Draft For Inclusion Of Tapentadol In Schedule H1 To Curb Its Misuse

Draft For Inclusion Of Tapentadol In Schedule H1 To Curb Its Misuse The Health Ministry has amended the D&C rules to include Tapentodol under schedule H1 to restrain its abuse.

Bringing it under stricter drug regulations in India.

Tapentadol is one of the synthetic opioid analgesics regulated under schedule H1 for sale and distribution.

Contact No: +91 7672005050 Email: contact@cliniexperts.com

The drugs that are under schedule H1 can only be sold when prescribed. As per the draft amendment provided by the ministry on Oct 20, 2020, in the Drugs and Cosmetics rules 1945, in schedule 1 after serial number 47 and any entry after that.

CDSCO has approved Tapentadol’s immediate release preparations for moderate to acute pain along with extended-release preparation for severe acute pain. But it is well known to all that Tapentadol available in India since the year 2011 has been subject to misuse a lot because of its easy availability and cost-effectiveness.

Contact No: +91 7672005050 Email: contact@cliniexperts.com

The drug packaging never indicates that it is a schedule H, X or H1 drug, for which it is available over the counter.

Because of this widespread Tapentadol abuse, the stakeholders appealed to the control authorities to consider Tapentadol's regulation.

With Tapentadol being used at a very high rate, it is usually associated with a rise in hepatitis C infection in South India. One of the major reasons for abuse is the easy availability at a low price that can be easily used for injections. Therefore, immediate regulatory procedures were needed to restrict Tapentadol abuse.

Contact No: +91 7672005050 Email: contact@cliniexperts.com

Mainly abusers take Tapentadol through an intravenous route that is very dangerous. Due to a lack of parenteral preparations of Tapentadol, there is very little safety data for using intravenously. The bioavailability of Tapentadol for oral use is 32% because of exclusive first-pass metabolism.

Adding Tapentadol to the schedule H1 of drugs will ensure that the misuse of such potentially harmful medicines will be curbed to a significant extent.

Contact No: +91 7672005050 Email: contact@cliniexperts.com