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How Relevant Is A Pharma Brand Name To Patients?

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Are brand names necessary for medicines? Well – its’s a contentious issue, at least, as on date. It becomes the subject of a raging debate when the same question is slightly modified to: – Are brand names necessary for prescription drugs?

The current reality is, almost all pharma companies believe, and have been following this practice. This has been happening for decades, regardless of the fact that unlike other branded non-pharma products, each and every drug also carries another specific name – the generic name. Which is why, questions are often raised, why can’t drugs be prescribed only in generic names by the doctors?

Before I proceed further, let me recapitulate the definition of a ‘brand’. One of the most comprehensive definitions of a brand is: Unique design, sign, symbol, words, or a combination of these that identifies a product and differentiates it from its competitors. It helps create a level of credibility, quality, and satisfaction in the consumer’s mind, by standing for certain benefits and value. And, the creative marketing practices followed in this process is termed as ‘branding’. Keeping this at the center, in this article, let me try to arrive at a relevant perspective on this subject.

The arguments in favor:

Votaries of pharma branding believe that a pharma brand helps establish an emotional connect with the consumers on various parameters, including quality, efficacy, safety and reliability. This is expected to establish a preferential advantage of a brand over its competitors. Quoting the ‘father of advertising’ David Ogilvy, some of these proponents relate the outcome of branding to offering ‘intangible sum of a product’s attributes’ to its consumers, and also prospective consumers.

Entrepreneur India puts across such favorable outcome of ‘branding’ very candidly, which is also applicable to branding medicines – both patented and generic ones. It says, “Consistent, strategic branding leads to a strong brand equity, which means the added value brought to your company’s products or services that allows you to charge more for your brand than what identical, unbranded products command.”

The general belief within the pharma industry is that, ‘branding’ facilitates doctors in choosing and prescribing medicines to patients, especially in those situations where the choices are many. Aficionados of pharma product branding argue, that to save time, doctors usually select those top of mind products, which they are familiar with and feel, can serve the purpose well. This belief prompts the necessity to go all out for ‘branding’ by the pharma companies, even when the process is an expensive one.

Where pharma ‘branding’ is necessary:

There are a few old publications of the 1980’s, which claim that studies based on human psychology have found that medicines with brand names can have a better perceived impact on the actual effectiveness of ‘Over the Counter (OTC)’ medications. One of the examples cited was of aspirin.

Be that as it may, the relevance of branding for OTC pharmaceutical products is undeniable, where a medicinal product is generally treated just as any other Fast-Moving Consumer Goods (FMCG) goods. Establishing an emotional connect of OTC brands with consumers is, therefore, considered an important process to create a preferential perceived advantage over its competitors.

There is no well-laid out legal or procedural pathway, as yet, for pharma OTC brands in India. No ‘Direct to Consumer (DTC) promotion is allowed in the country for Schedule H and Schedule X drugs – the only exceptions being Ayurvedic proprietary medicines and for homeopathy drugs. That said, the question continues to haunt, how relevant is branding for prescription drugs – now?

Relevance of ‘branding’ for prescription drugs:

The juggernaut of ‘branding prescription drugs’, riding mostly the wave of vested interests – of many hues and color, has been made to be perceived as necessary to ensure drug quality and safety for patients. It continues to move on, up until today, even for highly specialized prescription drugs. Nonetheless, some initiatives are visible from some Governments to gradually shift this contentious paradigm.

This move has been catalyzed by a blend of changing times with changing expectations of a large number of patients. They want to be an integral part in their treatment decisions, receive more personalized healthcare from both doctors and pharma companies. Patients, ultimately, want to feel confident that they’re receiving the best treatment – says a fresh study.

A number of other research papers also confirm that, a virtually static bar of patients’ expectations, in the disease treatment process – either for themselves or their near and dear ones, is slowly but surely gaining height, measurably. For better outcomes, patients have started expecting new types of services both from their doctors and the drug manufacturers. This process begins, even before a final decision is taken in the treatment process. As this paradigm shifts, pharma players would be significantly impacted – in several parameters.

