Health Ministry Notifies Inclusion Of Tapentadol In Schedule H1 To Curb Its Abuse

Mumbai, 23 April 2021:

The Union health ministry has finally notified inclusion of Tapentadol in Schedule H1 to curb its abuse in the country.

Centre had in October last year notified a draft amendment to the Drugs and Cosmetics (D&C) Rules, 1945 to bring Tapentadol, a synthetic opioid analgesic under Schedule H1 to regulate its sale, distribution and prevent its abuse. Schedule H1 stipulates that the drug can be sold only on prescription.

According to the draft 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.

“Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, was published, as required under sub-Section (1) of Sections 12 and sub-Section (1) of 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 656(E), dated the 20th October, 2020, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And whereas, copies of the said Official Gazette were made available to the public on the 21st October, 2020; And whereas, objections and suggestions received from the public on the said rules have been considered by the Central Government,” the draft amendment stated.

“Now, therefore, in exercise of the powers conferred by Sections 12 and 33 of the D&C Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board (DTAB), hereby makes the following rules further to amend the Drugs Rules, 1945, namely:- (1) These rules may be called the Drugs (3rd Amendment) Rules, 2021. (2) They shall come into force with effect from the 1st day of November, 2021. (2) In the Drugs Rules, 1945, in Schedule H1, after serial number 47 and the entry relating thereto, the following serial number and entry shall be inserted, namely:— “48. Tapentadol”, the notification to this effect stated.

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 had also appealed to drug control authorities to consider regulation of the drug.

According to a study carried out on Tapentadol abuse and dependence in India by Centre for Addiction Medicine, Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bengaluru, “injection drug abuse of Tapentadol is emerging rapidly and is associated with high rates of hepatitis C infection in southern India. A possible reason is the easy and cheap availability of tablets that can be easily repurposed for injection.”

Analysis of internet search data also shows that Tapentadol is receiving attention from internet users in India and this interest is maximum in northern states like Punjab, Jammu & Kashmir, Himachal Pradesh with a high prevalence of current opioid use. Pharmabiz