## Report on the Drugs (3rd Amendment) Rules, 2021
**1. Executive Summary:**
This report analyzes the Drugs (3rd Amendment) Rules, 2021, based on the official notification published in the Gazette of India. This amendment to the Drugs Rules, 1945, specifically adds "Tapentadol" to Schedule H1 of the Drugs Rules, 1945. The amendment aims to regulate the sale, distribution, and use of Tapentadol. This report outlines the background, key provisions, affected stakeholders, and anticipated impact of this specific change.
**2. Introduction:**
This report provides an overview and analysis of the Drugs (3rd Amendment) Rules, 2021, as detailed in the provided official government notification. The analysis focuses on the key provisions of this amendment and its potential implications, based solely on the information presented in the notification.
**3. Policy Overview:**
* **Original Policy Amended:** The Drugs Rules, 1945.
* **Core Objective(s) of the Amendment (Inferred):** To regulate the availability, sale, and distribution of Tapentadol by including it in Schedule H1 of the Drugs Rules, 1945.
**4. Background and Rationale:**
This is an amendment to existing rules. The inclusion of Tapentadol in Schedule H1 suggests a need to control and monitor its usage, likely due to its potential for misuse, abuse, or specific safety concerns. Schedule H1 typically lists drugs that require strict prescription controls to prevent inappropriate use and ensure patient safety.
**5. Key Provisions / Changes:**
* **Specific Part of Original Policy Changed:** Schedule H1 of the Drugs Rules, 1945.
* **New Rule/Provision:** The amendment inserts the following entry into Schedule H1 after serial number 47: "48. Tapentadol."
* **Difference/Effect of the Change:** This change subjects Tapentadol to the regulations and restrictions applicable to drugs listed in Schedule H1. These typically include requirements for prescription-only dispensing, maintenance of records, and restrictions on over-the-counter sales. This will likely increase regulatory oversight on the manufacturing, distribution, and sale of Tapentadol.
**6. Target Audience and Stakeholders:**
The primary stakeholders directly affected by this amendment include:
* **Pharmaceutical Manufacturers:** Companies that manufacture Tapentadol will need to comply with the regulations applicable to Schedule H1 drugs.
* **Pharmacists and Retail Drug Stores:** Pharmacies will be required to dispense Tapentadol only on prescription and maintain appropriate records.
* **Medical Practitioners:** Doctors prescribing Tapentadol will need to be aware of the scheduling requirements and ensure proper documentation.
* **Patients:** Patients requiring Tapentadol will be affected by the prescription-only requirement and potential monitoring by healthcare professionals.
* **Regulatory Authorities:** The Drugs Controller General of India (DCGI) and State Drug Controllers will be responsible for enforcing the amended rules.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The Ministry of Health and Family Welfare, specifically the Department of Health and Family Welfare, is responsible for implementing and enforcing the amended rules. The Drugs Controller General of India (DCGI) and State Drug Controllers will likely play key roles in monitoring compliance.
* **Timelines/Procedures:** The amendment comes into force on November 1st, 2021.
**8. Expected Outcomes / Impact of Changes:**
The intended outcome of this amendment is likely to:
* **Reduce the potential for misuse and abuse of Tapentadol.**
* **Improve patient safety by ensuring that Tapentadol is used only under medical supervision.**
* **Enhance monitoring and control over the distribution and sale of Tapentadol.**
* **Ensure proper documentation and record-keeping related to Tapentadol prescriptions and dispensing.**
**9. Conclusion:**
The Drugs (3rd Amendment) Rules, 2021, represents a significant step towards regulating the use of Tapentadol in India. By including Tapentadol in Schedule H1 of the Drugs Rules, 1945, the government aims to enhance patient safety and prevent potential misuse. The amendment will require pharmaceutical manufacturers, pharmacists, medical practitioners, and regulatory authorities to adapt their practices to comply with the new requirements.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules related to drugs and cosmetics, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: An act of the parliament governing drugs and cosmetics, which provides the legal basis for the rules being amended.
Ministry of Health and Family Welfare: The government ministry responsible for health and family welfare policies. The notification originates from this ministry.
Department of Health and Family Welfare: A department within the Ministry of Health and Family Welfare. This is the specific department issuing the notification.
New Delhi: The location where the notification was issued.
Central Government: The governing body that considered public feedback and is exercising powers to amend the rules.
Drugs Technical Advisory Board: A board consulted by the Central Government regarding the amendment of the Drugs Rules.
Drugs 3rd Amendment Rules, 2021: The name given to the specific set of amendments introduced by this notification.
