## Policy Analysis Report: Amendment to the Drugs and Cosmetics Act, 1940
**1. Executive Summary:**
This report analyzes a draft amendment to the Drugs and Cosmetics Act, 1940, specifically focusing on changes related to Homoeopathic systems. The core purpose of this amendment is to update and expand the recognized standards for Homoeopathic drugs. Key findings include the inclusion of specific Homoeopathic texts within the First Schedule of the Act and the broadening of pharmacopeia references in the Second Schedule to include French and European Pharmacopeias alongside the German Homoeopathic Pharmacopoeia. This will likely impact Homoeopathic drug manufacturers and practitioners, influencing the standards and guidelines they must adhere to.
**2. Introduction:**
This report aims to provide an informative analysis of a draft amendment to the Drugs and Cosmetics Act, 1940 (23 of 1940), as published in the Gazette of India on September 28, 2021. The analysis is based solely on the provided text and focuses on the changes related to Homoeopathic systems.
**3. Policy Overview:**
* This report concerns an *amendment* to the Drugs and Cosmetics Act, 1940.
* **Core Objective(s):** The core objective, as inferred from the provided text, is to update and expand the regulatory framework for Homoeopathic drugs by incorporating specific texts and broadening the scope of recognized pharmacopeias.
**4. Background and Rationale:**
The amendment seems designed to address a need for updating the existing standards for Homoeopathic drug manufacturing and regulation within India. The inclusion of specific Homoeopathic texts in the First Schedule suggests a desire to formally recognize these texts as authoritative references. The expansion of accepted pharmacopeias in the Second Schedule indicates a move towards aligning with international standards or recognizing diverse formulations. This could be driven by the need to improve quality control, promote standardization, or facilitate international trade of Homoeopathic medicines.
**5. Key Provisions / Changes:**
This section details the changes introduced by the amendment:
* **Change 1: First Schedule - Inclusion of Homoeopathic Texts:**
* **Original Policy Part Changed:** The First Schedule to the Drugs and Cosmetics Act, 1940.
* **New Rule/Provision:** After the heading "B. UNANI TIBB SYSTEM," a new heading "C. HOMOEOPATHIC SYSTEM" is inserted, followed by a list of 20 specific Homoeopathic texts with their authors, titles, editions, and publishers. These texts are assigned serial numbers 1 through 20.
* **Difference/Effect:** This amendment formally incorporates these specific Homoeopathic texts into the First Schedule, likely establishing them as recognized references for defining and regulating Homoeopathic medicines. It sets a standard for what texts are considered valid resources.
* **Change 2: Second Schedule - Expansion of Pharmacopeia References:**
* **Original Policy Part Changed:** Item number 4A in the Second Schedule, under "Class of drug," in subitem b and c.
* **New Rule/Provision:** In both subitems b and c, after the words "the German Homoeopathic Pharmacopoeia," the following phrase is added: "or the French Homoeopathic Pharmacopoeia or the European Pharmacopeia."
* **Difference/Effect:** This amendment broadens the scope of recognized pharmacopeias for Homoeopathic drugs. Previously, the reference was limited to the German Homoeopathic Pharmacopoeia. Now, the French Homoeopathic Pharmacopoeia and the European Pharmacopeia are also accepted. This change potentially allows for a wider range of formulations and manufacturing practices to be considered compliant with the Act.
**6. Target Audience and Stakeholders:**
Based on the provided text, the target audience and stakeholders directly affected by this amendment include:
* Homoeopathic drug manufacturers and suppliers.
* Homoeopathic practitioners.
* Regulatory bodies responsible for enforcing the Drugs and Cosmetics Act, 1940, particularly those dealing with Homoeopathic medicines (e.g., Ministry of AYUSH, Drugs Technical Advisory Board).
* Consumers of Homoeopathic medicines.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The Ministry of AYUSH is the primary responsible agency, as indicated by the notification's origin and the address for submitting objections. The Drugs Technical Advisory Board was consulted prior to drafting the amendment.
