Govt to bring Tapentadol under Schedule H1 to curb its misuse
New Delhi: Through a recent Gazette Notification, the Union Ministry of Health and Family Welfare(MoHFW) 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.
The government has decided to amend the said rules that will be called the Drugs and Cosmetics (…..Amendment) Rules, 2020, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board.
As per the proposed amendment;
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"
This comes in wake of misuse of Tapentadol which has been available in India since 2011. Tapentadol immediate-release (IR) preparations (50, 75 and 100 mg) was approved by the Central Drug Standard Control Organisation (CDSCO) 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.
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