INDIA’S PROBLEM — DIFFERENT DRUGS, IDENTICAL BRAND NAMES
IMOX is a brand that belongs to IPCA Laboratories Pvt Ltd; INIMOX is of Indian Immunologicals Ltd. IPCA objected (successfully) to INIMOX to the Registrar of Trade Marks Registry. A legal dispute ensued, which was settled by the Madras High Court last month.
The Court ruled in favor of Indian Immunologicals Ltd, noting that there were key differences between the two drugs. IMOX is a tablet for humans; INIMOX an injection for animals. Case closed.
Indian Immunologicals Ltd offered several legal precedents of similar-sounding names where no relief was granted to the objecting party. Some of them are: Stimuliv (Corona Remedies) and Stimu-let (Franco-Indian Pharmaceuticals), Meto (Orchid Chemicals) and Metox (Wockhardt), Zincovit (Apex Laboratories) and Zinconia (Zuventus Health Care), Meronem (Astrazeneca) and Meromer (Orchid Chemicals), Netromycin (Schering Corporation) and Netmicin (United Biotech).
However, there is a larger issue underlying the dispute. The names of most of the drugs sold in the market are derived from their underlying ‘active pharmaceutical ingredient’. Therefore, when rival companies name their drugs, the names are bound to be somewhat similar. How do you register their names?
The Madras High Court judgment lays down certain principles, which have been analysed by Vindhya Mani, Mohit Kar and Kriti Sood, lawyers at the law firm Lakshmikumaran & Sridharan, in an article in Mondaq. They note: “The Court concluded that marks that are derived from API or generic names are weaker in comparison to arbitrary or coined marks. The Court held that the larger the portion of the API or disease name that a mark uses, the weaker is its protection. Similarly, if a mark contains additional terms and unique elements apart from what it has borrowed from an API or disease name, then its protection would be stronger. This apart, the Court maintained that the analysis of “visual, phonetic and structural” similarity will play an important role in deciding the outcome of infringement, passing off, or proceedings involving strength of marks.”
Why in the News?
- Oncologist Dr. Vincent Rajkumar recently shared his astonishment on social media regarding a concerning issue involving two distinct drugssharing the identical brand name ‘Linamac.’
- The drug labeled as‘Linamac 5’ is specifically designed to address multiple myeloma, a form of cancer, while the other drug named ‘Linamac’ is intended for the treatment of diabetes.
- Rajkumar emphasized the potential seriousness of the situation, pointing out the risk of confusion at the pharmacy level, which could have severe consequences for patients.
- The shared brand name poses a significant challenge as patients and healthcare providers may encounter difficulties distinguishing between these two medications, leading to potential medication errors.
Problem of Identical Trade Names in India
The challenge of identical trade names for drugs with distinct active ingredients has been a persistent problem in India, drawing concerns from the medical community for several decades.
- One prominent illustration frequently cited by doctors is the case of the brand name ‘Medzole,’ employed by four different companies for drugs addressing entirely different medical conditions.
- Variety of Medzole Drugs:
- Medzol – Sedative: The first company utilizes ‘Medzol’ to market a drug containing Midazolam, serving as a sedative in medical applications.
- Medzole-DSR – Acidity Treatment: The second company adopts the name ‘Medzole-DSR’ for a combination drug comprising domperidone and pantoprazole, designed to treat stomach acidity.
- Medzole 400 – Deworming Treatment: The third company employs ‘Medzole 400’ for a formulation incorporating albendazole, specifically used in deworming treatments for children.
- Medzole 200 – Antifungal Medication: The fourth company uses ‘Medzole 200’ for a formulation containing Itraconazole, a potent antifungal drug employed in the treatment of diseases such as “black fungus.”
- Phonetic and Visual Similarity: These names not only sound phonetically similar to each other but also share visual similarities, with only slight variations involving the substitution of one or two letters.
- Example of Similar Trade Names:
- Medpol – Paracetamol: One company employs the brand ‘Medpol’ to market paracetamol, a commonly used pain reliever and fever reducer.
- Medrol – Corticosteroid: A second company utilizes the brand ‘Medrol’ to sell a corticosteroid, serving a different therapeutic purpose than paracetamol.
- Metrozole – Antibiotic: Another company uses the brand ‘Metrozole’ to sell an antibiotic, representing yet another distinct class of medication.
- Intra-Company Brand Name Replication: It’s not uncommon for pharmaceutical companies to reuse successful brand names for different formulations, creating potential confusion for both healthcare providers and patients.
- Example of ‘I-Pill’ Brand Name Usage:
- ‘I-Pill’ – Emergency Contraceptive: The company utilizes the brand name ‘I-Pill’ for an emergency contraceptive pill containing Levonorgestrel, intended for use after sexual intercourse to prevent fertilization.
- ‘i-Pill Daily’ – Daily Contraceptive: The same company extends the ‘I-Pill’ brand to ‘i-Pill Daily,’ a daily contraceptive pill containing both Levonorgestrel and Ethinylestradiol. This formulation is designed for regular use to prevent ovulation and fertilization.