Fast expanding digital empowerment options for all, across the world, is expediting this process further, including India. Placing oneself in the midst of it, one may ponder – how relevant is pharma branding today, as is being highlighted by many, since long.

In my view, a part of the answer to the above question arguably lies in a study titled, “Product Launch: The Patient Has Spoken”. The Key findings from the survey that covered 8,000 patients from three generations in the US, the UK, Germany and France, were published by ‘Accenture Life Sciences’ in January 2018. The research reveals how these patients evaluate and select new treatments in eight therapeutic areas (immune system, heart, lungs, brain, cancer, hormone/ metabolism and eye disease) across three generations, spanning across – Baby boomers, Generation X and Millennials.

Brands don’t matter to most patients…outcomes do:

69 percent of patients said, the benefits of the product are more important to them than the brand of the product. The four top factors influencing patients’ while making decisions about their healthcare are listed in the report as:

  • The doctor/ physician relationship: 66 percent
  • The patient’s ability to maintain their current lifestyle: 55 percent
  • Patients’ ease of access to health care they’ll need: 53 percent
  • Patients’ financial situation / ability to pay: 51 percent. When this is read with another finding where, 48 percent of patients believe that their doctors discuss the whole range of product options with them, a more interesting scenario emerges.

Further, lack of knowledge about the treatments available, as expressed by 42 percent of patients obviously indicate, pharma players’ intent to better inform patients by educating the doctors through brand promotion is not working. Interestingly, brand loyalty or popularity appeared relatively unimportant, ranking twelfth out of 14 influencing factors. Just 25 percent of patients characterized themselves as having a strong affinity with brands in a healthcare setting – the above report revealed.

Could there be an alternative approach?

An effective ‘branding’ exercise should lead to creating a ‘brand loyalty’ for any product. For pharma companies, doctors’ brand loyalty should lead to more number of its brand prescriptions. This expectation emanates from the idea that the prescription brand will represent something, such as quality, trust, assured relief, or may well be anything else. That means pharma product ‘branding’ is primarily aimed at the medical profession.

In an alternative approach to the current practice, an article titled, “From Managing Pills to Managing Brands”, published sometime back in the March-April 2000 issue of the Harvard Business Review (HBR), finds its great relevance, even today. It says, pharma companies can retain the loyalty of customers by building a franchise around specific therapeutic areas based on a focused approach to R&D. In other words, their corporate brand can replace individual drug brands. For example, a doctor looking for a treatment for – say asthma, would look for the latest GlaxoSmithKline medicines. Let me hasten to add, I used this example just to illustrate a point. This may appear as a long shot to some. Nonetheless, it would significantly reduce the cost of marketing, and subsequently the cost of a drug to patients. Incidentally, I also wrote about the relevance of ‘Corporate Branding’ in this Blog on June 15, 2015.

Conclusion:

With this fast-emerging backdrop, the Accenture Study raises an important issue to this effect. It wonders, whether the expenses incurred towards branding medicines, especially, during product launch be significantly reduced and be made more productive?

Illustrating the point, the report says, in 2016, the US pharmaceutical and healthcare industry alone spent US$ 15.2 billion in marketing. To earn a better business return, could a substantial part of this expenditure be reallocated to other programs that matter more to patients, such as access to patient service programs, and creating ‘Real-World Evidence (RWE)’ data that can document improved health outcomes, particularly those that matter to patients?

Well-crafted pharma branding and other associated initiatives, targeted predominantly to the medical profession, may make a doctor emotionally obligated to prescribe any company’s specific brands, for now. However, in the gradually firming-up ‘patient outcomes’-oriented environment, where patients want to participate in the treatment decision making process, will it remain so?

