What are these drugs? – Firstpost

India has banned the manufacture and export of two highly addictive opioids: Tapentadol and Carisoprodol after an exhibition discovered that they were feeding a public health crisis in parts of Western Africa.

The Apex drug regulatory authority of India has asked the drug control authorities and the union territories that withdraw all the exports and permission to manufacture all the combinations of the two drugs, with the general of the controller of the controller of Drugs, Dr. Rajev Singh Raguvanshi, said the decision to ban the two drugs occurred after officials had examined “the potential of abuse of drugs and its harmful impact on the population. “

So what is happening exactly? What are the drugs that India has prohibited and, more importantly, why?

What drugs have prohibited India?

On Sunday, the drug regulator of India announced that the process had begun to immediately withdraw the export and manufacturing licenses of Tapentadol and Carisoprodol.

Tapentadol is a strong opioid, which is a kind of drugs usually made of the opium poppy plant. According to the National Cancer Institute, this type of drug is generally used as an analgesic, since it blocks pain signs by joining opioid receptors in nerve cells.

Used medically for the treatment of moderate to severe pain, the tapentadol is approved in tablet forms of 50, 75 and 100 mg, as well as in prolonged release tablets of 100, 150 and 200 mg.

India has also prohibited Carisoprodol, which is a muscle relaxant. However, due to its highly addictive nature, it is prohibited in Europe and is approved for sale in the US. UU only for short periods, up to only three weeks. Medical experts point out that Carisoprodol’s abstinence symptoms include anxiety, insomnia and hallucinations.

It is important to take into account here that both – Tentadol and Carisoprodol, are approved individually by the Standard Control Organization of Central Medicines in India. However, the combination of the two drugs is prohibited throughout the world, since it has been discovered that it causes respiratory difficulties, seizures and overdose can cause death.

But why have these drugs be banned now?

The prohibition of the export and manufacture of a combination of tapentadol and carisoprodol comes after a BBC The research revealed that a pharmaceutical company based in Maharashtra, Aveo Pharmaceuticals PVT LTD, was illegally exporting this combination of drugs to countries such as Nigeria, Ghana and Ivory Coast.

In a video filmed in secret, the BBC It shows the director of Aveo, Vinod Sharma, showing dangerous drugs. According to the images, an operation tells Sharma that his plan is to sell drugs to adolescents in Nigeria, who “love this product.” Answering, Sharma is seen saying that if users take two or three pills at the same time, they can “relax.” At the end of the meeting, Sharma is seen saying: “This is very harmful to health,” but “today, this is a business.”

He BBC Reports that these drugs are ruining the lives of millions in Western Africa such as Ghana and Nigeria. In fact, Nigeria has become the main market for these pills with the president of the drug agency and application of the Nigeria Law (NDLEA), Brig Mohammed Buba Marwa’s gen, which tells the BBC That opioids are “devastating our young people, our families, are in all the communities of Nigeria.”

The data show that Nigeria has one of the highest opioid abuse rates, with an estimated four million users.

What is even more worrying is that this new combination of tapentadol and carisoprodol, which is marketed under a variety of names, including tafrodol, is even more dangerous than tramadol, which was previously prohibited. Many experts compared the tramadol crisis in Africa with the Oxycontin crisis that devastated the United States.

Speaking about the combination of Tapentadol and Carisoprodol, said Dr. Lekhash Shukla, assistant professor at the National Institute of Mental Health and Neuro Sciences in Bangalore BBC that sounded like a “very dangerous combination.”

“It does not sound like a rational combination,” he said, and added, “this is not something that has a license to be used in our country.”

What measures has India taken?

Following him BBC The investigation, the state and central drug inspectors assaulted the Aveo warehouse in the Boisar de Maharashtra and arrested approximately 1.3 million tablets and 26 lots of active pharmaceutical ingredients of Tapentadol and Carisoprodol.

In addition, Maharashtra’s FDA issued a stop production order to Aveo Pharma, effectively stopping the manufacture of medication combinations in question. It is also the withdrawal of the Noc of Export and the manufacturing licenses granted for any combination of Tapentadol and Carisoprodol, and alerted the customs offices of enruting all the shipments of products referred to through the CDSCO port offices.

An FDA official said Times of India“Aveo has been on our radar in recent months. We notify you in October by the lack of coincidence of your manufacturing and distribution records. The standard control organization of central medications is responsible for testing exports according to their protocols, and the State does not play a role. “

The Ministry of Health of India also issued a statement, which said: “The Ministry of Health and Family Welfare, together with the CDSCO, remains committed to guaranteeing the security 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 the illegal or unusual ethical export of drugs not approved and potentially harmful.

“India, as a leading global supplier of pharmaceutical products, is dedicated to maintaining the highest drug safety standards and regulatory compliance. The Ministry of Health of the Union assures the public and global community that the Government will continue to monitor and regulate pharmaceutical exports to safeguard against any improper use of medicines made in India, “the statement added.

What does Aveo say?

Meanwhile, Aveo Pharmaceuticals PVT LTD has dismissed the accusations against him, qualifying them as “without foundation and without merit.”

“We have always adhered to the rules and regulations established by several regulatory authorities to manufacture and export our products,” he said. “Tofrodol is our registered trademark, which contains tapentadol and carisoprodol. This combination has a degree by the State Food and Medicines Administration and is exported under the necessary non -objection certificate of attending drug controllers and with an export license issued by the Organization of Standard Control of Central Medicines. ”

The pharmaceutical company also added that the manufacturing code shown in the BBC Expose does not coincide with yours, which represents that it was manufactured by another company.

With agencies inputs