Novo Nordisk Set to Stop Supply of a Key Diabetic Drug, Indian Patients Urge WHO, Govt to Intervene

New Delhi: As many as ten advocacy groups for diabetes patients in India shot a letter to the World Health Organisation (WHO) on Monday (May 5), urging it to urgently consider taking steps on insulin availability in the country.

This comes in the wake of Novo Nordisk, a Danish pharma multinational, deciding to phase out a key diabetic drug.

Novo Nordisk is going to stop the production of ‘human insulin’ in pen forms. Only the currently available stock will be available to patients in India, and worldwide where it is mostly used.

Insulin comes in two forms – ‘human’ and ‘analogue’ – both being injectable.

Diabetes patients who either don't produce insulin at all or do so in negligible amounts are categorised as type-1 (T1) diabetes patients.

Type-2 (T2) diabetes patients do produce insulin, but in lesser quantities than required.

T1 diabetes patients are totally dependent on injectable insulin, while T2 patients may or may not need insulin in its injectable form and oral medicines may suffice for some of them.

Human and analogue forms of insulin

The difference between the two forms lies in their efficiency. The analogue is the superior form.

The human form of insulin has to be consumed, for example, 30-60 minutes before a meal. In other words, the patients consuming it have to be very precise about when they do so.

On the other hand, the analogue form can be consumed right before a meal, without waiting at all. In other words, analogue forms are fast-acting.

However, in low-and-middle-income countries (LMICs) like India and some African ones, it is mostly human insulin that is consumed because it is cheaper than analogue insulin.

Both the human and analogue forms can be self-administered by two means – pens and vials.

One type of pen contains ‘pre-filled’ insulin. Once the insulin is consumed, they are disposed of. Hence, they are also referred to as disposable pens.

The other type is a ‘reusable pen’, in which insulin cartridges can be inserted multiple times. By pushing a pen into one’s abdomen or upper thigh, a very thin needle delivers the insulin. It is an almost painless procedure.

Vials, on the other hand, have to be consumed through conventional syringes. Doing so can be painful and is a deeply cumbersome process.

Nonetheless, vials are cheaper than pens by at least a factor of five.

So for the sake of convenience, patients generally prefer pens to vials, regardless of whether they are consuming human or analogue insulin.

However, a majority of patients in LMICs make a trade-off. They try to consume the pen form – the more convenient method – but the human, and not analogue insulin, as the former is cheaper, even if it is inferior.

Harsh Kohli, 44, is a Delhi-based T1 diabetes patient who has battled the disease for 32 years now. His 12-year-old son has also suffered the same ailment for eight years.

Kohli is a part of many patient advocacy groups. But he is also a pharmacist and sells diabetes drugs.

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According to Kohli, the MRP of one of Novo Nordisk's disposable human insulin pens (which don't require a cartridge) is Rs 626, as against its analogue counterpart, whose MRP is Rs 1,158.

Reusable pens (non-pre-filled) require cartridges. He states that the MRP of one of Novo Nordisk's cartridges for a human insulin pen is Rs 425 as against its analogue counterpart's Rs 937.

These two examples clearly indicate the difference in prices between the human and analogue forms of insulin pens.

Vials, which are to be used with syringes as stated above, are cheaper than pens.

Hence, the pen forms of human insulin are preferred in ‘poor countries’.

Novo Nordisk will phase out the pen form of human insulin in the next six months. And herein lies the problems for patients, especially T1 patients: they will have to take insulin in its injectable form only.

“For us, it is as important as food, water and air,” says Kohli.

Novo Nordisk is going to continue the vial form of insulin.

Now, such patients are left with two options: those who are administering human insulin via pens must transition to buying analogue insulin. Thus, they will be forced to buy the costlier product.

Or, if they want to stick to human insulin – the cheaper form – they can go back to using vials and syringes.

The advocacy groups who have written to the WHO have primarily demanded that it should amend its essential medicines list (EML) to include analogue insulin. The WHO’s EML guides the national EMLs of many countries. Once a medicine is included in the EML, its cost comes down.

Dr Anoop Mishra, president of the Diabetes Foundation of India, calls the transition “significantly challenging” as drug adherence, that is, the regular intake of doses, could drop due to  inconvenience in consuming insulin via vials.

If patients decide to switch to vials, the worst affected would be children. They fear syringes. Their future may be in limbo.

The elderly, people without vision, people with compromised dexterity (due to ailments such as arthritis), and those who are not well-trained in using syringes will also suffer more than others.

“Pens offer a level of simplicity, discretion and [most significantly] the accuracy [in the self-administration of the drug] that vials and syringes often cannot match,” he adds. Vials consumed through syringes can lead to dosing errors.

