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Laxmi Yadav, Mumbai October 31 , 2020
The Union ministry of health and family welfare has notified a draft amendment to the Drugs and Cosmetics Rules, 1945 that would bring Tapentadol, a synthetic opioid analgesic under Schedule H1 to regulate its sale, distribution and prevent its abuse.

Schedule H1 stipulates that the drug can be sold only on prescription.

According to the draft amendment issued by the ministry on October 20, 2020, in the Drugs and Cosmetics Rules, 1945, in Schedule H1, after serial number 47 and entry relating thereto, the following serial number and entry shall be inserted, namely — 48. Tapentadol.

The Central Drug Standard Control Organisation (CDSCO) approved Tapentadol immediate-release (IR) preparations (50, 75 and 100 mg) for moderate to severe acute pain and extended-release (ER) preparations (50,100,150 and 200 mg) for severe acute pain in April 2011 and December 2013 respectively.

Tapentadol which has been available in India since 2011 is widely abused due to its easy and cheap availability. The packaging of the drug does not indicate that it is a schedule H, H1 or X drug and is thus available more or less over the counter.

Taking serious note of widespread abuse of Tapentadol, psychiatrists have appealed to drug control authorities to consider regulation of the drug.

According to a study carried out by Centre for Addiction Medicine, Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore last year to assess Tapentadol abuse and dependence in India, injection drug abuse of Tapentadol is emerging rapidly and is associated with high rates of hepatitis C infection in southern India. A possible reason is easy and cheap availability of tablets that can be easily repurposed for injection, stated the study.

Analysis of internet search data also shows that Tapentadol is receiving attention from internet users in India and this interest is maximum in northern states like Punjab, Jammu & Kashmir, Himachal Pradesh with a high prevalence of current opioid use.

Said Diptadhi Mukherjee, MD, senior resident, Centre for Addiction Medicine, Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, who is among eight authors of the study, “Urgent regulatory measures were required to curb Tapentadol abuse. The increase in the number of cases at our centre last year shows that Tapentadol is attaining notoriety as an easily and cheaply available drug of abuse. In India, prescription opioids have contributed more to opioid abuse than illicit opioids in the past as well as present.”

It has been eight and a half years since Tapentadol entered the Indian market. There are no drug safety alerts or advisories from the Pharmacovigilance Programme of India (Indian Pharmacopoeia Commission, 2019), and the current drug label does not indicate that Tapentadol is a Schedule H or H1 drug, Dr Mukherjee pointed out.

Abusers mostly take Tapentadol through an intravenous route which is very dangerous. Unlike Tramadol, parenteral preparations of Tapentadol are not available, and there is minimal safety data for intravenous use. This is important as the bioavailability of oral Tapentadol is only 32%, due to extensive first-pass metabolism, added the senior resident doctor.

Regulatory systems take a long time to respond to the abuse of new drugs. For example, doctors reported that widespread tampering and injecting of dextropropoxyphene in northeastern states was causing high morbidity and mortality as early as 2005. It was banned much later in 2013, only to be reintroduced in 2017 with strict regulations. Similarly, Tramadol received approval in 1993 and was brought under Schedule H1 in 2013 followed by being classified as a psychotropic drug under Narcotic Drugs and Psychotropic Substances (NDPS) Act in 2018.

“We aver that initially allowing unregulated sale of a new opioid medication and responding later with excessive regulations constitutes double jeopardy. During the initial period several users get addicted and when there is decreased availability due to regulation, they switch to other opioids,” Dr Mukherjee stated.

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