Soon, trade names of drugs may be regulated
India’s top drug advisory board will discuss the issue of branding names of drugs in a meeting on Thursday
Drug pharma companies may not be able to repeat the same trade names for different drugs, after changes to rules aimed at helping consumers avoid confusion. The central drug regulatory authority is likely to amend the drugs and cosmetics rules to include a provision for regulating brand names by the central licensing authority, said two people aware of the matter.
Currently, trade names of drugs are neither controlled by the licencing authority nor the trademarks office.
India’s top drug advisory board will discuss the issue in a meeting on Thursday. Health officials said the move can help ensure patient safety. “Too many medicines in India are being sold under similar brand names, putting patients at risk,” said the first person cited above.
The Union health ministry held a meeting on 13 November to discuss the issue of brand names and trade names of pharmaceuticals, concluding that it is neither controlled by the licensing authority under the drugs and cosmetics Act nor the trademarks office, which leaves companies free to manufacture and sell different drugs under the same trade names.
“Since it is not mandatory to register brand names, there are two classes of trade names in India: registered and unregistered. A huge majority of brand names are unregistered allowing manufacturers to use such brands without violating any law. However registered brand names cannot be used for the “same class”. For example if Crocin is registered for paracetamol i.e. a drug, then it cannot be used for any drug. But Crocin can still be used for say bicycles or shoes,” said Dr Chandra M Gulhati, editor, Monthly Index of Medical Specialities (MIMS).
Dr Gulati had in 2004 written an editorial citing how same trade names can create problems for patients. “A prescription was written for Lona, a brand name of anti-epilepsy drug clonazepam. The patient was sold Lona, exactly as prescribed but it contained low sodium salt marketed by another company,” he wrote.
“The solution lies in having a national law on the use of brand names. For immediate, urgent solution to ensure patient safety, the Drugs and Cosmetic Rules can be expanded to cover the use of brand names for pharmaceuticals,” he added. Stating that it’s the responsibility of the licencing authority to ensure that no issues are left unaddressed which have a bearing on the safety, efficacy or quality of drugs, hence the health ministry decided to take immediate action. “The matter will be taken by the drug technical advisory board in its meeting on Thursday,” said the second person.
Sunil Attavar, president of Karnataka Drugs and Pharmaceuticals Manufacturers’ Association (KDPMA), said that from a patient and doctor perspective, it was a long overdue step.
“We welcome the proposal to submit the official trade mark search report when applying for a licence. This will prevent duplication of trade names and potential grave risk to patients as we have seen some products with similar names with different active ingredients. This will require a change in law as currently the licences are issued to the generic name and companies are free to use any brand name. With a common registry of names and an online process, it is now quite easy to get an official search report and hence the industry should welcome it.”
However, according to him the bigger challenge will be to get all the existing brands online, many of which are being marketed without registration, as otherwise it will render the process useless as the official report will give an all clear whereas some similar brand which has not been registered is still in the market.
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