## Policy Analysis Report: Drugs (7th Amendment) Rules, 2021
**1. Executive Summary:**
This report analyzes the Drugs (7th Amendment) Rules, 2021, which amends the Drugs Rules, 1945. The core purpose of this amendment, as derived from the provided text, is to modify Rule 43A of the Drugs Rules, 1945, by adding "Tihi" to the list of designated Inland Container Depots. The key finding is that this amendment expands the recognized locations for specific regulatory purposes related to drugs.
**2. Introduction:**
This report aims to provide a clear and concise overview of the Drugs (7th Amendment) Rules, 2021, based solely on the provided government policy text. The analysis will focus on the specific changes introduced by this amendment and their potential implications.
**3. Policy Overview:**
* This document is an amendment to the **Drugs Rules, 1945.**
* **Core Objective(s):** As inferred from the text, the core objective of *this amendment* is to update the list of designated Inland Container Depots within the Drugs Rules, 1945.
**4. Background and Rationale:**
* **Amendment Rationale:** The amendment likely aims to add "Tihi" to the recognized Inland Container Depots. This suggests that "Tihi" has become an important location for handling drugs or related materials, necessitating its inclusion within the regulatory framework of the Drugs Rules, 1945. This could be due to increased trade, new infrastructure, or other logistical developments in that area. The original rules did not include Tihi, thus this amendment to ensure compliance at Tihi.
**5. Key Provisions / Changes:**
* **Specific Part of Original Policy Changed:** Rule 43A of the Drugs Rules, 1945.
* **New Rule/Provision:** The amendment substitutes "Inland Container Depot Dhannad" with "Inland Container Depot at Dhannad and Tihi."
* **Difference/Effect of Change:** The amendment expands the scope of Rule 43A to include the Inland Container Depot at Tihi, in addition to Dhannad. This implies that Rule 43A likely pertains to regulations or procedures that are now applicable to both Dhannad and Tihi. The regulations are now enforceable at Tihi.
**6. Target Audience and Stakeholders:**
Based on the text, the directly affected stakeholders include:
* Pharmaceutical companies and related businesses using the Inland Container Depots at Dhannad and Tihi for importing, exporting, or handling drugs and cosmetics.
* Regulatory bodies responsible for enforcing the Drugs Rules, 1945, at the Inland Container Depot in Tihi.
* Customs and logistics providers operating at the Inland Container Depot in Tihi.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The Ministry of Health and Family Welfare, Department of Health and Family Welfare, Central Government, and the Drugs Technical Advisory Board are explicitly mentioned. They are responsible for the implementation and enforcement of these rules.
* **Timelines/Procedures:** The amendment came into force on the date of its publication in the Official Gazette (December 9, 2021).
* **Amendment Specifics:** Regulatory bodies now need to update their procedures and oversight to include the Inland Container Depot at Tihi. Companies must ensure compliance with the Drugs Rules at the Tihi location.
**8. Expected Outcomes / Impact of Changes:**
* The intended outcome of this amendment is likely to ensure that the handling of drugs and cosmetics at the Inland Container Depot in Tihi is subject to the same regulations and oversight as at Dhannad. This promotes standardization and compliance.
* **Impact of Changes:** The amendment may necessitate adjustments to logistical operations for businesses utilizing the Tihi depot. It may also increase regulatory scrutiny at that location. Further, this demonstrates the ongoing nature of regulations which businesses need to monitor.
**9. Conclusion:**
The Drugs (7th Amendment) Rules, 2021, represents a minor but important update to the Drugs Rules, 1945. By expanding the scope of Rule 43A to include the Inland Container Depot in Tihi, the amendment ensures consistent regulatory oversight of drug handling at this location. While the provided text offers limited context, the amendment's significance lies in its adaptation to evolving logistical and trade patterns within the pharmaceutical industry. This amendment is an example of the ongoing nature of regulation that the pharmaceutical industry must remain aware of.
Key Entities Referenced
New Delhi: Location of the Ministry of Health and Family Welfare, India.
Ministry of Health and Family Welfare: The Indian government ministry that issued the notification.
Department of Health and Family Welfare: The department within the Ministry of Health and Family Welfare responsible for the notification.
Drugs Rules, 1945: The set of rules being amended by this notification.
Drugs and Cosmetics Act, 1940: The primary legislation authorizing the rules being amended.
Central Government: The government body exercising powers conferred by the Drugs and Cosmetics Act, 1940.
Drugs Technical Advisory Board: The advisory board consulted by the Central Government for amending the Drugs Rules.
Drugs 7th Amendment Rules, 2021: The title of the amendment rules introduced by this notification.
Inland Container Depot Dhannad: The original name of an Inland Container Depot mentioned in Rule 43A of Drugs Rules, 1945.
