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Delhi High Court allows Mankind Pharma Limited to run modified advertisement on DMF Quality APIs with disclaimer

Delhi High Court: A suit was filed seeking a decree of permanent injunction restraining the defendant, its directors, principals, officers, employees, agents, representatives and assigns from creating impediments in the dissemination of the plaintiff’s advertisement. Dinesh Sharma, J. directed the plaintiffs to run its original advertisement in a modified form with the disclaimer that DMF is not mandated under Indian law and is not a quality norm for products in India.

The plaintiff company started using Active Pharmaceutical Ingredients (APIs) procured from United States Food and Drug Administration (USFDA) registered plants with valid DMF numbers, in its medicines. The Drug Master File (DMF) has all the information on the manufacturing, stability, quality, packaging, purity and impurity profile of API, for authorities to ensure that medicines of higher quality including very detailed and strict impurity profiles which safeguard against unknown adverse reactions. In June 2023, plaintiff came up with an advertisement campaign informing the public about the company’s initiative regarding procuring DMF Quality APIs for its medicines and spent INR 33 Crores on the advertisement. A law student filed complaint before Advertising Standards Council of India (ASCI) claiming that the advertisement claims that the medicines sold by the plaintiff are more effective and of better quality than of other Indian medicines, however, as DMF is not required by law for quality approval in India, promoting the advertisement on that basis may lead the public to believe other drugs are not safe to consume.

The suit further seeks permanent injunction restraining the defendant from circulating the order dated 08-11-2023 to its members, the Government or the public in any manner and to set aside the findings in the defendant’s order dated 8-11-2023 against the plaintiff’s advertisement. It also seeks a declaration that the plaintiff’s advertisement and the claims made are fair and honest and does not constitute a violation of the requirements under the ASCI Code or any other advertising laws.

Counsel for the plaintiff submitted that the advertisement is about the company’s initiative, not regarding a particular product. Further, the Plaintiff is not a member and therefore cannot be subject to ASCI, yet it sent a detailed response. However, the ASCI vide review order dated 08-11-2023 passed an order upholding the Complaint without considering the preliminary submissions made by Mankind and has also not given any reasoning as to why the previous order passed was incorrect.

Counsel for defendants submitted that the suit is filed on the basis of a recommendation made by an advisory expert body which has no penal repercussions and the only action taken by the defendant in case of non-compliance is to inform the regulatory authorities thereby, leaving it up to them to take whatever action, if at all, is necessary. It further submitted that the Plaintiff is attempting to avert the regulatory/statutory proceedings, by approaching the Court prematurely as the issue in the present suit was limited to the way in which the product was being advertised and not to the actual sale of the product. Thus, the present suit was liable to be dismissed on account of lack of cause of action as the impugned order was merely a recommending order and the entire suit rests on the apprehension of future injury i.e. a quia timet case.

The Court noted that without prejudice to the rights and contentions of the plaintiff, the plaintiff is ready to run declaimer as “DMF is not mandated under Indian law and is not a quality norm for products in India”. The Court directed that the plaintiff shall run the modified advertisement i.e., original advertisement with the disclaimer. The plaintiff shall avail the remedy of the “Independent Review Process” (IRP) within 10-days and may take all the objections as available under law. The department shall take the steps for the decision of the same in accordance with the law.

The Court further directed that in the meanwhile, the defendant shall not send the recommendation as contained in the impugned order in the e-mail dated 08-11-2023 addressed to Mankind Pharma Limited. However, in case, the “Independent Review Process” (IRP) decides against the plaintiff, the respondent shall not send the recommendation to the appropriate authority for two weeks.

Dec 04,2023

Source: Scconline