When Will The Weight-Loss Drug Tirzepatide Debut In India? Can It Be Misused?

Weight loss is all the buzz these days and the wait of India’s Weight Watchers has almost reached its end. Several weight loss drugs like Ozempic and Zepbound which are very popular in European and American markets are soon to make their debut in India.
Last week, the subject expert committee of India’s apex drug regulator, the Central Drug Standard Control Organisation (CDSCO), approved Eli Lilly’s tirzepatide, the active ingredient in the company’s medications Mounjaro and Zepbound.

However, Elli Lilly told the Economic Times: “The apex drug regulator has so far given a go-ahead for its import and marketing for diabetes and not for weight loss. The obesity indication is undergoing review by the Central Drugs Standard Control Organisation (CDSCO).”

What is the Drug all about?

Tirzepatide serves as the primary ingredient in Eli Lilly’s pharmaceuticals, Mounjaro and Zepbound. Notably, Mounjaro targets diabetes management, whereas Zepbound is aimed at facilitating weight loss. According to medical experts, tirzepatide functions by mimicking two crucial hormones naturally produced in the body: GIP and GLP-1.

Upon Injecting the drug, it activates and triggers receptors for these hormones. It has a stimulating effect on the pancreas which causes it to produce more insulin and also stimulates the brain into thinking that the stomach is full. This indicates that the medication not only lowers blood sugar levels but also suppresses appetite, resulting in weight loss among individuals dealing with obesity.

Some experts highlight that tirzepatide’s effectiveness is enhanced by its mimicry of GIP, which not only curbs appetite but also potentially improves the body’s metabolism of sugar and fat, thereby augmenting its weight loss benefits.

Research indicates that tirzepatide is highly effective in combating obesity. According to a study published in The New England Journal of Medicine in July 2022, participants on a lower dose of tirzepatide experienced an average weight loss of 16% (approximately 16 kilograms) over a year. Those on a higher dose achieved a weight reduction of 21.4% (about 22 kilograms).

What are the side effects we need to watch out for?

Initially, the study revealed that gastrointestinal issues were the most recurring ones and the most common side effects. Roughly one-third of individuals taking the highest dose of tirzepatide reported experiencing nausea, while approximately one-fifth reported diarrhoea. Other side effects noted among participants included abdominal pain, vomiting, constipation, headache, and dizziness.

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As per the US FDA people who consume Zepbound experience hair loss, gastroesophageal reflux and the occasional burping. The intake of drugs should be avoided during pregnancy. The FDA emphasized the importance of monitoring patients for signs of depression or suicidal thoughts while taking tirzepatide. If these symptoms arise, patients should cease using the medication.

How might Tirzepatide be misused?

Although India’s drug regulator’s SEC has approved tirzepatide for treating type 2 diabetes, there are concerns that it could be prescribed off-label, meaning for purposes other than its approved use.

A similar scenario unfolded in the US with Danish pharmaceutical company Novo Nordisk’s Ozempic in 2017. Initially approved by the FDA for managing type 2 diabetes, doctors soon observed an unexpected side effect — significant weight loss. This discovery sparked widespread interest and discussions both online and offline.

Responding to the demand, Novo Nordisk introduced Wegovy in 2021, a semaglutide injection specifically approved by the FDA for treating obesity.

Today, both drugs face a global shortage due to higher-than-anticipated demand.

When can we anticipate the arrival of Tirzepatide in India?

Earlier this year, Eli Lilly CEO David Ricks shared with Reuters that Mounjaro could potentially debut in India as soon as 2025. In contrast, Novo Nordisk aims to introduce its weight-loss medication in the country by 2026.

Once these medications are launched in India, they are expected to make significant strides. India, with the world’s second-highest number of people diagnosed with type 2 diabetes and increasing rates of obesity, presents a promising market. A Lancet study in 2023 estimated that 101 million Indians, comprising 11.4 per cent of the population, are living with diabetes.

Additionally, obesity rates are also climbing in India. According to the World Obesity Federation Atlas, approximately 11 per cent of Indian adults are projected to be obese by 2034.

However, medical experts caution against viewing these drugs as quick fixes for weight loss. Clinical data indicates that sustained use is necessary to maintain weight loss and other therapeutic benefits. For instance, research on Wegovy showed that users achieved an impressive average weight loss of 17.3 per cent over 68 weeks. Yet, by week 120 after discontinuation, most users had regained much of the lost weight, resulting in an average weight loss of only 5.6 per cent.

Nonetheless, the approval of these drugs is anticipated to have a transformative impact in the field of medicine.

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