- Non-Interchangeable Purposes: It’s crucial to recognize that emergency contraceptives (ECP) and daily contraceptives serve different purposes, and confusion between the two at the pharmacy level can lead to unintended pregnancies.
- Example of ‘I-Pill’ Brand Name Usage:
- Example of Similar Trade Names:
Consequences and Medical Concerns:
- Risk of Confusion: The widespread use of identical trade names raises a significant risk of confusion among healthcare professionals, pharmacists, and patients.
- Potential Medication Errors: The striking resemblance between these names increases the likelihood of medication errors, as individuals may inadvertently substitute one medication for another due to the similarities in their names, potentially compromising patient safety.
- Need for Regulatory Intervention: The medical community advocates for regulatory measures to address and rectify the issue of identical trade names, emphasizing the importance of distinct nomenclature for drugs with different active ingredients.
- Confusion Among Stakeholders: The use of names that are phonetically and visually similar poses a substantial risk of confusion among healthcare professionals, pharmacists, and patients.
- Need for Enhanced Distinctiveness: Addressing the broader problem involves emphasizing the importance of unique and distinctive trade names to mitigate the potential risks associated with similar-sounding and visually alike pharmaceutical names.
- Regulatory Considerations: The pharmaceutical industry may benefit from regulatory measures that promote clear differentiation in trade names to enhance patient safety and prevent inadvertent substitution of medications with similar names.
- Language Barrier on Packaging: The use of English language exclusively on drug packaging poses a significant challenge in India, where less than 10% of the population speaks English. This language barrier may contribute to misunderstandings and errors in medication usage.
- Poor Regulation of Pharmacies: Pharmacies in India face issues of inadequate regulation, with instances of dispensing drugs without prescriptions and operating without registered, trained pharmacists as required by law.
- Potential for Prescription Errors: The combination of language barriers, lax pharmacy regulations, and identical/similar brand names elevates the risk of prescription errors, increasing the likelihood of patients receiving the wrong medication or formulation.
- Need for Awareness: Addressing this complex issue requires improvements in pharmacy regulation, increased awareness among healthcare providers, pharmacists, and the general public, and possibly stricter measures to ensure distinct nomenclature for different formulations, especially within the same company.
Judiciary’s recommendation
- The issue of similar or identical trade names for drugs has persisted for decades.
- The Supreme Court of India and the Parliamentary Standing Committee on Health and Family Welfare highlighted the problem in 2001 and 2012, respectively.
- Both entities urged the Ministry of Health to establish processes preventing the use of confusingly similar names for drugs.
- Despite the Supreme Court and Parliamentary recommendations, the Ministry of Health did not take action until 2019.
- Justice Pratibha M. Singhof the Delhi High Court, a former intellectual property lawyer, addressed pharmaceutical trademark infringement cases that came before her.
Introduction of Rules in 2019:
- In response to Justice Singh’s involvement, the Ministry of Health implemented the Drugs and Cosmetics (Thirteenth Amendment) Rules in 2019.
- These rules aimed to address the issue by requiring pharmaceutical companies to provide an “undertaking” to State drug controllers along with their manufacturing license applications.
- The undertaking stated that the brand name of the drug would not cause confusion or deception in the market.
- Flawed Framework:
- The rules established a system reliant on self-certification by pharmaceutical companies.
- This approach proved ineffective, as many drugs in India continued to have confusingly similar names.
- The framework also required companies to conduct searches for similar names in various sources, including the trademarks registry, CDSCO’s central database, literature, reference books on drug formulations in India, and the internet.
- Inherent Issues:
- Self-certification was deemed ineffective in the Indian context.
- The absence of a comprehensive database of all pharmaceutical brand names in India posed a significant challenge.
- Building such a database required data collection from the 36 different drug controllers in each State and Union Territory.
NO DATA IN INDIA
- Lack of Prescription Error Data in India:
- India lacks comprehensive data on prescription errors, creating a challenge in addressing the issue effectively.
- The Ministry of Health seems to operate under the notion that the absence of data equates to the absence of a problem.
- Need for Recognition of the Problem:
- Acknowledging the existence of prescription errors is crucial for initiating reforms in the healthcare system.
- The Ministry of Health must recognize the gravity of the situation before undertaking any meaningful reforms.
- Modeling After Successful Mechanisms:
- The United States and Europe serve as examples with established mechanisms to address drug name-related issues and minimize prescription errors.
- Both jurisdictions have specific divisions within their drug regulators dedicated to evaluating drug names based on various factors to prevent confusion.
- Lack of Political Will:
- Despite successful models in the U.S. and Europe, there is a notable absence of political will within India’s Drug Regulation Section of the Ministry of Health.
- The reluctance to undertake reforms indicates a lack of commitment to implementing measures proven effective in other regions.
- Reform Process Initiation:
- Acceptance of the problem is the first step towards initiating reforms in the Ministry of Health.
- Replicating successful mechanisms from the U.S. and Europe can serve as a blueprint for addressing prescription errors in India.
