Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • MD Brand Connect
  • Vaccine Hub
  • MDTV
    • Breaking News
    • Medical News Today
    • Health News Today
    • Latest
    • Journal Club
    • Medico Legal Update
    • Latest Webinars
    • MD Shorts
    • Health Dialogues
  • Fact Check
  • Health Dialogues
Medical Dialogues
  • Medical News & Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • Fact Check
      • Bone Health Fact Check
      • Brain Health Fact Check
      • Cancer Related Fact Check
      • Child Care Fact Check
      • Dental and oral health fact check
      • Diabetes and metabolic health fact check
      • Diet and Nutrition Fact Check
      • Eye and ENT Care Fact Check
      • Fitness fact check
      • Gut health fact check
      • Heart health fact check
      • Kidney health fact check
      • Medical education fact check
      • Men's health fact check
      • Respiratory fact check
      • Skin and hair care fact check
      • Vaccine and Immunization fact check
      • Women's health fact check
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Abroad
  • Industry
      • Health Investment News
      • Health Startup News
      • Medical Devices News
      • Pharma News
      • Pharmacy Education News
      • Industry Perspective
  • MDTV
      • Health Dialogues MDTV
      • Health News today MDTV
      • Latest Videos MDTV
      • Latest Webinars MDTV
      • MD shorts MDTV
      • Medical News Today MDTV
      • Medico Legal Update MDTV
      • Top Videos MDTV
      • Health Perspectives MDTV
      • Journal Club MDTV
      • Medical Dialogues Show
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news & Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • Fact Check
    • Bone Health Fact Check
    • Brain Health Fact Check
    • Cancer Related Fact Check
    • Child Care Fact Check
    • Dental and oral health fact check
    • Diabetes and metabolic health fact check
    • Diet and Nutrition Fact Check
    • Eye and ENT Care Fact Check
    • Fitness fact check
    • Gut health fact check
    • Heart health fact check
    • Kidney health fact check
    • Medical education fact check
    • Men's health fact check
    • Respiratory fact check
    • Skin and hair care fact check
    • Vaccine and Immunization fact check
    • Women's health fact check
  • AYUSH
    • Ayurveda
      • Ayurveda Giuidelines
      • Ayurveda News
    • Homeopathy
      • Homeopathy Guidelines
      • Homeopathy News
    • Siddha
      • Siddha Guidelines
      • Siddha News
    • Unani
      • Unani Guidelines
      • Unani News
    • Yoga
      • Yoga Guidelines
      • Yoga News
  • State News
    • Andaman and Nicobar Islands
    • Andhra Pradesh
    • Arunachal Pradesh
    • Assam
    • Bihar
    • Chandigarh
    • Chattisgarh
    • Dadra and Nagar Haveli
    • Daman and Diu
    • Delhi
    • Goa
    • Gujarat
    • Haryana
    • Himachal Pradesh
    • Jammu & Kashmir
    • Jharkhand
    • Karnataka
    • Kerala
    • Ladakh
    • Lakshadweep
    • Madhya Pradesh
    • Maharashtra
    • Manipur
    • Meghalaya
    • Mizoram
    • Nagaland
    • Odisha
    • Puducherry
    • Punjab
    • Rajasthan
    • Sikkim
    • Tamil Nadu
    • Telangana
    • Tripura
    • Uttar Pradesh
    • Uttrakhand
    • West Bengal
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Abroad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
    • Industry Perspective
  • Home
  • News
  • Industry
  • Pharma News
  • Govt to include...

Govt to include psoriasis drug Acitretin in Schedule H of Drugs Rules 1945

Dr. Divya ColinWritten by Dr. Divya Colin Published On 2022-02-05T17:05:06+05:30  |  Updated On 7 Feb 2022 11:14 AM IST
Govt to include psoriasis drug Acitretin in Schedule H of Drugs Rules 1945
  • facebook
  • twitter
  • linkedin
  • whatsapp
  • Telegram
  • Email

New Delhi: Through a recent Gazette Notification, the Ministry of Health And Family Welfare has issued draft rules proposing to include psoriasis drug Acitretin in schedule H of Drugs Rules 1945 limiting it to be sold by retail on the prescription of a Registered Medical Practitioner only.

