The Current Status of Rybelsus Generic Drugs: Quality and Safety of Indian-Made Semaglutide | TASAKI PHAMA

About Rybelsus and Its Generic Medicines

Rybelsus is an oral semaglutide formulation used as a treatment for type 2 diabetes. Semaglutide is a type of glucagon-like peptide-1 (GLP-1) receptor agonist that has the effect of improving blood sugar control. In recent years, it has also been attracting attention as a treatment for obesity due to its effects.

Rybelsus is developed and manufactured by Novo Nordisk, a Danish pharmaceutical company. Because a patent exists, other pharmaceutical companies are usually unable to manufacture and sell generic drugs of the same ingredient during the patent period. However, due to patent strategies and differences in national laws and regulations, generic drugs or biosimilars of Rybelsus may be manufactured and sold in some countries (especially India).

Generic drugs are required to have the same active ingredients, dosage, and safety as brand-name drugs (original drugs). However, there may be differences in additives and manufacturing methods, and the possibility of differences in efficacy and side effects cannot be ruled out. In particular, for overseas generic drugs, it is necessary to thoroughly check the quality control system and the approval status of regulatory authorities.

Mechanism of Action of Rybelsus

Semaglutide acts on pancreatic β-cells to promote insulin secretion in response to blood glucose levels. It also suppresses glucagon secretion and delays gastric emptying, thereby suppressing postprandial blood glucose elevation. Furthermore, it has been reported to act on the appetite center in the brain and suppress appetite. Through these actions, improvements in blood sugar control, weight loss, and reduction of cardiovascular event risk can be expected.

Indications and Precautions for Rybelsus

Rybelsus is used as a treatment for type 2 diabetes in addition to diet and exercise therapy. It may also be used as a treatment for obesity (however, in Japan, only Saxenda®︎ (semaglutide subcutaneous injection) is approved as a treatment for obesity).

When using Rybelsus, the following points should be noted:

• Risk of hypoglycemia: The risk of hypoglycemia may increase when used in combination with sulfonylurea drugs or insulin preparations.
• Gastrointestinal symptoms: Gastrointestinal symptoms such as nausea, vomiting, diarrhea, and constipation may occur.
• Risk of pancreatitis: Rarely, there have been reports of the risk of developing pancreatitis.
• Other: Administration to patients with gallstones, cholecystitis, severe renal impairment, or severe gastrointestinal disorders should be performed with caution.

When using Rybelsus, it is important to follow the doctor’s instructions and adhere to the dosage and administration. If any side effects appear, consult your doctor immediately.

Current Status and Quality of Indian-Made Semaglutide (Oral)

In recent years, cases have been seen where Indian-made semaglutide (oral) is personally imported via the Internet. These products are often sold as generic drugs or biosimilars of Rybelsus.

India is a country where the manufacture of generic drugs is thriving, and many pharmaceutical companies exist. However, quality control systems and the approval status of regulatory authorities may vary greatly depending on the country and pharmaceutical company. Therefore, when purchasing Indian-made semaglutide (oral), the following points should be noted:

• Reliability of the manufacturer: Check whether the manufacturing pharmaceutical company complies with GMP (standards for the manufacture and quality control of drugs) and has received certification from a reliable third-party organization.
• Content of ingredients: Check whether the content of semaglutide indicated on the product matches the amount actually contained.
• Presence or absence of impurities: Check whether the product contains harmful impurities.

In order to confirm this information, it is important to obtain a Certificate of Analysis (CoA). The CoA will be explained in detail in the next section.

Risks of Personal Importation

The personal importation of medicines is, in principle, the responsibility of the individual. If health damage occurs due to personally imported medicines, it may not be covered by the drug side effect relief system. In addition, the risk of counterfeit or substandard products being mixed in cannot be ruled out. Therefore, the personal importation of medicines should be considered carefully.

The Ministry of Health, Labor and Welfare is issuing warnings regarding the personal importation of medicines, etc. When personally importing medicines, it is important to collect information from the Ministry of Health, Labor and Welfare’s website and fully understand the risks.

Importance and Confirmation Method of Certificate of Analysis (CoA)

A Certificate of Analysis (CoA) is a document issued by the manufacturer to guarantee the quality of a drug. The CoA contains the product’s lot number, manufacturing date, content of active ingredients, presence or absence of impurities, test methods, test results, etc.

When purchasing Indian-made semaglutide (oral), it is important to obtain a CoA and thoroughly check its contents. By checking the CoA, you can judge the quality and safety of the product to some extent.

CoA Confirmation Points

When checking the CoA, please note the following points:

• Reliability of the issuer: Check whether the organization that issued the CoA is a reliable third-party organization.
• Validity of test items: Check whether the test items listed in the CoA are appropriate for evaluating the quality of semaglutide.
• Validity of test results: Check whether the test results listed in the CoA meet the standard values.
• Consistency of lot numbers: Check whether the lot number listed in the CoA matches the lot number listed on the product.

Professional knowledge may be required to confirm the CoA. If necessary, we recommend consulting with a specialist such as a pharmacist or doctor.

How to Obtain a CoA

When purchasing Indian-made semaglutide (oral), please request the seller to provide a CoA. A reliable seller should be happy to provide a CoA. If the seller refuses to provide a CoA or if there are suspicious points in the contents of the CoA, we recommend that you refrain from purchasing the product.

Proper Use of Semaglutide and Coordination with Medical Institutions

Semaglutide is an effective drug for the treatment of type 2 diabetes and obesity, but it is important to adhere to the proper usage methods. Using it based on your own judgment or based on incorrect information may cause health damage.

When using semaglutide, be sure to see a doctor and follow their instructions. If you experience any symptoms of concern during use, consult your doctor immediately.

Coordination with Medical Institutions

Coordination with medical institutions is important when using semaglutide. Doctors will consider the patient’s medical history, constitution, lifestyle, etc., and create an optimal treatment plan. They will also monitor the effects and side effects of semaglutide and adjust the dosage or change to other drugs as necessary.

At Tasaki Pharmaceutical Co., Ltd., we are working with medical institutions to promote the proper use of semaglutide and other pharmaceuticals. We actively provide information from doctors and pharmacists and strive to ensure that patients can receive treatment with peace of mind.

If you have any questions or concerns regarding semaglutide, please feel free to contact your local medical institution.

Summary

Rybelsus (semaglutide) is an effective drug for the treatment of type 2 diabetes and obesity, but caution should be exercised regarding its generic drugs, especially products made in India, regarding quality and safety. By obtaining a Certificate of Analysis (CoA) and thoroughly checking its contents, you can judge the quality of the product to some extent. However, personal importation involves risks and should be considered carefully.

When using semaglutide, be sure to see a doctor and follow their instructions. It is also important to maintain close coordination with medical institutions and receive appropriate treatment. Proper use of medicines is essential to protect the health of patients.

In recent years, treatments for diabetes and obesity have made remarkable progress. GLP-1 receptor agonists, including semaglutide, are expected to have various effects, including not only improving blood sugar control but also reducing weight loss and cardiovascular event risk. By using these drugs appropriately, it is believed that complications caused by diabetes and obesity can be prevented and healthy life expectancy can be extended.