Regulatory authorities have informed that drug manufacturing companies have to now mandatorily give an undertaking in Form 51 as per Drugs Act to the state licensing authority (SLA) for marketing a drug under a brand name or trade name after making change in active pharmaceutical ingredients (APIs) in the interest of patient safety.
They have also recommended that there is also a need for manufacturers to adopt usage of same brand name with suitable prefix or suffix if the product with changed composition belongs to same therapeutic segment.
Experts say that there need to be awareness on this subject in order to rule out any confusion in the minds of physicians or prescribers and to also prevent risk posed to the patient’s safety.
State Drug Controllers (SDCs) have raised an alarm about discouraging the practice of using or retaining same brand name even after change in APIs by drug manufacturing companies for patient safety.
As per Form 51 under the Drug Rules, the undertaking on behalf of the manufacturer will state that to the best of my knowledge based on search in trademarks registry, central data base for brand name or trade name of drugs maintained by Central Drugs Standard Control Organisation (CDSCO), literature and reference books on details of drug formulations in India, and internet, such or similar brand name or trade name is not already in existence with respect to any drug in the country and the proposed brand name or trade name shall not lead to any confusion or deception in the market. The undertaking besides mentioning the place and date should also mention signature, name, designation seal/stamp of manufacturer or on behalf of the manufacturer,” Former Drug Controller and Regulatory Expert O S Sadhwani informed.
In order to curb the practice of retaining the same brand name of drugs after changing the composition of the APIs in the new formulation or fixed dose combination (FDC), Drugs Controller General of India (DCGI) had issued a circular to all State/UTs Drugs Controllers dated May 16, 2019 to discourage such type of practices and ensure that the same brand name should not be permitted to be retained by the manufacturers, if the composition of the API(s) in the new formulation is changed.
Giving further clarity on the subject, Nilesh Gandhi, Former Assistant Commissioner, Maharashtra Food and Drug Administration (FDA), “State Drugs Controllers (SDCs) issue product licenses in generic names in view of directions issued by the Government of India under section 33p of Drugs and Cosmetics (D&C) Act, 1940. In absence of the brand name repository with the composition, it’s difficult to enforce the directions issued by the DCGI about use of same brand name after change in API.”
The Indian Drug Manufacturers Association (IDMA) had also proposed to the government that brand name of medicines be allowed to be retained if change of API formulation is in same therapeutic segment with suitable prefix or suffix in an existing brand name for patient safety.
In a circular sent to all central and state regulators offices on May 16, 2019, DCGI had stated that his office has received information that some drug manufacturing companies, after changing the APIs of a formulation are still continuing with marketing the products in the old registered brand names.
The drug regulator stated that the practice of changing the key therapeutic ingredients in a drug formulation without changing the brand name “is not only misleading but may also result in undesirable pharmacological effects as the consumer would take the formulation assuming that it has the earlier composition.” It had asked SDCs to take “all measures” to prevent companies from retaining the same brand name for different formulations.
The apex drug regulator’s move aims at preventing patients from accidentally taking the wrong medicine in cases where pharmaceutical companies change the composition of their drug brands, but continue to sell the new formulation under the old brand name.