## Report on Amendment to the Drugs and Cosmetics Rules, 1945
**1. Executive Summary:**
This report analyzes a notification from the Ministry of AYUSH, Government of India, representing a draft amendment to the Drugs and Cosmetics Rules, 1945. The primary purpose of this amendment, as inferred from the text, is to refine the regulations regarding the import of New Homoeopathic Medicines and the qualifications of certain personnel involved in drug manufacturing. The key changes involve specifying the criteria for what constitutes a "New Homoeopathic Medicine," updating educational qualifications for specific roles, and expanding the list of accepted pharmacopoeias. This report aims to provide a clear and concise overview of these changes and their potential impact on relevant stakeholders, particularly those involved in the Homoeopathic medicine industry.
**2. Introduction:**
This report provides an informative analysis of a draft amendment to the Drugs and Cosmetics Rules, 1945, as published in the Gazette of India. The analysis focuses solely on the information provided within the given policy text and aims to elucidate the key changes, their rationale, and potential implications.
**3. Policy Overview:**
* This notification amends the existing Drugs and Cosmetics Rules, 1945.
* The core objective, based on the provided text, is to refine and update the regulatory framework governing Homoeopathic medicines, specifically regarding import regulations and personnel qualifications.
**4. Background and Rationale:**
This amendment likely aims to address perceived gaps or ambiguities within the existing Drugs and Cosmetics Rules, 1945, specifically related to the regulation of Homoeopathic medicines. The introduction of a detailed definition for "New Homoeopathic Medicine" suggests a need for clearer categorization and control of these medicines, especially concerning safety and efficacy. Expanding the list of acceptable pharmacopoeias and educational qualifications indicates an effort to align the rules with current scientific and professional standards.
**5. Key Provisions / Changes:**
The amendment introduces the following key changes:
* **Rule 30AA (Import of New Homoeopathic Medicines):** This rule is entirely substituted. The new rule defines "New Homoeopathic Medicine" with specific criteria:
* Medicines not specified in certain pharmacopoeias (Homoeopathic Pharmacopoeia of India, United States of America, United Kingdom, German Homoeopathic Pharmacopoeia, French Homoeopathic Pharmacopoeia or the European Pharmacopeia).
* Medicines not recognized in authoritative Homoeopathic books specified in the First Schedule of the Act.
* Combinations containing medicines not in the specified pharmacopoeias or authoritative books.
* New fixed-ratio combinations or changes in ingredient ratios of existing combinations, even if individual ingredients are listed in pharmacopoeias or authoritative books.
* All nosodes and sarcodes, unless certified otherwise by the licensing authority under rule 21.
* *Effect:* This detailed definition provides greater clarity and control over the import of New Homoeopathic Medicines, subjecting them to stricter scrutiny regarding safety and efficacy. The rule states that medicines will be considered new for four years after the date of first approval.
* **Rule 85E (Qualifications for certain personnel):** Subrule 1, clause a is amended to add "or Botany or Zoology" after "a graduate in Science with Chemistry".
* *Effect:* This broadens the pool of eligible candidates for positions requiring specific scientific expertise in drug manufacturing, which could ease recruitment challenges and potentially introduce diverse perspectives.
* **Rule 106A (Pharmacopoeias):** Subrule A, clause ii, subclause a is amended to include "or the French Homoeopathic Pharmacopoeia or the European Pharmacopeia" after "German Homoeopathic Pharmacopoeia".
* *Effect:* This expands the range of recognized pharmacopoeias, potentially allowing for the import and sale of Homoeopathic medicines formulated according to these additional standards.
**6. Target Audience and Stakeholders:**
The primary target audience and stakeholders directly affected by these changes include:
* Manufacturers and importers of Homoeopathic medicines, particularly those dealing with "New Homoeopathic Medicines."
* Licensing authorities responsible for regulating the import and sale of Homoeopathic medicines.
* Individuals seeking employment in roles requiring scientific qualifications in drug manufacturing.
**7. Implementation Aspects (Inferred):**
* The **Licensing Authority as defined in clause b of rule 21** is the responsible body for granting permission for the import of New Homoeopathic Medicines.
* The amendment specifies a 30-day period for public consultation and feedback, suggesting that the final implementation will occur after this period and subsequent review.
* The Licensing Authority is responsible for assessing the safety and therapeutic efficacy, and for issuing approvals subject to conditions.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcomes of these changes are:
* Enhanced regulatory control over "New Homoeopathic Medicines," ensuring greater safety and efficacy.
* A more streamlined and transparent process for importing Homoeopathic medicines.
* A broader pool of qualified personnel in the Homoeopathic drug manufacturing industry.
