for a large section of the global population.

In this article, I shall briefly focus on two such instances, both revolving around the same centerpiece – one from India and the other from the land of ‘pharmaceutical innovation’ – America.

An interesting article written recently by the well-regarded Indian expert of global stature Dr. K. Srinath Reddy, President, Public Health Foundation of India (PHFI), reiterates emphatically,  “India must protect access to medicine”.

In a more focused context related to EU-FTA, the author wrote about possible adverse impact of more stringent product patent and regulatory data protection related issues on access to generic medicines in India and other developing countries. Thus, he argued that EU-FTA should be well negotiated by India and cautioned as  follows:

“It must be remembered that India needs to protect its vital interests in any trade agreement, just as other nations strive to. Our interest lies in protecting the lives and safeguarding the health of Indians, without permitting unreasonable restrictions on our ability to produce, use and even export, generic versions of drugs the patents of which have lapsed (or where compulsory licensing has been invoked to protect public health).

India needs to tread carefully while negotiating the FTA with the EU, so that the health of the Indian people is not compromised through provisions that shackle our generic drug industry.”

The debate has assumed a global dimension:

Such raging debates on a critical public health issue, like access to medicines, are also taking place in many other countries, as I write, including America, irrespective of the fact whether these are generic or patented drugs.

Marcia Angell, M.D, a faculty of Harvard Medical School and a former Editor in Chief of the world’s leading medical journal ‘The New England Journal of Medicine’ wrote an interesting book.

In this book titled “The Truth About the Drug Companies: ‪How They Deceive Us and What to Do About It”, she makes many interesting comments on the American pharmaceutical industry on access to medicines and the kind of pharmaceutical innovations that they are involved in.

The world noticed it:

This book arrested global attention and was extensively reviewed. Since, the author wrote more specifically about the American pharmaceutical industry, following are some excerpts quoted from her book reviews in the USA:

New York Times: “A scorching indictment of drug companies and their research and business practices…tough, persuasive and troubling.”

Boston Globe: “A sober, clear-eyed attack on the excesses of Drug Company power…a lucid, persuasive, and highly important book.”

Washington Post: “Always authoritative…[this book] delivers the message—that drug-company money and power is corrupting American medicine—in a convincing, no-nonsense manner.”

Some key issues raised in the book:

Like the above article of Dr. Reddy, here also the author raises some interesting issues related to the American drug companies. I am penning below some of those issues exactly as expressed by the author (verbatim):

  • “The magic words, repeated over and over like an incantation, are research, innovation, and American. Research. Innovation. American. It makes a great story.”
  • “R&D is a relatively small part of the budgets of the big drug companies—dwarfed by their vast expenditures on marketing and administration, and smaller even than profits.”
  • “The great majority of ‘new’ drugs are not new at all but merely variations of older drugs already on the market. These are called ‘me-too’ drugs.”
  • “If I’m a manufacturer and I can change one molecule and get another twenty years of patent rights, and convince physicians to prescribe and consumers to demand the next form of Prilosec, or weekly Prozac instead of daily Prozac, just as my patent expires, then why would I be spending money on a lot less certain endeavor, which is looking for brand-new drugs?”
  • “Over the past two decades the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centers, and the medical profession itself. (Most of its marketing efforts are focused on influencing doctors, since they must write the prescriptions.)”
  • “Now universities, where most NIH-sponsored work is carried out, can patent and license their discoveries, and charge royalties. Similar legislation permitted the NIH itself to enter into deals with drug companies that would directly transfer NIH discoveries to industry.”
  • “Many medical schools and teaching hospitals set up “technology transfer” offices to help in this activity and capitalize on faculty discoveries. As the entrepreneurial spirit grew during the 1990s, medical school faculty entered into other lucrative financial arrangements with drug companies, as did their parent institutions.”
  • “One of the results has been a growing pro-industry bias in medical research—exactly where such bias doesn’t belong.”
  • “In the 1990s, Congress enacted other laws that further increased the patent life of brand-name drugs. Drug companies now employ small armies of lawyers to milk these laws for all they’re worth—and they’re worth a lot. The result is that the effective patent life of brand-name drugs increased from about eight years in 1980 to about fourteen years in 2000.”
  • “The biggest single item in the budget is neither R&D nor even profits but something usually called ‘marketing and administration – a name that varies slightly from company to company.”
  • “The industry is fighting these efforts—mainly with its legions of lobbyists and lawyers. It fought the state of Maine all the way to the US Supreme Court, which in 2003 upheld Maine’s right to bargain with drug companies for lower prices, while leaving open the details. But that war has just begun, and it promises to go on for years and get very ugly.”
  • “The fact that Americans pay much more for prescription drugs than Europeans and Canadians is now widely known.”
  • “There are very few drugs in the pipeline ready to take the place of blockbusters going off patent. In fact, that is the biggest problem facing the industry today, and its darkest secret. All the public relations about innovation is meant to obscure precisely this fact.”
  • “Of the 78 drugs approved by the FDA in 2002, only 17 contained new active ingredients, and only seven of these were classified by the FDA as improvements over older drugs.”
  • “While there is no doubt that genetic discoveries will lead to treatments, the fact remains that it will probably be years before the basic research pays off with new drugs. In the meantime, the once-solid foundations of the big pharma colossus are shaking.”
  • “Clearly, the pharmaceutical industry is due for fundamental reform. Reform will have to extend beyond the industry to the agencies and institutions it has co-opted, including the FDA and the medical profession and its teaching centers.”
  • “The me-too market would collapse virtually overnight if the FDA made approval of new drugs contingent on their being better in some important way than older drugs already on the market.”
  • “A second important reform would be to require drug companies to open their books. Drug companies reveal very little about the most crucial aspects of their business.”
  • “But the one thing legislators need more than campaign contributions is votes. That is why citizens should know what is really going on. Contrary to the industry’s public relations, they don’t get what they pay for. The fact is that this industry is taking us for a ride, and there will be no real reform without an aroused and determined public to make it happen.”

