|
The presence of look-alike and sound-alike (LASA) medicines in the pharmaceutical market in the country has been a major issue the drug authorities have been facing for a long time now. It is obvious that the use of same or similar brand name for drugs with different active ingredients will mislead consumers and create confusion regarding their therapeutic use. It is a fact that there are many LASA drugs in the country that can result in medication errors. These errors could cause serious harm to the patients. 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 medicine in India is confusing to healthcare professionals, pharmacists as well as to the patients. It is a fact that a large number of drugs are being sold in India with identical brand names treating entirely different conditions. Examples of such cases include ‘Olvance’, the brand name for the antihypertensive drug ‘olmesartan’, and ‘Oleanz’, a brand for the antipsychotic drug ‘olanzapine’. Another example is IMOX (amoxicillin tablets for humans) versus INIMOX (a combination of amoxicillin and cloxacillin as an injection for veterinary use). The consequences of confusion between these medications at the pharmacy can be serious for patients. There have been incidents where drugs used for female health, got permission for acidity control in some other State. This created huge medication errors. Due to all these issues, Delhi High Court in 2022 had ordered to the DCGI that he should constitute a central drug database which should be accessible to all the State drug controllers and only after crossing-checking the brand name, State authorities should give permission for drugs.
It is not that the government did not do anything on the issue. Earlier, way back in 2019, the Union Health Ministry had come out with a draft amendment to the Drugs & Cosmetics Rules, 1945 to include a clause where a manufacturer or applicant intending to market a drug under a brand name should furnish an undertaking that the brand name or the trade name used by them should not lead to any confusion or deception in the market. In case the applicant intends to market the drug under a particular brand name, the applicant should ensure that such or similar brand name is not already in existence in the market. By this amendment, the government wanted to regulate drug brand names as, till then, neither the licensing authority nor the trademark office regulated the drug brand name in the country. Because of this, there were chances of assigning similar trade names for different drugs which created confusion among medical practitioners as well as the patients. But, the fact remains that in spite of the government’s efforts during the last some years, there are still many LASA drugs in India that can result in medication errors. Under this background, the suggestion of an expert of the stature of Dr BR Jagashetty is relevant. As the issue is still being debated, Dr Jagashetty has recently stated that the CDSCO should maintain a registry of all branded drugs in a time-bound manner as it will avoid confusion in medicine dispensing across pharmacy outlets in the country thereby avoiding LASA medicines in the market. Establishing a comprehensive drug brand name registry that records every approved brand name along with its exact composition would enable systematic screening for confusingly similar names before market approval. Such a registry would strengthen the regulation of pharmaceutical branding and marketing practices, promote compliance with applicable laws, protect consumer interests, and enhance patient safety by reducing medication errors associated with LASA drugs.
|