Govt issues guidelines on use of GLP-1 drugs, cautions against illegal sale

With multiple weight loss drugs flooding the pharmacy stacks, the drug regulators of India have tightened their hold on the unauthorized sale of these medicines.

The authorities have issued an advisory on the use and sale of Glucagon-like-peptide 1 (GLP-1) medicines.

Last month, semaglutide, the parent chemical of GLP-1 brands like Ozempic and Wegovy, lost its patent, enabling new brands to fill up the drug market.

The newer brands, offering the same salt at lower prices will prompt more people to buy weight loss drugs.

The Drug Controller of India has intensified its regulatory exercises to prevent unsupervised consumption of these drugs without a prescription, a news agency informed.

What did the advisory say?

Introduced to treat diabetes, these medicines are now managing obesity. Most of them are given as injectables, some are available as tablets. 

On March 10, the drug regulatory body of India issued a comprehensive advisory, asking the drug manufacturers to stop misleading advertisements, encouraging people to buy these medicines without a doctor's consent.

According to a news agency, about 49 businesses in India were inspected, including online pharmacy warehouses, drug wholesalers and weight-loss clinics to identify any unauthorized sale or promotion of the medicines.

In case of violations, the drug makers and distributors will face license cancellation and legal action, the advisory cautioned.

The GLP-1 drugs can cause serious side effects if not taken under medical supervision, said the advisory, including nausea, dizziness, pancreatitis and thyroid cancer.

GLP-1 drugs must not become a quick fix for diabetes or obesity. They should only be prescribed by an endocrinologist or a doctor trained in internal medicine, a senior endocrine specialist told ANI.

As per medical experts, these medicines are not suitable for all. They have to be used cautiously around those who are pregnant, have a history of depression, eating disorders, thyroid cancer and pancreatic disorders.

How do GLP-1 medicines work?

When the food enters the digestive tract, the pancreas releases insulin to enable the body cells to absorb glucose. Another hormone glucagon raises blood glucose when levels go too down. 

At the same time, some incretin hormones are released by the intestine which facilitate the stimulation of insulin and glucagon.

GLP-1 is an incretin hormone produced by the intestine which stimulates the release of insulin and inhibits the activity of glucagon. These dual actions lower the blood glucose levels, slows down gastric emptying and increases feelings of satiety.

Mimicking the action of GLP-1 hormones, these new weight loss drugs do the same in bringing down levels of blood glucose. 

In people with diabetes or insulin resistance, this natural balance of blood glucose is out of order, increasing food cravings. 

Semaglutide is a GLP-1 drug which functions like the natural incretin hormones, allowing the food to stay in the gastric tract for extended periods, thus killing appetite.

Experts found these drugs showed similar restorative function in people having obesity. 

Some other drugs like Tirzepatide mimic the action of both GLP-1 and glucose-dependent insulinotropic polypeptide (GIP), another type of incretin hormone.

Among some generic manufacturers of these medications are Sun Pharmaceutical, Dr Reddy’s Laboratories, Natco Pharma and others.