Miracle Drugs

Miracle Drugs

News: In recent times, numerous Indian publications have been discovered to feature deceptive advertisements promoting unapproved miracle drugs. Specifically, there has been an active promotion of a purported magical injection for weight loss, which includes the use of a drug named Semaglutide. It has come to light that several of these miraculous drugs have not obtained the necessary approvals for sale in India. Despite the absence of regulatory endorsements, these drugs are reportedly being administered by medical practitioners to well-to-do patients in the country.

Background: What are Miracle Drugs?

Miracle Drugs:
• Miracle drugs refer to pharmaceutical substances that revolutionize the treatment of specific medical conditions. These medications stand out for their remarkable efficacy, groundbreaking therapeutic outcomes, and their ability to significantly enhance patient well-being.
For Example:
• Penicillin: Effectively treats bacterial infections.
• Insulin: A life-saving drug for Diabetes treatment.
• Antiretroviral Drugs for HIV/AIDS: Critical for AIDS treatment.
• Sovaldi/Sofosbuvir: Vital in the treatment of Hepatitis C.
• Trikafta: Medications for managing cystic fibrosis.

Unapproved Miracle Drugs in India:
Despite the positive impact of approved miracle drugs, certain unapproved miracle drugs are being utilized in India.
For Example:
• Semaglutide & Fen-Phen: Drugs used for weight loss in India.
• Adcetris: Employed in the treatment of blood cancers.

Drug Approval Process in India

Regulatory Framework: The process for drug approval in India is governed by the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.
• A formal application is submitted by the pharmaceutical company or sponsor to the CDSCO. The application includes comprehensive data on the drug’s quality, safety, and efficacy obtained through pre-clinical and clinical trials.
• A clinical trial is approved by the Drug Controller General of India (DCGI) to assess the safety and efficacy of the drug in humans. If the drug is found to be safe and effective, the DCGI grants approval for marketing and manufacturing.
• Once approved, the regulator mandates monitoring and reporting all adverse events for two years.
However, many Global pharma companies sometimes choose to stay out of the Indian market and not launch drugs in India. In such circumstances, patients can get a licence from the drug regulator based on a doctor’s prescription to import these drugs for personal use. Similarly, hospitals also apply for import licences of these drugs.

Impacts of the unapproved miracle drugs in India
• Public Health Ramifications - Unauthorized miracle drugs lack comprehensive clinical testing, heightening the potential for medical uncertainties and adverse reactions among patients.
• Emergence of Illicit Markets - Unethical acquisition practices of unapproved miracle drugs have fostered 
the growth of a shadow market for unauthorized weight loss injectables in India.
• Issues of Drug Integrity and Taint - Unapproved miracle drugs often elude regulatory scrutiny, raising concerns about contamination. Instances include Semaglutide contamination by Ozempic and Wegovy, posing significant health risks. Recent scandals involve counterfeit imported drugs like Adcetris for blood cancer treatment.
• Cardiovascular Complications - Several unapproved miracle drugs have been linked to heart valve defects. A case in point is Fen-Phen, formerly used as a weight loss medication, associated with heart valve abnormalities in a substantial number of patients.
• Potential Collusion within the Medical Community - There exists a risk of complicity within the medical community in endorsing these unapproved drugs in India.
• Economic Fallout - Vulnerable populations are enticed by the allure of these unauthorized and costly miracle drugs, jeopardizing their economic stability.
• Dissemination of Misinformation - Deceptive medical advertisements, such as those claiming miraculous weight reduction, contribute to the spread of misinformation. This can erode public trust in scientifically validated treatments.

Way Forward
• Rigorous Enforcement of Regulations - The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 should be enforced with strict adherence to curb the proliferation of unapproved magical drugs in India.
• Enhanced Regulatory Vigilance- Increased government oversight is imperative for monitoring and regulating medical advertisements, as highlighted by the Supreme Courts rebuke of government inaction in the Patanjali case.
• Advocacy for Mass Tort Actions - Initiating mass tort litigations against pharmaceutical companies engaged in the sale of unapproved magical drugs is crucial to hold them accountable for their actions.
• Ethical Accountability within the Medical Community - The medical profession bears an ethical responsibility to refrain from endorsing unapproved drugs. Any physicians found deviating from these ethical standards should face legal consequences, including arrest and imprisonment.
• Public Awareness Campaigns- Strengthening public education initiatives is essential to disseminate information about scientifically validated treatments and counteract the impact of misleading advertisements promoting unapproved drugs.