## Report: Analysis of Amendments to the Drugs Rules, 1945
**1. Executive Summary:**
This report analyzes amendments to the Drugs Rules, 1945, as published in the Gazette of India, Extraordinary, Part II, Section 3, Subsection (i) on May 28, 2025. The core purpose of these amendments is to refine existing regulations regarding drug testing, licensing, and oversight of competent persons involved in drug sales, and to clarify conditions for sale of drugs to certain manufacturers. Key changes include updated testing protocols for bacterial endotoxins/pyrogens, modifications to licensing conditions related to competent persons, and revisions to restrictions on drug sales to manufacturers of non-medicinal products.
**2. Introduction:**
This report provides an informative analysis of the recent amendments to the Drugs Rules, 1945, based solely on the policy text published in the Gazette of India on May 28, 2025. The objective is to offer a clear understanding of the implemented changes for affected industries.
**3. Policy Overview:**
* This document pertains to *amendments* to the Drugs Rules, 1945.
* Core Objectives (as inferred from the provided text):
* To update and harmonize testing procedures for parenteral drugs.
* To strengthen the supervision and accountability surrounding the sale of drugs.
* To refine the scope of restrictions on drug sales to manufacturers of beverages, confectionary, biscuits, and other non-medicinal products.
**4. Background and Rationale:**
The amendments likely aim to address potential gaps or ambiguities in the existing Drugs Rules, 1945. The specific reasons for these changes (based on the amendment text) include:
* **Testing Procedures:** The amendment related to Rule 121A suggests a need to align testing protocols for bacterial endotoxins and pyrogens with the latest standards of the Indian Pharmacopeia (I.P.). This implies a drive for enhanced quality control and safety in parenteral drug administration.
* **Competent Person Oversight:** The amendments to Forms 20B, 20G, and 21B regarding competent persons indicates a desire to improve the oversight and accountability in drug sales. This suggests concern that existing regulations may have been insufficient to ensure responsible sales practices. The requirement for reporting changes in competent personnel likely ensures continuity of supervision.
* **Restrictions on Drug Sales:** The amendments to Forms 20B, 20BB, 21B and 21BB clarify the conditions of license for sales to manufacturers of non-medicinal products. The original condition *c* was too broad and is now more defined. The addition of the second proviso, excluding sales of all drugs *except* antimicrobial drugs suggests a risk assessment determined the need to control only the use of these types of drugs.
**5. Key Provisions / Changes:**
The amendments introduce the following changes:
* **Rule 121A (Test for Bacterial endotoxinsPyrogens):**
* **Original:** Unspecified testing standards.
* **New:** Mandates that solutions intended for parenteral administration comply with a test for bacterial endotoxins or, where justified and authorized, with the test for pyrogens. The test *must* be conducted according to the current edition of the Indian Pharmacopeia (I.P.).
* **Effect:** This change enforces standardized and updated testing procedures, promoting drug safety through compliance with the most recent Indian Pharmacopeia (I.P.) standards.
* **Schedule A (Forms 20B, 20G, and 21B):**
* **Original:** Lack of explicit requirement for competent person supervision and reporting changes.
* **New:** Requires all sales to be made under the personal supervision of a competent person, and name to be available on record. Licensees *must* report any changes in competent persons to the licensing authority within one month.
* **Effect:** This strengthens the accountability and supervision in drug sales and enhances the oversight role of licensing authorities by mandating prompt notification of personnel changes.
* **Schedule A (Forms 20B, 20BB, 21B and 21BB):**
* **Original:** Broad prohibition of sales under condition *c*.
* **New:** A proviso is added that allows sales of any drug *except* antimicrobial drugs to a manufacturer of beverages, confectionary biscuits and other nonmedicinal products, where such drugs are required for processing these products.
* **Effect:** This allows for broader sales as long as the drugs are not antimicrobial.
**6. Target Audience and Stakeholders:**
Based on the provided text, the primary target audience and stakeholders affected by these amendments include:
* Pharmaceutical manufacturers producing parenteral drugs.
* Pharmacists and retailers involved in drug sales.
* Manufacturers of beverages, confectionary, biscuits and other nonmedicinal products.
* Licensing authorities responsible for regulating drug sales.
* Competent persons involved in drug sales.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency:** The Ministry of Health and Family Welfare, Department of Health and Family Welfare, is responsible for implementing and overseeing these amendments. The "Under Secretary Drugs" is specified as the point of contact for objections and suggestions.
