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Tirzepatide: the Weight-loss Drug nearing Approval in India

Prelims Only | Science Tech | Mains Paper 3: Awareness in various sc and tech fields
Note4Students

From UPSC perspective, the following things are important :

Prelims level: CDSCO; Tirzepatide and its working.

Why in the News?

  • India’s apex drug regulator Central Drug Standard Control Organisation (CDSCO) gave preliminary approval to the drug Tirzepatide.
    • Tirzepatide is known to have assisted in weight control treatment among diabetic patients.

About Central Drugs Standard Control Organisation (CDSCO): 

  • CDSCO is India’s national regulatory body for cosmetics, pharmaceuticals and medical devices.
  • It serves a similar function to the Food and Drug Administration (FDA) of the US or the European Medicines Agency of the European Union.
  • The Indian government has announced its plan to bring all medical devices, including implants and contraceptives under a review of the CDSCO.
  • Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices and is positioned within the Ministry of Health and Family Welfare.
  • The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).

Mandate and Responsibilities:

  • Drug Approval: CDSCO is responsible for the approval of new drugs and clinical trials.
  • Standards Enforcement: Ensures standards of drugs and medical devices through various acts such as the Drugs and Cosmetics Act, 1940.
  • Import and Export: Regulates the import and export of drugs and medical devices in India.
  • Licensing Authority: Issues licenses for the manufacture, sale, and distribution of drugs in India.
  • Surveillance: Conducts drug quality surveillance and monitors adverse drug reactions.

 

Diabetes Drug for Weight Loss

  • In 2017, the US Food and Drug Administration (FDA) approved a drug called Ozempic for managing type 2 diabetes.
  • The active ingredient, semaglutide, was later noted for causing weight loss, which led to its off-label use for treating obesity.
  • This usage became popular on social media, influencing further developments.

What is Tirzepatide?

  • Tirzepatide is the main component of Eli Lilly’s drugs, Mounjaro and Zepbound.
  • It’s important to note here that Mounjaro is the brand name for diabetes, while Zepbound is for weight loss.

How does it work?

There is a dual action involving two hormones:

(1) Regulation of glucagon-like peptide-1 (GLP-1): 

  • GLP-1 is a hormone that regulates appetite and calorie intake through effects on the brain and digestive tract.
  • Both semaglutide and tirzepatide function as polypeptides that enhance the body’s levels of GLP-1.
  • The higher levels of GLP-1 trigger satiety, the feeling of fullness, reducing the desire to eat.

(2) Regulation of Glucose-dependent Insulinotropic polypeptide (GIP):

  • Unlike semaglutide, tripeptide also increases levels of GIP, the other hormone involved.

Promising Global Trials

  • Global clinical trials for tirzepatide (Zepbound) have shown significant results, with the highest dosage leading to an average weight loss of 20.9% over 72 weeks.
  • The approval in India is due on further post-marketing surveillance (Phase IV trials) to monitor the drug’s side effects and its effectiveness across India’s diverse population.

Long-term side effects:

  • Cardiovascular risks like increased heart rate and potential blood pressure elevation.
  • Gastrointestinal effects include nausea, vomiting, diarrhoea, and constipation. Endocrine concerns involve thyroid C-cell tumours in MEN syndrome patients.
  • Other issues include kidney problems, eye complications, mental health impacts, and long-term risks like pancreatic enzyme elevation and gallbladder problems.

Why under-consideration in India?

  • India has the world’s second-highest number of people with type 2 diabetes and high obesity rates.
  • A study in Lancet in 2023 estimated that 101 million people in India — 11.4 per cent of the country’s population — are living with diabetes.
  • As per the World Obesity Federation Atlas, around 11 per cent of Indian adults will be obese by 2034.

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