On February 26, 2019 Central Government published draft amendment to the Drug & Cosmetic Rules, 19451 (the 'Rules') to include a clause where a manufacturer / applicant intending to market a drug under a brand name shall furnish an undertaking that the 'brand name or the trade name' used by them shall not lead to any confusion or deception in the market over look alike, sound alike (LASA) drugs.

At present, neither licensing authority nor trademark office regulates the brand name or trade name. There are probabilities of assigning similar trade names for different drugs which may create confusion to medical practitioners or patients over LASA drugs.

There are many LASA drugs in India that can result in medication errors. These errors could cause harm to patients or even death. Recently, the Hon'ble Delhi High Court directed the Drug Controller General of India (DCGI) and the state Food and Drug Administration (FDA) offices to implement an action plan to stop giving licenses to drugs with identical or near identical brand names or marks. The court issued the directive in a trademark infringement lawsuit involving Curewell Drugs and Pharmaceuticals and Ridley Sciences. Vitamin B capsules marketed by both the companies had the same brand name, Bevital, which had prompted Curewell to file the suit against Ridley.

The Government has proposed Drugs and Cosmetics (Amendment) Rules, 2019 wherein rule 71 A [for the renewal of the license for products or drugs other than those specified in [schedules c, c (1)] and rule 76 [manufacture for sale or for distribution drugs specified in Schedule C and C(1) excluding drugs specified in Schedule X or of Large Volume Parenterals, Sera and Vaccine and recombinant DNA (r-DNA) derived drugs] the following sub-rule shall be inserted, namely:-

"In case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking to the licensing authority that such or similar brand name or trade name is not already in existence so that the brand name or the trade name to be used by the applicant shall not lead to any confusion or deception in the market."


The draft amendment in Drug and Cosmetic Act once finalized, will expect to control irrational naming practice of branded medicines and will increase the chances of patient safety by removing LASA factor.


1. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDExNw==

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