Miracle Drugs- Explained Pointwise

Recently, several Indian newspapers have been found to be carrying misleading advertisements regarding unapproved miracle drugs. The magic injection for weight loss, containing a drug called Semaglutide, is being actively advertised. However, many of these miracle drugs have not been approved for sale in India. Despite the lack of regulatory approval, these drugs are being administered by doctors to affluent patients in India.

What are Miracle Drugs? 

Miracle drugs- Miracle drugs are pharmaceutical substances that have a transformative impact on the treatment of certain medical conditions. These drugs are often characterized by their exceptional efficacy, groundbreaking therapeutic outcomes, and the ability to significantly improve patient outcomes.

For Ex- Penicillin (Effectively treating bacterial infections), Insulin (Life saving drug for Diabetes treatment), Antiretroviral Drugs for HIV/AIDS (AIDS treatment), Sovaldi/Sofosbuvir (Hepatitis C treatment), Trikafta (cystic fibrosis medications).

Unapproved Miracle Drugs in India- However, several unapproved miracle drugs are being used in India. For ex- Semaglutide & Fen-Phen (Drugs used for weight loss in India), Adcetris (To treat blood cancers).

What is the Drug Approval Process in India?

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.

a. 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.

b. 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.

c. 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.

What are the impacts of the unapproved miracle drugs in India?

1. Public Health Impacts- Unapproved miracle drugs lack clinical test data, which increases risks of medical uncertainty for patients like cases of adverse drug reactions.

2. Development of Grey Market- The unscrupulous ways of procurement of unapproved miracle drugs have led to the development of grey market for unapproved weight loss injectables in India.

3. Problems of Drug Quality and Contamination- There are challenges of contamination of unapproved miracle drugs as they escape regulatory oversight. For ex- Contamination of Semaglutide by Ozempic and Wegovy, which makes the drug harmful and unsafe. Recent scandal about spurious imported drugs such as Adcetris (to treat a type of blood cancer).

4. Cardiovascular defects- Many of the unapproved miracle drugs have been involved in causing heart valve defects in many patients. For ex- Fen-Phen, which was once used as a weight loss drug, was associated with heart valve defects in as many as a third of patients.

5. Complicity of Medical Community- There are chances of complicity of medical community in recommending these unapproved drugs in India.

6. Economic Impact- Vulnerable populations fall into the lure of these unapproved, costly magical drugs, which endangers their economic security.

7. Public Misinformation- Misleading medical ads, like weight reduction due to miracle drugs, spread misinformation. This can lead to public mistrust in scientifically proven treatments.

What should be the way Forward?

1. Strict implementation of Regulations- Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 must be strictly implemented to curb the menace of unapproved magic drugs in India.

2. Strict Oversight- Increased government intervention in monitoring and regulating medical advertisements, as exemplified by the Supreme Court criticizing the government’s inaction in the Patanjali case.

3. Mass Tort litigations- Mass tort litigations must be initiated against the pharma companies involved in selling of unapproved magical drugs.

4. Ethical Responsibility of Medical Community- The medical fraternity must exude their ethical responsibilities in recommending these drugs. The errant doctors must be arrested and sent to jail.

5. Public Awareness- Enhance public education about scientifically proven treatments to combat the influence of misleading advertisements promoting these unapproved drugs.