## Report on the Drugs and Cosmetics Compounding of Offences Rules, 2025
**1. Executive Summary:**
This report analyzes the "Drugs and Cosmetics Compounding of Offences Rules, 2025," a new policy established by the Central Government as detailed in the provided text. The core purpose of these rules is to provide a framework for compounding offences under the Drugs and Cosmetics Act, 1940, allowing certain violations to be settled by paying a compounding amount instead of facing prosecution. Key findings include the establishment of compounding authorities, procedures for application and processing, and conditions for granting and withdrawing immunity from prosecution. The policy aims to streamline enforcement of the Drugs and Cosmetics Act.
**2. Introduction:**
This report aims to provide an informative overview of the Drugs and Cosmetics Compounding of Offences Rules, 2025, based solely on the text provided. The report outlines the policy's objectives, key provisions, target audience, and expected outcomes, offering a clear understanding of its implications.
**3. Policy Overview:**
* Core Objective(s): The primary objective is to establish rules and procedures for compounding offences under the Drugs and Cosmetics Act, 1940. This involves creating a mechanism for resolving certain violations through payment of a compounding amount, offering an alternative to prosecution.
**4. Background and Rationale:**
* This is a new policy. The policy likely addresses the need for a more efficient and potentially less burdensome mechanism for addressing violations of the Drugs and Cosmetics Act, 1940. The introduction of compounding allows for faster resolution of certain offenses, potentially freeing up resources for more serious violations and encouraging compliance.
**5. Key Provisions / Changes:**
As a new policy, the following provisions are established:
* **Short Title and Commencement:** The rules are titled "Drugs and Cosmetics Compounding of Offences Rules, 2025" and come into force on the date of their publication in the Official Gazette.
* **Definitions:** Key terms are defined, including "Act," "applicant" (defined as entities involved in manufacturing, import, sale, distribution, or other activities covered under the Drugs and Cosmetics Act), "compounding authority," "Form," "reporting authority," and "section." Terms not defined within the rules are to be interpreted according to their definitions in the Drugs and Cosmetics Act.
* **Appointment of Compounding Authority:** The Central and State Governments can appoint officers not below the rank of reporting authority to act as compounding authorities. These authorities are responsible for exercising the powers and functions related to compounding offences under the rules.
* **Form and Manner of Application:** Applicants can apply to the compounding authority for compounding an offense using a prescribed form, either before or after prosecution is initiated. Applications must be made individually by the company or person involved.
* **Procedure for Compounding:** The compounding authority, upon receiving an application, requests a report from the reporting authority. After reviewing the application and report, the compounding authority can either allow the application, specifying the compounding amount and granting immunity from prosecution, or reject the application after providing the applicant an opportunity to be heard. The applicant must pay the compounding amount within thirty days of receiving the order.
* **Power of Compounding Authority to Grant Immunity from Prosecution:** The compounding authority can grant immunity from prosecution to applicants who cooperate in the proceedings and make full and true disclosures of facts.
* **Withdrawal of Immunity from Prosecution in Certain Conditions:** Immunity can be withdrawn if the applicant fails to pay the compounding amount, comply with the conditions of the order, conceals material particulars, or provides false evidence.
* **Application Form:** A specific form is provided for applicants to submit their requests for compounding, requiring detailed information about the applicant, product, alleged contravention, and related details.
**6. Target Audience and Stakeholders:**
Based on the text, the primary target audience and stakeholders are:
* Companies and individuals involved in the manufacturing, import, sale, or distribution of drugs and cosmetics.
* Licensing Authorities (Central and State).
* Reporting Authorities (Central Licensing Authority or the Central License Approving Authority appointed by the Central Government or the Licensing Authority appointed by State Government).
* The Central Government (Ministry of Health and Family Welfare).
* State Governments
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The Ministry of Health and Family Welfare (Department of Health and Family Welfare) is the responsible agency. The Central and State Governments are responsible for appointing compounding authorities.
