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:
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:
- Are all generic medicines of dubious quality and branded generics are of good quality?
- If quality parameters can be doubted for both in many cases, why then raise this issue only in context of generic medicines?
- 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?
- 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?
- Why are the generic medicines available at ‘Jan Aushadhi’ outlets (though small in number) cost a fraction of their branded generic equivalents?
- Why do the doctors also not show much interest in prescribing generic medicines as of date?
- 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 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.
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.