Articles
Tapentadol To Fall Under Stricter Restrictions To Curb Its Misuse
by Dolly K. Digital Marketing ExecutiveThe 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.
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About Dolly K. 
Digital Marketing Executive
33 connections, 4 recommendations, 183 honor points.Joined APSense since, March 24th, 2020, From New Delhi, India.
Created on Jul 26th 2021 09:04. Viewed 215 times.