An opposite view:

On this an article in Forbes Magazine commented as follows:

“The problem with Angell’s arguments is that they are rife with inaccuracies and fallacies. Furthermore, she makes no accounting for changes in the industry that have occurred over the last decade.”

“It is time for those in the medical profession to spur a more truthful and factual discussion about the pharmaceutical industry and its role in the discovery and development of new medicines. The pharmaceutical industry is a key player in the evolution of healthcare and this needs to be recognized if the industry is to operate effectively.”

Conclusion:

One of the key counter arguments that very often comes up in this area, including in India is, the protection of Intellectual Property Rights (IPR) is the responsibility of the Government concerned at any cost, even if such protective measures severely restrict access to these drugs to a large population of the society across the globe, due to ‘affordability’ considerations.

It is also claimed that, to come out with innovative medicines, large pharmaceutical companies invest a huge amount of money and time towards R&D related activities.

Thus, the global innovator companies, by and large, with a few exceptions though, believe that stricter enforcement of stringent patent laws by the Governments is the only answer to foster innovation within the industry. Such stringent measures, as they argue, will help them keep investing in R&D to meet the ‘unmet needs’ of patients on a continuous basis.

However, as we have seen above, many experts, like Harvard faculty Marcia Angell and Dr. K. Srinath Reddy have strong and quite different view points. It is certain that the debate on access to affordable medicines is not going to die down, at least any time soon.

Despite all these, it is not difficult, I reckon, to identify an emerging but a clear trend indicating, the priority of the Governments to protect public health interest in the longer term, will ultimately prevail in most parts of the world, including India.

Consequently, the world will probably witness more and more new government policies and legal frameworks in this area striking a right balance between improving access to medicines and fostering innovation, as the countries move on.

That said, taking note of the above two paintings, as it were, painted on the same canvas of ‘improving access to medicines for all’, is it not amazing to note a striking similarity in the thought pattern between two highly credible and independent think tanks, belonging to the oldest and largest democracies of the planet earth, to ensure affordable medicines for all?

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.

Small Steps, yet Giant Leaps: In Pursuit of Affordable Medicines for All

Posted on by
Reply

Since last few years, some small yet very significant steps are being taken, mostly by the respective Governments, in and outside India, to provide affordable healthcare in general and affordable medicines in particular, for all.

It is well recognized that drug prices play as critical a role as a robust healthcare infrastructure and quality of its delivery system to provide affordable healthcare to the general population of any country. Thus, it is not a ‘chicken and egg’ situation. All these issues must be addressed simultaneously and with equally great care.