Dispassionately thinking, to most patients, a brand is as good or bad as the perceived value it delivers to them in the form of outcomes. Or, in other words, prescription pharma brands may not even matter to most of them, at all, but the outcomes will be. Hopefully, before it is too late pharma players would realize that, especially the well-informed patients are becoming co-decision makers in choosing the drug that a doctor will prescribe to them. If not, the current targeted process of pharma prescription drug branding, may lose its practical relevance, over a period of time.

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.

Pioglitazone Conundrum: Should The Drug Regulator Step Over The Line?

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Recent order of the Indian drug regulator to withdraw all formulations of the well known, yet controversial, anti-diabetic drug – Pioglitazone from the domestic market has created a flutter in the country, ruffling many feathers at the same time.

Withdrawal of any drug from the market involves well-considered findings based on ongoing robust pharmacovigilance data since the concerned product launch. To ascertain long-term drug safety profile, this process is universally considered as important as the processes followed for high quality drug manufacturing and even for R&D.

A paper titled, “Withdrawing Drugs in the U.S. Versus Other Countries” brings to the fore that one of the leading causes of deaths in the United States is adverse drug reaction. Assessing enormity and impact of this issue, the United Nations General Assembly for the first time in 1979 decided to publish a list of banned pharmaceutical products that different countries may use for appropriate decisions keeping patients’ safety in mind, as they will deem necessary from time to time.

An interesting finding:

Quite interestingly, the paper also highlights:

“There are a number of pharmaceuticals on the market in the USA that have been banned elsewhere and similarly, there are some drug products that have been banned in the United States, but remain on the market in other countries.”

Different policies in different countries:

The reason for the above finding is mainly because, various countries follow different policies to address this important health related issue. For example, though the United States will withdraw drugs based on the decision taken by its own FDA, it will also compare the action taken by countries like, UK, Japan, Australia and Sweden on the same subject.

However, many experts do believe that United Nations must take greater initiative to make all concerned much more aware about the UN list of dangerous drugs, which should be continuously updated to expect the least.

Need transparency in pharmacovigilance:

Pharmacovigilance has been defined as:

“The task of monitoring the safety of medicines and ensuring that the risks of a medicine do not outweigh the benefits, in the interests of public health.”

An article on Pharmacovigilance by A.C. (Kees) van Grootheest and Rachel L. Richesson highlights as follows:

“The majority of post marketing study commitments are never initiated, and the completion of post marketing safety studies (i.e., phase IV studies) declined from 62% between 1970 and 1984 to 24% between 1998 and 2003.”

Thus, in many countries, due to lack of required transparency in the pharmacovigilance process, harmful drugs continue to remain in the market for many years before they are withdrawn, for various reasons.

The above paper strongly recommends, “While there might be monetary benefits for each country in keeping these drugs on the market, the U.N. must step up the visibility of the withdrawal of dangerous drugs list.”

Recent Pioglitazone withdrawal in India:

Recently in India, the Ministry of Health under Section 26A of the Drugs and Cosmetics Act, 1940 has suspended the manufacture and sale of Pioglitazone, along with two other drugs, with immediate effect, through a notification issued on June 18, 2013.

As per the Drugs and Cosmetic Rule 30-B, import and marketing of all those drugs, which are prohibited in the country of origin, is banned in India. Just as in the United States, the Ministry of health, while taking such decisions in India, compares long-term safety profile of the concerned drugs in countries like, USA, UK, EU and Australia.

A Parliamentary Standing Committee of India has already indicted the drug regulator for not taking prompt action on such issues to protect patients’ treatment safety.

Pioglitazone: the risk profile:

In India:

A leading medical journal (JAPI) cautions:

“Given the possible risk of bladder cancer, physicians have to be extremely careful about using pioglitazone indiscriminately in the future.”

The JAPI article continues to state:

“We require more robust data on the risk of bladder cancer with pioglitazone and Indian studies are clearly needed. Till that time, we may continue the use of this drug as a second or third line glucose-lowering agent. In all such cases, the patient should be adequately informed about this adverse effect and drug should be used in as small a dose as possible, with careful monitoring and follow up.”

