India: Regulating Brand/ Trade Names For Pharmaceuticals

Last Updated: 21 March 2019
Article by Essenese Obhan and Meetali Agarwal

The branding of a new drug by pharmaceutical companies is a crucial decision for the success of that drug in the market. However, the present regulatory regime in India does not provide any rules or guidelines for selecting a brand/ trade name for a pharmaceutical drug in India. Often, the absence of such guidelines leads to fly-by-night operators or smaller traders attempting to brand their products as closely as possible to the trademark of a reputed drug, even if they do not share characteristics or have the same active ingredient(s). This creates confusion amongst health professionals and pharmacists alike, which further has the potential to endanger the lives of patients and consumers.

It is no surprise then, that Indian courts have frequently called for the need for regulatory oversight over the branding of drugs proposed to be manufactured. Acknowledging the public interest in the issue, the Supreme Court has laid down that the test for similarity of names between medicinal products requires a lesser threshold of proof, as confusion amongst the goods involved can have disastrous effects.  The three-judge bench of the Supreme Court in Cadila Health Care Limited vs Cadila Pharmaceuticals Limited (2001) 5 SCC 73 held:

"...Drugs are poisons, not sweets. Confusion between medicinal products may, therefore, be life threatening, not merely inconvenient....

.... Keeping in view the provisions of Section 17-B of the Drugs and Cosmetics Act, 1940 which inter alia indicates that an imitation or resemblance of another drug in a manner likely to deceive being regarded as a spurious drug it is but proper that before granting permission to manufacture a drug under a brand name the authority under that Act is satisfied that there will be no confusion or deception in the market. The authorities should consider requiring such an applicant to submit an official search report from the Trade Mark Office pertaining to the trade mark in question which will enable the Drug Authority to arrive at a correct conclusion..."

It is fairly common in India for medicinal products being purchased over the counter, without a proper prescription (prescriptions with muddled/illegible handwriting). When patients are illiterate or infirm, awareness about the drugs being bought is lower still. Therefore, it is only rational to seek to introduce a mechanism under the Trade Marks Act, 1999 and Rules 2017, along with the Drugs and Cosmetic Act, 1940 and Rules 1945, to prevent the use of similar/ same brand/ trade names for drugs.

Existing Laws

The World Health Organization (WHO) has specific guidelines on the use and protection of international non-proprietary names (INNs) for pharmaceutical substances or active pharmaceutical ingredients (see). Each INN is unique, globally recognized, and is deemed to be public property. INNs were necessitated to ensure that the active ingredients in a drug could not be trademarked, thereby saving doctors from the duty of prescribing specific brands of drugs to their patients.

Section 13 of the Trade Marks Act mandates that words that are names of chemical elements or INNs or any deceptively similar name shall not be registered under the Act. However, neither the Trade Marks Act, 1999, nor the Drugs and Cosmetic Act, 1940, or their respective accompanying rules have a regime of registration specifically for pharmaceutical trademarks. As a result, there is no check on the fraudulent and deceptively similar names of medicinal products. The absence of such a regime results in the – possibly fatal – confusion of the identity of drugs in the market.

Moving Forward

Acknowledging the directions by Indian courts to implement an action plan by which drugs with identical or near identical brand names are not given licenses, on 13 November 2018, the Health Ministry held a meeting to discuss this issue. The Agenda, as contained in the minutes of the meeting of the Drugs Technical Advisory Board , specifically highlighted the absence of an authority regulating brand names/trade names of pharmaceuticals (see ). The Board further discussed the scope for amending the Drugs and Cosmetic Rules 1945, to include provisions for regulating brand names/ trade names by Central and State Licensing Authorities.

With appropriate amendments to the Trademarks Act as well as the Drugs and Cosmetic Act, the grant of a manufacturing license of a drug by the Drug Authorities may be subject to appropriate clearances given by the Trademark Registry. This would potentially mean that the licensing authority, while granting a license for a pharmaceutical drug, would require an official Search Report from the Trade Marks Office stating that no identical or deceptively similar pharmaceutical names are pending/ registered under the Trade Marks Act. This is not a new development in Indian law: a similar power has been granted to the Central Government under section 16 of the Companies Act, 2013 with regard to the names of registered companies. Such a responsibility granted to the Trade Mark and Drug Authorities, would ensure that the temptation to pass off pharmaceutical drugs by mala fide traders are successfully prevented at an early stage.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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