PYQ Relevance:

Prelims:
Recently, there was a growing awareness in our country about the importance of Himalayan nettle (Girardinia diversifolia) because it is found to be a sustainable source of [UPSC CSE 2019]
a) Anti-malarial drug
b) Biodiesel
c) Pulp for paper industry
d) Textile Fibre

Mains:
1. Can overuse and free availability of antibiotics without Doctor’s prescription, be contributors to the emergence of drug-resistant diseases in India? What are the available mechanisms for monitoring and control? Critically discuss the various issues involved. (UPSC CSE 2014)

2. What do you understand about Fixed Dose Drug Combinations (FDCs)? Discuss their merits and demerits. (UPSC CSE 2013)

Note4Students:

Mains: Drug Regulation and Disease control in India;

Prelims: Drugs in News;

Mentor comments: The Semaglutide which works as ‘magic injections for weight loss’, is a drug not approved for sale in India. Doctors are administering these drugs to affluent patients without proper approval or clinical trials in India. The lack of clinical trials in India poses risks on Indian patients and potential interactions with other medications too. We need to study the challenges and mechanisms for monitoring and control of these unapproved drugs in India.

Let’s learn.

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Why in the News?

Concerns are raised around the use of unapproved drugs like Semaglutide in India.

The recent scandal involved spurious imported drugs like Adcetris which highlights the need for stricter controls and verification of imported medications to ensure patient safety.

Statistics and Reports on unapproved drugs in India:

The research revealed that around 64% of the 118 different formulations of fixed dose combination (FDC) drugs sold in the country between 2007 and 2012 were not approved by the national drugs regulator, the Central Drugs Standard Control Organization (CDSCO), even though the sale of unapproved new medicines is illegal in India.

The current Major two Regulatory Challenges in India:

1) No Clinical Trials in India:

Approval Process: Drugs are normally approved for sale in India after conducting clinical trials in the country. Once approved, the regulator mandates monitoring and reporting of adverse events for two years
Unapproved Drugs: Unapproved drugs have not undergone clinical trials in India, posing health risks and potential adverse reactions. Global pharma companies sometimes choose to stay out of the Indian market and not launch drugs in India.
Exceptional cases: Patients and hospitals can also apply for import licenses for unapproved drugs, but these are narrow exceptions to the rule.

2) Professional issues with Doctors:

Ethical Dilemma with Medical Professionals: Doctors face ethical questions about prescribing unapproved drugs when patients demand these drugs based on miracle reports. In such situations, it usually influences their decisions regarding unapproved medications.
- For example, recent scandals such as Adcetris (a drug used to treat a type of blood cancer) and imported drugs highlight the importance of doctors ensuring the authenticity and safety of medications before administration.

Lack of Knowledge and Training: Many doctors have still not studied the full effects of these drugs and are trained to identify and treat adverse events. Doctors need to be cautious as patients may be using illegally imported drugs, raising concerns about safety and authenticity.

Case study:

Many decades ago, in the US, other types of weight loss drugs like ‘Rimonabant and Fen–Phen’ were marketed as a miracle weight loss cure. Soon, the miracle was demystified and pharma companies paid out approximately $4 billion in damages in mass tort litigation.

What are the potential challenges of Unapproved Drugs on Patients in India?

Health Risks: Patients face potential health risks due to the unknown effects and interactions of unapproved medications, leading to adverse reactions and complications.
Antimicrobial Resistance: The use of unapproved antibiotics contributes to antimicrobial resistance, undermining efforts to combat infectious diseases and posing a global health threat.
Legal Implications: Patients may unknowingly receive medications that are not approved for safety and efficacy, raising legal concerns for healthcare providers and regulatory authorities.
Lack of Oversight: Patients receiving unapproved drugs may lack proper monitoring and oversight, increasing the risk of adverse events and inadequate treatment outcomes.

What measures can be taken to prevent potential harm in India? (Way Forward)

To address the importation of unapproved drugs in India several measures can be taken:

Implement Clear Guidelines: Establish clear guidelines and regulations regarding the importation and use of unapproved drugs, ensuring that healthcare providers adhere to approved medications and treatments.
Strengthen Regulatory Oversight: Enhance regulatory oversight by conducting thorough inspections of drug manufacturing facilities in India and abroad to prevent the importation of unapproved or counterfeit drugs.
Enforce Accountability: Hold accountable those involved in administering unapproved drugs, including healthcare providers who prescribe them, by enforcing strict penalties for violating regulations.
Increase Awareness: Raise awareness among healthcare providers, patients, and the public about the risks associated with unapproved drugs and the importance of using only authorized medications.

Promote Compassionate Use Programs: Encourage the development of compassionate use programs that allow access to potentially life-saving drugs under specific circumstances while ensuring proper oversight and monitoring.

Practice Question:
The prescription of unauthorized “miracle drugs” by doctors highlights gaps in the regulatory framework. Examine the potential harm to patients and suggest regulatory measures to prevent that harm.

Approach for the Answer:

Introduction:
Theme: Unapproved Miracle Drugs and their use by affluent people by doctors’ prescription

Body:
Demand 1: Highlight regulatory gaps in approval of Miracle drugs
Demand 2: Enlist potential harms to patients
Demand 3: Suggest regulatory measures to prevent harm

Way Forward:
Summarize along with value addition.