A WHO report:

A World Health Organization (WHO) titled, “Improving access to medicines through equitable financing and affordable prices” highlights as follows:

“In many countries medicines account for over half of total health expenditures and are often unavailable and unaffordable to consumers who need them. Up to 90% of the population in developing countries still buys medicines through out-of-pocket payments, and are often exposed to the risk of catastrophic expenditure.”

Definition of ‘Access to Medicines’:

How then one will define ‘access to medicines’?

United Nations Development Group, in a paper titled ‘Indicators for Monitoring the Millennium Development Goals (United Nations, New York, 2003) defined  ‘Access to Medicines’ as follows:

‘Having medicines continuously available and affordable at public or private health facilities or medicine outlets that are within one hour’s walk from the homes of the population.’

Healthcare ‘affordability’ is critical:

Despite healthcare infrastructure in India being inadequate with a slow pace of development, affordability of healthcare, including medicines, still remains critical. 

This is mainly because, even if a quality healthcare infrastructure together with an efficient delivery system is put in place without ensuring their affordability, patients’ access to quality healthcare products and services will not improve, especially in India, where private healthcare dominates.

Diversionary measures should not cause distraction:

Although, maximum possible resources must be garnered to address the critical issue of expanding quality healthcare infrastructure and delivery system sooner, the focus of the government, as stated above, must not get diverted from making healthcare products and services affordable to patients, at any cost.

This should continue despite diversionary measures from some quarter to deflect the focus of all concerned from affordability of healthcare to lack of adequate healthcare infrastructure and its delivery mechanisms in India.

This, in no way, is an ‘either/or’ situation. India needs to resolve both the issues in a holistic way, sooner.

Small Steps:

In an earnest endeavor to provide affordable medicines to all, the following small and simple, yet significant steps have been taken in and outside India:

  1. Strong encouragement for generic drugs prescriptions
  2. Regulatory directive for prescriptions in generic names
  3. In case that does not work – Government initiative on Patient Empowerment

In this article, I shall try to capture all these three small steps.

1. Strong encouragement for generic drugs prescriptions:

A. Generic drugs improve access and reduce healthcare cost:

A Special Report From the ‘US-FDA Consumer Magazine’ and the FDA Center for Drug Evaluation and Research, Fourth Edition / January 2006 states that generic drugs offer significant savings to the consumers.

Quoting a 2002 study by the Schneider Institute for Health Policy at Brandeis University in Waltham, Mass., it reiterated that if Medicare increased the rate of generic usage to that of similar high-performing private sector health plans, its 40 million beneficiaries could see potential savings of US$14 billion.

Another US-FDA report titled, ‘Greater Access to Generic Drugs’ also reinforced the argument that rising costs of prescription drugs remain a major challenge for consumers, especially older Americans. To address this issue effectively generics can play a critical role by providing less expensive medications.

B. ‘Obamacare’ followed this direction resulting decline in spend on high priced Patented Drugs:

Recently The New York Times quoting IMS Health reported that nationwide turnover of patented drugs in the U.S actually dropped in 2012. This decline though was just by 1 percent to US$ 325 billion, is indeed very significant and happened due to increasing prescription trend for low cost generics across America since past several years.

It is interesting to note this trend in America where the cost of medicines account for just about 15 percent (against over 70 percent in India) of the nation’s health care expenditures.

IMS Health reported that in 2012, 84 percent of all prescriptions were dispensed as generics and estimated use of generics may reach even as high as 86 to 87 percent in the U.S.

However, many experts believe that this trend is a result of many blockbusters like Lipitor going off patent during this period and no major breakthrough medicines coming with perceptible added value in these large therapy areas.

That said, lesser number of small molecule blockbuster drugs is set to lose patent protection over the next several years and the complexity in manufacturing and getting marketing approvals of large molecule biosimilar drugs in the U.S could arrest this trend.

Biosimilar drugs though are available in European Union, are expected to be available in the America not before at least two more years.

Despite a sharp increase in prescriptions for generic drugs, some of the patented medicines came with ‘jaw-dropping’ price tags: four drugs approved in 2012 carry a yearly cost of more than US$ 200,000 per patient, though the cost of development of some of these drugs do not exceed US$ 250 million, as reported by Forbes.

