By Shilpa Sheth, India TodayThe first trial in the US is set to begin in the next few weeks, and in the meantime, the Indian government has been pushing for the use of a generic drug called Rheumatoid Arthritis Therapy (RAET) in India.
The Indian government says that the drug works in the same way as the drugs currently approved by the US for treating cramps in humans, and will provide relief to the country’s chronic cramps patients for an estimated 20,000.
But there are several concerns.
First, there are questions about the safety of RAET in humans.
In a recent study published in the Lancet Diabetes & Endocrinology, Dr. Shruti Prakash and colleagues, from New Delhi’s Indian Institute of Medical Sciences, looked at RAET and found that its main ingredients were in fact higher in salicylic acid, a type of preservative commonly found in processed foods, than in the actual ingredient in RAET.
They also found that the ingredient found in RAES can be toxic to kidneys.
The second concern is that it could cause side effects.
Dr. Prakashi said that RAET was tested in animals, and the side effects are similar to those found in humans when using corticosteroids for treating arthritis.
The researchers said that the research was funded by a US pharmaceutical company called Pharmacia Biopharma, and that they are currently recruiting clinical trials to compare the safety and effectiveness of RAETS with existing medications in humans to determine whether the drug can be considered a viable alternative.
Dr. Prikash said that while the research showed the drug was safe, it was still too early to say that it is safe and effective for people with chronic cramp, especially since there is no approved treatment for it yet.
He said that there was no reason why a drug that has been used to treat people with severe cramp for more than a decade could not be effective for cramping as well.
“There are no specific side effects associated with this drug, but it has been tested in a number of animal models.
It has shown promise in treating cramp in mice, but we need to see the efficacy in humans,” he said.
India, however, is not alone in using this drug.
In fact, there have been a number studies published in recent years that suggest that the FDA should approve the drug, too.
Dr Prakasa said that one study showed that the use rate of RAES was 10% higher in India than in other countries where the drug is currently available.
“This is an important finding because there is a lot of uncertainty about the efficacy of this drug in humans in terms of its safety,” he told The Hindu.
In fact, Dr Prakasar said, it is not clear whether the study actually showed the efficacy, as the FDA hasn’t approved RAET as an emergency treatment.
“We should be careful that there is not a conflict between these two important outcomes, so that when they are approved, the safety profile of the drug will be the same,” he added.
The FDA has been slow to approve RAET, and Dr Prikasa said he is hoping that the agency will give the drug a full-blown trial soon.
But in the mean time, India is trying to move ahead with its own trials, and it plans to introduce the drug in India by the end of 2019.
Dr Keshav K. Bhagwat, from the Indian Institute for Medical Sciences (IIMS), said that his lab had been working on the development of a RAET-like drug for about a year.
“In the meantime we have been doing tests to evaluate the safety,” Dr Bhagwant told The Indian Express.
“I am hopeful that the trials will be conducted soon.”