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Ramesh Shankar
Wednesday, July 14, 2021, 08:00 Hrs  [IST]

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 over look alike, sound alike (LASA) drugs. In case the applicant intends to market the drug under a particular brand name or trade name, the applicant should ensure that such or similar brand name or trade 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 or trade 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 over LASA drugs. For instance, there was a case involving 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 had also released pantoprazole under the brand name Medzol. Pantoprazole is used for treating certain stomach and esophagus problems such as acid reflux.

But, the fact remains that there are many LASA drugs in India that can result in medication errors. These errors could cause serious harm to patients or even death. Errors in medicine use are attributed to the same brand name which comes about due to the absence of co-ordination between central-state regulatory authorities. Besides, there is no central database and monitoring by the Central Drugs Standards Control Organisation (CDSCO). This has resulted in identical brands being licensed in different states for different drugs. 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 creating confusion among healthcare professionals as well as the patients. Today, there is no record with the government on how many drug products are in the market with same brand names or similar sounding names and brands with changed compositions. The need of the hour is to have a separate wing under CDSCO to approve drug brand names to be marketed in the country, have a uniform control on brands movement which may not be possible by individual state regulators. This would be the only way to regulate the use of brand names pan-India to avoid any LASA medicines. Unless CDSCO does this to endorse all brand names, there may not be any solution in sight to tackle this issue. The Union Health Ministry should take initiatives to put in place a documentation system of registered drug brands which could substantially reduce chances of misbranding and wrong dispensing. This could ultimately help India to build a national registry of drug brand names.


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