2. Regulatory directive for prescriptions in generic names:

A. Different situation in India:

Although increasing trend of generic prescriptions is bringing down the overall cost of healthcare in general and for medicines in particular elsewhere in the world, the situation is quite different in India.

In India over 99 percent of over US$ 13 billion domestic pharmaceutical market constitutes predominantly of branded generics and some generic medicines without brand names.

B. Allegation of branded generic prescriptions linked with marketing malpractices:

As Reuters reported, quoting public health experts and some Indian doctors, that due to an unholy nexus between some pharmaceutical companies and a large section of the medical profession, drugs are not only dangerously overprescribed, but mostly expensive branded generics are prescribed to patients, instead of cheaper equivalents. The reports said that this situation can be ‘devastating for patients — physically and financially — in a country where health care is mostly private, out of pocket, unsubsidized and 400 million people live on less than US$ 1.25 a day’.

It is now a matter of raging debate that many branded generic prescriptions are closely linked with marketing malpractices.

Not just the media and for that matter even a Parliamentary Standing Committee in one of its reports highlighted, bribing doctors by many pharma players in various forms and garbs to prescribe their respective brand of generic drugs has now reached an alarming proportion in India, jeopardizing patients’ interest seriously, more than ever before and  observed that speedy remedial measures are of utmost importance.

C. MCI initiative on prescription in generic names: 

To address this major issue the Medical Council of India (MCI) in its circular dated January 21, 2013 addressed to the Dean/Principals of all the Medical Colleges, 
Director of all the hospitals and the
 Presidents of all the State Medical Councils directed as follows:

“The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 inter-alia prescribes as under regarding use of generic names of drugs vide clause 1.5.

1.5 – Use of Generic names of drugs: Every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that there is a rational prescription and use of drugs.”

All the Registered Medical Practitioners under the IMC Act are directed to comply with the aforesaid provisions of the Regulations without fail.

You are requested to give wide publicity of the above regulation to ensure that all the doctors practicing medicine under your jurisdiction comply with the regulation.”

MCI also urged the Medical profession to implement the above provision for prescriptions in generic names both in its letter and spirit.

As the situation has not changed much just yet, it is up to the MCI now to enforce this regulation exactly the way as it has intended to. Otherwise the value of this circular will not even be worth the paper on which it was printed by this august regulatory body.

D. Parliamentary Standing Committee recommends it:

As mentioned above, prior to this circular, Parliamentary Standing Committee (PSC) for Health and Family Welfare in its recommendation to the ‘Rajya Sabha’ of the Indian Parliament on August 4, 2010, also recommended prescription of medicines by their generic names.

E. Why is the bogey of ‘product quality’ so active only for generic prescriptions and not for branded generics?

It is indeed difficult to fathom why is the product quality issue, which could make drugs unsafe for the patients, being raised so much for generic medicines without a brand name and not for branded generics?

The following questions should well be raised for greater clarity on the quality issue with generic medicines without a brand name, for all concerned:

  • Are all generic medicines of dubious quality and branded generics are of good quality?
  • If quality parameters can be doubted for both branded generics and generics without a brand name, in many cases, why then raise this issue only in context of prescribing generic medicines ?
  • If quality issues are not much with the larger companies and are restricted to only smaller companies, why then some branded generic drugs of smaller companies are being prescribed so much by the doctors?
  • Currently many large companies market the same drugs both as generics without a brand name and also as branded generics, why then the branded generic versions are prescribed more than their generic equivalents, though manufactured by the same large companies having the same quality profile?
  • Why are the generic medicines of good quality available at ‘Jan Aushadhi’ outlets (though small in number) cost a fraction of their branded generic equivalents and not being prescribed by most of the doctors?
  • Why do the doctors not show much interest in prescribing generic medicines as of date and defend the branded generics on the same ‘quality’ platform?
  • Why not those who argue that phonetically similar or wrong reading of generic names at the chemist outlets may cause health safety hazard to the patients, also realize that many already existing phonetically similar brand names in totally different therapy areas may cause similar hazards too?
  • How does a doctor while prescribing a branded generic or generic medicine pre-judge which ones are of good quality and which others are not?

These questions, though may be uncomfortable to many, nevertheless merit clear, unambiguous, straight and specific answers.