Novo Nordisk said in a statement in November 2023 that it would phase out some human insulin pens in order to focus its production on Wegovy – a popular weight-loss drug that is in high demand. It justified its focus on Wegovy by reasoning that high body weight is one of the main causes of diabetes.

It must be clarified here that T1 diabetes is not caused due to being overweight and is an autoimmune disorder. T2 diabetes is linked with excessive weight.

Novo Nordisk's presence in the Indian market

Novo Nordisk occupies the lion's share of the insulin market – across all the brands it supplies– globally and in India. The Economic Times reported that it had a market worth of more than Rs 4,500 crore in India.

But what could be the alternatives to Novo Nordisk's human-pen form of insulin once they are phased out?

There are a handful of pharma firms other than Novo Nordisk that make human insulin pens.

The prices of their products also vary. Sample the case of human insulin pens which can be reused and require a cartridge. The MRP of a cartridge produced by Biocon Biologics is Rs 284, according to Kohli. Novo Nordisk's counterpart – which the company will phase out – has an MRP of Rs 424.

Besides Biocon, there are a few companies making various forms of insulin like El Lily, Sanofi and Eris Life Sciences. But all of them will have to significantly increase their production to fill the gap left by Novo Nordisk.

Mishra says that while it is a fortunate scenario that alternatives are available, stock-outs may pose a challenge if patients indeed make a shift towards different forms or brands.

“In the short term, we may see a rise in insulin administration errors [if vials are used], skipped doses [till alternatives are available] and poor glucose control,” he warns.

Some countries have already issued guidance for clinicians in the wake of Novo Nordisk's decision, considering the gravity of the situation. The National Health Service (NHS) Nottingham and Nottinghamshire, which functions under NHS England – has suggested alternatives to each of the drugs being phased out that clinicians may consider.

There has been no advisory or guidance that has come from the government's scientific institutions for clinicians in India. At least none that is available in the public domain.

India, incidentally, has 133 million diabetic patients who remain untreated, according to a Lancet study. The country contributes nearly 30% of all untreated diabetic patients across the world – the highest of any country.

Patients' demands in India

Mridula Kapil Bhargava has been a T1 diabetes patient for more than 30 years and heads the Diabetes Fighter's Trust, a patient advocacy group. She laments that there is no specific government scheme or policy to support patients living with T1 diabetes – a condition that is going to stay with them for life.

“The government can at least supply the analogue insulin through Jan Aushadhi Kendras (JAKs),” she says. JAKs are a Union government initiative. She says the government must hand-hold Indian companies to increase the production of analogue insulin to at least partially alleviate their expenditure on drugs.

Kohli says he also approached the previous Aam Aadmi Party government of Delhi to intervene, but to no avail.

“Why is a cost attached to my and my son's life that is increasing exponentially every year?” he asks. 

Asked how much a patient spends on injectable insulin, he said it differs by individual. Speaking for himself and his son, he gave a rough estimate. He uses reusable analogue pens and considers himself fortunate enough to be able to afford them.

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A cartridge for a reusable analogue pen costs him Rs 937. It runs out in about a week. Kohli's son has to consume a higher dose, because, according to him, his insulin doses need to align with his growth hormones, which remains increased during adolescence and the teenage years. The same cartridge lasts about four or five days for his son.

Leena Menghaney, a noted public health lawyer, says she is alarmed by “Novo Nordisk’s double standard toward people with diabetes in low- and middle-income countries.”

“This move will enable Novo Nordisk – now valued at half a trillion dollars – to prioritise the production and sale of its high-priced, patented GLP-1 [glucagon-like peptide-1] medicines, Ozempic and Wegovy, in pen form for wealthier countries,” she added.

Although the mode of delivery for these drugs – the pen – is similar, the company in a statement to Reuters given in November 2024 claimed that the pens it uses for human insulin are not the same as those for its GLP-1 agonists Wegovy and Ozempic.

Novo Nordisk told the Times of India on April 25, 2025: “In order to meet increasing patient demand and ensure a stable supply of our medicines, we have decided to consolidate our insulin portfolio. This will create space needed in our global manufacturing network.”

“Hence, in this process, we are phasing out the Penfill. We acknowledge that this will be disruptive to people living with diabetes who rely on our treatments. However, by doing this now, we will increase the number of patients we reach with our insulin portfolio by many millions in the next decade," the statement added. 

Medicines Sans Frontiers and T1International conducted a survey in May 2024 of over 400 people on insulin in 38 countries. It found that 82% of respondents wanted to use pens instead of vials and syringes. The higher costs of the former proved to be an impediment to make the choice that they wanted to make.

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