“The drug’s effect lasts only for one hour. The video doesn’t mention that,” says Dr Charulata Sankhla, President, Movement Disorders Society of India, Mumbai.
Having said that, the video has achieved “viral” status. Or so doctors say.
Parkinson’s Disease is a disorder of the central nervous system that causes tremors and affects movement. Its symptoms include stiffness, difficulty in speaking, poor balance, amnesia, anxiety, and loss of smell. It usually affects patients aged 60 or older, but now, earlier onset is being seen in patients under 40.
And India, most bafflingly, is treating it as a non-issue. There’s little to no access to the drug shown in the video—Apomorphine—that can help contain symptoms of Parkinson’s if taken regularly. In its injectable form, the drug is rapidly absorbed by the body, providing relief to patients within six to nine minutes. In the US and Europe, the drug has been in use for more than 20 years, and yet, until recently, Indian Parkinson’s patients couldn’t get it anywhere.
But is Parkison’s really that prevalent in India? Enough to warrant access to the only effective drug.
According to the medical journal The Lancet, in 2016, 6.1 million had the disease worldwide as opposed to 5,75,946 in India. However, doctors suspect the numbers are much higher—to the tune of 300-400 for every 100,000 citizens, and they expect this will double by 2030.
The mainstay of Parkinson’s treatment in India is orally-administered medicine, namely Levodopa and Carbidopa, which help control the tremors and ease muscle movement. There are also other tablets such as Pramipexole, Ropinirole, Amantadine, Trihexyphenidyl, Safinamide, and Rotigotine which take 30-60 minutes to kick in.
The tablets are cheaper. But don’t come anywhere near the effectiveness of Apomorphine, which takes a patient from an “off” to an “on” state in minutes, making her feel alive.
Apomorphine is a necessity for Parkinson’s patients. According to Dehradun-based Rusan Pharmaceutical Ltd—an indigenous manufacturer of the drug—it is a non-controlled (no narcotic permission required), non-narcotic, non-addictive substance.
Dr Sankhla, says, “Imagine if one wants to go out to a restaurant or is already in a public place and becomes stiff. It is convenient to get an injection and get going in six to nine minutes than wait for half-an-hour or one hour.”
UK-based Britannia Pharmaceutical Ltd’s ‘APO-GO’ Apomorphine injection finally entered the Indian market via tie-ups with three hospitals in three different cities—Bengaluru’s Vikram Hospital, Mumbai’s Nanavati Hospital and Kolkata’s Medica Superspecialty Hospital—in December last year.
Shortly after, Rusan’s Apomorphine injection, APOSAN, launched in January this year. In Bengaluru, Mumbai, Delhi and Chennai. 250 patients have already taken the test dose with the starter pack and many of them are ordering monthly packs. Rusan is now taking the drug to Hyderabad, Ahmedabad, Pune, Kolkata, Lucknow and Bhopal as well.
Despite the options though, the drug won’t reach most people who need it.
Unvia(l)able
59-year-old Lalithamma AU, a government school teacher in the southern Indian city of Mysuru, was diagnosed with Parkinson’s in 2007. With time, her speech slurred, her limbs shivered and she experienced more and more fatigue. Movement became a problem.
For the past two months, she has been taking 3mg of Rusan’s drug APOSAN twice a day to enable easier muscle movement. “The effect is there for around two hours. There is a significant improvement in my movement,” Lalithamma says.
The price of the 2ml vial that she needs per day costs more than the Rs 23.74 ($0.3) she spends on the tablet Levodopa. But not anywhere close to the price of Britannia’s alternative APO-GO, according to doctors in Vikram Hospital.
A 3ml vial of APO-GO is reportedly likely to be priced at Rs 1,500-2,000 ($22-30), but The Ken could not independently verify this. There’s also no official announcement on when it will be available to patients. The Ken’s emails to Britannia, with regard to its Apomorphine pricing, went unanswered.
Meanwhile, 2ml and 5ml vials of Rusan’s APOSAN cost Rs 315 ($4.5) and Rs 700 ($10), respectively. With APOSAN, the cost of daily dosage (between 30-60 mg), comes to Rs 475-950 ($7-14) per day. In sharp contrast, Apomorphine pens in the UK—which contain 30 mg of Apomorphine—range between Rs 2,250 ($32.5) and Rs 4,500 ($65) per day.
In its first year, Rusan plans to achieve sales of Rs 15-20 crore ($2.1 million-$2.9 million). For FY18, Rusan recorded revenues of Rs 153.52 crore ($22.2 million). Its profit for the same period stood at Rs 24.5 crore ($3.5 million), an almost 68% jump from the Rs 14.6 crore ($2.1 million) profit it made in the previous fiscal.
The company is, to its credit, trying to make Apomorphine accessible. It will provide pens and pumps for drug administration free of cost once it receives approval for the devices from the Drug Controller General of India (DCGI). Under its ‘Hope’ programme, it has introduced a toll-free number—18001030475—for patients and their caregivers to call for assistance. Under the programme, nurses train caregivers to administer the drug under the skin.
Rusan is the only company which has Drug Controller General of India (DCGI) approval for the finished formulation (Form 46) and the raw material (Form 46A).
With Britannia’s drug, patients have to apply to the DCGI for a permit to import small quantities of the drug for personal use under Form 12(A) provided by India’s Central Drugs Standard Control Organisation, just like cancer patients, who often import expensive drugs from other countries by applying to the DCGI. This is an arduous process, say doctors.
So far, only two patients from Nanavati Hospital have successfully applied to import Britannia’s drug. However, thus far, they have only been administered the test dose.