* **Timelines/Procedures:** The text specifies a three-month period following the publication of the Gazette of India for stakeholders to submit objections and suggestions regarding the proposed amendment. After this period, the Central Government will take the draft amendment into consideration.
* **(Amendment Specific):** Implementation of the amendment will require updating existing regulations and guidelines to reflect the newly included Homoeopathic texts and the broadened range of accepted pharmacopeias. Regulatory bodies will need to familiarize themselves with these changes and adapt their enforcement practices accordingly.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcome of these specific changes introduced by the amendment includes:
* **Standardization and Quality Control:** The inclusion of specific Homoeopathic texts may lead to greater standardization of Homoeopathic drug manufacturing and practice.
* **Increased Choice:** The recognition of French and European Pharmacopeias might allow for a wider variety of Homoeopathic medicines to be available.
* **Enhanced Regulatory Clarity:** By explicitly defining the acceptable references and pharmacopeias, the amendment should provide greater clarity for manufacturers and regulators.
* **Potential for International Harmonization:** Recognizing European Pharmacopeia could facilitate trade and alignment with international standards.
**9. Conclusion:**
The draft amendment to the Drugs and Cosmetics Act, 1940, concerning Homoeopathic systems, represents a significant update to the regulatory framework for Homoeopathic medicines in India. By incorporating specific texts into the First Schedule and broadening the scope of accepted pharmacopeias in the Second Schedule, the amendment aims to enhance standardization, provide regulatory clarity, and potentially facilitate international harmonization. This will have a significant impact on Homoeopathic drug manufacturers, practitioners, and regulators. The changes will likely improve the quality and availability of homeopathic medicines in India.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: An act of the Central Government which the notification proposes to amend.
Central Government: The governing authority proposing amendments to the Drugs and Cosmetics Act, 1940.
Drugs Technical Advisory Board: An advisory board consulted by the Central Government regarding the Drugs and Cosmetics Act, 1940.
Ministry of AYUSH: The ministry to which objections and suggestions regarding the draft amendment should be addressed. Located at AYUSH Bhawan, B Block, GPO Complex, INA, New Delhi 110023
First Schedule to the Drugs and Cosmetics Act, 1940: A schedule to the Drugs and Cosmetics Act, 1940, which the draft amendment modifies by inserting headings related to the Homoeopathic system.
B.UNANI TIBB SYSTEM: A heading in the First Schedule to the Drugs and Cosmetics Act, 1940.
C. HOMOEOPATHIC SYSTEM: A heading to be inserted in the First Schedule to the Drugs and Cosmetics Act, 1940, as part of the draft amendment.
Hahnemann Samuel: Author of Materia Medica Pura and The Chronic Diseases Their Peculiar nature and their homoeopathic cure.
Hering Constantine: Author of The Guiding Symptoms of Our Materia Medica.
Allen TF: Author of The Encyclopaedia of pure Materia Medica.
Allen HC: Author of The Materia Medica of Nosodes with proving of Xrays.
Clarke JH: Author of A Dictionary of Practical Materia Medica.
Hughes Richard: Author of A Manual of Pharmacodynamics and Cyclopaedia of Drug Pathogenesy.
Dake JP: Author of Cyclopaedia of Drug Pathogenesy.
Julian OA: Author of Materia Medica of Nosodes with Repertory and Materia Medica of New Homoeopathic Remedies.
Paterson John: Author of The Bowel Nosodes.
Ghose SC: Author of Drugs of Hindoostan.
Anshutzs EP: Author of New, Old and Forgotten Remedies.
Boericke William: Author of The Twelve Tissue Remedies and Pocket Manual of Homeopathic Materia Medica
Dewey Willis A: Author of The Twelve Tissue Remedies.
Kent JT: Author of Lectures Homoeopathic Materia Medica.
