Natl Branding Code 4 OIOP
Drug names need a National Branding Code
• Recently, the New Delhi High Court ruled that medicines having the same composition but produced by different manufacturers cannot have deceptively similar names. The order was passed in July this year, in a trademark infringement suit filed by Stiefel Laboratories, Inc. Stiefel
which owns the trademark Clindoxyl had dragged Ajanta
Pharma Ltd. which had launched a me-too brand initially under
the name Clinoxid and later christened as Clinoxide and Clinoxide – A.
• Earlier, in January 2008, the Bombay High Court in another matter beween Wyeth Holdings Corporation, (Folvite) v/s Burnet Pharmaceuticals Pvt Ltd disallowed the latter's move to change the name of its medicine from Folacid to Fol-V. The judges ruled that the brand ‘Fol-V’ being deceptively similar to their brand Folvite, it infringes on the latter’s trademark.
Relying on a SC judgment, which held that deceptive similarity in the case of medicinal products must be dealt with a greater degree of strictness in order to protect public from the serious consequences that may ensue, Justice D.Y.Chandrachud
restrained Burnet from using the mark Fol-V.
• In yet another matter Bombay High Court, in 2004, restrained Sun Pharmaceutical Industries from marketing Parkitane which has ingredients identical and the name sounding similar to Pacitane, a brand owned by Wyeth Holdings Corporation for over 5 decades.
These three judgments are a representation of the total number of suits filed across various courts in the country relating to confusing brand names of drugs. In spite of these judgements, several brands are available in the market even today with barely a few spellings different. It also brings into sharp focus the sorry state of drug branding and registration in our country.
Very often when a pharmaceutical representative introduces a new brand to a physician in his clinic, the former is immediately able to recall a similar (spelt or sounding) brand already in the market. Yet, the manufacturer seems to be surprisingly unaware of the existence of the other brand. Under the circumstances, one can safely conclude that, either the regulatory or the licensing authorities are sitting with blinkers on.
There are numerous brands in the market which have similar spellings or whose names sound similar when shouted out. Every year around 25% prescriptions are erroneously dispensed globally.
Unclearz case report!
In 2005, a case report published in the Journal of Postgraduate Medicine vividly highlighted the pathetic scene that unfolded in a doctor’s cabin. The report mentioned the case of a 52-year old lady who visited a private skin clinic complaining of intense itching, redness and swelling of both cheeks of three days duration. Enquiry revealed that she had applied an ointment on the cheeks for a harmless, dark patch on the cheeks. She had been prescribed the medication by her dermatologist so as to treat the patch of dark skin which she was not comfortable with. The physician diagnosed her current state to be a case of Allergic Contact Dermatitis to the suspected local medication and treated with appropriate medicines.
When the lady returned to the clinic the subsequent week, the skin specialist noted that the offending agent was Clindamycin phosphate 1% w/w in a gel base which the patient had rubbed vigorously into her ageing, dry skin. A close scrutiny of the original dermatologist’s prescription revealed no mention of clindamycin gel at all! She was in fact prescribed a totally different cream as a fading agent. From a comparison of the dispensed gel and the prescription it was concluded that she had been erroneously dispensed the phonetically similar brand (Clearz cream instead of Clear gel)!
Fortunately for the patient in question, the confusion in brand names resulted only in an allergic rash on the skin and not any life-threatening drug reaction, like Stevens-Johnson’s syndrome. Unknown to us there would surely be cases of similar confusion occurring sometime, somewhere in the corners of our country resulting in more dangerous consequences to some unfortunate patient.
An earlier report published in the Indian Journal of Pharmacology mentioned the case of a patient who was dispensed Unicontin (an anti-asthmatic) instead of Indicontin (antihypertensive) that was prescribed.
A general browsing of any of the drug indices available in the country will unravel the shocking similarities between unrelated generic compounds. It is incredible that the manufacturers concerned were unaware of the prior availability of drugs with similar sounding names before their own brand was launched. According to another study published in the March 2005 issue of Journal of Postgraduate Medicine, there are more than 8000 brands of drugs available in the country. A very large number of them have similar sounding or similar looking names, which is a reason for major concern among the prescribing physicians.