In a country with only around 8,000 neurologists and 800 movement disorder specialists, as one pharma company representative remarked, it is hardly surprising that patients and their treating doctors are left to their own devices to import this drug.
According to Dr Kunal Saxena, Managing Director of Rusan, there is a large population in India that is susceptible to Parkinson’s. But there are also many patients who don’t get diagnosed and spend their lives suffering. The market size is much bigger than hundreds of thousands, doctors claim, saying that a lack of awareness contributes to people not coming forward for treatment.
“In about two to three years, Rusan plans to reach about 5-10% of the existing market,” he says.
Out of the shadows
Dr Vinay Goyal, head of the Department of Neurology at All India Institute of Medical Sciences, New Delhi, says the problem is that whenever foreign players come to India they want a large market which is not the case with Parkinson’s Disease. And hundreds of thousands doesn’t make the cut. A foreign company, around 12 years ago, wanted to sell Levodopa, one of the main drugs in Parkinson’s Disease treatment. “Their per month drug cost came up to Rs 2 lakh ($2,900), for which there was no market in India, so they left India,” he says.
That is why the video put out by Nanavati Hospital reached far and wide, because finally, there were companies taking an interest in Parkinson’s patients. Someone was listening.
Goyal says every hospital has a right to create awareness, and the only mistake in the video is that they had a physiotherapist talk, someone who’s not authorised to prescribe the drug.
On the brighter side, he wonders if there is any Parkinson’s patient in the country who has not seen this video. “A large number of my patients sent it to me asking if I know about the drug and what it does. Even my ‘non-medical’ friends are asking me about this drug,” he says.
According to Goyal, it generally takes five years for a drug to be known. “This drug was known to everyone in five days. What more publicity can one want? Even [Bollywood celebrity] Amitabh Bachchan couldn’t have gotten such publicity for the drug. Whether the patients will use it or not, that is up to the doctor to decide, but now every patient knows that such a drug exists,” he says.
But is that enough information about the drug and its efficacy?
Dr Sanjeev CC, Movement Disorder Specialist from Bengaluru and Lalithamma’s doctor, says, “Apomorphine is a good drug as it acts as a rescue therapy when patients do not respond to oral medication. But it has side effects like dyskinesia (uncontrollable movement), an effect on heart rate, confusion, and hallucination.”
However, caregivers who have seen their loved ones under the effect of the drug say they fall less often, their sense of balance is improved, and they are a lot more independent. At least for the duration of each dose of the drug. Sometimes an hour or maybe two.
In either case, Apomorphine isn’t one of two options. It’s the only choice. As a patient ages, oral medication loses its efficacy. Some patients, despite taking pills, experience morning stiffness and find themselves unable to go to the bathroom, says Saxena. In such extreme cases, Deep Brain Stimulation Surgery is suggested, which costs Rs 10-15 lakh ($14,450-21,680). In this, a device is placed in the brain, which sends electrical impulses to specific targets in the brain. But not everyone is a suitable candidate for the surgery, and after the age of 70, it is generally not prescribed.
Apomorphine acts as an alternative between oral medication and surgery.
But in India, this alternative comes with hurdles.
Saxena says though his company had been supplying the active pharmaceutical ingredient globally since 2004, it was only in September last year that they got the approval for the finished formulation and hence the delay in launch.
According to Dr Sanjeev, availability of raw material plays a role and also the ability of the companies to import it or manufacture in India. “Specialised laboratories are required for the same,” he says.
Indian pharma companies have been focusing primarily on oral medications to manage the symptoms of Parkinson’s. “Since globally there are very few manufacturers of the active pharmaceutical ingredient, Apomorphine, this could be a reason why many Indian pharma companies have not developed and launched the product in India,” Saxena added.
The naysayers
But not everyone is as sold on Apomorphine. An employee of one of the largest pharmaceutical companies in India with a Central Nervous System (CNS) profile—companies which make drugs in the area of neurology—says this drug can be misused as it causes dopamine (a chemical released by nerve cells in the brain to send signals to other nerve cells) levels to rise though it is a powerful emetic—a medicine which causes vomiting.
Also, the drug can be used only by a small section of the Parkinson’s Disease population. “It is used by those whose symptoms can’t be controlled by oral medication. These drugs don’t have a long-term effect,” he claims.
The company is yet to seriously consider Apomorphine as it doesn’t reach the rural population, he says. “Let’s not go by the epidemiology but look at how many of these patients actually get access to medical care and specialists. This is mainly restricted to cities.”
“We can have a marketing tie-up once the product is established in the Indian market,” he adds.
Another official of a company active in the therapeutic area of CNS claims that it is not a primary therapy. “Levodopa and Carbidopa are the main drugs used to treat Parkinson’s symptoms. Apomorphine is just an add-on,” he argues
It’s also used for treating erectile dysfunction. “It’s not a must-have for companies. If an existing drug is launched by us with our resources and efforts then the attention from our focus drug will be diverted. If I am a general division employee then I will not promote something for neurologists’ benefit ignoring my primary drug,” he says.
Essentially, business as usual.
Meanwhile, the likes of Lalithamma lie in wait.
In an ageing population, neurological disorders are the leading source of disability. Dr Pramod Kumar Pal says that 50% of the neurodegenerative disorders he sees are cases of Parkinson’s. Pal heads the Department of Neurology and the Parkinson’s Disease and Movement Disorder Clinic at National Institute of Mental Health and Neurosciences, Bengaluru.
“Early onset of the disease in India is much higher compared to western countries,” he adds. But for the first time in a while, there is finally a ray of hope. The need now is to ensure that it reaches as many of India’s Parkinson’s sufferers as possible.