NEW DELHI: Have you ever bought a medicine only to return home and discover that the brand name is correct, the packaging is same, but the drug is not what you wanted? The brand name Medzole, for example, is used to market different kinds of medicines.
It could be an anti-fungal and also an antibiotic. Vitamin B capsules by Curewell Drugs and Ridley Life Science have the same brand name Bevital. There are many such instances that often pose the risk of improper treatment if it goes unnoticed. The government has geared up to resolve the confusion, restricting companies from using same brand names for different drugs. The health ministry has proposed to make an amendment in the Drugs and Cosmetics Rules to include a provision for regulating brand names by the central licensing authority and has issued a notification on this.
“The companies get approval for their drugs on the generic name, which leaves room for duplication. Once the new notification comes into effect, the companies will have to get the trade names registered and also certify to the government that to the best of their knowledge there is no other product available in the market with the same brand name,” a senior government official said.
The manufacturer will have to furnish an undertaking in Form 51to the licensing authority to the effect that a similar brand name is not in existence and it would not lead to any confusion or deception in the market.
Trade names of drugs are now controlled neither by the licencing authority, nor the trademarks office, which leaves the companies free to manufacture and sell different drugs under the same trade names. The top drug advisory board had discussed the matter in November last year and suggested amendment to the Drugs and Cosmetic Rules 1945 to include the provisions for regulating brand names/ trade names by the Central and State Licensing Authorities.
Earlier in 2018, Curewell Drugs & Pharmaceuticals had filed a trademark infringement lawsuit against Ridley Sciences for its Vitamin B capsules. The court hearing the plea asked the Drug Controller General of India (DCGI) and the state drug regulators to implement an action plan in which drugs with identical or near-identical brand names or marks are not given licences to ward off confusions.
“There is no central or state law specific to the use or registration of brand names of medicines as it is for consumer items like telephones, cars and air-conditioners,” said Dr Chandra M Gulhati, editor of the Monthly Index of Medical Specialities (MIMS).
Dr Ghulati had written an editorial in 2004, 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 and meant for hyper sensitives,” he wrote.
The notification to regulate the brand names of drugs is much needed considering patient safety and compliance,” said Sunil Attavar, president of Karnataka Drugs and Pharmaceuticals Manufacturers’ Association (KDPMA). “Since we moved to the licences being issued in the generic name, there is absolutely no control on the brand names used and could have led to some serious consequences.
However, we will need to see how well it can be implemented as we do not have a validated central database of brand names, the licences for drugs are issued by the states. It will be good to see the method for confirmation and what is the document of proof that the state licensing authorities will rely on to approve a brand as otherwise it could lead to many legal issues,” he said.