* Greater alignment of Indian regulations with international standards and practices, as reflected in the expanded list of recognized pharmacopoeias.
**9. Conclusion:**
The draft amendment to the Drugs and Cosmetics Rules, 1945, represents a significant effort to refine and update the regulatory framework for Homoeopathic medicines in India. The detailed definition of "New Homoeopathic Medicine," the expanded qualifications for personnel, and the broadened list of acceptable pharmacopoeias are all aimed at enhancing the safety, efficacy, and quality of Homoeopathic medicines available in the country. These changes will likely have a notable impact on manufacturers, importers, and regulatory bodies within the Homoeopathic medicine sector. It is important for stakeholders to carefully review these changes and provide their feedback during the consultation period.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules that are being amended by the notification.
Central Government: The governing body proposing the amendments to the Drugs and Cosmetics Rules, 1945.
Drugs and Cosmetics Act, 1940: The Act under which the powers are conferred to amend the Drugs and Cosmetics Rules, 1945.
Drugs Technical Advisory Board: An advisory board consulted for the amendments to the Drugs and Cosmetics Rules, 1945.
Ministry of AYUSH: The ministry responsible for the notification and to whom objections and suggestions should be addressed. Located at AYUSH Bhawan, B Block, GPO Complex, INA, New Delhi 110023.
Drugs and Cosmetics .Amendment Rules, 2021: The name of the rules that are being introduced as an amendment.
Official Gazette: The publication in which the final rules will be published.
New Homoeopathic medicine: A type of medicine that the amendment defines conditions for importing, specifying criteria for what constitutes a 'New Homoeopathic medicine'.
Licensing Authority: An authority responsible for granting permission for import of New Homoeopathic medicine under specific rules.
Homoeopathic Pharmacopoeia of India: A pharmacopoeia that specifies Homoeopathic medicines.
United States of America: One of the countries whose Homoeopathic Pharmacopoeia is referenced.
United Kingdom: One of the countries whose Homoeopathic Pharmacopoeia is referenced.
German Homoeopathic Pharmacopoeia: A pharmacopoeia that specifies Homoeopathic medicines.
French Homoeopathic Pharmacopoeia: A pharmacopoeia that specifies Homoeopathic medicines.
European Pharmacopeia: A pharmacopeia that specifies medicines.
First Schedule of the Act: A schedule in the Drugs and Cosmetics Act, 1940 that specifies authoritative Homoeopathic books.
Government of India Press, Ring Road, Mayapuri, New Delhi: Location where the document was printed.
Controller of Publications, Delhi: The publisher of the document.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-29092021-230040
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CG-DL-E-29092021-230040
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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.ं 552] नई दिल्ली, मगं लवार, जसतम्ब र 28, 2021/आजव न 6, 1943
No. 552] NEW DELHI, TUESDAY, SEPTEMBER 28, 2021/ASVINA 6, 1943
आयषु मंत्रालय
अजधसूचना
नई दिल्ली, 23 जसतम्बर, 2021
सा.का.जन. 669(अ).—औषजध और प्रसाधन सामग्री जनयमावली, 1945 का और संिोधन करने के जलए,िैसा दक
औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (के 23 1940) की धारा 12 और धारा 33 द्वारा प्रित् त िजतियय का प्रयोग
करते हुए और औषजध तकनीकी सलाहकार बोडड के परामि ड के बाि केन्द्र सरकार का प्रस्ट्ताव है, जनम्न जलजखत कजतपय
जनयम के प्रारूप को, इसके द्वारा प्रभाजवत होने की संभावना वाले सभी व् यजतियय की िानकारी के जलए प्रकाजित दकया
िाता ह ै और एतिद्वारा सूचना िी िाती ह ै दक उक्त मसदिा जनयम पर जहतधारक की आपजतियय अववा सुााव पर उस