In India, Schedule H refers to a group of prescription drugs that are listed as an appendix to the Drugs and Cosmetics Rules, 1945, which were introduced in 1945. There are medications that can only be purchased with a qualified doctor's prescription and can not be purchased over-the-counter.

Acitretin is a retinoid similar to vitamin A that is prescribed for individuals with extreme psoriasis, a skin condition characterised by swollen, scaly, or thickened skin and irregular skin cell formation. Acitretin works by inhibiting the excessive cell growth and keratinisation (process by which skin cells become thickened due to the deposition of a protein within them) seen in psoriasis. It therefore reduces the thickening of the skin, plaque formation and scaling.

Acitretin is marketed in India by Glenmark, Dr. Reddy, Cipla, Ranbaxy, and IPCA Laboratories under the brand names Aceret, Acetec, Zoratame, Acrotac, and Acitrin respectively.

However, Acitretin is highly teratogenic and must not be used during pregnancy. Acitretin use during pregnancy is strongly restricted because it can harm the unborn child and cause congenital disabilities. During Acitretin therapy and for three years after quitting acitretin, strict birth control methods must be used. As a result, acitretin is rarely prescribed to women who are planning to start a family.

In this regard, it is worth noting that CDSCO had approved Acitretin for severe psoriasis in adults (excluding female of childbearing potentials) on 09.09.2005 with the condition that the label of the immediate container of the drug as well as the packing in which the container is enclosed should contain the following warning;

"Acitretin should be prescribed by Dermatologists knowledgeable in systemic use of retinoid"

Last year, the Medical Dialogues Team had reported that after considering the serious teratogenicity effect of Acitretin, a systemic retinoid prescribed particularly in dermatological diseases, the Drugs Technical Advisory Board (DTAB) had recommended including Acitretin in Schedule H of the Drugs Rules, 1945 to prevent adverse events during pregnancy.

Also Read:DTAB recommends adding psoriasis drug Acitretin in Schedule H of Drugs Rules, 1945

Now in continuation, the draft of certain rules further to amend the Drugs Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board is published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to public.

Furthermore, the draft rules stated, "Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government."

"Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in.," the notice added.

In view of the above, as per the proposed amendment;

"1. (1) These rules may be called the Drugs (…..Amendment) Rules, 2022.
(2) These rules shall come into force on the date of their final publication in the Official Gazette.
2. In the Drugs Rules, 1945, in Schedule H, after serial number 551 and the entries relating thereto, thefollowing shall be inserted, namely:—
"552. Acitretin". "

Also Read:Govt to bring Tapentadol under Schedule H1 to curb its misuse

Acitretinschedule HTeratogensMOHFWpsoriasis drugDrugs Rules 1945
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Show Full Article
    Next Story

    Editorial

    Real-World Case study: Darbepoetin Alfa for Chemotherapy-Induced Anemia in Metastatic Breast Cancer - Dr Aditya Murali

    Real-World Case study: Darbepoetin Alfa for Chemotherapy-Induced Anemia in Metastatic Breast Cancer...

    Aspirin in Primary Prevention- When to Consider?

    Aspirin in Primary Prevention- When to Consider?

    Featured image representing medico legal

    What's the Role of Expert Opinion in Medical Negligence?

    7- Point Discharge Protocol for AECOPD: Time to Inculcate in Practice

    7- Point Discharge Protocol for AECOPD: Time to Inculcate in Practice

    Aspirin Use in Women Aged 40-50 with Diabetes and Hypertension: Identifying the Ideal Candidates

    Aspirin Use in Women Aged 40-50 with Diabetes and Hypertension: Identifying the Ideal Candidates

    View All

    Journal Club Today

    Can Just a Few Nights of Poor Sleep Increase Your Risk of Heart Disease? Study Finds Out

    Can Just a Few Nights of Poor Sleep Increase Your Risk of Heart Disease? Study Finds Out

    View All

    Health News Today

    Health Bulletin 10/ May/ 2025

    Health Bulletin 10/ May/ 2025

    View All
    © 2022 All Rights Reserved.
    Powered By: Hocalwire
    X
    We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok