Context:
In recent months, newspapers have consistently featured articles discussing the prevalence of ‘magic injections’ touted for their purported ability to ensure weight loss. These injections, containing the drug Semaglutide originally designed for treating Type 2 diabetes mellitus, have gained attention for their additional weight-loss effects. However, it’s worth noting that these articles often omit the fact that the weight loss drug hasn’t received approval for sale in India, despite doctors administering it to predominantly affluent patients.
Relevance:
GS2-
- Health
- Awareness in the Field of Biotechnology
Mains Question:
With reference to ‘magic drugs’ being promoted in media, examine the possible impact they can have on human health. What is the role played by regulators and doctors in this regard and how should these drugs be tackled? (15 Marks, 250 Words).
More on the Magic Injections and other Unauthorized Drugs:
- Despite global pharmaceutical companies releasing press statements cautioning against the use of this product in India, these warnings receive little media coverage.
- Furthermore, the media is also neglectful in reporting on the significant potential side effects associated with these drugs.
- For those who have experienced similar situations in the past, this scenario bears a striking resemblance to the controversies surrounding Rimonabant and Fen-Phen.
- Several decades ago, in the United States, a different category of weight loss medication was promoted as a miraculous cure for shedding pounds.
- However, this supposed miracle was later debunked, leading pharmaceutical companies to pay around $4 billion in damages as part of mass tort litigation.
- It’s worth noting that unauthorized drugs, including those for weight loss, constitute only a small fraction of such instances.
Trials, Sale Approval in India, Exceptions:
- In India, drugs typically receive approval for sale only after the local subsidiary or licensee of the global brand owner conducts clinical trials.
- Once approved, the regulatory authority mandates monitoring and reporting of all adverse events for a period of two years.
- There are instances where global pharmaceutical companies opt not to launch certain drugs in the Indian market. In such cases, patients can obtain a license from the drug regulator, based on a doctor’s prescription, to import these drugs for personal use. Similarly, hospitals can also apply for import licenses.
- However, these exceptions are narrow and do not override the general requirement for a drug to undergo clinical trials in India and receive approval from the drug regulator before being available for sale.
Risks Associated with Unapproved Miracle Drugs:
- For these unapproved “miracle drugs,” no clinical trials have taken place in India. Consequently, the potential differences in how Indians may react to the drug remain unknown.
- Doctors in India will lack information on how patients, particularly those already taking medications for conditions such as diabetes and hypertension (which may differ from prescriptions in most developed countries), will respond to these injections.
- This presents a significant and challenging risk that cannot be easily disregarded. It is a risk that cannot be accurately assessed and addressed.
Role of Doctors and Regulatory Authorities:
- Dilemmas for healthcare professionals in this context are abundant. Patients might be requesting these unapproved drugs based on recent reports of miraculous outcomes, and physicians could be actively recommending them. In such situations, doctors bear ethical responsibilities to ensure the safety and well-being of their patients.
- The motivation behind doctors prescribing these drugs raises concerns, and it is essential to determine how many practitioners administering these injections have thoroughly examined the full spectrum of effects associated with these drugs.
- Additionally, it is crucial to assess whether these doctors have received adequate training to recognize and address potential adverse events. Doctors should be aware of the high likelihood of clients using illegally imported drugs, as these medications have not yet obtained approval for sale in India.
- The recent controversy surrounding counterfeit imported drugs, such as Adcetris, prescribed for a form of blood cancer, draws additional attention to this matter. The drug regulatory body only issued a warning about counterfeit drugs after the World Health Organization did so in September 2023. Notably, this alert was delayed by two years, as Mumbai police arrests in October 2021 had initially exposed this issue.
- Consequently, it prompts the question of how sure doctors can be that the unapproved imported drugs they administer are not potentially hazardous counterfeits. Should doctors not ascertain the origin and authenticity of these drugs before administering them?
Conclusion:
These situations are often likened to luxury items like designer watches or premium whiskey. The legality of their importation or authenticity might be overlooked. The government may argue it has more urgent matters to address, just as there was a lack of concern when spurious cough syrup claimed the lives of the less privileged. However, a potential deterrent in this case could be the arrest and imprisonment of a few doctors involved in such practices. The issue raises a fundamental question about societal concern that needs to be properly addressed.