तारीख से तीस दिन की अवजध समाप् त होन े पर या उसके बाि जवचार दकया िाएगा जिस तारीख को इन प्रारूप जनयम
वाले भारत के रािपत्र की प्रजतयां िनता को उपलब्ध कराई िाएंगी;
केंर सरकार द्वारा उपयुडक्त जन्िडष् ट अवजध के भीतर दकसी भी व् यजतिय स े उक्त प्रारूप प्राप् त होने वाली आपजतियय
और सुााव पर जवचार दकया िाएगा;
आपजतिययां या सुााव, यदि कोई ह , तो सजचव, आयुष मंत्रालय, आयुष भवन,‘बी’ ब् लॉक, िीपीओ कॉम् पलेक्स ,
आईएनए, नई दिल्ली-110023 को अग्रेजषत दकए िाएं अववा ई-मेल dcc-ayush@nic.in. पर भेिें।
मसदिा जनयम
1. (1) इन जनयम को औषजध एव ंप्रसाधन सामग्री (..................संिोधन) जनयम, 2021 कहा िाएगा।
(2) ये जनयम सरकारी रािपत्र में इनके अंजतम प्रकािन की तारीख से लागू ह गे।
2. औषजध और प्रसाधन सामग्री जनयम, 1945(इसके बाि इन्द्ह ें उतिय जनयम कहा िाएगा), जनयम 30कक के जलए,
जनम्नजलजखत जनयम को प्रजतस्ट्वाजपत दकया िाएगा, अवाडत्:-
5502GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
“30कक. नई होम्योपवै ी औषजधय का आयात - (1) जनयम 21 के खंड (ख) में पररभाजषत अनुज्ञजि अजधकारी द्वारा
जलजखत में िी गई अनुमजत के अलावा और उसके अनुसार दकसी भी नई होम्योपैवी औषजध का आयात नहीं दकया
िाएगा।
(2) उप-जनयम (1) के तहत अनुमजत के जलए आवेिन करते समय नई होम्योपैवी औषजध का आयातक, अनुज्ञजि
अजधकारी के समक्ष ऐस े िस्ट्तावेिी और अन्द्य साक्ष्य प्रस्ट्ततु करेगा िो अनुज्ञजि अजधकारी औषजध की सुरक्षा,
जचदकत्सीय प्रभावकाररता और इसके साव दकए गए न्द्यूनतम होम्योपैवी प्रयोग का आकलन करन े के जलए आवयक
समाता हो।
स्ट्पष्टीकरण.- इस जनयम के प्रयोिन के जलए, 'नई होम्योपैजवक औषजध' का अजभप्राय ह,ै -
(i) ऐसी होम्योपैवी औषजध िो भारत या संयुतिय राज्य अमेररका या यूनाइटेड ककंगडम के होम्योपैजवक
फामाडकोपोइया या िमडन होम्योपैजवक फामाडकोजपया या फ्ासं ीसी होम्योपैजवक फामाडकोजपया या यरू ोपीय
फामाडकोजपया में जन्िष्टड नहीं ह;ै या
(ii) िो अजधजनयम की पहली अनसु ूची में जन्िष्टड होम्योपैवी की प्राजधकृत पुस्ट्तक में संस्ट्ततु ितों के तहत
प्रभावोत्पािक के रूप म ेंमान्द्यता प्राि नहीं ह;ै या
(iii) िो होम्योपैवी औषजधय का संयोिन ह ै जिसमें ऐसी एक या अजधक औषजधयां ह ैं िो खंड (i) में उजल्लजखत
दकसी भी फामाडकोजपया में जन्िष्टड नहीं ह ैं या िो खंड (ii) में उजल्लजखत होम्योपैवी की प्राजधकृत पस्ट्ु तक म ें
मान्द्यता प्राि नहीं ह;ैं या
(iv) िो िो या िो स े अजधक होम्योपैवी औषजधय का संयोिन ह ै भले ही उनका खंड (i) के अनसु ार होम्योपैवी
फामाडकोजपया में या अजधजनयम की प्रवम अनुसूची में जन्िष्टड होम्योपैवी की प्राजधकृत पुस्ट्तक में अलग-अलग
उल्लेख हो, जिन्द्ह ें अब पहली बार एक जनजित अनुपात म ें संयोजित करने का प्रस्ट्ताव है, या पहले से ही
जवपणन संयोिन म ेंअवयव के अनुपात को कजतपय िाव के साव बिलने का प्रस्ट्ताव ह;ै या
(v) िो जनयम 21 के तहत अनुज्ञजि अजधकारी द्वारा अन्द्यवा प्रमाजणत दकए िाने तक सभी नोसोड्स और
सारकोड्स ह।ैं
(3) दकसी नई होम्योपैवी औषजध को उसकी पहली मंिूरी की तारीख से चार साल की अवजध के जलए नई होम्योपैवी
औषजध के रूप म ेंमाना िाता रहगे ा।
(4) अनुज्ञजि अजधकारी जनयम 21 के खंड (ख) में जन्िष्टड ानुसार यह संतुष्ट होने के बाि दक औषजध िेि में उपयोग के
जलए प्रभावी और सरु जक्षत होगी, जनम्नजलजखत ितों का उल्लेख करते हुए अनुमोिन िारी करेगा:
परंत ु अनुज्ञजि अजधकारी, िहां नई होम्योपैवी औषजध पर उपलब्ध कराए गए या उत्पन्न आंकडे अपयाडि ह,ैं वहां
आवेिक को जलजखत रूप म ें सूजचत करेगा, और अनुमजत पर जवचार दकए िाने से पहल े ितों को पूरा दकया िाना
होगा।’’
3. उतिय जनयम म,ें जनयम 85ड.म,ें उप-जनयम (1) म,ें खंड (क) म,ें "रसायन जवज्ञान के साव जवज्ञान में स्नातक" िब्ि के
बाि, "या वनस्ट्पजत जवज्ञान या िीव जवज्ञान" िब्ि को अंतर्नडजवष्ट दकया िाएगा।उतिय जनयम में, जनयम 106क म,ें
उप-जनयम (क)म,ेंखंड (II) म,ें उप-खंड (क) म,ें "िमडन होम्योपैजवक फामाडकोजपया" िब्ि के बाि, जनम्नजलजखत को
अंतर्नडजवष्ट दकया िाएगा, अवातड ्,-
“या फ्ेंच होम्योपैजवक फामाडकोजपया या यूरोपीय फामाडकोजपया,"
[फा.सं.के.11025/01/2016-डीसीसी(आयुष)]
कजवता गग,ड संयुतिय सजचव
MINISTRY OF AYUSH
NOTIFICATION
New Delhi, the 23rd September, 2021
G.S.R. 669(E).—The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945
which the Central Government proposes to make in exercise of the powers conferred by section 12 and section 33 of