Boericke OE: Author of Pocket Manual of Homeopathic Materia Medica, Boericke Runyon.
Stephenson J: Author of Hahnemannian Provings, A Materia Medica and Repertory.
Homoeopathic Pharmacopeia India: Reference book published by Govt. of India.
Central Council for Research in Homoeopathy: Institution published Study of Homoeopathic Medicines through Clinical Verification and Homoeopathic Drug Provings
Second Schedule to the said Act: A schedule to the Drugs and Cosmetics Act, 1940, which the draft amendment modifies.
German Homoeopathic Pharmacopoeia: A pharmacopoeia referenced in the context of drug classifications.
French Homoeopathic Pharmacopoeia: A pharmacopoeia to be inserted in the context of drug classifications.
European Pharmacopeia: A pharmacopoeia to be inserted in the context of drug classifications.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-29092021-230039
xxxGIDHxxx
CG-DL-E-29092021-230039
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.ं 551] नई दिल्ली, मगं लव हार, जसतम्ब र 28, 2021/आजव ह न 6, 1943
No. 551] NEW DELHI, TUESDAY, SEPTEMBER 28, 2021/ASVINA 6, 1943
आयषु मंत्रालय
अजधसूचना
नई दिल्ली, 23 जसतम्बर, 2021
सा.का.जन. 668(अ).—औषजध और प्रसाधन सामग्री अजधजनयम, 1940(1940 का 23) का और संिोधन करन े
के जलए,िैसा दक औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 8 और धारा 16 तथा
धारा 33-ण द्वारा प्रित् त िजतियय का प्रयोग करत े ुएए और औषजध तकनीकी सलाककार बोड ड के परामि ड के बाि कद्र सरकार
का प्रस्ट् ताव ह क,ै जनम्न जलजखत मसदिा संिोधन को,इसके द्वारा प्रभाजव हत कोने की संभाव हना व हाल े सभी व् यजतियय की िानकारी
के जलए प्रकाजित दकया िाता कै और एतिद्वारा सूचना िी िाती क ै दक उक्त मसदिा संिोधन पर जकतधारक की आपजतियय
अथव हा सुझाव ह पर उस तारीख से तीस दिन की अव हजध समाप् त कोन े पर या उसके बाि जव हचार दकया िाएगा जिस तारीख
को इस मसदिा संिोधन व हाल ेभारत के रािपत्र की प्रजतया ंिनता को उपलब् ध कराई िाएगं ी
कद्र सरकार द्वारा उपयुड क् त जन्ि ड ष्ट अव हजध के भीतर दकसी भी व् यजतिय से प्राप् त कोन े व हाली आपजतियय और सुझाव ह
पर जव हचार दकया िाएगा
आपजतिययां या सुझाव ह, यदि कोई क , तो सजचव ह, आयुष मंत्रालय, आयुष भव हन,‘बी’ ब्ल ॉक, िीपीओ कॉम् पलेक्स ,
आईएनए, नई दिल्ली-110023 को अग्रेजषत दकए िाएं अथव हा ई-मेल dcc-ayush@nic.in. पर भेिद
मसदिा सिं ोधन
1. औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (इसके बाि इसे उतिय अजधजनयम कका िाएगा) की प्रथम
अनुसूची म,द िीषड क ‘‘ख—यूनानी जतब्ब पद्धजत’’ और उससे संबंजधत प्रजव हजिय के पश्चात,् जनम्नजलजखत िीष ड और
प्रजव हजियां अंतर्नड जव हि की िाएगं ी, अथाड त्:
5501GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
“ग.-कोम्योपथै ी पद्धजत
क्रम संख्या पुस्ट्तक का नाम
1. कनै ीमैन सैमअु ल. मटेररया मेजडका पुरा. व हाल्यूम I-II.तीसरा सस्ट्ं करण. लंिन: कनै ीमैनपजब्लशिगं
सोसायटी; 1830/ 1986 मद पनु :मुद्र त संस्ट्करण.