In the USA:

In 2011 The US FDA as a part of its ongoing safety review of pioglitazone informed physicians and the public that use of this drug for more than 12 months is linked to an increased risk of bladder cancer.

The USFDA review is reportedly based on “an ongoing 10-year observational cohort study as well as a nested, case-control study of the long-term risk of bladder cancer in over 193,000 patients with diabetes who are members of the Kaiser Permanente Northern California (KPNC) health plan.”

Based on this finding US FDA directed that physicians should:

  • Not use pioglitazone in patients with active bladder cancer.
  • Use pioglitazone with caution in patients who have a prior history of bladder cancer, adding, “The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.”
  • Tell patients to report any signs or symptoms of “blood in the urine, urinary urgency, pain on urination, or back or abdominal pain, as these may be due to bladder cancer.”
  • Urge patients to read the pioglitazone medication guide.
  • Report adverse events involving pioglitazone medicines to the FDA MedWatch program.

The moot point:

Considering the above US FDA directives in the Indian context, the moot point therefore is, whether it will be possible for the drug regulator to ensure that physicians and the patients in India follow such steps for drug safety with pioglitazone?

In Canada:

Another new Canadian study has again reportedly linked Pioglitazone with risks of bladder cancer and cautioned, “physicians, patients and regulatory agencies should be aware of this association when assessing the overall risks and benefits of this therapy.”

Pioglitazone and its combinations banned in France and Germany:

After a government-funded study, tracking diabetics from 2006 to 2009, concluded that Pioglitazone increases bladder cancer risk, the French Medicines Agency (FMA) announced withdrawal of Pioglitazone along with its fixed-dose combination with Metformin, as well.

FMA also advised doctors to stop prescribing Pioglitazone, plain or in combination, and asked patients, who are on this drug to consult their doctors immediately.

Simultaneously, German health authorities also acted on similar lines.

An intriguing comment by the Indian drug regulator:

Keeping all these in view, it is indeed intriguing to note that the Indian drug regulator is reportedly open to re-examine the case of pioglitazone and revoking its ban in India, if strong scientific evidences emerge in support of safety and efficacy of the drug.

However, the question then comes up is what more new scientific evidences that the Indian drug regulator is now expecting, especially when the pharmacovigilance studies are almost non-existent in India?

Moreover, such comments of the drug regulator not only prompt raising doubts about the fragility and hastiness of his own decision of banning Pioglitazone in India, but also amply demonstrate lack of seriousness in his part on this extremely important decision on drug safety?

‘Drug Product Liability Claims’ in India virtually non-existant:

In most of the developed countries, appropriate regulations are in place for product liability claims.

Under this law, if any patient suffers injury in any form while administering  a pharmaceutical drug, the patient concerned is eligible to make pharmaceutical-drug-based product liability claims, which usually involve a huge amount of money by any imaginable standard.

These claims are based on:

  • Improperly marketed pharmaceutical drugs. This category includes:

- Failure to provide adequate or accurate warnings regarding a dangerous side effect.

- Failure to provide adequate instructions on safe and appropriate use of the drug.

- The “bad advice”, which may have been given by the manufacturer or by a doctor, pharmacist, sales rep, or some other medical provider.

In the United States drug safety and effectiveness related litigations reportedly also include:

-        Criminal and civil complaints brought by the U.S. Department of Justice.

-        Lawsuits brought by state Attorney Generals and private plaintiffs under state consumer protection acts and other causes of action.

In India, closer to the above system there is a law in paper, named as “Products Liability”. This law deals with the liability of manufacturers, wholesalers, distributors, and vendors for injury to a person or property caused by dangerous or defective products. The aim of this law is to help protecting consumers from dangerous or defective products, while holding manufacturers, distributors, and retailers responsible for putting into the market place products that they knew or should have known were dangerous or defective. However, in reality, there are hardly any damages slapped by consumers on to the manufacturers in India under this ‘Product Liability’ law.

