On 5 October, the World Health Organization issued an alert over four cough and cold syrups – manufactured by an Indian pharmaceutical company – that were linked to the death of 66 children from diethylene glycol (DEG) poisoning in the Gambia. Two months later, Uzbekistan linked another made-in-India cough syrup to the deaths of 16 children.
DEG poisoning is a well-known contamination. India has had at least five incidents of DEG poisoning in the past, and yet, something like this happen yet again in 2022.
Tracing the history of DEG poisoning in India leads down a murky path of convoluted, and dysfunctional drugs regulation systems in the country, and throws up the big question of, just how safe are the drugs made in India?
To discuss this and more, public health activist Dinesh Thakur and lawyer Prashant Reddy, co-authors of The Truth Pill: The Myth of Drug Regulation in India, join FIT on this week's episode of News and Views.
Below are some snippets from the podcast.
What the Gambia Tragedy Tells Us About Indian Pharma
"When we were working on this book for the last three and a half years, never did we imagine that this would be the kind of launch we would be having," Dinesh Thakur says, referring to the deaths of 66 children in the Gambia from DEG poisoning that is eerily similar to an incident in Jammu in 2019 that the book opens with.
"Since we became independent, we recount five such instances (in India). The question then becomes, why is it so," he adds.
"The only thing that we can point to is that... the root cause of this nonsense that happens time and time again is our regulatory system and the regulators who are charged with enforcing them."Dinesh Thakur, Public Health Activist
Thakur goes on to say that the fact that we don't seem to learn from such incidents repeatedly occurring shows "we either don't care, or that the people who are accountable to the people of India are not doing their job."
Adding to this, Prashant Reddy says that as far as the Gambia incident goes, "it's quite clear who is responsible. It was the Haryana State Drug Controller who had licenced the plant for manufacture, and the central regulator, that is the Central Drugs Standard Control Organisation (CDSCO), also had to give certification for export."
"The larger problem is that we have a very fragmented system of regulation. "Prashant Reddy, Lawyer
What Consumers Should Know: Can Generic Made-in-India Drugs be Trusted?
There are generic drugs like Saridone which were banned in India in 2018. However, this ban was lifted a year later by the Supreme Court.
Similarly, there is also Analgin, a popular ingredient in painkillers and muscle relaxants, which is banned in many parts of the world, but not in India.
What are consumers to make of such inconsistencies?
If the drug regulatory systems that are in place to ensure the safety and efficacy of the medicines that are passing through into the markets are failing us, how then can we, as consumers, know which drugs to trust?
Thakur explains that when the United States Food and Drug Administration, for instance, bans a drug, they will tell you clearly why they are doing it, and why they don't have confidence in the safety of that drug.
But in India, the system can be convoluted, with little explanation.
"In India, bans come under an obscure section of the drugs law called section 26A where the government exercises its power to take away 'drugs that don't make clinical sense' from circulation."Dinesh Thakur, Public Health Activist
Many of these drugs are approved by state regulators, he adds.
"We also have to look at how a drug works in Indian conditions, for which you need to know how the drug is behaving in the market and we don't have good enough systems to collect this data," says Thakur.
"One way to check which drugs are safe, and which aren't safe would have been if we had a central database which contained the results of all test reports conducted by all the central and state governments."Prashant Reddy, Lawyer
This really just brings us back to the fragmented system of drug regulation in the country that leaves little room for transparency and accountability.
Drug Regulations in India: Where Are We Going Wrong?
We have a regulator in every state and union territory, called the drugs controller. They are responsible for licencing manufacturing facilities and for market surveillance, and prosecutions, explains Reddy.
On the other hand, the Central drugs regulator has a smaller role mainly confined to keeping a check on what type of drugs can be sold in the Indian market, and the import and export of drugs, he adds.
"There's very little that states can do under the present legal framework to block companies situated in another state from selling in their states."Prashant Reddy, Lawyer
"So one of the suggestions is to centralise at least part of the drug regulation with the Central government. At least licencing and inspection of manufacturing facilities should be conducted by one central authority," he adds.
A lack of transparency means accountability is often left tangled in red tape.
"If you go back and look at the reporting in the last year or so, you will see how completely opaque the decision to approve drugs (for COVID-19) by the CDSCO were."Dinesh Thakur, Public Health Activist
The lack of transparency accounts for a lot of questionable stuff that's going on, Thakur says.
What About Counterfiet Drugs?
In the first week of October, the ministry of health and family welfare (MHoFW) announced their plan to start requiring companies to print barcodes or Quick Response (QR) codes on medicine packets so that consumers can check the genuineness of the medicine.
Could a move like this help counter the problem of lower quality counterfeit drugs flooding the market?
Reddy doesn't think so. "The perception of the problem needs to be changed," he says.
"From the government's own records and our own research that we have been conducting over the last seven years, we actually haven't come across many cases of counterfiet medicines. What really sticks out is the issue of substandard drugs – that the manufacturer is legitimate, but they aren't able to manufacture up to quality."Prashant Reddy, Lawyer
"There's been this demand for having a track and trace system for a very long time... even after the tragedy in Gambia, the first response of the government is to trot out this track and trace system with a QR code, but as long as policy makers and media keep thinking that counterfiet drugs are the problem, we are barking up the wrong tree," he adds.
Listen to the full episode here.
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