New Delhi: As the top-selling anti-diabetic drug Sitagliptin will be losing its patent protection, many pharmaceutical companies are expected to launch the generic version of Merck, Sharp & Dohme’s (MSD‘s) Januvia (brand name for Sitagliptin) in the domestic market. The news comes as a huge relief for patients with type-2 diabetes in India as it is expected to majorly reduce the cost of the drug.
According to 2019 estimates, 77 million individuals had diabetes in India, which is expected to rise to over 134 million by 2045. Diabetes was the ninth leading cause of death with an estimated 1.5 million deaths directly caused by the disease in 2019.
ETHealthworld spoke to diabetes experts on how the reduction in price will impact diabetes management for Indian patients.
“When a drug goes off patent and it becomes available in a generic form, the price of the drug falls sharply, sometimes by more than 50-70 per cent,” said Dr V Mohan Chairman & Chief Diabetologist, Dr Mohan’s Diabetes Specialities Centre and Director, Madras Diabetes Research Foundation.
Elaborating on the use and efficacy of the drug he added, “Sitagliptin is not a new drug and has been in the Indian market for more than 10 years. It belongs to a group of drugs called the ‘DPP4 Inhibitors’. These medicines are very safe because they do not produce severe hypoglycemia. There are also very few contraindications to the use of Sitagliptin. Our studies and that of others have shown that the DPP4 in general, and Sitagliptin in particular, works very well in Indians and in Asians, perhaps because we have a greater degree of insulin deficiency. Sitagliptin is already a good drug, if it becomes more affordable, definitely many more people will be benefitted from the drug.”
Speaking on similar lines Dr Anoop Misra, Chairman, Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology said, “Sitagliptin is one of the first drugs of class DPP-4 inhibitors introduced in India. This drug has an excellent mechanism of action and benefits a variety of patients with diabetes and continues to be one of the blockbuster drugs. It is without any significant side effects and has reliable blood glucose lowering effect. Because of the minimal risk of low sugar with this drug, it can be used in elderly patients with confidence. Sitagliptin has been robustly researched in diabetes.”
With the background of this fact, Dr Misra believes many doctors will start using Sitagliptin because of its low price and proven effectiveness. He feels about 20 per cent of patients will be shifted to a cheaper version of Sitagliptin.
How Sitagliptin works
Sitagliptin is a drug used in patients with type-2 diabetes mellitus- a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Hyperglycaemia, or high blood sugar, is a common effect of uncontrolled diabetes and over time causes serious damage to many of the body’s systems.
“JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in adults with type-2 diabetes mellitus,” mentions Merck’s website.
This means that Sitagliptin is used with a proper diet and exercise programme in order to control high blood sugar; however, lifestyle modification remains one of the major challenges in the management of diabetes in India.
Dietary indiscretions or lack of exercise are the major causes of uncontrolled diabetes in India states Dr V Mohan. Underlining the reasons behind the huge burden of uncontrolled diabetes he said, “In India, consumption of excess carbohydrate is very common and almost 65-75 per cent of the diet in different parts of the country comes from carbohydrates. Since carbohydrates, especially refined carbohydrates like highly polished white rice and refined wheat get easily converted into glucose, this elevates the blood sugars and makes it difficult to control diabetes. Lack of exercise, sleep, and stress are yet other reasons. Sometimes people are not regular with their medications. Most importantly regular follow-up with the doctor is the secret behind good control of diabetes.”
Every patient needs a change in dose of drugs or combination as with advancing age, drugs lose their efficacy, informs Dr Misra. “Non-compliance to diet, exercise and drugs is very common. An additional major hurdle is an increase in weight in individuals which puts roadblocks to blood sugar control,” he added.
Uncontrolled diabetes directly or indirectly affects many organs of the body, further impacting the quality of life. It can lead to acute complications like infections, tiredness, excessive urination, thirst, and wounds that don’t heal. In the long term, it can lead to the damage of blood vessels which can affect the eyes, kidneys, heart, feet, and nerves. The presence of diabetes and obesity increases the chances of cancer as well.
“Lack of knowledge about diabetes, self-management practices, cultural practices, insufficient counselling, lack of guidelines and protocols for counselling, and financial problems further compound the problem of uncontrolled diabetes,” said Dr Navneet Agarwal, SVP & Head of Care Programmes, BeatO- a digital app-based platform that provides diabetes care programmes.
Role of digital technologies in diabetes management
Technology has been an integral part of diabetes care with the introduction of novel products in blood glucose monitoring systems, treatment devices, and app based-doctor guidance. The global Diabetes Care Devices Market size was valued at $20 billion in 2020 and is projected to reach $38.3 billion by 2030, growing at a CAGR of 6.6 per cent from 2021 to 2030, stated Allied Market Research.
Informing how technology plays a big role in the management of diabetes, Dr V Mohan, said, “Teleconsultations are today possible for patients in very remote areas. Thanks to the use of continuous glucose monitoring sensors which are placed on the arm, one can get an idea about the blood sugar levels throughout the day. This also avoids unnecessary needle pricks and thereby the pain is also reduced. Retinal cameras which were earlier unaffordable, are now made in India and have become inexpensive and therefore affordable for the majority of patients. Various diabetes apps are also used today which helps to connect to the patient and helps to keep the sugars under good control and also try to prevent or reverse diabetes in those who are in the early stages.”
Emphasizing that digital technologies empower patients to track, monitor, and manage their condition with easy access, convenience and personalisation, Dr Navneet Agarwal, said, “Digital technology can help in diabetes management in several ways. It helps patients with remote sugar monitoring options thereby making home care more effective and reducing the need to travel to a lab or a doctor just to check sugar levels. Additionally, virtual care through doctors, diabetes educators and AI-based insights can help people make changes in their diet, lifestyle and regime in real-time. Studies reveal that digital monitoring supported by real-time personalised care can effectively lower hypoglycemia incidents and improve blood glucose levels. Today, digital tools facilitate the management of diabetes even in rural regions, thanks to widespread connectivity and pan-India penetration of mobile phones.”
Experts emphasized on strict adherence to medication, healthy eating habits, daily exercise and routine testing for effectively controlling blood sugar levels in people suffering from type-2 diabetes. All aspects are imperative considering the number at which the disease burden is rising to become the largest global health emergency.