## Policy Analysis Report: Amendment to the Drugs Rules, 1945
**1. Executive Summary:**
This report analyzes a draft notification proposing amendments to the Drugs Rules, 1945, specifically focusing on rule 127. The core purpose of this amendment is to incorporate updated standards from the Bureau of Indian Standards regarding Schedule Q items. The key finding is that this amendment aims to align the Drugs Rules with current industry standards, potentially impacting manufacturers and quality control processes related to Schedule Q drugs.
**2. Introduction:**
This report provides an informative overview of a proposed amendment to the Drugs Rules, 1945, based on the provided government policy text. The report aims to detail the specific changes, their rationale, and potential impact, focusing exclusively on information available within the supplied document.
**3. Policy Overview:**
* **Original Policy:** The amendment pertains to the Drugs Rules, 1945.
* **Core Objective(s):** The core objective of the *amendment* is to update and clarify the standards referenced in rule 127, specifically regarding items under Schedule Q, by incorporating the latest standards from the Bureau of Indian Standards. This inferred objective points to a goal of ensuring that the Drugs Rules remain current and aligned with evolving industry best practices.
**4. Background and Rationale:**
The amendment seems designed to address the need for regular updates to quality standards within the pharmaceutical industry. By explicitly including “IS 4707 Part I as amended by Bureau of Indian Standards from time to time,” the amendment addresses a potential gap where older versions of the standards may have been referenced, leading to ambiguity or non-compliance. This change ensures that manufacturers adhere to the most current and relevant guidelines for Schedule Q drugs.
**5. Key Provisions / Changes:**
This amendment focuses on a single, specific change within the existing Drugs Rules:
* **Specific Part Changed:** Rule 127, sub-rule 1, proviso.
* **New Rule/Provision:** The amendment inserts the phrase "and IS 4707 Part I as amended by Bureau of Indian Standards from time to time" after "under Schedule Q".
* **Difference/Effect of Change:** The original rule likely referenced Schedule Q without specifying a particular standard or version. This amendment clarifies that the relevant standard is IS 4707 Part I, as updated by the Bureau of Indian Standards. This compels manufacturers to comply with the *latest* version of the IS 4707 Part I standard when dealing with Schedule Q drugs, promoting greater accuracy and consistency in quality control.
**6. Target Audience and Stakeholders:**
The target audience and stakeholders directly affected by this change include:
* **Pharmaceutical manufacturers** producing drugs listed under Schedule Q.
* **Quality control personnel** responsible for ensuring compliance with regulatory standards in the pharmaceutical industry.
* **The Bureau of Indian Standards**, as their updated standards are now explicitly referenced.
**7. Implementation Aspects (Inferred):**
* **Responsible agency/bodies mentioned:** Ministry of Health and Family Welfare, Drugs Technical Advisory Board, Bureau of Indian Standards.
* **Timelines or procedures specified:** The draft rules were published for public comment, with a 30-day period for objections and suggestions. The final rule will come into force on the date of its final publication in the Official Gazette. The Ministry of Health and Family Welfare is responsible for considering feedback and finalizing the amendment.
* **Specific to the Changes:** Implementation will require manufacturers to ensure their processes and quality control measures align with the *most recent* version of IS 4707 Part I issued by the Bureau of Indian Standards.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcome of this amendment is to:
* **Enhance the quality and safety of Schedule Q drugs** by ensuring adherence to the most up-to-date industry standards.
* **Reduce ambiguity** regarding the applicable standards for Schedule Q drugs.
* **Promote consistency and compliance** within the pharmaceutical industry.
* May require some level of re-tooling or process changes to meet new standards.
**9. Conclusion:**
The proposed amendment to the Drugs Rules, 1945, specifically targeting rule 127, signifies an effort to maintain the relevance and effectiveness of pharmaceutical regulations. By incorporating the evolving standards of the Bureau of Indian Standards related to Schedule Q items, this amendment aims to promote higher quality control and consistent application of current industry best practices. This update is a crucial step in ensuring the safety and efficacy of drugs available in the market.
Key Entities Referenced
Drugs Rules, 1945: A set of rules being amended by the Central Government.
Central Government: The governing body proposing amendments to the Drugs Rules.
Drugs and Cosmetics Act, 1940: The primary legislation authorizing the Drugs Rules, specifically referencing Subsection 1 of section 12 and Subsection 1 of section 33.
Drugs Technical Advisory Board: An advisory body consulted regarding the draft rules.
Ministry of Health and Family Welfare: The government ministry responsible for the notification and the amendment of the Drugs Rules.
New Delhi: Location of the Ministry of Health and Family Welfare, specifically Nirman Bhavan, New Delhi.
Drugs ......Amendment Rules, 2021: The short title for the amendment rules being proposed.
