The union health minister has given a notification GSR 258(E) dated 07.04.2021 for including Tapentadol in Schedule H1 at S.no 48 to curb its abuse in our country. Last year in October gave notification of a draft amendment to the Drugs and Cosmetics (D&C) Rules, 1945, to include Tapentadol. Making it adherent to the drug license application process in India.
Tapentadol is a synthetic opioid analgesic under schedule H1 for the proper regulation of its sale, circulation and prohibits its abuse. Schedule H1 specifies that a drug can only be sold if it is prescribed.
As per the draft amendment made last year, in the Drugs and Cosmetics rules, 1945, after serial number 47 in schedule H1, 48 serial numbers with Tapentadol shall be inserted. So, for exercising the powers specified by sections 12 and 33 of the D&C Act, 1940, after proper consultation with the Drugs Technical Advisory Board, the central government made some further rules for amending the drugs rules 1946. Those rules might be called Drugs rules, 2021, and they will come into force in effect from the 1st day of November 2021.
Tapentadol has been available in India since 2011 and is being widely abused because of its ease and cheap availability. The drug package does not give any indications that it is included in Schedule H, H1, or X drugs. It is available easily over the counter. Because Tapentadol has been prone to a widespread abuse, therefore many psychiatrists also made an appeal to the drug control authorities for taking into consideration its proper regulation.
Tapentadol entered the Indian market for a long time. Still, there are no drug safety advisories from the Pharmacovigilance Programme of India, and the existing label in the drug also does not have any indication that Tapentadol is under Schedule H or H1.
Most of the time, abusers take Tapentadol through an intravenous route which is quite dangerous. There is no availability of parenteral preparations of Tapentadol, and also there is minimum safety data available for intravenous use.
As per the research done on Tapentadol abuse and its dependence in India by the Centre for Addiction Medicine, Department of Psychiatry, National Institute of Mental Health and Neurosciences, there is a rapid surge in injection drug abuse of Tapentadol, and this is leading to elevated rates of Hepatitis C infection in South India. One of the potential reasons for its abuse is its easy availability, and also, they are quite cheap.
It was said by Diptadhi Mukherjee, a senior resident of, Centre for Addiction Medicine, Department of Psychiatry, that proper regulatory rules are needed for curbing the abuse of Tapentadol. It is being noted that Tapentadol is gaining notoriety as an easily and cheaply available drug.
