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.
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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.
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