* **Timelines:** The rules will come into force on a date specified by the Government upon final publication in the Official Gazette. A thirty-day period is provided for stakeholders to submit objections and suggestions.
* **Competent Person Reporting:** Licensees must report changes in competent persons within one month of such change.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcomes and impacts of these amendments include:
* Improved quality control and safety of parenteral drugs due to standardized testing procedures.
* Enhanced accountability and oversight in drug sales, leading to reduced potential for misuse or improper handling of medications.
* A higher level of compliance from licensees due to mandated reporting on personnel changes.
* A reduced regulatory burden on manufacturers of non-medicinal products.
**9. Conclusion:**
The amendments to the Drugs Rules, 1945, represent a refinement of existing regulations aimed at enhancing drug safety, accountability, and regulatory efficiency. Specifically, the changes address testing protocols for parenteral drugs, supervision of drug sales, and the scope of restrictions on drug sales. These amendments are likely to have a significant impact on pharmaceutical manufacturers, retailers, and licensing authorities. It is crucial for stakeholders to thoroughly understand these changes and adapt their practices accordingly to ensure compliance.
Key Entities Referenced
Drugs Rules, 1945: A set of rules pertaining to drugs, which is being amended by this notification. This is the principal regulation being modified.
Central Government: The governing body proposing the amendments to the Drugs Rules, 1945.
Drugs and Cosmetics Act, 1940: The Act that confers powers to the Central Government to make rules. Specifically, subsection 1 of section 12 and sub section 1 of section 33 are mentioned.
Drugs Technical Advisory Board: An advisory board consulted by the Central Government regarding the draft rules.
Gazette of India: The official government publication where the draft rules are published for public notice.
Under Secretary Drugs, Ministry of Health and Family Welfare: The designated recipient for objections and suggestions regarding the draft rules.
Government of India: The government under which the Ministry of Health and Family Welfare operates.
Room No. 545, A Wing, Nirman Bhavan, New Delhi 110011: The physical address to which objections and suggestions can be addressed.
drugsdivmohfwgov.in: The email address to which objections and suggestions can be emailed.
Drugs Second Amendment Rules, 2025: The name given to the amendments being proposed.
Official Gazette: The official publication where the final rules will be published.
rule 121A: A specific rule within the Drugs Rules, 1945 that is being substituted.
Indian Pharmacopeia I.P.: A standard reference for tests, in this case, bacterial endotoxinsPyrogens.
Schedule A: A schedule within the Drugs Rules, 1945 that contains forms which are being modified.
Form 20B: A form within Schedule A of the Drugs Rules, 1945 that is being modified.
Form 20BB: A form within Schedule A of the Drugs Rules, 1945 that is being modified.
Form 21B: A form within Schedule A of the Drugs Rules, 1945 that is being modified.
Form 21BB: A form within Schedule A of the Drugs Rules, 1945 that is being modified.
Form 20G: A form within Schedule A of the Drugs Rules, 1945 that is being modified.
Schedule H: A schedule within the Drugs Rules, 1945 that is being modified by inserting an entry.
Schedule K: A schedule within the Drugs Rules, 1945 mentioned in the context of Schedule H.
RAJIV WADHAWAN: Adviser Cost.
Ministry of Health and Family Welfare: The government ministry responsible for health and family welfare.
Department of Health and Family Welfare: The department within the Ministry of Health and Family Welfare.
New Delhi: The location of the notification and address for objections.
G.S.R. 345E: A government standard rule number.