* **Timelines:** Reporting authorities have one month (or an extended period allowed by the compounding authority) to furnish reports. Applicants have thirty days from the date of the compounding order to pay the compounding amount.
* **Procedures:** A specific application process is defined. The compounding authority reviews applications and reports from reporting authorities before making a decision.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcomes of this policy are:
* More efficient resolution of certain violations of the Drugs and Cosmetics Act.
* Reduced burden on the judicial system by resolving cases through compounding.
* Encouragement of compliance through a potentially less punitive mechanism.
* Greater transparency and consistency in the handling of violations.
**9. Conclusion:**
The Drugs and Cosmetics Compounding of Offences Rules, 2025, as detailed in the provided text, establishes a framework for compounding offenses under the Drugs and Cosmetics Act, 1940. This policy introduces a mechanism for resolving certain violations through payment of a compounding amount, potentially leading to more efficient enforcement and greater compliance within the industry. The establishment of compounding authorities and defined procedures for application and processing are key elements of this policy, contributing to its significance in the regulatory landscape of drugs and cosmetics.
Key Entities Referenced
Drugs and Cosmetics Compounding of Offences Rules, 2024: Draft rules published for compounding offences related to Drugs and Cosmetics Act.
section 33: Refers to a specific section in the Drugs and Cosmetics Act that dictates publishing requirements.
Drugs and Cosmetics Act, 1940: The primary legislation governing drugs and cosmetics in India.
23 of 1940: Refers to act number 23 of the year 1940, which is the Drugs and Cosmetics Act, 1940.
Ministry of Health and Family Welfare: The government ministry responsible for health and family welfare policies.
Department of Health and Family Welfare: Department within the Ministry of Health and Family Welfare.
G.S.R. 374E: Notification number related to the draft rules.
10th July, 2024: Date of publishing the Gazette notification.
Gazette of India, Extraordinary, Part II, Section 3, Subsection i: Official publication where the notification was published.
Central Government: The Union Government of India.
section 32B: Refers to specific section in the Drugs and Cosmetics Act relating to compounding of offences.
Drugs Technical Advisory Board: Advisory board to be consulted as per the provisions.
Drugs and Cosmetics Compounding of Offences Rules, 2025: Rules pertaining to the compounding of offenses under the Drugs and Cosmetics Act.
Official Gazette: Official publication for government notifications.
State Government: The government of a state within India.
rule 3: Refers to rule number 3 regarding appointment of compounding authority.
reporting authority: Licensing Authority or the Central Licensing Authority or the Central License Approving Authority appointed by the Central Government or the Licensing Authority appointed by State Government
rule 4: Refers to rule number 4 regarding application for compounding.
Form: Form appended to these rules
rule 5: Refers to rule number 5 regarding procedure for compounding.
rule 6: Refers to rule number 6 regarding compounding authority to grant immunity from prosecution.
rule 7: Refers to rule number 7 regarding withdrawal of Immunity from Prosecution in certain conditions.
Form 17 of Drugs Rules, 1945: Form related to Drugs Rules.
Form COS10 of Cosmetics Rule 2020: Form related to Cosmetics Rules.
Form MD 36 of Medical Device Rules 2017: Form related to Medical Device Rules.
Form 13: Form related to Drugs Rules.
Form 2 of Drugs Rules, 1945: Form related to Drugs Rules.
Form COS14: Form related to Cosmetics Rules.
Form COS21of Cosmetics Rule 2020: Form related to Cosmetics Rules.
Form MD32: Form related to Medical Device Rules.
Form MD31 of Medical Device Rules 2017: Form related to Medical Device Rules.
National Accreditation Board for Testing and Calibration Laboratories: NABL lab.
COS10: Form related to Cosmetics Rule 2020.