3. In case MCI directive does not work – Government initiative on ‘Patient Empowerment’:

A. Laudable Government initiative:

Recognizing this issue in tandem, on December 7, 2012 the Department of Pharmaceuticals together with the National Pharmaceutical Pricing Authority announced as follows:

“There are number of drugs available in the market with same medicament composition with wide variation in their prices.  The prescription of doctors also varies from low price to high priced drugs for the same ailment. Government of India intends to launch an SMS based patient awareness scheme, which would enable the patients to know the cheaper alternatives medicines available”.

The timeline for implementation of this initiative was announced as six month from the date of awarding the contract.

It was reported that in this mobile phone based program, consumers by sending a text message of any branded generic drug prescribed by the doctors would get an SMS reply with a list of brands of the same molecule along with their prices to exercise their choice of purchase.

As usually happens with most government decisions, the gestation period of this laudable ‘patient empowerment’ initiative perhaps will get over not before end 2013.

B. One interesting private initiative:

One interesting private websites that I have recently come across offering information on branded generic drugs is www.mydawaai.com (I have quoted this website just to cite an example and not to recommend or promote it in any form or manner). There may be other such websites, as well, in the cyberspace.

However, in this website, if anyone types the brand name of the drug that one is looking for, the following details will be available:

  1. The generic version of branded medicine.
  2. The company manufacturing the brand.
  3. Its estimated cost in India
  4. Alternative brand names with same generic salt.
  5. The cost effectiveness for different brand for the same salt.

Such information, if available easily from the Government or any highly credible source, will indeed help patients having access to affordable low cost medicines to lessen their out of pocket financial burden, at least for medicines.

Conclusion:

In India, even if branded generic prescriptions continue despite MCI directive, to empower patients making an informed choice to buy low priced formulations of the same prescribed molecule, the above ‘Patient Empowerment’ initiative will play a very critical role.

Thus, I reckon, to improve access to affordable medicines in India, like many other countries elsewhere in the world, the above small steps that are being taken by the MCI, the Department of Pharmaceuticals, the National Pharmaceutical Pricing Authority and other private players are indeed laudable and must be encouraged.

Kudos will pour in, from India and abroad, if such small and simple steps get ultimately translated into a giant leap in the healthcare space of the country…for patients’ sake.

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.

MCI asks Doctors to Prescribe Medicines in Generic Names

Posted on by
Reply

Last week, on January 21, 2013, in a circular addressed to the Dean/Principals of all the Medical Colleges, Director of all the hospitals and Presidents of all the State Medical Councils, the Medical Council of India (MCI) called upon the doctors practicing medicine to prescribe Drugs with Generic names, as far as possible.

The MCI circular reinforced that all Registered Medical Practitioners under the Indian  Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 will comply with it without fail. At the same time, wide publicity of this regulation be given and necessary steps be taken to ensure observance of this provision in its letter and spirit.

PSC also recommended it:

Prior to this circular, Parliamentary Standing Committee (PSC) for Health and Family Welfare in its recommendation to the ‘Rajya Sabha’ of the Indian Parliament on August 4, 2010, also recommended prescription of medicines by their generic names.

The basic premises:

All these recommendations are reportedly based on the basic premises that high ‘Sales and Marketing’ costs of branded generic drugs in India can be significantly reduced, if prescription in generic names are encouraged, to make medicines available to patients at cheaper and much affordable prices.

‘Sales and Marketing’ expenses of ‘Branded’ drugs:

According to a recent report in BMJ every dollar that the pharmaceutical companies spend on “basic research,” US$ 19 goes toward promotion and marketing.

Another recent report from Forbes India titled “Will Pharma Companies Have to Stop ‘Gifting’ Doctors?“ states as follows:

“The budget that pharma companies have for freebies is huge. According to one estimate, the top 20 drug makers in India spend about $600 million a year on only freebies for doctors. It is still a paltry sum compared to the US, where drug makers spend $58 billion or more annually on marketing drugs, including freebies for doctors.

While the practice of giving gifts to doctors is rampant internationally, several sources told Forbes India that in India it borders on petty corruption. Doctors often refuse to write prescriptions unless they are offered at least Rs 50,000 in cash every time a new drug needs to be prescribed.” 

