## Policy Analysis Report: Amendment to Drugs Rules, 1945
**1. Executive Summary:**
This report analyzes an amendment to the Drugs Rules, 1945, as notified by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, Government of India, on June 22, 2021. The amendment, identified by S.O. 2450(E), adds two new members to an unspecified committee or body related to the Drugs and Cosmetics Act, 1940. The core purpose of this amendment is to expand the pool of technical and scientific expertise available to this committee. The key finding is that this is a minor administrative amendment focusing on personnel additions.
**2. Introduction:**
This report provides an overview and analysis of a specific amendment to the Drugs Rules, 1945, based solely on the provided government notification. The report aims to inform stakeholders about the nature of the amendment and its likely implications.
**3. Policy Overview:**
* This notification amends the notification of the Government of India in the Ministry of Health and Family Welfare Department of Health and Family Welfare number S.O. 2810E, dated 30th November, 2012, published in Part II, Section 3, Subsection ii of the Gazette of India, Extraordinary.
* **Core Objective(s):** The core objective of this amendment, based on the provided text, is to expand the membership of an existing body or committee related to the enforcement or administration of the Drugs and Cosmetics Act, 1940. The addition of a Technical Officer and a Junior Scientific Officer suggests an intention to bolster the committee's technical and scientific capabilities.
**4. Background and Rationale:**
This amendment likely aims to enhance the expertise and operational capacity of a committee/body established under the Drugs Rules, 1945. The inclusion of a Technical Officer and a Junior Scientific Officer suggests a need for greater technical input in the committee's deliberations and activities. This could be due to an increased workload, a desire to incorporate more specialized knowledge, or a need to replace departing members.
**5. Key Provisions / Changes:**
This amendment adds the following members to an existing body/committee, as defined in the original notification S.O. 2810E:
* **What specific part of the original policy is being changed:** The amendment adds to item number iv in the original policy.
* **What the *new* rule/provision *is*:**
* v. Dr. Dilip Kumar Panda, Technical Officer
* vi. Smt. Suparna Maitra, Junior Scientific Officer
* **Explain the *difference* or the *effect* of this specific change:** The key change is the expansion of the committee's membership with the addition of two new expert roles.
**6. Target Audience and Stakeholders:**
The immediate target audience and stakeholders are:
* Dr. Dilip Kumar Panda and Smt. Suparna Maitra, who are directly affected by their appointment.
* The existing members of the committee, as their working dynamics and processes may be affected by the new additions.
* The Ministry of Health and Family Welfare, responsible for the implementation and oversight of the committee's activities.
* Indirectly, the pharmaceutical industry and consumers, who are affected by decisions and recommendations made under the Drugs and Cosmetics Act, 1940.
**7. Implementation Aspects (Inferred):**
* **Responsible agency/bodies mentioned:** The Ministry of Health and Family Welfare is the responsible agency. The specific committee/body being amended is not explicitly named in this text but is referred to through the original notification (S.O. 2810E).
* **Any timelines or procedures specified *in the text*?:** The text does not specify timelines or procedures beyond the effective date of the notification (June 22, 2021). The existing rules and procedures governing the committee outlined in S.O. 2810E are presumed to remain in effect, with the added members participating accordingly.
* As it is an amendment, specific timelines will be subject to the original policy's framework.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcome of this amendment is to enhance the technical and scientific rigor of the committee's work. The addition of these members is likely intended to:
* Provide more informed decision-making regarding drug regulation and related matters.
* Improve the committee's ability to address complex technical issues.
* Increase the overall effectiveness of the committee in fulfilling its mandate under the Drugs and Cosmetics Act, 1940.
**9. Conclusion:**
This report analyzed an amendment to the Drugs Rules, 1945, adding two new members to an existing committee within the Ministry of Health and Family Welfare. This amendment indicates a strategic effort to bolster the committee's technical expertise and overall effectiveness. While the specific impact is difficult to fully assess without examining the original notification (S.O. 2810E) and the committee's mandate, the changes are likely to contribute to more informed and robust decision-making in drug regulation.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: An Indian law regarding drugs and cosmetics.
Drugs Rules, 1945: Rules pertaining to the Drugs and Cosmetics Act, 1940 in India.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy.
Department of Health and Family Welfare: A department within the Ministry of Health and Family Welfare.
S.O. 2810E: A notification number related to health regulations in India.
Dr. Dilip Kumar Panda: Technical Officer mentioned in the notification.
Smt. Suparna Maitra: Junior Scientific Officer mentioned in the notification.
New Delhi: The location where the notification was issued.
Dr. Mandeep K Bhandari: Jt. Secy.
Gazette of India: Official government gazette publication
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-22062021-227763
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CG-DL-E-22062021-227763
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 2272] नई दिल्ली, मगं लवार, िनू 22, 2021/आषाढ़ 1, 1943
No. 2272] NEW DELHI, TUESDAY, JUNE 22, 2021/ASADHA 1, 1943
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 22 िून, 2021
का.आ. 2450 (अ).—केन्द्रीय सरकार, औषजध जनयम, 1945 के जनयम 44 के साथ परित औषजध और प्रसाधन सामग्री
अजधजनयम, 1940 (1940 का 23) की धारा 20 की उपधारा (2) के द्वारा प्रित्त िजियों का प्रयोग करते हुए, भारत के रािपत्र,
असाधारण, भाग II, खंड 3, उप-खंड (ii) में प्रकाजित भारत सरकार, स्ट् वास्ट् ् य और पररवार कल् याण मंत्रालय (स्ट् वास्ट् ् य और पररवार
कल् याण जवभाग) की अजधसूचना संखयांक का.आ. 2810(अ), तारीख 30 नवम्बर, 2012 म ेंजनम्नजलजखत संिोधन करती है, अथाात:्—
उि अजधसूचना में, मि संखयांक (iv) और इससे सम्बद्ध प्रजवजियााँ के पश्चात,् जनम्नजलजखत को अंतःस्ट्थाजपत दकया िाएगा, अथाात:्—
“ (v) डॉ दिलीप कुमार पांडा, तकजनकी अजधकारी; और
(vi) श्रीमती सुपणा ामैत्रा, कजनष्ठ वैज्ञाजनक अजधकारी ।”।
[फा.सं. एक्स.11014/5/2021-डीआर]
डॉ. मनिीप के भण् डारी, संयुक्त सजचव
रिप्प ण: मूल अजधसूचना भारत के रािपत्र, असाधारण, भाग II, खंड 3, उप-खंड (ii) संखयांक का.आ. 2810(अ), तारीख 30 नवम्बर,
2012 में प्रकाजित की गई थी ।
3385 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 22nd June, 2021
S.O. 2450 (E).― In exercise of the powers conferred by sub-section (2) of section 20 of the Drugs and
Cosmetics Act, 1940 (23 of 1940) read with rule 44 of the Drugs Rules, 1945, the Central Government hereby amends
the notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and
Family Welfare) number S.O. 2810(E), dated 30th November, 2012, published in Part II, Section 3, Sub-section (ii) of
the Gazette of India, Extraordinary, namely:—
In the said notification, after item number (iv) and the entries relating thereto, the following shall be inserted,
namely:—
“(v) Dr. Dilip Kumar Panda, Technical Officer; and
(vi) Smt. Suparna Maitra, Junior Scientific Officer.”.
[F.No. X.11014/5/2021-DR]
Dr. MANDEEP K BHANDARI, Jt. Secy.
Note: The principal notification was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section
(ii), vide number S.O. 2810(E), dated the 30th November, 2012.
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.