रजजस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-26042025-262711
CG-DxLx-xEG-I2D6H0x4x2x0 25-262711
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.ं 220] नई ददल्ली, िुक्रवार, अप्रलै 25, 2025/ विै ाख 5, 1947
No. 220] NEW DELHI, FRIDAY, APRIL 25, 2025/ VAISAKHA 5, 1947
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
सचू ना
नई ददल्ली, 24 अप्रैल, 2025
सा.का.जन. 259(अ).—जबदक औषजध और प्रसाधन सामग्री (अपराधों का िमन) जनयम, 2024 का प्ररूप औषजध
और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 33 की उपधारा (1) के अधीन अपेक्षा अनुसार भारत
सरकार के स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) की अजधसूचना संख्या
सा.का.जन. 374(अ), तारीख 10 जुलाई, 2024 द्वारा प्रकाजित दकया गया था, जजसे भारत के राजपत्र, असाधारण,
भाग II, खंड 3, उपखंड (i), तारीख 10 जुलाई, 2024 को प्रकाजित दकया गया था, जजसमें उससे प्रभाजवत होन े की
संभावना वाले व्यजियों से, उस तारीख से पैंतालीस ददनों की अवजध समाप्त होने से पहले, जजसको उि अजधसूचना वाल े
आजधकाररक राजपत्र की प्रजतयां जनता को उपलब्ध कराई गई थी, आपजियां और सुझाव आमजं त्रत दकए गए थ,े
और जबदक, उि राजपत्र की प्रजतयां 10 जुलाई, 2024 को जनता को उपलब्ध करा दी गई थीं;
और जबदक, उि प्ररूप जनयमों पर जनता स े प्राप्त आपजियों और सुझावों पर केन्द्रीय सरकार द्वारा जवचार दकया
गया ह;ै
अत: अब, केन्द्रीय सरकार, औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 32ख के
साथ परित धारा 33 की उपधारा (2) के खंड (द) द्वारा प्रदि िजियों का प्रयोग करते एए, इस बात पर जवचार करते एए
2741 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
दक औषजध तकनीकी सलाहकार बोडड के साथ परामिड उपबंधों के अनुसार दकया जाएगा, जनम्नजलजखत जनयम बनाती ह,ै
अथाडत:् -
1. संजक्षप्त नाम और प्रारंभ:
(1) इन जनयमों का संजक्षप्त नाम औषजध और प्रसाधन सामग्री (अपराधों का िमन) जनयम, 2025 ह।ै
(2) ये जनयम राजपत्र में प्रकािन की तारीख से प्रवृत होंगे।
2. पररभाषाए:ं
इन जनयमों म,ें जब तक संदभ डसे अन्द्यथा अपेजक्षत न हो:
(क) “अजधजनयम” से औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) अजभप्रेत ह;ै
(ख) "आवेदनकता"ड से कोई कंपनी या अन्द्य व्यजि(यों) अजभप्रेत ह ै जो औषजध और प्रसाधन सामग्री अजधजनयम और उसके
अधीन बन े जनयमों के उपबंधों के अधीन जवजनमाडण, आयात, जबक्री, जवतरण या अन्द्य दकसी गजतजवजध में सजममजलत ह;ै
(ग) " िमन प्राजधकरण" से वह प्राजधकरण अजभप्रेत ह ै जजसे यथाजस्ट्थजत केंरीय सरकार या राज्य सरकार, द्वारा इन जनयमों
के जनयम 3 के अधीन जनयिु दकया गया ह;ै
(घ) "प्रारूप" से इन जनयमों के साथ संलग्न प्ररूप अजभप्रेत ह;ै
(ड़) "ररपोर्टिंग प्राजधकारी" से अजधजनयम और उसके अधीन बनाए गए जनयमों के अधीन, यथाजस्ट्थजत, केन्द्रीय सरकार द्वारा
जनयुि लाइसेंससग प्राजधकारी या केन्द्रीय लाइसेंससग प्राजधकरण या केन्द्रीय लाइसेंस अनुमोदन प्राजधकारी या राज्य सरकार
द्वारा जनयुि लाइसेंससग प्राजधकारी अजभप्रेत ह,ै जजसका उस स्ट्थान पर क्षेत्राजधकार ह ै जहां अजधजनयम के अधीन कोई
