The tale of ‘have money, buy miracle drug’

That many of these ‘magic drugs’, which are being promoted in the media, have not undergone clinical trials in India highlights the role of the regulator and doctors

March 07, 2024 12:08 am | Updated 01:56 am IST

‘There are so many questions that doctors have to answer’

‘There are so many questions that doctors have to answer’ | Photo Credit: Getty Images

For almost every week in the last few months, newspapers have been publishing articles about the use of ‘magic injections that guarantee weight loss’. This ‘magic injection’ contains a drug called Semaglutide. Originally used for the treatment of Type 2 diabetes mellitus, this drug also results in weight loss. However, many of the articles promoting these drugs fail to mention that this weight loss drug has not been approved for sale in India but is being administered by doctors to patients who are mostly affluent.

The press releases by global pharma companies advising patients not to use this product in India do not get any publicity in the media. The media is also guilty of not reporting the significant side-effects that these drugs can cause. For some of us who lived to tell the tale, this is eerily similar to Rimonabant and Fen–Phen.

Many decades ago, in the United States, another type of weight loss drug was marketed as a miracle weight loss cure. Soon, the miracle was demystified and pharma companies paid out approximately $4 billion in damages in mass tort litigation. Weight loss drugs, however, form only a small fraction of such unauthorised drugs.

Trials, sale approval in India, exceptions

Drugs are normally approved for sale in India only after the Indian subsidiary or licensee of the global brand owner conducts clinical trials. Once approved, the regulator mandates monitoring and reporting all adverse events for two years. Global pharma companies sometimes choose to stay out of the Indian market and not launch drugs in India. In such circumstances, patients can get a license from the drug regulator based on a doctor’s prescription to import these drugs for personal use. Similarly, hospitals too can apply for import licences. But these are narrow exceptions to the rule that the drug needs to be tested in clinical trials in India and is available for sale only after approval by the drug regulator.

With these unapproved “miracle drugs”, there have been no clinical trials in India. That means we do not know if Indians will react differently to the drug. Doctors in India will be unable to know how patients who may be taking other drugs for ailments such as diabetes and hypertension in India (that are not prescribed in most developed countries), will react to these injections. This is a significant risk that cannot be wished away easily. It is a risk that cannot be accurately estimated and mitigated.

Questions for doctors...

In this background, there are so many questions for doctors. Should doctors prescribe a new drug when it is not approved for sale in India? Are doctors recommending these drugs? Or are their clients demanding them based on new reports of miracles? What is the duty of the doctors in these situations? What are the incentives for the doctors? How many doctors administering these injections have studied the full-effects of these drugs? How many of these doctors have been trained to identify and treat adverse events? Do doctors not know that it is very likely that clients will be using illegally imported drugs as the drugs are not yet approved for sale in India?

The recent scandal about spurious imported drugs such as Adcetris, a drug used to treat a type of blood cancer, brings further attention to this issue. The drug regulator only issued an alert regarding spurious drugs after the World Health Organization did so in September 2023. This alert too was delayed by two years as the arrests made by the Mumbai police in October 2021 had brought this issue to light earlier. Therefore, this raises the question of how sure doctors are that the unapproved imported drugs they are administering are not dangerous fakes. Should not doctors be sure of the provenance of these drugs before administering them? In the case of Semaglutide, is it a wonder that doctors look like they are complicit in this scam when the pharma companies manufacturing these drugs have issued alerts?

... and the regulators

There are questions for government and drug regulators too. What is being done to control the import of these drugs? All it will take is for a few doctors to be arrested and sent to jail, which will be a deterrent.

And, finally, do we really care? After all, this seems like this is a rich man’s problem as these are expensive drugs. What does it matter if a few rich people suffer as a result of this misadventure and their doctors make a tidy sum from it? These are like designer watches or scotch whisky. Who cares if they are being illegally imported? Who cares if they are fakes?

The government perhaps has more pressing priorities than to be bothered about this. We did not care when the poor died consuming spurious cough syrup either. So, who does the government care about?

One can only think of the song by Bob Dylan, “Blowin’ in the Wind”.

Murali Neelakantan is the Principal Lawyer at Amicus. Dr. Parth Sharma is a public health physician, researcher, and founder of Nivarana, a public health advocacy and information platform

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