2. कनै ीमैन सैमुअल. ि क्रोजनक जडिीिेि दियर पेक्यलू र नेचर एंड दियर कोम्योपैजथक क्योर.
(थ्योरी एंड प्रैजक्टस). प्रथम संस्ट्करण. न्यूयॉकड : डब्ल्य ूराडे; 1845.
3. करे रंग कॉन्स्ट्टैंरटन. ि गाइशडंग जसम्पटम्स ऑफ अव हर मटेररया मेजडका. व हाल्यूम I-X. प्रथम
संस्ट्करण. दफलाडेजल्फया: अमरे रकन कोम्योपैजथक पजब्लशिगं सोसायटी; िे.M स्ट्टोडाटड एंड
कंपनी; 1879. /पुन: मुद्र त संस्ट्करण. नई दिल्ली: बी िैन प्रकािक; 1989.
4. एलन टीएफ.ि इनसाइक्लोपीजडया ऑफ प्योर मटेररया मेजडका. व हाल्यूम I-XII.प्रथम संस्ट्करण.
न्यूयॉकड , दफलाडेजल्फया: बोएररक एडं टाफेल; 1877. /पुन: मुद्र त संस्ट्करण. नई दिल्ली: बी
िैन प्रकािक; 1986.
5. एलन एचसी. मटेररया मेजडका ऑफ नोसोड्स जव हि प्रूशव हंग ऑफएक्स-रे. प्रथम सस्ट्ं करण.
दफलाडेजल्फया: बोएररक एंड टाफेल; 1910/नई दिल्ली: िनै प्रकािन कंपनी; 1977
6. क्लाकड िेएच. ए जडक्िनरी ऑफ प्रैजक्टकल मटेररया मेजडका.व हाल्यूम I-III.प्रथम संस्ट्करण.
लंिन: ि कोम्योपैजथक पजब्लशिगं कंपनी; 1902.
7. कगेि ररचडड .ए मैनअु ल ऑफ फामाड कोडायनैजमक्स. 5व हां संस्ट्करण. लंिन: लीथ एडं रॉस; 1886.
8. कगेि आर, डेक िेपी.साइक्लोपीजडया ऑफ ड्रग पाइथोिीनसे ी. प्रथम संस्ट्करण. लिं न: गोल्ड;
1886.
9. िूजलयन ओए. मटेररया मेजडका ऑफ नोसोड्स जव हि ररपरटरी. प्रथम भारतीय संस्ट्करण. नई
दिल्ली: बी िैन पजब्लिस;ड 1980/नई दिल्ली: बी िैन प्रकािक; 1981
10. िूजलयन ओए. मटेररया मेजडका ऑफ न्य ू कोम्योपैजथक रेमेडीि. फ्रदच संस्ट्करण. यूके:
बीकन्सफील्ड पजब्लिसड जलजमटेड; 1971/बीकन्सफील्ड बक्स यूके: बीकन्सफील्ड पजब्लिस ड
जलजमटेड; 1979
11. पैटरसन िॉन. ि बाउल नोसोड्स.प्रथम संस्ट्करण कलकतिया: कनै ीमैन पजब्लशिंग कंपनी प्राइव हेट
जलजमटेड; 1950/कलकतिया: कनै ीमैन पजब्लशिंग कंपनी प्राइव हेट जलजमटेड
12. घोष एसी ड्रग्स ऑफ जकन्िस्ट्ु तान. संस्ट्करण कलकतिया: कनै ीमैन पजब्लशिंग कंपनी प्राइव हटे
जलजमटेड; 1952/9व हां संस्ट्करण. कलकतिया: कनै ीमैन पजब्लशिगं कंपनी प्राइव हेट जलजमटेड; 1984.
13. अंिुट्ज़ ईपी. न्य,ू ओल्ड एंड फॉरगदटन रेमडे ीि. प्रथम संस्ट्करण दफलाडेजल्फया: बोएररक एडं
टाफेल; 1900.