November 1, 2021: The date when the amendments come into force.
Schedule H1: A specific schedule within the Drugs Rules, 1945 that is being updated.
Tapentadol: The substance being added to Schedule H1 of the Drugs Rules, 1945.
Dr. Mandeep K Bhandari: Joint Secretary, Ministry of Health and Family Welfare, as indicated by the signature block.
Mayapuri, New Delhi: Location of the Government of India Press.
Delhi: Location of the Controller of Publications.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-12042021-226518
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CG-DL-E-12042021-226518
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 207] नई दिल्ली, सोमवार, अप्रैल 12, 2021/चत्रै 22, 1943
No. 207] NEW DELHI, MONDAY, APRIL 12, 2021/CHAITRA 22, 1943
स्ट्व ास्ट्् य और पररवार कल्य ाण मत्रं ालय
(स्ट्व ास्ट्् य और पररवार कल्य ाण जवभाग)
अजधसचू ना
नई दिल् ली, 7 अप्रलै , 2021
सा.का.जन. 258 (अ).― औषजध जनयम, 1945 का और संिोधन करने के जलए कजतपय जनयमों का प्रारूप, औषजध
और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उप-धारा (1) और धारा 33 की उप-धारा (1)
अधीन यथा अपेजित, भारत सरकार के स्ट् वास्ट् ् य और पररवार कल् याण मंत्रालय (स्ट् वास्ट् ् य और पररवार कल् याण जवभाग) की
अजधसूचना स.ं सा.का.जन. 656(अ), तारीख 20 अक्टूबर, 2020 द्वारा भारत के रािपत्र, असाधारण, भाग II, खंड 3, उपखंड
(i) म ें प्रकाजित दकया गया था, जिसम ें उन सभी व् यजययों स,े जिनके उससे प्रभाजवत होन े की संभावना ह ै उस तारीख स,े
जिसको उक्त अजधसूचना अन्तर्विष्ट करने वाली रािपत्र की प्रजतयां िनता को उपलब् ध करा िी गई थी, तीस दिनों की
अवजध के अवसान स े पहले आिेप और सुझाव आंमजत्रत दकए गए थ;े
और, उय रािपत्र की प्रजतयां 21 अक्टूबर, 2020 को िनता को उपलब् ध करा िी गई थी;
और, उक्त जनयमों पर िनता स ेप्राप्त आिेप और सझु ावों पर केन् रीय सरकार द्वारा जवचार कर जलया गया ह;ै
अत: अब, केन् रीय सरकार, औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 और धारा
33 द्वारा प्रित् त िजययों का प्रयोग करते हुए, औषजध तकनीकी सलाहकार बोडि स े परामि ि करने के पश् चात,् औषजध जनयम,
1945 का और संिोधन करन े के जलए जनम्न जलजखत जनयम बनाती ह,ै अथाित्:―
1. (1) संजिप्त नाम और प्रारंभ.― इन जनयमों का संजिप्त नाम औषजध सामग्री (तीसरा संिोधन) जनयम, 2021 ह।ै
(2) ये 1 नवंबर, 2021 स े प्रवृत होंगे ।
2164 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2. औषजध जनयम, 1945 की अनुसचू ी ि1 म,ें क्रम संखयांक 47 और इसस े संबद्ध प्रजवजष्ट के पश्चात्, जनम्नजलजखत क्रम
संखयांक और प्रजवष्टी अन्तःस्ट्थाजपत दकया िाएगा, अथाित:्―
“48. टपेंटाडॉल” ।
[फा.स.ं एक् स.11035/519/2019 – डीआरएस]
डॉ. मनिीप के भण्डारी, संयुक् त सजचव
रटप्प ण:- मूल जनयम, भारत के रािपत्र म ें अजधसूचना संखयांक एफ.28-10/45-एच (1), तारीख 21 दिसम् बर, 1945 द्वारा
प्रकाजित दकए गए थ े और अजधसूचना संखयांक सा.का.जन. 202(अ), तारीख 22 माच,ि 2021 द्वारा अंजतम बार संिोजधत
दकए गए थे।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 7th April, 2021
G.S.R. 258(E).— 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;
Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act,
1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby
makes the following rules further to amend the Drugs Rules, 1945, namely:—
(1) (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”.
[F.No. X.11035/519/2019-DRS]
Dr. MANDEEP K BHANDARI, Jt. Secy.
Note: The principal rules were published in the Gazette of India vide notification number F.28-10/45-H (1), dated the
21st December, 1945 and last amended vide notification number G.S.R. 202(E), dated the 22nd March, 2021.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.