It may sound however bizarre, but is a hard fact that many drugs in Fixed Dose Combinations (FDCs) had never even gone through any form clinical trials on human volunteers before they were for the first time allowed to be marketed in India by the drug regulators.

In absence of any active steps taken by the government to educate and encourage patients to make use of this law, patients, by and large, would continue to pay a heavy price for their ignorance, keeping their mouth shut all the way, while using:

- Defectively manufactured pharmaceutical drugs.

- Pharmaceutical drugs with dangerous side effects.

- And even improperly marketed pharmaceutical drugs.

As stated before, it is worth repeating, neither is their any functional pharmacovigilance system in place in India.

Drug product liability suit for Pioglitazone in the United States:

Just to cite an example, one report indicates:

“According to court filings, all of the Actos (Pioglitazone) lawsuits pending in the Western District of Louisiana allege Takeda Pharmaceuticals failed to provide adequate warnings to doctors and patients regarding the drug’s association with an increased risk of bladder cancer. Last month (April, 2013), the nation’s first trial involving Actos bladder cancer allegations ended with a Los Angeles Superior Court jury awarding $6.5 million to a plaintiff who was diagnosed with the disease after taking the drug for four years”. However, the judge overseeing the case granted Takeda Pharmaceuticals’ request to set aside the verdict.

The report also indicates, ‘more than 1,200 Actos bladder cancer claims are pending in the Louisiana litigation. Additional Actos lawsuits have been filed in state litigations in California and Illinois.’

Indian doctors and manufacturers protest together against Pioglitazone ban:

It is equally intriguing to note, despite serious life threatening side-effect and restricted usage profile of Pioglitazone, as established internationally through robust and large clinical studies, both the doctors and the Pioglitazone manufacturers in India are urging the government to lift ban on this drug immediately, keeping the silent patient community in the front line, as usually happens all over.

A news report highlighted that ‘doctors flayed the ban on anti-diabetes drug Pioglitazone and requested the Centre to reverse its decision in interest of patients.’

Another media report highlighted, major drug makers are strongly opposing the move of the government to ban Pioglitazone, in India.

Conclusion:

Without generating another set of robust evidence proving contrary to what has been already concluded in the United States and EU based on strong supporting pharmacovigilance data, if the Indian drug regulator revokes the ban of Pioglitazone, it will be construed as a huge compromise with patients’ safety interest with this drug.

This issue assumes even greater importance, when the ‘drug product liability’ system is almost dysfunctional in India.

The other alternative of the drug regulator is to revoke the ban, wilting under combined pressure of the manufacturers and doctors and ask for safety warnings trying to emulate, as it were, what has been done by the US FDA.  

In which case, with full knowledge that it is virtually impossible for any one to comply with the above US FDA requirements in India, will the drug regulator not step over the line, yet again?

By: Tapan J. Ray

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

The ruckus over Clinical Trials in India compels Government tightening regulations before flooring gas pedal for regional leadership

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The subject of Clinical Trials in India has created a huge ruckus, mainly for wide spread alleged malpractices, abuse and misuse of the fragile regulations of the country by the players in this field. The issue is not just of GCP or other clinical trial related standards but more of ethical mind-set and reported rampant exploitation of uninformed patients even in case of trial related injuries or death.

The Bulletin of the World Health Organization (WHO) in an article titled, “Clinical trials in India: ethical concerns” reported as follows:

“Drug companies are drawn to India for several reasons, including a technically competent workforce, patient availability, low costs and a friendly drug-control system. While good news for India’s economy, the booming clinical trial industry is raising concerns because of a lack of regulation of private trials and the uneven application of requirements for informed consent and proper ethics review.”

Damning report of the Parliamentary Standing Committee:

Recently the Department Related ‘Parliamentary Standing Committee (PSC)’ on Health and Family Welfare presented its 59th Report of 118 pages in total on the functioning of the Indian Drug Regulator – the Central Drugs Standard Control Organization (CDSCO) in both the houses of the Parliament on May 08, 2012.

The report begins with the following observations:

Medicines apart from their critical role in alleviating human suffering and saving lives have very sensitive and typical dimensions for a variety of reasons. They are the only commodity for which the consumers have neither a role to play nor are they able to make any informed choices except to buy and consume whatever is prescribed or dispensed to them because of the following reasons:

  • Drug regulators decide which medicines can be marketed
  • Pharmaceutical companies either produce or import drugs that they can profitably sell
  • Doctors decide which drugs and brands to prescribe
  • Consumers are totally dependent on and at the mercy of external entities to protect their interests.

In this prevailing condition, the committee felt that effective and transparent drug regulation, free from all commercial influences, is absolutely essential to ensure safety, efficacy and quality of drugs keeping just one objective in mind, i.e., welfare of patients.

Some critical findings on the Drug Approval Process:

The PSC in its report made, the following critical findings, besides others:

  • “A total of 31 new drugs were approved in the period January 2008 to October 2010 without conducting clinical trials on Indian patients.
  • Thirteen drugs scrutinized by the panel are not allowed to be sold in the United States, Canada, Britain, European Union and Australia.
  • Sufficient evidence is available on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts.
  • Due to the sensitive nature of clinical trials in which foreign companies are involved in a big way and a wide spectrum of ethical issues and legal angles, different aspects of clinical trials need a thorough and in-depth review.”

Proper Auditing of Clinical Trials are lacking:

It is sad that that adequate focus on the ‘Clinical Trial Registry’ and even ‘Auditing of Clinical Trials’ is currently lacking in India, which are considered so important not only to maintain the credibility of the studies, but also to demonstrate their scientific integrity and ethical values.

Unfortunately, there seems to be many loose knots in the current clinical trial policy, practices and guidelines in the country, which require to be tightened by the Government to make the system efficient and transparent in the national endeavor of establishing India as one of the most favored destinations for global clinical trials.

Health Ministry recently responded:

Facing this stark reality and pressured by the Parliament, the government has recently demonstrated its intention of tightening the loose knots in the following two critical areas:

  1. Permission to conduct Clinical Trial
  2. Compensation of the Clinical Trial victims

A. “Permission to conduct Clinical Trial in India’ – the draft notification:

In response to the prevailing conundrum, ‘The Ministry of Health and Family Welfare’ of the Government of India issued a draft notification on 17th July, 2012 seeking stakeholders’ views on the ‘Permission to conduct Clinical Trial’.

The draft notification says that the licensing authority after being satisfied with the adequacy of the data submitted by the applicant in support of proposed clinical trial, shall issue permission to conduct clinical trial, subject to the following conditions:

  1. Clinical trial shall be conducted in compliance to the approved GCP Guidelines.
  2. Approval of the ‘Ethics Committee’ shall be obtained before initiation of the study.
  3. Ethical aspects of the clinical trial as described in the “Ethical Guidelines for Biomedical Research on Human Participants” published by the Indian Council of Medical Research (ICMR), shall be fully complied with.
  4. Clinical trial shall be registered at Clinical Trials Registry of India (CTRI) before enrolling the first patient in the study.
  5. Annual status report on clinical trial viz. ongoing or completed to be communicated to the said Licensing Authority.
  6. Any ‘Suspected Unexpected Serious Adverse Reaction (SUSAR)’ occurring during clinical trial shall be communicated within fourteen calendar days to the Licensing Authority and to the other investigator(s) participating in the study.
  7. In case of study related injury or death, the applicant will provide complete medical care, as well as, compensation for the injury or death and statement to this effect shall be incorporated in the Informed Consent Document. The details of compensation provided shall also be intimated to the licensing authority.
  8. The premises of sponsor/Clinical Research Organization (CRO) and clinical trial sites shall be open to inspection by the officer of Central Drugs Standard Control Organization (CDSCO), who may be accompanied by an officer of the concerned ‘State Drug Control Authority’ to verify compliance to the requirements of Schedule Y, GCP guidelines and other applicable regulation.
  9. The sponsor/ CRO, investigators shall allow officers of CDSCO who may be accompanied by an officer of the concerned ‘State Drug Control Authority’, to enter with or without prior notice, any premises of sponsor/ CRO, clinical trial site to inspect, search and seize any record, data, document, books, investigational drugs etc. related to clinical trials and provide adequate replies to any queries raised by the inspecting authority in relation to the conduct of clinical trial.

This area of the clinical trial regulations will be finalized after taking into consideration of all the comments received from the stakeholders within the specified period.

B. ‘Compensation of the Clinical Trial victims’:

To address the pressing issues in this area Central Drugs Control Organization (CDSCO) in August 3, 2012, published an interim “GUIDELINES FOR DETERMINING QUANTUM OF FINANCIAL COMPENSATION TO BE PAID IN CASE OF CLINICAL TRIAL RELATED INJURY OR DEATH”

The document articulates as follows:

“Presently there is no specific provision under Drugs and Cosmetics Rules for payment of compensation in case of clinical trial related injury or death of the subject. However, the Good Clinical Practice (GCP) Guidelines for Clinical Trials of India under para 2.4.7 provides that the research subject who suffers physical injury as a result of their participation in clinical trials are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability subject to confirmation from Ethics Committee. In case of death, their dependents are entitled to material compensation. Guidelines further provide that it is the obligation of the sponsor to pay the compensation.”

Such concerns were also raised in the Parliament and other forums regarding payment of compensation in the cases of injury or death, related to clinical trials.

CDSCO’s interim guidelines now prescribe an interesting formula, which will be used to arrive at the financial compensation for all clinical trial related injuries and deaths.

To assess right compensation for clinical trial related injuries or deaths following parameters have been mooted in the document:

  • Age of the deceased
  • Income of the deceased
  • Seriousness and severity of the disease, the subject was suffering at the time of his/her participation into the trial.
  • Percentage of permanent disability.

Prior to the above new interim guidelines of the CDSCO, there was no standardization for the financial compensation either for clinical trial injuries or for that matter even death. In the past, such compensation was expected to be decided by the ‘Ethics Committee’ on case to case basis.

As stated above, the above formula has been indicated to be an interim measure before the final notification comes into force after taking into consideration all stakeholders’ comments and suggestions on this very important subject.

Drawing a comparison with China:

Driven by the stellar economic growth together with its booming pharmaceutical industry have enabled China to position itself as an emerging hub for global clinical trials. Following are some examples of the key growth drivers in the clinical research space of China:

  • A large diverse treatment naive patient population
  • Significant cost arbitrage
  • Recent improvements in the regulatory standards
  • Reverse brain drain of Chinese-born scientists educated in the west
  • Changing disease profile
  • Incentives to conduct clinical research in the country

However, linguistic and cultural barriers that affect patient reporting, enrollment and other medical practices in China could work as major barriers to the growth of Chinese clinical trial sector.

Clinical Trials: A ‘China – India’ comparison

It has already been reported  that India is ahead of China as most favored destination for global clinical trials, although the latter is quite close and breathing on the neck of India and could well even zoom past the former, if appropriate robust regulations and their effective implementation are still not ensured in India.

I. Majority of the Top 10 Pharma Companies conduct higher number of trials in India

Sr. No. Company

Clinical Trials in India

 Clinical Trials in China
1

Astra Zeneca

10

10
2

BMS

17

6
3

Eli Lilly

17

12
4

GSK

22

14
5

J&J

20

13
6

Merck

8

5
7

Novartis

9

6
8

Pfizer

16

5
9

Roche

5

14
10

Sanofi

15

13

Total

139

98

(Source: clinicaltrials.gov, 26 Oct 2007)

II. India leads China and Russia in Cardiology and Diabetes trials

Therapy India (%) China (%) Russia (%)
Cardiology 5.38 4.93 4.48
Diabetes 3.05 2.09 2.65
Neurology 0.90 0.90 3.62
Oncology 1.59 1.01 2.32

With the highest number of diabetic patients in the World and a very large population of patients with cardiovascular disorders, India has the potential to be the destination of choice for clinical trials in these two therapy areas, as we move on.