अपराध एआ ह ैया होना अजभकजथत ह;ै
(च) "धारा" से अजधजनयम की धारा अजभप्रेत ह;ै
(छ) इन जनयमों में उपयोग दकए गए िब्द और अजभव्यजियााँ जो पररभाजषत नहीं हैं दकन्द्त ु अजधजनयम में पररभाजषत ह,ैं
उनका वही अथ डहोगा जो अजधजनयम मे उनका ह।ै
3. िमन प्राजधकरण की जनयजु ि:
(1) केन्द्रीय सरकार, इन जनयमों के प्रयोजनों के जलए, राजपत्र में अजधसूचना द्वारा, ररपोर्टिंग प्राजधकारी से अन्द्यून की रैंक
के दकसी अजधकारी दकसी अजधकारी को इन जनयमों के अधीन केन्द्रीय सरकार की िजियों और कृत्यों का प्रयोग करन े के
जलए तथा इन जनयमों स ेउत्पन्न मामलों के संबंध में उपाय करने के जलए िमन प्राजधकारी के रूप म ेंजनयुि कर सकेगी।
2) राज्य सरकार, इन जनयमों के प्रयोजनों के जलए, राजपत्र म ेंअजधसूचना द्वारा, इन जनयमों के अधीन ररपोर्टिंग प्राजधकारी
से न्द्यून की रैंक के दकसी अजधकारी को इन जनयमों के अधीन राज्य सरकार की ऐसी िजियों और कृत्यों का प्रयोग करन े के
जलए तथा इन जनयमों स ेउत्पन्न मामलों के संबंध में उपाय करने के जलए िमन प्राजधकारी के रूप म ेंजनयुि कर सकेगी।
4. आवदे न का प्ररूप और रीजत:
(1) आवेदक अजभयोजन के प्रारंभ होने से पूवड या पश्चात,् अजधजनयम की धारा 32ख के अधीन िमन प्राजधकारी को,
अपराध के िमन के जलए, सुसंगत सूचनाओं और दस्ट्तावेजों के साथ प्ररूप में आवेदन कर सकेगा ।
(2) िमन के जलए आवेदन को व्यजिगत रूप स े उस कंपनी या व्यजि द्वारा प्रस्ट्तुत दकया जाएगा जो अजधजनयम और उसके
अधीन बन े जनयमों के उपबंधों के अधीन जवजनमाडण, आयात, जवक्रय, जवतरण या उनके अतं गडत आन े वाल े दकसी अन्द्य
दक्रयाकलाप में लगा एआ ह।ै[भाग II—खण् ड 3(i)] भारत का राजपत्र : असाधारण 3
5. िमन की प्रदक्रया:
(1) जनयम 4 के अधीन आवेदन प्राप्त होन े पर, िमन प्राजधकारी उस ररपोर्टिंग प्राजधकारी से, जजसके अजधकार क्षेत्र म ें
अपराध दकया गया ह,ै आवेदन में ददए गए जववरण या दकसी अन्द्य सूचना के संदभड में ररपोिंड मांगेगा, जजसे ऐसे आवेदन की
परीक्षा के जलए सुसंगत माना जा सकता ह।ै
(2) ऐसी ररपोिं,ड ररपोर्टिंग प्राजधकारी द्वारा, िमन प्राजधकारी से सूचना प्राप्त होन े की तारीख से एक माह की अवजध के
भीतर या िमन प्राजधकारी द्वारा यथा अनुमत ऐसी जवस्ट्ताररत अवजध के भीतर प्रस्ट्तुत की जाएगी।
(3) िमन प्राजधकारी उि आवदे न की जवषय-वस्ट्तु पर जवचार करने के पश्चात ् आदिे द्वारा या तो िमन की रकम दिाडते एए
आवेदन को स्ट्वीकार कर सकेगा और जनयम 6 के जनबंधनों के अनुसार अजभयोजन से उन्द्मुजि प्रदान कर सकेगा या ऐस े
आवेदन को अस्ट्वीकार कर सकेगा:
परन्द्त ुआवेदन तब तक अस्ट्वीकृत नहीं दकया जाएगा जब तक आवेदक को सुनवाई का अवसर न द ेददया गया हो
तथा ऐसे आदेि में ऐसी अस्ट्वीकृजत के आधारों का उल्लेख न कर ददया गया हो।
(4) उपजनयम (3) के अधीन प्रत्येक आदेि की एक प्रजत आवेदक को भेजी जाएगी।
(5) आवेदक, अपराधों के िमन की अनुमजत देन े वाले उप-जनयम (3) के अधीन आदेि की प्राजप्त की तारीख से तीस ददनों
की अवजध के भीतर, िमन प्राजधकारी द्वारा भुगतान दकए जाने के आदेि के अनुसार िमन की रकम का भगु तान करेगा और
िमन प्राजधकारी को ऐसे भुगतान का सबूत प्रस्ट्ततु करेगा:
परंत ु एक बार भुगतान की गई िमन की रकम वापस नहीं की जाएगी, जसवाय उन मामलों को छोड़कर जहा ं
न्द्यायालय अजभयोजन से उन्द्मुजि के अनुदान को अस्ट्वीकार कर देता ह।ै
(6) आवेदक अजधकार के रूप में यह दावा नहीं कर सकता दक उसके अपराध का िमन दकया जाएगा।
6. िमन प्राजधकरण की अजभयोजन स े उन्द्मजु ि देन ेकी िजि:
यदद िमन प्राजधकारी का यह समाधान हो जाता ह ै दक दकसी व्यजि ने, जजसने इन जनयमों के अधीन अपराध
के िमन के जलए आवेदन दकया है, प्राजधकारी के समक्ष कायडवाही म ें सहयोग दकया ह ै तथा मामल े से संबंजधत त्यों का पूण ड
और सही खुलासा दकया ह,ै तो वह ऐसे व्यजि को, ऐसी ितों के अधीन, जो उजचत समझी जाएं, अपराध के िमन के
अंतगतड आन े वाले मामले के संबंध में अजभयोजन से उन्द्मुजि प्रदान करेगा।
7. कजतपय पररजस्ट्थजतयों म ेंअजभयोजन स े उन्द्मजु ि वापस लने ा:
(1) जनयम 6 के अधीन दकसी व्यजि को दी गई उन्द्मुजि वापस ले ली जाएगी, यदद ऐसा व्यजि जनयम 5 के उप-
जनयम (3) के अधीन िमन प्राजधकारी द्वारा पाररत िमन आदेि में जवजनर्ददष्ट दकसी राजि का भुगतान ऐसे आदेि में
जवजनर्ददष्ट समय के भीतर करन े में जवफल रहता ह ै या दकन्द्ही अन्द्य ितों का पालन करन े में जवफल रहता ह ै जजसके अधीन
उन्द्मुजि प्रदान की गई थी और तत्पश्चात अजधजनयम के उपबंध लाग ूहोंगे मानो ऐसी कोई उन्द्मजु ि प्रदान नहीं की गई थी।
(2) उपजनयम (1) के अधीन दकसी व्यजि को दी गई उन्द्मुजि, दकसी भी समय, िमन प्राजधकारी द्वारा वापस ली जा
सकेगी, यदद उसका समाधान हो जाए दक ऐसे व्यजि ने िमन कायडवाही के दौरान कोई जवजिजष्टयां, सामग्री जछपाई ह ै या
जम्या साक्ष्य ददया ह,ै और तब ऐसे व्यजि पर उस अपराध के जलए, जजसके संबंध में उन्द्मुजि दी गई ह ै या दकसी अन्द्य
अपराध के जलए, जो िमन कायडवाही के संबंध में उसके द्वारा दकया गया प्रतीत होता है, जवचारण दकया जा सकेगा और तब
अजधजनयम के उपबंध इस प्रकार लाग ूहोंगे मानो ऐसी कोई उन्द्मुजि दी ही न गई हो।4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
प्ररूप
(जनयम 4 देख)ें
(अपराधों के िमन के जलए आवदे न)
1. आवेदक का परू ा नाम और पता:
2. संचार के जलए पता:
3. उत्पाद का नाम और संरचना:
4. जवजनमाडण लाइसेंस, आयात लाइसेंस या रजजस्ट्री प्रमाणपत्र जववरण (पता, ईमेल और संपकड जववरण सजहत):
5. द्वारा जनर्ममत या आयाजतत:
6. द्वारा जवपणन, यदद कोई हो:
7. जनयाडत या आयात कोड संख्या, यदद लाग ूहो:
8. जवजनमाडता या राष्ट्रीय परीक्षण और अंिांकन प्रयोगिाला प्रत्यायन बोड ड (एनएबीएल) प्रयोगिाला का जवश्लेषण
प्रमाणपत्र, यदद कोई हो:
9. नमूने का जववरण, यदद लाग ूहो:
10. नमूना लेने की तारीख (औषजध जनयम, 1945 का प्ररूप 17 या प्रसाधन जनयम 2020 का प्ररूप सीओएस-10 या
जचदकत्सा युजि जनयम 2017 का प्ररूप एमडी-36):
11. औषजध जनयम, 1945 के प्ररूप 13 या प्ररूप 2 या प्रसाधन जनयम 2020 का प्ररूप सीओएस-14 या प्ररूप सीओएस-
21 या जचदकत्सा युजि जनयम 2017 का प्ररूप एमडी-32 या प्ररूप एमडी-31, यदद लागू हो, में प्राप्त परीक्षण ररपोिं ड की
तारीख :
12. औषजध और प्रसाधन सामग्री अजधजनयम, 1940 के उपबंधों का उल्लंघन, जजसके जवरुद्ध अजभयोजन आरंभ दकया गया
ह ैया जवचार दकया जा रहा ह:ै
