Last Updated on November 11, 2019 by The Health Master
The Drugs Controller General of India (DCGI) has directed all manufacturers to furnish an undertaking in Form 51 to the licensing authority that respective company is not marketing similar brand names of any drug in the country so that the proposed brand name or trade name of the respective company could not lead to any confusion in the market.
A detailed format to implement the same has been notified in Form 51 as per amendment in Drugs and Cosmetic (D&C) Rules 71(9), 71A(5), 71B(v), 76(11) and 76A(v).
The manufacturer has to submit the form of undertaking to the licensing authority for marketing a drug under a brand name or trade name clearly mentioning name of the drug, dosage form and composition to avoid any confusion or deception in the market.
In a recent gazette notification, DCGI has stipulated that the concerned manufacturer has to mandatory furnish knowledge based on search in trade marks 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.
Now, therefore, in exercise of the powers conferred under sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board (DTAB), hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945 namely the Drugs and Cosmetics (Thirteenth Amendment) Rules, 2019.
In the Drugs and Cosmetics (D&C) Rules, 1945 (hereinafter referred to as said rules), in rule 71, after sub-rule (8), the following sub-rule shall be inserted, namely: “(9) In case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking in Form 51 to the licensing authority.
DCGI had in May this year had also directed state drug controllers (DCs) not to allow companies to market drug formulations in which the composition has been changed while retaining the old brand name in the interest of patient safety.
In the circular sent to all central and state regulators’ offices on May 16, 2019, DCGI said that his office has received information from across the country that some drug manufacturing companies, after changing the active pharmaceutical ingredients (APIs) of a drug formulation, still continuing with marketing the products in the old registered brand names.
The formulations in old brand names were being manufactured with different APIs. The DCGI asked the regulatory officers to curb this unethical tendency of the manufacturers because it confuses both the prescribers and patients.
DCGI reminded the drug controllers that this issue was discussed repeatedly in three Drugs Consultative Committee (DCC) meetings held on December 10, 2008, October 20, 2010 and February 15, 2011.
In all the three meetings, the experts found that this practice of the manufacturers was a serious issue and needed to be stopped with legal measures. He informed them that the change of formulation compositions without changing the brand names is not only misleading but also resulting in undesirable pharmacological effects as the consumer would take the formulations assuming that it was made with earlier compositions.