India’s drug regulatory agency, the Central Drugs Standard Control Organisation (CDSCO), is exploring a proposal to grant public access to a comprehensive database of all drugs marketed in India to tackle the issue of identical naming.
This database will enable pharmaceutical companies to search for existing brand names before submitting applications for registering theirs. The proposal says that if there are already brands in the market that are the same, similar, sound alike or look alike, the regulator will consider the first approved brand name valid for marketing.
Naming names
For instance, the drug known as Linamac 5 is prescribed for treating cancer, whereas another medication called Linamac is used for managing diabetes. Similarly, the drug Oxetol is used for bipolar disorder and epilepsy whereas the similar-sounding Exitol was used for treating constipation. Also, the drug Istamet is used for treating diabetes whereas another drug called Indamet is for treating asthma. Confusing these drugs at the pharmacy can have severe consequences for patients.
“It has been brought to the notice that a large number of drugs are being sold in India with identical brand names treating entirely different conditions,” said a document prepared by the CDSCO, accessed by News18. “The database of all the products with brand names in Sugam Portal may be made accessible to the general public…”
The consequences of confusion between these medications can be serious for patients as the doctors prescribe these drugs being sold under identical brand names for the treatment of different diseases, the government has realised as per the document.
To address the issue of identical brand names, the regulator is considering a proposal to make the Sugam Portal’s database of products with brand names accessible to the public. This will allow applicants to search existing brand names before submitting applications for endorsement, ensuring proposed names do not cause confusion or deception in the market.
Sugam is an e-governance portal launched by the government to enhance the regulatory framework for drug registration processes.
“…an applicant can search the existing brand names from this database along with search in other databases like the trade mark registry, literature and reference books on details of drug formulation in India and Internet, so that 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,” the document said.
“…Other brand name(s) of same, similar, sound alike, look alike etc., should not be marketed,” it said while adding that all the manufacturers should be directed to upload the formulation details along with the brand names on the Sugam portal.
Cases end up in courts, confusing consumers
Several such cases of similar-sounding brand names end up in Indian courts. For instance, Glenmark Pharmaceuticals versus Sun Pharma Laboratories where the appellant challenged the interim injunction against the use of the mark Indamet. “The trademark Istament was in use for a drug containing salts, ‘Metformin Hydrochloride’ and ‘Sitagliptin Phosphate Monohydrate’, and is used to treat diabetes,” explained the analysis published at Legal 500, a global publishing house focussed on legal matters. “Whereas, the mark Indamet is derived from the constituent chemical compounds, Inda from ‘Indacaterol acetate’ and ‘met’ from ‘Mometasone furorate’ and would need a dry powder inhaler or DPI device for its intake and is meant for asthma.”
According to the analysis by authors representing a law firm, Christine Chiramel and Prachi Sachar, the court cannot discount the potential for confusion or misunderstanding when ordinary consumers are faced with similar-looking prescription drugs, even if their therapeutic applications differ significantly.
They wrote that a purchaser of average intelligence cannot be expected to break down tradenames or undertake such an exercise at the time of the transaction.
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