New Delhi110064: Location of Dte of Printing at Government of India Press
Delhi110054: Location of the Controller of Publications
F.No. X.11014012025DR: File number of the notification
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-28052025-263437
CG-DxLx-xEG-I2D8H0x5x2x0 25-263437
xxxGIDExxx
असाधारण
EXTRAORDINARY
भाग II—खण्ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 302] नई दिल्ली, बधु वार, मई 28, 2025/ज्य ेष्ठ 7, 1947
No. 302] NEW DELHI, WEDNESDAY, MAY 28, 2025/JYAISTHA 7, 1947
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 28 मई, 2025
सा.का.जन. 345(अ).— औषध जनयम 1945 को और संिोजधत करने के जलए केन्द्रीय सरकार औषजध और प्रसाधन
सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उपधारा (1) और धारा 33 की उपधारा (1) द्वारा प्रित्त िजियों
का प्रयोग करते हुए, और औषजध तकनीकी सलाहकार बोडड से परामिड के पश्चात, जनम्नजलजखत जनयमों के मसौिे को प्रस्ट्ताजवत
दकया गया ह,ै यह मसौिा उन सभी व्यजियों की िानकारी के जलए प्रकाजित दकया िाता ह,ै जिनके इससे प्रभाजवत होन े की
संभावना ह ैऔर इसके द्वारा यह नोरिस दिया िाता ह ैकी उि प्रारूप जनयमों पर, इन प्रारूप जनयमों वाले भारत के रािपत्र
की प्रजतया ंिनता को उपलब्ध कराए िान े की तारीख से तीस दिन की अवजध समाप्त होने पर या उसके पश्चात जवचार दकया
िाएगा;
ऊपर जनर्िष्टड अवजध के भीतर दकसी भी व्यजि से प्राप्त आपजत्तयों और सझु ावों पर केंर सरकार द्वारा जवचार दकया
िाएगा;
3469 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
यदि कोई आपजत्त या सुझाव हो तो उसे अवर सजचव (औषजध), स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, भारत
सरकार, कमरा संख्या 545, ए ववंग, जनमाडण भवन, नई दिल्ली-110011 को भेिा िा सकता ह ै या drugsdiv-
mohfw@gov.in पर ईमले दकया िा सकता ह।ै
मसौिा जनयम
1. (i) इन जनयमों को औषजध ( िसू रा संिोधन) जनयम, 2025 कहा िा सकता ह।ै
(ii) ये जनयम आजधकाररक रािपत्र मे जनयमों के अंजतम प्रकािन के समय सरकार द्वारा जनर्िष्टड तारीख से
लाग ूहोंगे।
2. औषजध जनयम, 1945 के जनयम 121ए के स्ट्थान पर जनम्नजलजखत जनयम प्रजतस्ट्थाजपत दकया िाएगा, अथातड ्- :
"121A. बक्ै िीररयल एडं ोिॉजक्सन– पाइरोजन्े स की जाचां - परेंरल प्रिासन हते ु अजभप्रेत पिाथों के घोल (तथा ऐस े
पिाथों के साथ प्रिान दकया गया िल या कोई अन्द्य िलीय जवलायक) को बैक्िीररयल एडं ोिॉजक्सन की िांच अथवा
िहा ं उजचत और अनुमोदित हो, वहा ं पाइरोिेन्द्स की िांच के अनुरूप होना चाजहए। बैक्िीररयल एंडोिॉजक्सन-
पाइरोिेन्द्स की िांच भारतीय औषध संजहता (Indian Pharmacopeia - I.P.) के वतडमान संस्ट्करण के अनुसार की
िाएगी।"
3. औषजध जनयम, 1945 म,ें अनुसचू ी ‘ए’ म:ें
(अ) फॉमड 20बी में,
(i) अनुच्छेि 2 के बाि, जनम्नजलजखत अनच्ु छेि िोडा िाएगा, अथाडत:् –
“3. जबक्री एक सक्षम व्यजि की व्यजिगत जनगरानी म ेंकी िाएगी। (सक्षम व्यजियों का नाम)”
(ii) ‘लाइसेंस की ित’ें उप-िीषडक के अतं गतड , ितड 2 के बाि जनम्नजलजखत िोडी िाएगी, अथाडत:् –
“2ए . अनज्ञु जप्तधारी को सक्षम व्यजि म ेंदकसी भी प्रकार के पररवतडन की सूचना उस पररवतनड के एक माह
के भीतर अनुज्ञापन प्राजधकारी को िेनी होगी।”
4. औषजध जनयम, 1945 म,ें अनुसचू ी ‘ए’ म:ें
(अ) फॉमड 20बी एवं 20बीबी म,ें 'लाइससें की ित'ें के अंतगडत –
(i) लाइससें की ितों के खंड 3 (ii) में उजल्लजखत उपबंध के अतं गडत, भाग (ग) को, िो दक जनम्नजलजखत
ह,ै हिाया िाएगा:
“(ग) पेय पिाथों, जमठाइयों, जबस्ट्कुिों और अन्द्य गरै -औषधीय उत्पािों के जनमातड ा, िहााँ ऐसे औषजधयों
की आवश्यकता इन उत्पािों के प्रसंस्ट्करण हते ु होती ह।ै ”
