Mains GS3: GS3-17.Awareness in the fields of IT, Space, Computers, Robotics, Nano-technology, Bio-technology and issues relating to Intellectual Property Rights.
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.
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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.
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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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