MIRACLE DRUGS

SYLLABUS

GS 2 >> Public Health >> Regulation of pharmaceuticals

REFERENCE NEWS

Recently, several Indian newspapers have come under scrutiny for publishing misleading advertisements about unapproved miracle drugs. A prominent example is an advertisement for a so-called miracle injection for weight loss that contains Semaglutide. Even though many of these miracle drugs do not have regulatory approval for sale in India, they are still being administered by some doctors to well-off patients.

ABOUT MIRACLE DRUGS

Miracle drugs refer to pharmaceutical agents that revolutionize the management of specific health conditions due to their outstanding effectiveness, innovative therapeutic benefits, and their significant enhancement of patient health.

Examples include:

• Penicillin, which revolutionized the treatment of bacterial infections
• Insulin, a critical medication for managing diabetes
• Antiretroviral Drugs, which transformed HIV/AIDS therapy
• Sovaldi/Sofosbuvir, a breakthrough in Hepatitis C treatment
• Trikafta, a key advancement in cystic fibrosis treatment.

In India, however, there are instances of the use of miracle drugs that have not received official approval. Examples include Semaglutide and Fen-Phen for weight loss, and Adcetris for the treatment of blood cancers.

DRUG APPROVAL PROCESS IN INDIA

The regulatory framework for drug approval in India is governed by the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.

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

1. Quality and Safety Concerns: Bypassing regulatory checks raises the risk of contamination in these drugs, such as Semaglutide being tainted with Ozempic and Wegovy, rendering them potentially dangerous. Cases like the controversy over counterfeit Adcetris highlight the issue.
2. Cardiovascular Issues: A significant number of patients have experienced heart valve complications due to certain unapproved drugs, like the weight loss drug Fen-Phen, affecting up to one-third of its users.
3. Involvement of Healthcare Professionals: Some in the medical field might be implicated in the distribution and endorsement of these unauthorized medications.
4. Public Health Risks: Without clinical trials, unapproved miracle drugs present a gamble, increasing the likelihood of unforeseen adverse reactions among patients.
5. Emergence of a Grey Market: The clandestine acquisition of these drugs has spurred a shadow market, especially for unauthorized weight loss injections.
6. Financial Strain on Patients: Individuals, especially those from vulnerable groups, may be duped into spending significant amounts on these expensive, unverified treatments, jeopardizing their financial stability.
7. Spread of Misinformation: The promotion of such drugs through deceptive advertising, such as miraculous weight loss claims, can disseminate false information, potentially undermining trust in legitimate medical therapies.

WAY FORWARD

• Public Education Enhancement: Strengthening awareness campaigns about scientifically validated treatments can help counteract the effects of deceptive ads for unapproved drugs.
• Stricter Regulation Enforcement: To tackle the issue of unauthorized magic drugs, there must be a rigorous application of existing laws, like the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.
• Increased Government Surveillance: The government should step up its efforts to oversee and control medical advertising, drawing lessons from the Supreme Court's critique in the Patanjali case regarding governmental laxity.
• Legal Action through Mass Tort Litigation: There should be collective legal actions taken against pharmaceutical companies that market these unauthorized drugs.
• Upholding Medical Ethics: The medical community needs to adhere strictly to ethical guidelines when prescribing medication, with stringent consequences for those who deviate, including possible imprisonment for negligent practitioners.

PRACTICE QUESTION

Q: Evaluate the challenges and implications of unapproved miracle drugs on public health and regulatory frameworks in India. (15M, 250W)