The prescribers’ ‘diplomatic’ stand:

It is interesting to note that some doctors reportedly are of the view that:

“For the benefit of patients and to get the best possible results, highest quality drugs with best possible pharmacological properties should be used by all doctors. If the quality of generic drugs is up to high standards, doctors should prescribe generic medicines.”

This comment needs to be taken considering that it has been made in response to the above MCI circular by a doctor. However, I reckon, in the real world such intent, as reflected in various independent retail audit reports, is hardly seen getting translated into reality, at least not just yet.

Ongoing debate on the quality issue with generic medicines:

Many opine that there could be a huge quality issue with generic medicines, which could make such drugs unsafe for the patients.

In response, other school of thought leaders often raise, among many others, the following questions:

  1. Are all generic medicines of dubious quality and branded generics are of good quality?
  2. If quality parameters can be doubted for both in many cases, why then raise this issue only in context of generic medicines?
  3. If the quality issues are not much with the larger companies and are restricted to only smaller companies, why then some branded generic drugs of smaller companies prescribed so much by the doctors?
  4. Currently many large companies market the same drugs both as generics and also as branded generics, why then the branded generic versions sell more than their generic equivalents, though manufactured by the same large companies?
  5. Why are the generic medicines available at ‘Jan Aushadhi’ outlets (though small in number) cost a fraction of their branded generic equivalents?
  6. Why do the doctors also not show much interest in prescribing generic medicines as of date?
  7. Why not those who argue that phonetically similar or wrong reading of generic names at the chemist outlets may cause health safety hazard to the patients, also realize that many already existing phonetically similar brand names in totally different therapy areas may cause similar hazards too?
  8. How does a doctor while prescribing a branded generic or generic medicine decide which ones are of good quality and which others are not?

A recent study:

As reported by the US FDA, ‘A recent study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand-name counterparts. There was no evidence that brand-name heart drugs worked any better than generic heart drugs. [Kesselheim et al. Clinical equivalence of generic and brand name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA.  2008; 300(21) 2514-2526]‘.

Similar studies are also required in India to resolve much hyped ‘quality issue’ for generic medicines.

Some countries are taking similar steps: 

Just to cite an example, as reported by ‘The Guardian” on August 23, 2011, the Spanish government enacted a law compelling the doctors of Spain to prescribe generic drugs rather than more expensive patented and branded pharmaceuticals, wherever available. This move is expected to help the Spanish government to save €2.4 billion (£2.1billion) a year, as in Spain the drugs are partly reimbursed by the government.

As a result, the doctors in Spain will now have to prescribe only in the generic or chemical names of the respective drugs. Consequently the pharmacies will be obliged to dispense ‘the cheapest available versions of drugs, which will frequently mean not the better-known brand names sold by the big drugs firms’.

Interestingly, the above point, though considered as a positive fall-out in Spain, is reportedly taken negatively in India with the oft repeated argument, ‘India is different’.

Prescriptions for generic medicines were a record high in America in 2010:

As per published reports, last year i.e. in 2010, generic medicines accounted for more than 78 percent of the total prescriptions dispensed by retail chemists and long-term care facilities in the US. This is a record high and is four percentage points more than what it was in 2009 and came up from 63% as recorded in 2006.

This vindicates that prescription in generic names is encouraged in the US too for various reasons.

Concerns over pharmaceutical marketing malpractices in India:  

Ethical concerns on significant expenditure towards alleged sales and marketing malpractices since quite some time has further strengthened the demand for prescriptions only in the generic name of a drug.

Frequent reports by Indian media have already triggered a raging debate in the country on the subject, involving even the Government and also the Parliament. It has been reported that a related case is now pending with the Supreme Court for hearing in not too distant future.

In 2010, “The Parliamentary Standing Committee on Health’ expressed its deep concern that ‘the evil practice’ of inducement of doctors continued because the Medical Council of India (MCI) has no jurisdiction over the pharma industry and it could not enforce the code of ethics on it.”

It was widely reported that the letter of a Member of Parliament, Dr. Jyoti Mirdha to the Prime Minister Dr. Manmohan Singh, attaching a bunch of photocopies of the air tickets claiming, “Doctors and their families were beating the scorching Indian summer with a trip to England and Scotland, courtesy a pharmaceutical company”, compelled the Prime Minister’s Office (PMO) to initiate inquiry and action on the subject.

The letter had claimed that as many as 30 family members of 11 doctors from all over India enjoyed the hospitality of the said pharmaceutical company.

