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Govt amends D&C Rules to regulate brand names; cos need to furnish undertaking to avoid confusion over LASA drugs

Arun Sreenivasan, New Delhi
Thursday, February 28, 2019, 08:00 Hrs  [IST]

The Central government has amended the Drugs and Cosmetics (D&C) Rules of 1945 to include a provision for regulating brand names of pharmaceutical products. The move, aimed at helping doctors, chemists and patients avoid confusion, was recommended by the Drug Technical Advisory Board at its recent meeting.

Currently, the brand name or trade name of pharmaceuticals in the country is not controlled by the licensing authority or the Trademarks Office, which leaves scope for having same trade names for different drugs. The situation is detrimental to patient safety and the trade names which are repeated for different drugs can lead to medical errors.

As per the draft amendment issued on February 26, in Rule 71 of the D&C Rules, an additional sub-rule will be inserted to ensure that drug companies will not repeat the same trade names for different medications. “In case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking to the licensing authority that such or similar brand name or trade name is not already in existence so that the brand name or the trade name to be used by the applicant shall not lead to any confusion or deception in the market,” the new rule states.

There are many look alike, sound alike (LASA) drugs in India that would result in medication errors. These errors could cause harm or even death to patients. Last year, the Delhi High Court had directed the Drug Controller General of India (DCGI) and the state Food and Drug Administration (FDA) offices to implement an action plan to stop giving licences to drugs with identical or near identical brand names or marks. The court issued the directive in a trademark infringement lawsuit involving Curewell Drugs and Pharmaceuticals and Ridley Sciences. Vitamin B capsules marketed by both the companies had the same brand name, Bevital, which had prompted Curewell to file the suit against Ridley.

According to industry experts, trade names of medicine are given by many companies irrationally without any bearing on the therapeutic class, molecule and disease for which it is to be used. This irrational naming practice of branded medicine is confusing to healthcare professionals and patients alike, they say.

A recent such case involved a drug named Medzol. The Goa FDA issued an alert over the availability of two different pharmacological formulations being marketed under the Medzol brand name. The Medzol injection is used for conscious sedation, an awake but relaxed state of calmness during a medical test at an ICU. Another company has also released pantoprazole under the brand name Medzol. Pantoprazole is used for treating certain stomach and esophagus problems such as acid reflux.


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