Official Gazette: The official publication where the final rules will be published.
Schedule Q: A schedule within the Drugs Rules mentioned in rule 127.
IS 4707 Part I: An Indian Standard specification, as amended by the Bureau of Indian Standards, to be inserted into rule 127 of the Drugs Rules, 1945.
Bureau of Indian Standards: The standards body that amends IS 4707 Part I.
Dr. Mandeep K Bhandari: Joint Secretary who signed the notification.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-22072021-228415
xxxGIDHxxx
CG-DL-E-22072021-228415
xxxGIDExxx
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 404] नई ददल्ली, बहृ स्ट्प जतवार, िुलाई 22, 2021/आषाढ़ 31, 1943
No. 404] NEW DELHI, THURSDAY, JULY 22, 2021/ASHADHA 31, 1943
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई ददल्ली, 22 िुलाई, 2021
सा.का.जन. 502(अ).—औषजध जनयम, 1945 का और संिोधन करन े के जलए कजतपय जनयमों के जनम्नजलजखत
प्रारूप, जिस े केंद्रीय सरकार औषजध तकनीकी सलाहकार बोडड के परामि ड स े औषजध और प्रसाधन सामग्री अजधजनयम,
1940 (23 के 1940) की धारा 12 की उपधारा (1) और धारा 33 की उपधारा (1) द्वारा प्रदत्त िजियों का प्रयोग करत े
हुए, इसके द्वारा प्रभाजवत होने की संभावना वाले सभी व्यजियों की िानकारी के जलए प्रकाजित दकया िाता ह ै और
एतद्द्वारा सूचना दी िाती ह ै दक उक्त प्रारूप जनयमों पर उस तारीख स े तीस ददनों की अवजध समाप् त होने पर या उसके
बाद जवचार दकया िाएगा जिस तारीख को इन प्रारूप जनयमों वाले भारत के रािपत्र की प्रजतयां िनता को उपलब्ध कराई
िाएगी।
केंद्रीय सरकार द्वारा उपयुडि जवजनर्ददष्ट अवजध के भीतर दकसी भी व्यजि स े प्राप्त होने वाली आपजत्तयों और सुझावों
पर जवचार दकया िाएगा।
आपजत्तयां और सुझाव, यदद कोई हों, तो अवर सजचव, (औषजध), स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, भारत
सरकार, कमरा स.ं 434, सी ववग, जनमाडण भवन, नई ददल्ली - 110011 को अग्रेजषत दकया िाए अथवा
drugsdiv-mohfw@gov.in पर ई-मेल की िाए।
4005 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
प्रारूप जनयम
1. (1) इन जनयमों को औषजध (….संिोधन) जनयम, 2021 कहा िाएगा।
(2) ये जनयम रािपत्र म ें इनके अंजतम प्रकािन की तारीख को प्रभावी होंगे।
2. औषजध जनयम, 1945 में, जनयम 127 के उपजनयम (1) म,ें परन्तुक म,ें "परन्तु अनुसूची थ" के पश्चात, “और आईएस
4707 (भाग I) िैसा दक समय-समय पर भारतीय मानक ब्यरू ो द्वारा संिोजधत दकया गया ह,ै”, िब्द, अक्षर, कोष्ठक और
अंक को िाजमल दकया िाएगा।
[फा. स.ं एक् स.11014/14/2021-डीआर]
डॉ. मनदीप के भण्डारी, संयुि सजचव
रिप्पण : मलू जनयम को तारीख 21 ददसम् बर, 1945 की अजधसुचना स.ं एफ.28-10/45-एच (1) के तहत सरकारी रािपत्र
म ें प्रकाजित दकया गया और अंजतम बार अजधसुचना स0ं सा.का.जन.______(अ), तारीख: _____, के तहत
संिोजधत दकया गया।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 22nd July, 2021
G.S.R. 502(E).—The following 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 Sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby
published after consultation with the Drugs Technical Advisory Board 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 copies of the Gazette of India
containing these draft rules are made available to public;
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.
DRAFT RULES
(1) (i) These rules may be called the Drugs (......Amendment) Rules, 2021.
(ii) These rules shall come into force on the date of their final publication in the Official Gazette.
(2) In the Drugs Rules, 1945, in rule 127, in sub-rule (1), in proviso, after the words and letter “under
Schedule Q”, the words, letters, bracket and figures “and IS 4707 (Part I) as amended by Bureau of
Indian Standards from time to time” shall be inserted.
[F. No. X.11014/14/2021-DR]
Dr. MANDEEP K BHANDARI, Jt. Secy.
Note : The principal rules were published in the Official Gazette vide notification No. F.28-10/45-H(1)
dated 21st the December, 1945 and last amended vide notification number G.S.R.......(E), dated
the.......
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.