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India has banned the manufacture and export of two highly addictive opioids – tapentadol and carisoprodol after an expose found they were fuelling a public health crisis in parts of West Africa.
India’s apex drug regulatory authority has asked the drug control authorities of states and Union Territories to withdraw all export NOCs and permission to manufacture all combinations of the two drugs, with Drugs Controller General, Dr Rajeev Singh Raghuvanshi saying that the decision to ban the two drugs came after officials had looked into “the potential of drug abuse and its harmful impact on population”.
So, what exactly is going on? Which are the drugs that India has banned and more importantly why?
Which drugs have India banned?
On Sunday, India’s drug regulator announced that it had started the process to immediately withdraw the export and manufacturing licences of tapentadol and carisoprodol.
Tapentadol is a strong opioid, which is a class of drugs generally made from the opium poppy plant. According to the National Cancer Institute, this kind of drug is usually used as a painkiller, as it blocks pain signals by binding to opioid receptors on nerve cells.
Used medically for the treatment of moderate to severe pain, tapentadol is approved in 50, 75 and 100-mg tablet forms as well as 100, 150 and 200-mg extended-release tablets.
India has also banned carisoprodol, which is a muscle relaxant. However, owing to its highly addictive nature, it is banned in Europe and is approved for sale in the US only for short periods — of up to only three weeks. Medical experts note that withdrawal symptoms from carisoprodol include anxiety, insomnia and hallucinations.
It is important to note here that both —tapentadol and carisoprodol — are individually approved by the Central Drugs Standard Control Organisation in India. However, the combination of the two drugs is banned across the globe, as it has been found to cause breathing difficulties, seizures and an overdose can lead to death.
But why have these drugs been banned now?
The banning of the export and manufacture of a combination of tapentadol and carisoprodol comes after a BBC investigation revealed that a Maharashtra-based pharma company, Aveo Pharmaceuticals Pvt Ltd, was illegally exporting this combination of drugs to countries like Nigeria, Ghana and Ivory Coast.
In a video secretly shot, the BBC shows Aveo’s director Vinod Sharma showing off the dangerous drugs. As per the footage, an operative tells Sharma that his plan is to sell the drugs to teens in Nigeria, who “love this product”. Responding, Sharma is seen saying that if users take two or three pills at once, they can “relax”. At the end of the meeting, Sharma is seen saying: “This is very harmful for the health,” but “nowadays, this is business.”
The BBC reports that these drugs are ruining the lives of millions in West African countries such as Ghana and Nigeria. In fact, Nigeria has emerged as the main market for these pills with the Chairman of Nigeria’s Drug and Law Enforcement Agency (NDLEA), Brig Gen Mohammed Buba Marwa, telling the BBC that opioids are “devastating our youths, our families, it’s in every community in Nigeria”.
Data shows that Nigeria has one of the highest opioid abuse rates, with an estimated four million users.
What is even more concerning is that this new combination of tapentadol and carisoprodol, which is marketed under a range of names including Tafrodol, is even more dangerous than tramadol, which was banned earlier. Many experts compared the tramadol crisis in Africa to the oxycontin crisis that ravaged the US.
Speaking on the combination of tapentadol and carisoprodol, Dr Lekhansh Shukla, assistant professor at the National Institute of Mental Health and Neuro Sciences in Bengaluru, told BBC that it sounded like a “very dangerous combination”.
“It does not sound like a rational combination,” he said, adding, “This is not something that is licensed to be used in our country.”
What action has India taken?
Following the BBC investigation, state and central drug inspectors raided Aveo’s warehouse in Maharashtra’s Boisar and detained approximately 1.3 crore tablets and 26 batches of active pharmaceutical ingredients of tapentadol and carisoprodol.
Additionally, the Maharashtra FDA issued a stop production order to Aveo Pharma, effectively halting the manufacturing of the concerned drug combinations. It also the withdrawal of export NOCs and manufacturing licences granted for any combination of tapentadol and carisoprodol, and alerted customs offices to route all consignments of referred products through CDSCO port offices.
An FDA official told Times of India, “Aveo has been on our radar for the past few months. We served them notice in October for non-matching of their manufacturing and distribution records. The Central Drugs Standard Control Organisation is responsible for testing the exports as per their protocols, and the state does not play a role.”
India’s health ministry also put out a statement, which read: “The Ministry of Health and Family Welfare, along with the CDSCO, remains committed to ensuring the safety and well-being of citizens in India and abroad. The steps taken in response to this issue reflect the government’s zero-tolerance policy towards illegal or unethical export of unapproved and potentially harmful drugs.
“India, as a leading global supplier of pharmaceuticals, is dedicated to maintaining the highest standards of drug safety and regulatory compliance. The Union Health Ministry assures the public and global community that the government will continue to monitor and regulate pharmaceutical exports to safeguard against any misuse of Indian-made medicines,” the statement added.
What does Aveo say?
Meanwhile, Aveo Pharmaceuticals Pvt Ltd has dismissed the allegations against it, terming them as “baseless and without merit”.
“We have always adhered to the rules and regulations set by various regulatory authorities to manufacture and export our products,” it said. “Tafrodol is our registered trademark, which contains both tapentadol and carisoprodol. This combination is licensed by the relevant State Food and Drug Administration and is exported under the necessary No Objection Certificate from the Assistant Drug Controllers and with an export licence issued by the Central Drugs Standard Control Organisation.”
The pharma company further added that the manufacturing code shown in the BBC expose does not match theirs, depicting it was manufactured by some other company.
With inputs from agencies