- 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 Supreme Court 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.
These above cases are a mere 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 judgments, several brands are available in the market even today with barely a few letters differentiating one from the other. 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. Every year around 25% prescriptions are erroneously dispensed globally.
The Clearz 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 for a harmless, dark patch on the cheeks on the recommendation of her dermatologist. The physician diagnosed her current state 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.
Perilous twins
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 a 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: for instance, Rinitrin and Ranitin; Coxid and Coxib; Eltocin and Eltroxin. It would be shocking for 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.
The Indian scene
Most patients in our country accept drugs dispensed by the chemist. Most chemists’ 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!
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 firststep towards remedial action, it should take a close look at all recently launched brands, and insist that the manufacturer 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.
Proposed branding code for drugs in India
- In a single generic category, no drugs should have any more than fi rst three alphabets similar
- If the brand name is of five alphabets or less, not more than two alphabets should be similar
- Irrespective of generic names, not more than three brands should be permitted with similar ‘beginner‘ alphabets
- If names of more than one generic category begin with somewhat identical spellings, the subsequently launched drugs should have distinctly different spellings, including the fi rst three
- The above system should also be followed for the last five alphabets in different generic classes. (e.g. Ketoconazole / Metronidazole / Miconazole)
- If brand extension is launched, the added suffi x should be highlighted and the generic name should be bolder than the brand name
- Its presentation, packaging and colour scheme should make it look different from the original brand
- Unless the generic compound is identical, oral agents, inhalants, injections and locally applied medicaments should not have identical brand names
- In addition to similarity in spellings no two brands should have identical phonetic (similar sounding) names.
Corrective measures
For a long time now, patient’s rights have been taken for granted. It is for the physicians’ 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.
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. 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 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 box). 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.
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Dr. T.D. Rajan
The writer is a senior skin and sexually transmitted diseases specialist, practising in Mumbai. He advises pharmaceutical companies on drug branding, promotion and marketing. He is a writer on social topics in the print and electronic media, as well as in pharmaceutical magazines. Dr. Rajan is also an hon. consultant to ONGC, Larsen & Toubro and Air India.[/column]