India Issues Strict Guidelines on GLP-1 Diabetes and Obesity Drugs

Diabetes is a chronic disease that occurs when the pancreas does not produce adequate insulin, or when the body cannot effectively use the insulin it produces, leading to high blood sugar. If left untreated, it can lead to complications like blindness, kidney failure, heart attacks, stroke and lower limb amputation.

Insulin and glucagon are hormones produced by the pancreas that regulate blood sugar (glucose) levels. Insulin helps convert food into energy and lowers blood sugar by enabling cells to absorb glucose, while glucagon raises blood sugar when levels drop too low. Together, the two hormones keep blood sugar within a healthy range.

In patients with type 2 diabetes, however, this balance breaks down. The body's cells become resistant to insulin, or the pancreas does not produce enough of it, or both - while glucagon continues to drive blood sugar higher. It is this dual dysfunction that GLP-1 drugs are designed to address, the release stated.

People with excess body weight, a family history of diabetes and excess sugar in the diet are at high risk of developing type 2 diabetes. Being obese - with a body mass index of over 25 kg/m² - also increases the risk of diabetes. Abdominal fat particularly raises the risk of insulin resistance. Obesity is also a major driver of non-communicable diseases such as cardiovascular disease and some cancers.

Further, the press release noted that there are two kinds of diabetes.

Type 1 diabetes is characterised by deficient insulin production by the pancreas. Type 1 diabetic patients require daily doses of insulin for life.

Type 2 diabetes stops the body from using insulin properly. Family history of diabetes, obesity/overweight, and not getting enough exercise increase the risk of getting type 2 diabetes. It is preventable, and to keep it at bay, people should reach and maintain a healthy body weight, be physically active with at least 150 minutes of moderate exercise each week, eat a healthy diet and avoid sugar and saturated fats, and not smoke tobacco.

The press release emphasised that obesity is a chronic disease caused by excess body fat. Obesity is defined by a BMI greater than or equal to 25 kg/m², while overweight is defined as a BMI ranging from 23.00 to 24.99 kg/m².

BMI is a metric calculated from height and weight. Obesity is preventable and reversible. To prevent and reduce obesity, people should reduce the number of calories consumed from fats and sugars, increase the daily portion intake of fruit, vegetables, legumes, whole grains and nuts, and engage in regular physical activity (60 minutes per day for children and 150 minutes per week for adults).

GLP-1 drugs (glucagon-like peptide-1 receptor agonists) are medications developed to treat both type 2 diabetes and obesity by correcting hormonal imbalance - stimulating insulin release and suppressing excess glucagon -to bring blood sugar back under control. The drugs regulate blood sugar and appetite and are also used to treat obesity. Essentially, they slow down the gastric emptying, increasing the feeling of fullness. This decreases patients' appetite and thereby leads to their weight loss.

Multiple variants of GLP-1 drugs have been recently introduced in the Indian market, and concerns have emerged regarding their on-demand availability through retail pharmacies, online platforms, wholesalers, and wellness clinics.

To prevent unauthorised sale, unsupervised use, and other malpractices, the Drug Controller of India has intensified its regulatory surveillance, warning that the drugs can lead to serious side effects if not taken under strict medical supervision, the press release stated.

The release noted that when we eat, the digestive system breaks food down into simple sugars that enter the bloodstream. GLP-1 is activated in response, triggering the pancreas to release insulin, which moves glucose out of the bloodstream and into cells, where it is used for energy.

The hormone also suppresses glucagon, preventing the liver from releasing additional glucose into the bloodstream. These two actions bring blood sugar back to normal levels.

GLP-1 agonist medications work by mimicking this hormone and trigger the same effects for longer. They stimulate the pancreas to release more insulin, suppress the glucagon hormone, working together as a replacement for the GLP-1 hormone to control blood sugar levels in people with type 2 diabetes.

The release said that this process keeps food in the digestive system for longer, making people feel fuller for longer, thus reducing appetite and inducing weight loss. Hence, the drugs are also prescribed to people with obesity.

While the first GLP-1 medication was approved by the United States' Food & Drug Administration in 2005, many new ones have recently become very popular in treating diabetic and obese patients.

Semaglutide injection, Semaglutide tablets, Liraglutide, Tirzepatide, Dulaglutide. Exenatide and Exenatide extended release are the same GLP-1 medications available in the market currently, the release stated.

Most of these medications are administered via pre-filled injection pens, although some (like oral semaglutide) are available in tablet form.

GLP-1 drugs must be taken under medical supervision. The misuse of GLP-1 drugs without clinical oversight can lead to severe health complications.

There are various side-effects - both mild and serious - to taking GLP-1 drugs, including nausea and dizziness to pancreatitis and medullary thyroid cancer.

GLP-1 medications may also complicate various health conditions.

To ensure ethical pharmaceutical practices in the supply chain of GLP-1, the Drug Controller General of India has intensified its regulatory surveillance against the drug's unauthorised sale and promotion. In India, the drug can be prescribed only by endocrinologists, internal medicine specialists and cardiologists.

To ensure that people do not take GLP-1 drugs without a medical prescription and to curb malpractices, the Drug Controller General of India, in collaboration with State Drug Controllers, took the following actions:

On 10th March 2026, a comprehensive advisory was issued to all drug manufacturers to stop misleading advertisements and any promotion that could encourage people to use GLP-1 drugs without a prescription, the release noted.

In recent weeks, 49 businesses were audited and inspected across the country, including online pharmacy warehouses, drug wholesalers, retailers, and weight loss clinics. These inspections spanned multiple regions across India and focused on identifying violations related to unauthorised sale, improper prescription practices, and misleading marketing. Notices have been issued to those found breaking the rules.

Stricter inspections and surveillance will continue in the coming weeks. Businesses that break the rules will face license cancellation, fines, and legal action.

GLP-1 drugs are a significant medical breakthrough in treating type 2 diabetes and obesity, but they are not without risk. The drugs carry a wide range of side effects - from common symptoms like nausea and vomiting to severe complications including pancreatitis, kidney injury, and bowel obstruction. These risks make it essential that GLP-1 drugs are only taken under the supervision of a registered medical practitioner/specialists.

India's regulatory authorities have taken firm steps to prevent unsupervised use and malpractices in the supply chain. Patients and the public are strongly advised to consult a qualified medical specialist before use, and to obtain these medications with a prescription only through legitimate, regulated channels.

- ANI