14. बोएररक जव हजलयम, डेव ही जव हजलस ए. ि ट्जव हेल्व ह रटिू रेमेडीि. प्रथम संस्ट्करण. दफलाडेजल्फया:
बोएररक एंड टाफेल; 1888.
15. कदट िेटी लेक्चसड कोम्योपैजथक मटेररया मेजडका.प्रथम संस्ट्करण. कलकतिया: रॉय पजब्लशिंग
काउस: 1904.
16. बोएररक ओई. पॉकेट मैनुअल ऑफ कोम्योपैजथक मटेररया मेजडका.बोएररक एंड रूजनयन. छठा
संस्ट्करण. न्यूयॉकड : बोएररक और टाफेल; 1916/नई दिल्ली: बी िैन प्रकािक; 1971.
17. स्ट्टीफदसन िे कनै ीमैजनयन प्रूशव हग्ं ि, ए मटेररया मेजडका एंड ररपरटरी. न्यूयॉकड : बोएररक एडं
टाफेल; 1963/नई दिल्ली: बी िैन प्रकािक; 1986.[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3
18. कोम्योपैजथक फामाड कोजपया इंजडया (एचपीआई) - भारत सरकार द्वारा प्रकाजित सभी खंड
19. स्ट्टडी ऑफ कोम्योपैजथक मेजडजसन्स थ्रू क्लीजनकल व हेररदफकेिन. केन््र ीय कोम्योपैथी अनुसंधान
पररषि, नई दिल्ली द्वारा प्रकाजित सभी खंड
20. कोम्योपैजथक ड्रग प्रूशव हंग्ि- केन््र ीय कोम्योपैथी अनुसंधान पररषि, नई दिल्ली द्वारा प्रकाजित
सभी खंड’’
2. उतिय अजधजनयम की िसू री अनुसूची मद, मि संख्या 4क म,द 'औषजध का व हग'ड के तकत, -
(क) उप-मि (ख) म,द "िमड न कोम्योपैजथक फामाड कोपोइया" िब्ि के बाि, जनम्नजलजखत अतं र्नड जव हिदकया िाएगा,
अथाड त,् -
“या फ्रदच कोम्योपैजथक फामाड कोजपया या यूरोपीय फामाड कोजपया.”
(ख) उप-मि (ग) म,द "िमड न कोम्योपैजथक फामाड कोजपया" िब्ि के बाि, जनम्नजलजखत अतं र्नड जव हि दकया िाएगा,
अथाड त,् -
“या फ्रदच कोम्योपैजथक फामाड कोजपया या यूरोपीय फामाड कोजपया.”
[फा.सं. के.11025/01/2016-डीसीसी(आयुष)]
कजव हता गग,ड संयुतिय सजचव ह
MINISTRY OF AYUSH
NOTIFICATION
New Delhi, the 23rd September, 2021
G.S.R. 668(E).—The following draft amendment further to amend the Drugs and Cosmetics Act, 1940 (23
of 1940), which the Central Government proposes to make in exercise of the powers conferred by Section 8 and
Section 16 and Section 33-O 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 amendment will be taken into consideration on or after the expiry of a period of three
months from the date on which copies of the Gazette of India containing these draft amendment are made available to
the 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 Secretary, Ministry of AYUSH, AYUSH
Bhawan, ‘B’ Block, GPO Complex, INA, New Delhi – 110023 or emailed at dcc-ayush@nic.in.
DRAFT AMENDMENT
1. In the First Schedule to the Drugs and Cosmetics Act, 1940(23 of 1940) (hereinafter referred to as the said Act),
after heading “B.—UNANI TIBB SYSTEM” and the entries relating thereto, the following heading and entries
shall be inserted, namely,-
“C. —HOMOEOPATHIC SYSTEM
Serial No. Name of Book
1. Hahnemann Samuel. Materia Medica Pura. Vol. I-II. 3rded. London: Hahnemann Publishing
Society; 1830/ reprint ed. 1986.