(Source: clinicaltrials.gov, 26 Oct 2007)

III. India has a greater % of phase II and III trials while China has more of Phase I and IV

Clinical Trials in India

Clinical Trials in China
Phase I

4%

 Phase I

7%
Phase II

16%

 Phase II

9%
Phase III

65%

 Phase II

51%
Phase IV

15%

 Phase IV

33%

(Source: clinicaltrials.gov, 26 Oct 2007)

IV. Of the total Industry sponsored trials only 3.5% are carried out in India and 2.63% in China

Company

Global Trials

India + China

Astra

231

20

BMS

148

23

Eli Lilly

238

29

GSK

347

36

J&J

461

33

Merck

213

13

Novartis

440

15

Pfizer

389

21

Roche

302

19

Sanofi

209

28

Total

2978

237

 

India 3.50%
China 2.63%
Global 93.87%

India and China’s share in the Industry sponsored Global clinical trial market is miniscule

Source: clinicaltrials.gov

Overall increasing trend of Clinical Trials Initiated in India:

The following table will substantiate the above point:

Year

No. Of Clinical Trials

1999

1

2000

0

2001

6

2002

6

2003

11

2004

26

2005

141

2006

206

2007

220

2008

295

2009

189

(Source: U.S. NIH, Pharmexcil Research)

India has the potential to accelerate its pace of growth significantly:

If robust regulatory measures are put in place, addressing serious concerns on the inadequacy of clinical trial regulations in India, together with uniform requirements for informed patients’ consent and appropriate ethics review, global pharmaceutical majors can be easily attracted to India for several reasons like:

  1. Technically competent and English speaking workforce,
  2. Patient availability and huge pool of naive patients
  3. Low costs and an improving drug-control system.

Thus, quite a number of criteria, as stated above, favor India to establish itself as a global hub for clinical research. Besides, availability of a number of government-funded medical and pharmaceutical institutions with state-of-the-art facilities could be very useful for mufti-centered clinical trials in the country.

Moreover, the cost to conduct a trial in India is lower by almost 50% – 75% than in the United States or in the EU. In addition, a good communication link favors quick recruitment of patients and faster regulatory approvals. Thus, clinical trials in India could be concluded faster, offering a sharp cutting edge for effective competition.

Due to all these reasons, India is gradually attracting more collaborative contract clinical research proposals in the country. Even many global Clinical Research Organizations (CRO) have already started establishing their set up in India. This pace can be accelerated significantly with the regulatory measures, as stated above.

Conclusion:

Clinical trials are the core of research-based pharmaceutical industry. No new drug can come into the market without clinical trials, which involve both potential benefits and risks to the participants. All clinical trials are conducted with the primary aim of bringing to patients new medicines with a favorable benefit–risk ratio.

Global clinical trials being relatively new to India, no wonder there are several misconceptions on the subject. The companies conducting research need to proactively publicize their commitment to protecting the rights, safety and well-being of trial participants.

All concerned must ensure that the proposals for clinical trials are approved by the government regulatory authorities before commencement and the trials must strictly follow the prescribed norms and procedures. For Phase I-IV human trials, the rights and privileges of the participants must be explained and the trials should commence only after their informed consent. The regulatory authorities, at the same time, should also ensure that any attempt of shortcuts or to bend the system by any means is met with severe consequences.

Although the Ministry of Health has already started initiating some action, as stated above, there is an urgent need for the players in this field to reassure the public, in general, about the high ethical standards that the pharmaceutical companies and Clinical Research Organizations require to comply with and continuously practice, while conducting clinical research.

It is therefore, high time for the Government to tighten the loose knots of the Clinical Trial regulations in the country before flooring the gas pedal to help India surging ahead as a major hub in the clinical trials space of the world, significantly distancing itself from China.

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.