Inland Container Depot at Dhannad and Tihi: The new name of the Inland Container Depot mentioned in Rule 43A of Drugs Rules, 1945, after amendment.
Dr. Mandeep K Bhandari: Joint Secretary of the Indian government who signed the notification.
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
xxxGIDHxxx
सी.जी.-डी.एxलxx.-GअID.E-0xx9x1 22021-231742
CG-DL-E-09122021-231742
असाधारण
EXTRAORDINARY
भाग II—खण्ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 689] नई दद्ली, बहृ स्ट्प जतवार, ददसम्ब र 9, 2021/अग्रहायण 18, 1943
No. 689] NEW DELHI, THURSDAY, DECEMBER 9, 2021/AGRAHAYANA 18, 1943
स्ट्व ास्ट्् य रर पिरवार क्य ाण मरालं ालय
(स्ट्व ास्ट्् य रर पिरवार क्य ाण जवभाग
अजधसचू ना
नई दद्ली, 9 ददसम् बर, 2021
सा.का.जन. 848(अ).— रषजध जनयम, 1945 का रर संिोधन करने के जलए कजतपय जनयमों का प्रारूप, रषजध
रर प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23 की धारा 12 की उप-धारा (1 रर धारा 33 की उप-धारा (1
की अपेक्षानुसार, भारत के रािपराल, असाधारण, भाग II, खंड 3, उप-खंड (i), तारीख 01 जसतंबर, 2021 म ें भारत सरकार
के स्ट् वास्ट् ् य रर पिरवार क् याण मंरालालय (स्ट् वास्ट् ् य रर पिरवार क् याण जवभाग की अजधसूचना स.ं सा.का.जन. 611(अ ,
तारीख 01 जसतंबर, 2021 द्वारा प्रकाजित दकए गए थ,े जिसम ें उन सभी व् यजययों से, जिनके उससे प्रभाजवत होने की
संभावना ह,ै उस तारीख स,े जिसको उक्त अजधसूचना को अन्तर्ववष्ट करन े वाली रािपराल की प्रजतयां िनसाधारण को
उपलब् ध कराई गई थी, तीस ददन की अवजध के अवसान के पूव,व आपजि रर सुझाव आंमजरालत दकए गए थ;े
रर, रािपराल की प्रजतयां िनसाधारण को 01 जसतंबर, 2021 को उपलब् ध करा दी गई थी;
रर, उय जनयमों पर िनता स ेप्राप्त आक्षेप रर सुझावों पर केन् रीय सरकार द्वारा जवचार कर जलया गया ह;ै
अत: अब, केन् रीय सरकार, रषजध रर प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23 की धारा 12 रर
धारा 33 के अधीन प्रदत् त िजययों का प्रयोग करते हुए, रषजध तकनीकी सलाहकार बोड व स े परामि व करने के पश् चात,्
रषजध जनयम, 1945 का रर संिोधन करने के जलए जनम्न जलजखत जनयम बनाती ह,ै अथावत:्—
1. (1) इन जनयमों का संजक्षप्त नाम रषजध (सातवां संिोधन जनयम, 2021 ह।ै
(2) ये रािपराल म ें उनके प्रकािन की तारीख को प्रवृत होंगे।
7185 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2. रषजध जनयम 1945 म,ें जनयम 43क म,ें “रर मध्यप्रदिे म ें धन्नड़” िब्दों के स्ट्थान पर, “रर मध्यप्रदेि म ें धन्नड़
तथा टीही” िब्द रखे िाएंगे।
[फा. सं. एक् स.11014/17/2021–डीआर]
डॉ. मनदीप के भण्डारी, संयुक् त सजचव
िटप्प ण : रषजध जनयम, 1945, भारत के रािपराल में अजधसूचना संख् या एफ.2 -10/45-एच (1 , तारीख 21 ददसम् बर,
1945 द्वारा प्रकाजित दकए थ े रर अजधसूचना संख् या सा.का.जन. 839(अ , तारीख 29 नवंबर, 2021 द्वारा
अंजतम बार संिोजधत दकए गए।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 9th December, 2021.
G.S.R. 848(E).—Whereas a draft of certain rules further to amend the Drugs Rules, 1945, was
published, as required under sub-section (1) of section 12 and sub-section (1) of section 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. 611(E), dated the
1st September, 2021, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), dated the
1st September, 2021, 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 1st
September, 2021;
And whereas, objections and suggestions received from the public on the said draft 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 (7th Amendment) Rules, 2021.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Drugs Rules, 1945, in rule 43A, for the words “Inland Container Depot Dhannad”, the words
“Inland Container Depot at Dhannad and Tihi” shall be substituted.
[F. No. X.11014/17/2021-DR]
Dr. MANDEEP K BHANDARI, Jt. Secy.
Note : The Drugs Rules, 1945 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. 839(E),
dated the 29th November, 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.