New Delhi: Maharashtra’s Food and Drug Administration (FDA) is investigating Mumbai’s Nanavati Hospital for a video in which they advertise an unapproved drug for Parkinson’s disease.
In the video, a patient is injected with the drug apomorphine. Soon after, the patient is shown walking, jogging and doing push ups. It also features the Indian cricket team’s former physiotherapist, Ali Irani, recommending the drug.
Parkinson’s disease affects nerve cells in the brain and can cause rigidity or tremors in muscles and can change speech and gait. It can’t be cured, but symptoms can be managed.
Maharashtra’s FDA has asked Nanavati Hospital to clarify if they are carrying out clinical trials for apomorphine and if they have permission, according to a report in Mumbai Mirror. The FDA is also reviewing this video in case it is actually a promotion of this drug, which could be a violation of the Drugs and Cosmetics Act, 1940.
Several doctors have also objected to the video, which shows apomorphine as some sort of miracle drug. The video does not disclose that apomorphine’s effect is only temporary, lasting for just an hour or so, after which the patient continues to have either tremors or stiffness.
Also read: Drug Controller Conducts Third Raid on Pharma Firms for Unapproved Drugs
The video also does not mention that the drug has not had clinical trials in India and has not been approved by government authorities in India either, according to another article in Mumbai Mirror, not does it talk about the side effects or the high cost of the drug.
Nanavati Hospital has been pursuing research on apomorphine along with King’s College London.
According to a document on the hospital’s website, they have been promoting this as a “treatment” since at least December 2018. In December, they held a one-day conference on apomorphine, claiming: “An extraordinary treatment for Parkinson’s. An exclusive chance to be a part of it.” During the event, they screened videos showing “improvement of patients”. The main speaker from the hospital was Professor Neeta Shah, a senior consultant neurologist at Nanavati Hospital.
Apparently Nanavati hospital has been flooded with “over 5,000 calls” of people asking about apomorphine and they have waitlisted 2,000 patients for the treatment, according to Mumbai Mirror. They have reportedly been testing the drug since last December.
The hospital later did issue a statement saying that the effect of apomorphine is actually “short lasting and a patient may require multiple injections…”
The Movement Disorders Society of India released a statement in which they cautioned against any undue excitement over the drug: “Physicians, people with Parkinson’s and their caregivers are advised to be wary of any misleading information appearing in social media falsely assuring the same.”
The statement also said that patients should consult neurologists or movement disorder specialists before trying any therapies and that there is no “magic drug or a cure all or a one size-fits-all” treatment for Parkinson’s disease.
Despite the opposition to the video, the president of the society, Professor Kalyan Bhattacharya, was one of the speakers at Nanavati Hospital’s event on apomorphine in December 2018.