the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board, is
hereby published for information of all persons likely to be affected thereby and notice is hereby given that said draft
rules will 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 the public.[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3
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 Secretary, Ministry of AYUSH, AYUSH
Bhawan, ‘B’ Block, GPO Complex, INA, New Delhi – 110023 or emailed at dcc-ayush@nic.in.
DRAFT RULES
1. (1) These rules may be called the Drugs and Cosmetics (……….Amendment) Rules, 2021.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945 (herein after referred to as the said rules), for rule 30AA, the following
rule shall be substituted, namely:-
“30AA. Import of New Homoeopathic medicines.— (1) No New Homoeopathic medicine shall be imported
except under and in accordance with the permission in writing by the Licensing Authority as defined in clause
(b) of rule 21.
(2) The importer of a New Homoeopathic medicine when applying for permission under sub-rule (1) shall
produce before the Licensing Authority such documentary and other evidence as may be required by the
Licensing Authority for assessing the safety, therapeutic efficacy of the medicine including the minimum
homoeopathic provings carried out with it.
Explanation.- For the purpose of this rule, ‘New Homoeopathic Medicine’ means,—
(i) a Homoeopathic medicine which is not specified in the Homoeopathic Pharmacopoeia of India or United
States of America or of the United Kingdom or the German Homoeopathic Pharmacopoeia or the French
Homoeopathic Pharmacopoeia or the European Pharmacopeia; or
(ii) which is not recognized in authoritative Homoeopathic books specified in the First Schedule of the Act,
as efficacious under the conditions recommended; or
(iii) a combination of Homoeopathic medicines containing one or more medicines which are not specified in
any of the Pharmacopoeias referred to in clause (i) or not recognized in authoritative Homoeopathic
books referred to in clause (ii); or
(iv) a combination of two or more Homoeopathic medicines even if individually mentioned in Homoeopathic
Pharmacopoeia as in clause (i) or in authoritative Homoeopathic books specified in the First Schedule of
the Act, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of
ingredients in an already marketed combination is proposed to be changed, with certain claims; or
(v) all nosodes and sarcodes unless certified otherwise by licensing authority under rule 21.
(3) A New Homoeopathic Medicine shall continue to be considered as New Homoeopathic Medicine for a period
of four years from the date of its first approval.
(4) The Licensing Authority as defined in clause (b) of rule 21 after being satisfied that the drug shall be
effective and safe for use in the country, shall issue approval subject to the conditions stated therein:
Provided that the Licensing Authority shall, where the data provided or generated on the New
Homoeopathic Medicine is inadequate, intimate the applicant in writing, and the conditions, which shall be
satisfied before permission could be considered.”
3. In the said rules, in rule 85E, in sub-rule (1), in clause (a), after the words “a graduate in Science with Chemistry”,
the words “or Botany or Zoology” shall be inserted.
4. In the said rules, in rule 106A, in sub-rule (A), in clause (ii), in sub-clause (a), after the words “German
Homoeopathic Pharmacopoeia”, the following shall be inserted, namely,-
“or the French Homoeopathic Pharmacopoeia or the European Pharmacopeia,”
[F.No. K.11025/01/2016-DCC(AYUSH)]
KAVITA GARG, Jt. Secy.
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.