The Central Drugs Standard Control Organisation (CDSCO) has initiated discussion with the stakeholders in the pharmaceutical industry on the use of same brand name with different extensions for multiple formulations. The central drug regulator’s action in this regard comes in the backdrop of a recommendation from the Drugs Consultative Committee (DCC) to carry out a stakeholder consultation on this issue. DCC, which is the advisory committee that advises the Central and state governments on matters that require uniform implementation of drug laws across the country, made this recommendation after considering a representation received by it in which it was alleged that a pharmaceutical company is marketing multiple drug formulations under the same established brand name with different extensions. After detailed deliberations, the DCC expressed concerns that the use of the same brand name for drugs with different active ingredients may mislead consumers and create confusion regarding their therapeutic use. It is a fact that there are many look-alike and sound-alike (LASA) drugs in the country that can result in medication errors. These errors could cause serious harm to patients or even death. It is true that trade names of medicine in India are given irrationally without any bearing and any relevance to the therapeutic class, molecule and disease for which it is to be used. This irrational naming practice of branded medicine in India is confusing to healthcare professionals, pharmacists as well as to the patients. One such case involved a drug named Medzol. The Goa FDA had some time back issued an alert over the availability of two different pharmacological formulations being marketed under the Medzol brand name. The Medzol injection is used for conscious sedation, an awake but relaxed state of calmness during a medical test at an ICU. Another company has also released pantoprazole under the brand name Medzol. Pantoprazole is used for treating certain stomach and esophagus problems such as acid reflux. This is not an isolated case as there are several such cases in the country.
Certainly, this kind of chaotic situation should not be allowed to continue in the pharmaceutical market in the country as this marketing practice often creates confusion among prescribers, pharmacists and patients, increasing the likelihood of medication errors and incorrect dispensing. It is a fact that brand names that differ only by a prefix, suffix, or modifier can be easily misread, misheard, or misinterpreted, particularly in busy healthcare settings. Sometimes, errors in medicine use are attributed to the same brand name which comes about due to the lack of co-ordination between central-state regulatory authorities. Besides, there is no central database and monitoring by the CDSCO. This has resulted in identical brands being licensed in different states for different drugs. There have been incidents where drugs used for female health, got permission for acidity control in some other state. This created huge medication errors. Now, the Union Health Ministry should take some decisive action to prohibit pharmaceutical companies from using the same brand name with different suffixes or extensions for multiple drug formulations. One brand has to be assigned to only one type of composition either single or multiple ingredient pharma product just like done in Trade Marks Act, 1999 for registration of brands. Requiring each formulation to have a distinct and unique brand name would strengthen medication safety, improve prescribing and dispensing accuracy, and reduce the risk of preventable adverse drug events. |