(ii) उपरोि भाग (ग) को हिाने के पश्चात उपबधं के बाि, जनम्नजलजखत िब्ि जद्वतीय उपबंध के रूप म े
िोडे िाएंग,े अथाडत:् –
“यह भी उपबंजधत ह ै दक य े ितें उन सभी औषजधयों की जबक्री पर लाग ू नहीं होंगी, एंिीमाइक्रोजबयल
औषजधयों को छोडकर, िो पेय पिाथों, जमठाइयों, जबस्ट्कुिों तथा अन्द्य गैर-औषधीय उत्पािों के जनमाडताओं
को बेची िाती ह,ैं िहााँ ऐसे उत्पािों के प्रसंस्ट्करण हते ु इन औषजधयों की आवश्यकता होती ह।ै ”[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3
(ब) फॉमड 21बी एवं 21बीबी म,ें 'लाइससें की ित'ें के अतं गतड –
(i) लाइससें की ितों के खंड 4 (ii) में उजल्लजखत उपबंध के अतं गडत, भाग (ग) को, िो दक जनम्नजलजखत
ह,ै हिाया िाएगा:
“(ग) वनस्ट्पजत घी (हाइड्रोिनीकृत वनस्ट्पजत तेल), पेय पिाथ,ड जमठाइयााँ तथा अन्द्य गरै -औषधीय उत्पािों
के जनमाडता, िहााँ ऐसे उत्पािों के प्रसंस्ट्करण हते ु इन औषजधयों की आवश्यकता होती ह।ै ”
(ii) उपरोि भाग (ग) को हिाने के पश्चात उपबधं के बाि, जनम्नजलजखत िब्ि जद्वतीय उपबंध के रूप म े
िोडे िाएंग,े अथाडत:् –
"यह भी उपबंजधत ह ै दक य े ितें दकसी भी औषजध की जबक्री पर लागू नहीं होंगी, एंिीमाइक्रोजबयल
औषजधयों को छोडकर, यदि वह जबक्री वनस्ट्पजत घी (हाइड्रोजनीकृत वनस्पतत तेल), पेय पिाथों,
जमठाइयों तथा अन्द्य गैरऔषधीय उत्पादों के तनर्ााता को की जाती है-, िहााँ ऐसे उत्पािों के प्रसंस्ट्करण
हते ु इन औषजधयों की आवश्यकता होती ह।ै "
5. औषजध जनयम, 1945 म,ें अनुसचू ी ‘ए’ म:ें
(अ) फॉमड 20िी में,
(i) अनुच्छेि 3 के बाि, जनम्नजलजखत अनच्ु छेि िोडा िाएगा, अथाडत:् –
“3ए. जबक्री एक सक्षम व्यजि की व्यजिगत जनगरानी में की िाएगी। (सक्षम व्यजियों का नाम)”
(ii) ‘लाइसेंस की ित’ें उप-िीषडक के अतं गतड , ितड 2 के बाि जनम्नजलजखत िोडी िाएगी, अथाडत:् –
“2ए . अनज्ञु जप्तधारी को सक्षम व्यजि में दकसी भी प्रकार के पररवतडन की सूचना उस पररवतनड के एक
माह के भीतर अनज्ञु ापन प्राजधकारी को िेनी होगी।”
6. औषजध जनयम, 1945 म,ें अनुसचू ी ‘ए’ म:ें
(अ) फॉमड 20बी में,
(i) लाइसेंस की ितें उपिीषडक के अंतगडत ित ड 1 के बाि जनम्नजलजखत िोडा िाएगा, अथाडत् :–
“1ए. अनुज्ञजप्तधारी को सक्षम व्यजि में दकसी भी प्रकार के पररवतडन की सूचना, उस पररवतडन की जतजथ
से एक माह के भीतर अनुज्ञापन प्राजधकारी को िेनी होगी।”
7. औषजध जनयम, 1945 म,ें अनुसचू ी ‘एच’ के फुिनोि में प्रजवजष्ट संख्या 5 के बाि, जनम्नजलजखत प्रजवजष्ट िोडी
िाएगी, अथाडत:् –
“6. अनुसूची ‘के’ (Schedule K) की क्रम संख्या 15 में उजल्लजखत औषजधयों की श्रणे ी इस अनसु ूची के अंतगडत नहीं
आएगी।”
[फा. सं. एक्स. 11014/01/2025-DR]
रािीव वधावन, सलाहकार (लागत)
नोि:— मूल जनयम अजधसूचना संख्या एफ 28-10/45-एच (1), तारीख 21 दिसम्बर 1945 द्वारा आजधकाररक रािपत्र में
प्रकाजित दकए गए थे और अंजतम बार अजधसूचना संख्या िीएसआर 127(ई), तारीख 11 फ़रवरी, 2025, द्वारा
संिोजधत दकए गए थे।4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 28th May, 2025
G.S.R. 345(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), 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 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 the copies of the Gazette of India containing these draft rules 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 Under Secretary (Drugs), Ministry of Health and
Family Welfare, Government of India, Room No. 545, A Wing, Nirman Bhavan, New Delhi - 110011 or emailed at
drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (i) These rules may be called the Drugs (Second Amendment) Rules, 2025.