2. Hahnemann Samuel. The Chronic Diseases Their Peculiar nature and their homoeopathic
cure. (Theory & Practice). 1st ed. New York: W Radde; 1845.
3. Hering Constantine. The Guiding Symptoms of Our Materia Medica. Vol. I-X. 1ST ed.
Philadelphia: American Homoeopathic Publishing Society; J.M. Stoddart & Co; 1879.
/Reprinted ed. New Delhi: B. Jain Publishers; 1989.
4. Allen TF. The Encyclopaedia of pure Materia Medica. Vol. I-XII. 1sted. New York,
Philadelphia: Boericke & Tafel; 1877. /Reprinted ed. New Delhi: B. Jain Publishers; 1986.4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
5. Allen HC. The Materia Medica of Nosodes with proving of X-rays. 1st ed. Philadelphia:
Boericke & Tafel; 1910/ New Delhi: Jain Publishing Co; 1977.
6. Clarke JH. A Dictionary of Practical Materia Medica. Vol. I-III. 1sted. London: The
Homoeopathic Publishing Company; 1902.
7. Hughes Richard. A Manual of Pharmacodynamics. 5th ed. London: Leath and Ross; 1886.
8. Hughes R, Dake JP. Cyclopaedia of Drug Pathogenesy. 1st ed. London: Gould; 1886.
9. Julian OA. Materia Medica of Nosodes with Repertory. 1stIndian ed. New Delhi: B. Jain
Publishers; 1980/ New Delhi: B. Jain Publishers; 1981.
10. Julian OA. Materia Medica of New Homoeopathic Remedies. French ed. UK: Beaconsfield
Publishers Ltd; 1971/ Beaconsfield Bucks UK: Beasconsfield Publishers Ltd; 1979.
11. Paterson John. The Bowel Nosodes. 1st ed. Calcutta: Hahnemann Publishing CO. Private
Ltd; 1950/Calcutta: Hahnemann Publishing Co. Private Ltd.
12. Ghose SC. Drugs of Hindoostan. ed. Calcutta: Hahnemann Publishing Co. Pvt. Ltd; 1952/
9th ed. Calcutta: Hahnemann Publishing Co. Pvt. Ltd; 1984.
13. Anshutz’s EP. New, Old and Forgotten Remedies. 1st ed. Philadelphia: Boericke&Tafel;
1900.
14. Boericke William, Dewey Willis A. The Twelve Tissue Remedies. 1st ed. Philadelphia:
Boericke&Tafel; 1888.
15. Kent JT. Lectures Homoeopathic Materia Medica. 1th ed. Calcutta: Roy Publishing House:
1904.
16. Boericke OE. Pocket Manual of Homeopathic Materia Medica, Boericke & Runyon. 6th ed.
New York: Boericke & Tafel; 1916/New Delhi: B. Jain Publishers; 1971.
17. Stephenson J. Hahnemannian Provings, A Materia Medica and Repertory. New York:
Boericke & Tafel; 1963/ New Delhi: B. Jain Publishers; 1986.
18. Homoeopathic Pharmacopeia India (HPI)-all volumes published by Govt. of India.
19. Study of Homoeopathic Medicines through Clinical Verification all Volumes published by
Central Council for Research in Homoeopathy, New Delhi.
20. Homoeopathic Drug Provings- all Volumes published by Central Council for Research in
Homoeopathy, New Delhi.”
2. In the Second Schedule to the said Act, in item number 4A, under ‘Class of drug’, -
(a) in sub-item (b), after the words “the German Homoeopathic Pharmacopoeia”, the following shall be inserted,
namely,-
“or the French Homoeopathic Pharmacopoeia or the European Pharmacopeia.”
(b) in sub-item (c), after the words “the 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.