New Delhi: The Drugs Consultative Committee (DCC), the advisory committee that advises the Central and state governments on matters that require uniform implementation of drug laws across the country, has recommended making the Sugam portal database of all the products with brand names accessible to the general public.
The recommendation, according to the Committee, is to address the issue of different drug formulations of different therapeutic categories being sold in the country in same or similar brand name that creates confusion in the market.
“The database of all the products with brand names in Sugam portal may be made accessible to the general public, so that when application for endorsement of brand name in Form 51 is submitted to SLA, they can search the existing brand names from this data base of CDSCO along with the trade mark registry, literature and reference books on details of Drug Formulation in India and Internet, such or similar brand names or trade name is not already in existence with respect to any drug in the country and the proposed brand names or trade names shall not lead to any confusion or deception in the market,” said the Committee in a recent meeting.
“Cases of existing same, similar, sound alike, look alike brands, if any available in the market should also be addressed by the concerned State Licensing Authorities with the help of such databases etc.,” added the Committee.
In case of existing brands with the same name available in the market, whoever has first submitted Form 51 under Drugs Rules, 1945 shall be allowed to continue the marketing and brand names of other manufacturers shall be withdrawn by the SLAs.
In other cases where Form 51 does not apply, the claim of being “First” shall be evaluated by the concerned SLAs on the basis of approval history and take appropriate decisions. In order to strengthen the database available with the drug regulator, all the manufacturers should be directed to upload the formulation details along with the brand names on the Sugam portal (as per rule 84AB), added the Committee.
The Drugs Technical Advisory Board (DTAB), in its 90th meeting held on January 25, 2024, recommended that the DCC meeting should deliberate the issue of the same brand name (including look alike and sound alike) for different categories of products in order to ensure patient safety. It also suggested that the opinion of the States may also be taken for having single licensing/approving authority in the country. Besides, it recommended writing a letter by the DGHS office to the trademark authority regarding strict implementation of brand name especially in case of medicines.
It may be noted that the National Human Rights Commission (NHRC), India, has taken Suo motu cognisance in February, this year, of a newspaper article published in January, that a large number of drugs are being sold in India with identical brand names for treating entirely different conditions. The Commission issued notice to the secretary, Union health ministry and the Drugs Controller General of India, in the matter.
“The Commission has observed that the contents of the article, if true, amount to a serious issue of human rights,” said a press release issued by the Commission in February. It sought the Ministry and the drug regulator to file a detailed report in the matter including steps taken or proposed to be taken to address the issue.
The Commission observed that according to the report, the consequences of confusion between these medications at the pharmacy can be serious for patients as these drugs are being prescribed by the doctors for treatment of different diseases. The Central Drugs Standard Control Organisation (CDSCO) needs to first build a database for all pharmaceutical brand names by collecting data from the 36 different Drug Controllers in each state and Union Territory as there is no such database in the country. Also, no data on prescription errors is being maintained by the authorities, it added.
The news article refers to cases such as use of brand name Linamac 5 for a cancer drug, while the name Linamac is used to treat diabetes. Similarly, the name Medzole is used by four different companies to sell four different active ingredients treating entirely different medical conditions. The article further elaborates on the use of similar trade names but companies which seem to be phonetically and visually similar, added the Commission.