There are several look-alike brands e.g. Rinitrin & Ranitin; Coxid & Coxib; Eltocin & Eltroxin. It would be shocking for our patients to know that these pairs of drugs are for totally distinct illnesses. For instance while the first brand is an anti-allergic drug, its namesake is used for acidity! Similarly, Clear gel is a cream for treating pimples while Clearz cream is for removing dark patches from the skin.
Most patients in our country would quietly walk home with the drugs dispensed by the chemist. .Most chemist’s counters are managed by school-dropouts who fill in for the mandatory pharmacist and are barely in a position to make sense of the prescription. To make matters worse, most physicians do not bother to write prescriptions neatly – lest people hold him in low esteem! It is a miracle how our medical system works in the face of such patent bewilderment when it comes to interpreting a physician’s prescription. .
Practicing doctors are deeply perturbed by our system of registration of pharmaceutical brands. One expects that any manufacturer desirous of marketing a new brand would apply to the authority concerned who would verify the existence of the proposed name or an identical sounding brand from the list of registered brand names. One wonders whether the appropriate officer at the Trade Marks Authority or Drugs Controller General of India verifies whether a new name allotted to a drug is either similar looking
or similar sounding to an existing brand.
Under the currently laid out procedure, the company desiring to get a name for a drug simply sends the proposed brand name to the registering authority of the state and if no objections are filed within a stipulated period, the manufacturer is free to use the brand name. Very often, after the brand is launched by the company, they learn that a similar sounding / looking drug is already marketed from some other state. Eventually, it is the unsuspecting patient who is at the receiving end.
The Ministry of Commerce and Health & Family Welfare should own up responsibility for their faux pas and have a nationwide registry of brand names of drugs. In addition, as a first-step towards remedial action, it should take a close look at all recently launched brands and insist on the manufacturer to register afresh the confusing brands. There is also a definite need for a procedure to be put in place where a
physician or a medical association can recommend
alteration of a brand name if there is genuine similarity.
For a long time now, patient’s rights have been taken for granted. Physicians seem helpless as individuals to sort out the mess created by a chaotic branding system. It is for the physician’s associations to take up issues on behalf of the patients
to get the entire naming procedure streamlined.
Most physician associations are “welfare” associations for their members and the office bearers are usually preoccupied with meeting the Health Minister for increasing the number of question papers for the medical graduate exams.
Their main aim is to get their speciality or sub-speciality into the spotlight. It would be worthwhile for these bodies to act as watchdogs and recommend discrepancies in the branding exercise. They could advise the pharmaceutical companies as well as caution the Trade Mark Authority about new drug names which are potentially confusing.
A firm guideline needs to be drawn up to prevent two drugs from having similar looking or similar sounding names. They should not differ just by one alphabet, syllable, suffix or prefix. There should be absolute clarity and differentiation of any two drugs whether the names are spoken or written.
It needs no genius to point out that a great chunk of our population is illiterate, living in rural areas and it is these unfortunate ones whose health will be at stake if we do not strengthen the foundation of our drug industry. If an elderly lady’s temporary skin allergy can upset everyone’s mood in a physicians consulting room, imagine what would happen if a wrongly dispensed brand were to claim somebody’s life. One hopes that we need not have to wait for more catastrophe to occur before corrective action is taken.
In one of the cases the judge held that “public interest lies in protecting the consumer against an unwary purchase of a deceptively similar product. The consumer must be protected against a reasonable possibility of confusion arising out of a deceptively similar mark.” In the light of the above, it would only be appropriate for the pharmaceutical industry to take a close, hard look at all the available brands that could give rise to such confusion and formulate a ‘Branding Code for Drugs in India’ (see Table 1) to prevent future pitfalls. The Drug Controller General of India could issue a directive to recall all such confusing brands within a reasonable period of time if the manufacturers fail to alter their brand names under the common code.