Suppose you are prescribed a drug for a particular diagnosis, say a simple headache, you discover that the medicine you bought has the correct brand name, the packaging is also more or less the same as the drug that you wanted to buy, however in reality and substance the drug is not the one that you wanted to buy, but an antibiotic. Won’t it amount to improper and defective treatment, or worse lead to harmful side effects? This is exactly where one of the biggest anomalies in the Indian drug regime lies.
The Drugs and Cosmetics Act, 1940 deals with the regulation of medicines and drugs. It does ban and punish manufacture, sale, distribution or import of misbranded, adulterated and spurious drugs. However, there is no specific provision regulating trade names in which drugs are sold.
Trade names of drugs are not controlled either by the licencing authority, or the trademarks office. There is, therefore, no restriction on the companies when it comes to manufacturing and selling different drugs under the same trade name.
Because of lack of any regulation, the Indian pharmaceutical market is full of such anomalies. Take for example the case of Vitamin B capsules sold by Curewell Drugs and Ridley Life Science. Both the companies use the same brand name, viz. Bevital. Then there can also be cases of two medicines having completely different uses, being sold in the same brand name. In such cases, patients who are laymen are at a constant risk of improper treatment and dangerous side effects on account of confusing brand names.
Medical practitioners have pointed out lack of any legislative safeguards to combat the anomaly of identical drug names for different drugs and how has resulted in undue hardships for patients. Dr Chandra M Gulhati, editor of the Monthly Index of Medical Specialities (MIMS) said, “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.” In a 2004 editorial, Dr. Ghulati had said, “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.”
The Modi government has now taken a historic step to resolve this anomaly in the drug law and the Health Ministry has proposed an amendment in the Drugs and Cosmetics Rules, in order to regulate brand names by the Central licensing authority. The Ministry has also issued a notification in this regard. The medicine companies will now, therefore, be restricted from selling medicines with identical brand names.
A senior government official said, “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.”
As per the proposed amendment, the manufacturers will now have to furnish an undertaking in Form 51 to the licensing authority. This undertaking would be 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.
In 2018, Curewell Drugs & Pharmaceuticals had sued Ridley Sciences for trademark infringement for its Vitamin B capsules. The Court asked the Drug Controller General of India (DCGI) and the state drug regulators to implement an action plan to ensure that drugs with identical or near-identical brand names were not licensed in order to ward off confusions. The Health Ministry now seems to have taken cognisance of this mischief, and therefore the Modi government seems all set to take a decisive step in the right direction.
The essence of the trademark law is to ensure that consumers are able to differentiate between different products. However, it is an absurdity how health companies have been allowed to sell different drugs in the same brand name. Patients need to be guarded in the pharmaceutical sector due to the very nature of the sector, and the fact that patients are usually laymen who cannot be expected to be able to differentiate between two different drugs under the same brand name. The Modi government is therefore set to end a historical anomaly and mischief by launching this new policy.