13. अजभग्रहण की तारीख, यदद कोई हो:
14. मामले के संजक्षप्त त्य और आरोजपत अपराध(ओं) की जवजिजष्टयााँ :
15. क्या कारण बताओ नोरिंस या आरोप पत्र जारी दकया गया:
16. क्या यह औषजध और प्रसाधन सामग्री अजधजनयम, 1940 के अधीन पहला अपराध ह,ै यदद नहीं तो जपछल ेमामलों का
ब्यौरा:
17. क्या समान अपराधों के जलए दकसी अन्द्य काननू के अधीन कोई कायडवाही प्रस्ट्ताजवत ह,ै यदद हां तो उसका ब्यौरा:
आवदे नकता डका नाम और हस्ट्ताक्षर
घोषणा:
1. म,ैं औषजध और प्रसाधन सामग्री (अपराधों का िमन) जनयम, 2025 के जनयम _____ के अधीन िमन की रकम
का भुगतान करूंगा, जो िमन प्राजधकरण द्वारा जनयत की जाए।
2. मैं समझता ह ाँ दक मैं अजधकार के रूप में यह दावा नहीं कर सकता दक मेरे द्वारा अजधजनयम के अधीन दकए गए
अपराधों का िमन दकया जाएगा।
आवदे नकता डका नाम और हस्ट्ताक्षर[भाग II—खण् ड 3(i)] भारत का राजपत्र : असाधारण 5
सत्यापन:
म,ैं ………………, पुत्र/पुत्री/पत्नी……………………….., जो …………. में जनवास करता ह,ाँ सत्यजनष्ठा से घोषणा
करता ह ाँ दक इस आवेदन को अपनी ………… हजै सयत के रूप में प्रस्ट्तुत कर रहा ह ाँ और मुझे इसे सत्याजपत करने का
अजधकार ह।ै
मैं यह घोषणा करता ह ाँदक इस आवेदन की अंतवडस्ट्त ु मेरे सवोिम ज्ञान और जवश्वास के अनुसार सही ह ै और इसमें मामले के
त्यों से सुसंगत कोई जानकारी जछपाई नहीं गई ह।ै इस आवदे न के साथ संलग्न दस्ट्तावेज मलू की सही प्रजतजलजपयााँ ह ैं और
मैंने इन्द्ह ेंसमयक रूप से प्रमाजणत दकया ह।ै
आज तारीख …… (महीना), …… (वषड) …… में सत्याजपत दकया गया।
आवदे नकता डका नाम और हस्ट्ताक्षर
[[फा. सं. X 11035/127/2023-DR]
राजीव वधावन, सलाहकार (लागत)
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 24th April, 2025
G.S.R. 259(E).—Whereas the draft of Drugs and Cosmetics (Compounding of Offences) Rules, 2024 was
published, as required under sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide
notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and
Family Welfare) number G.S.R. 374(E), dated the 10th July, 2024, published in the Gazette of India, Extraordinary,
Part II, Section 3, Sub-section (i), dated the 10th July, 2024 inviting objections and suggestions from persons likely to
be affected thereby, before the expiry of a period of forty-five days from the date on which the copies of the Official
Gazette containing the said notification were made available to the public;
And whereas, copies of the said Official Gazette were made available to the public on the 10th July, 2024;
And whereas, objections and suggestions received from the public on the said draft rules have been
considered by the Central Government;
Now, therefore, in exercise of the powers conferred by clause (r) of sub-section (2) of section 33 read with
section 32B of the Drugs and Cosmetics Act, 1940 (23 of 1940), with consideration that consultation with Drugs
