Home  >  Editorial
you can get e-magazine links on WhatsApp. Click here
+ Font Resize -


Ramesh Shankar
Wednesday, June 15, 2022, 08:00 Hrs  [IST]

The Delhi High Court has recently issued notice to the Drug Controller General of India (DCGI) seeking clarification on the steps it has taken pursuant to a 2019 order which directed measures to ensure that medicines with identical brand names and identical packaging are not allowed to be manufactured or marketed in the country. The Court was hearing a suit filed by Sanofi India against Ridley Life Science, in which Sanofi alleged that the latter continued to sell its products Conciflam and Coriflam, despite the injunction order passed on May 31, 2021. Sanofi alleges that these brand names are identical to its painkiller medicine Combiflam. Earlier on February 6, 2019, while hearing such cases, the Court had directed the national drug authorities to consider various measures including creation of a secured platform under the supervision of DCGI, accessible to all State drug regulators, for access and uploading of data. It directed the drug authorities to create a master electronic database of all the approved brand names for manufacture and sale of drugs issued both by the DCGI and State Food and Drug Administrations (FDAs) and making the same available to all the State FDAs and drug controllers. The Court further directed that the list has to be maintained and made available both brand wise and manufacturer wise, on the secured platform and the list of registered Trade Marks under Class 5 for pharma and medicinal preparations should be obtained from the Controller General of Patents, Trade Marks and Designs and be made to the due approving authorities and it should be updated bi-annually on January 1 and July 1, every calendar year. The Court observed that if the products are sold with identical brand names, especially for different pharmaceutical compositions, the result could be life threatening to a patient and opined that the DCGI and State drug regulators should implement an action plan.
It is a fact that there are many drugs with identical brand names in India that can result in medication errors. Some of the names are dangerously similar. There are around 10,000 brands of drugs available in the country. And several of them have similar sounding or similar looking names, which is a reason for major concern among the prescribing physicians as there are chances of medical errors. These errors could cause serious harm to patients or even death. It is true that brand 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 as well as to the patients. It was under this background, the Central Drugs Standards Control Organisation on February 26, 2019 brought out 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 aimed to regulate brand names as neither the licensing authority nor the trademark office regulates the brand name or trade name in the country. But, the fact remains that there are still many drugs with similar brand names in India that can result in medication errors. Today, there is no record with the government on how many drugs 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.


Post Your commentsPOST YOUR COMMENT
* Name :     
* Email :    
  Website :  
Copyright © 2016 Saffron Media Pvt. Ltd |