(ii) These rules shall come into force from the date as specified by the Government at the time of final publication
of the rules in the Official Gazette.
2. In the Drugs Rules, 1945, for rule 121A, the following rule shall be substituted, namely: -
“121A. Test for Bacterial endotoxins-Pyrogens. – Solution of substances intended for parenteral
administration (as well as water or any other aqueous solvent supplied along with such substances) shall comply
with a test for bacterial endotoxins or where justified and authorized, with the test for pyrogens. The test for
Bacterial endotoxins-Pyrogens shall be carried out as per current edition of Indian Pharmacopeia (I.P).”
3. In the Drugs Rules, 1945, in Schedule A: -
(a) In Form 20B,
(i). after paragraph 2, the following paragraph shall be inserted, namely: -
“3. The sale shall be made under the personal supervision of a competent person. (Name of the competent
persons)”
(ii). under the sub-heading ‘Conditions of Licence’, after condition 2, the following shall be inserted, namely: -
“2A. The licensee shall report to the licensing authority any change in competent person within one month
of such change.”
4. In the Drugs Rules, 1945 under SCHEDULE A,
(a) In Form 20-B and Form 20-BB, under the Conditions of License,
(i). Under the proviso to the Condition of License at clause 3 (ii), the part(c), namely, the following shall be
deleted.
“(c) a manufacturer of beverages, confectionary biscuits and other non-medicinal products, where such
drugs are required for processing these products”
(ii). After the proviso with the part (c) so deleted, following words shall be inserted as second proviso,
namely:-
“Provided further that the conditions shall also not apply to the sale of any drug except antimicrobial
drugs to a manufacturer of beverages, confectionary biscuits and other non-medicinal products, where
such drugs are required for processing these product”
(b) In Form 21-B and Form 21-BB, under the Conditions of License,
(i). Under the proviso to the Condition of License at clause 4 (ii), the part(c), namely, the following shall be
deleted.[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 5
“(c) a manufacturer of hydrogenated vegetable oils, beverages, confectionary and other non-medicinal
products, where such drugs are required for processing these products”
(ii). After the proviso with the part (c) so deleted, following words shall be inserted as second proviso,
namely:-
“Provided further that the conditions shall also not apply to the sale of any drug except antimicrobial
drugs to a manufacturer of hydrogenated vegetable oils, beverages, confectionary and other non-
medicinal products, where such drugs are required for processing these product”
5. In the Drugs Rules, 1945, in Schedule A: -
(a) In Form 20G,
(i). after paragraph 3, the following paragraph shall be inserted, namely: -
“3A. The sale shall be made under the personal supervision of a competent person. (Name of the competent
persons)”
(ii). under the sub-heading ‘Conditions of Licence’, after condition2, the following shall be inserted, namely: -
“2A. The licensee shall report to the licensing authority any change in competent person within one month of
such change.”
6. In the Drugs Rules, 1945, in Schedule A: -
(a) In Form 21B,
(i). under the sub-heading ‘Conditions of Licence’, after condition 1, the following shall be inserted, namely: -
“1A. The licensee shall report to the licensing authority any change in competent person within one month of
such change.’’
7. In the Drugs Rules, 1945, after entry no. 5 under the foot note of Schedule H, the following entry shall be inserted,
namely: -
“6. Class of drugs mentioned at serial no. 15 of Schedule K shall not be covered under this Schedule.”
[F.No. X.11014/01/2025-DR]
RAJIV WADHAWAN, Adviser (Cost).
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 127 (E), dated the 11th February, 2025.
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.