In addition Dr. Mirdha reportedly wrote to the PMO stating, “The malpractice did not come to an end because while medical profession (recipients of incentives) is subjected to a mandatory code, there is no corresponding obligation on the part of the healthcare industry (givers of incentives). Result: Ingenious methods have been found to flout the code.”

The report also indicated that the Department of Pharmaceuticals (DoP) is trying to involve the Department of Revenue under the Ministry of Finance to explore the possibilities in devising methods to link the money trail to offending companies and deny the tax incentives.

Incidences of such alleged malpractices related to financial relationship between the pharmaceutical companies and the medical profession are unfolding reasonably faster now. All these issues are getting increasingly dragged into the public debate where government can no longer play the role of a mere bystander.

Taking the first step closer to that direction, Central Board of Direct Taxes (CBDT), which is a part of Department of Revenue in the Ministry of Finance, has now decided to disallow expenses on all ‘freebies’ to Doctors by the Pharmaceutical Companies in India.

A circular dated August 1, 2012 of the CBDT that the any expenses incurred by the pharmaceutical companies on gifts and other ‘freebies’ given to the doctors will no longer be allowed as business expenses. 

The response in favor of ‘Branded Generics’:

The proponents of ‘Branded Generics’ argue that the brand name is built on various differential value parameters to create a proper position of the brand in the minds of healthcare professionals as well as the patients. Thus, brand names offer a specific identity to generic drugs and is of high importance for both the doctors and the patients. 

The areas of complexity:

Those who favor branded generics also highlight, among others, the following three areas of complexity:

1. In India, over 50% medicines prescribed by the physicians are for Fixed Dose Combinations (FDCs), spanning across almost all therapeutic categories. Thus, it could be difficult for doctors to prescribe such medicines in generic names and might equally be difficult for the chemists to dispense such prescriptions.

They also argue that in case of any mistake of dispensing the wrong drug by the chemist inadvertently, the patients could face serious consequences.

2. Currently doctors use brand names to differentiate one formulation from the others. Different brands of even single ingredient medicines may have inherent differences in their formulations like, in the drug delivery systems (controlled/sustained release), kind of coatings allowing dissolution in different parts of alimentary canal, dispersible or non-dispersible tablets, chewable or non-chewable tablets etc. Since doctors are best aware of their patients’ conditions, they may wish to prescribe a specific type of formulation based on specific conditions of the patients, which may not be possible by prescribing only in generic names.

3. Patients also could face other difficulties due to generic prescribing. As is known, different brands of FDCs may have different proportions of same active ingredients. If chemists do not know or have the exact combination prescribed by the doctor in their shops, they would possibly substitute with a different combination of same drugs, which could well be less effective or even harmful to the patients.

The common perception:

The entire issue arises out of the key factor that the patients do not have any say on the use/purchase of a brand/brands that a doctor will prescribe.

It is generally believed by many that doctors predominantly prescribe mostly those brands, which are promoted to them by the pharmaceutical companies in various questionable ways, as reported above.

Thus, in today’s world and particularly in India, the degree of commercialization of the noble healthcare services, as often reported by the media, has reached a new high, sacrificing the ethics and etiquette both in the medical and also in the pharmaceutical sales and marketing practices at the altar of greed and conspicuous consumption.

Conclusion:

The recent MCI circular to doctors calling upon them to prescribe medicines in the generic names making them more affordable to patients, may be an important step towards a better future.

This assumes even greater importance when medicines constitute over 70 percent of the total treatment cost, especially for domiciliary treatment, and around 80 percent of total healthcare expenses is ‘out of pocket’ in our country.

However, the moot point is, the need of the hour calls for a total change in the mindset of all concerned. The importance of genuine care for the societal needs, while being in pursuit of professional excellence, in tandem, should ideally be demonstrated through voluntary measures by the concerned players in this area, leaving enforcement of stringent regulations as a last resort by the Government.

That said, while generic drugs per se are in no way bad for the patients, a careful analysis of all possible risk factors against expected benefits, especially for FDCs and different drug delivery formulations, will be important in the Indian perspective. Without effectively addressing the above issues, if prescriptions in generic names are made mandatory for all drugs, it could possibly be counter productive jeopardizing patients’ safety and interest.

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.