Technical Advisory Board, shall be held as per the provisions, the Central Government hereby makes the following
rules, namely:—
1. Short title and commencement.―(1) These rules may be called the Drugs and Cosmetics (Compounding of
Offences) Rules, 2025.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. Definitions.―In these rules, unless the context otherwise requires,―
(a) “Act” means the Drugs and Cosmetics Act, 1940 (23 of 1940);
(b) "applicant" means any company or any other person(s) involved in manufacturing, import, sale,
distribution or other activity covered under the provisions of the Drugs and Cosmetics Act and rules
thereunder;
(c)"compounding authority" means the authority appointed under rule 3 of these rules by the Central
Government or State Government, as the case may be;6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(d) "Form" means the Form appended to these rules;
(e) "reporting authority" means the Licensing Authority or the Central Licensing Authority or the Central
License Approving Authority appointed by the Central Government or the Licensing Authority appointed
by State Government, as the case may be, under the Act and rules made thereunder, having jurisdiction
over the place where an offence under the Act has been or alleged to have been committed;
(f) "section" means a section of the Act; and
(g) Words and expressions used in these rules and not defined but defined in the Act shall have the
respective meanings assigned to them in the Act.
3. Appointment of compounding authority.―(1) The Central Government may, for the purposes of these
rules, by notification in the Official Gazette, appoint any officer not below the rank of reporting authority
under these rules, as compounding authority for the purpose of exercising powers and functions of the Central
Government under these rules and for taking measures with respect to matters arises from these rules.
(2) The State Government may, for the purposes of these rules, by notification in the Official Gazette, appoint
any officer not below the rank of reporting authority under these rules, as compounding authority for the
purpose of exercising such powers and functions of the State Government under these rules and for taking
measures with respect to matters arisen from these rules.
4. Form and manner of application.― (1) The applicant may, either before or after institution of prosecution,
make an application to the compounding authority under section 32B of the Act in the Form along with such
relevant informations and documents, to the compounding authority for compounding of the offence.
(2) The application for compounding shall be made individually by the company or person involved in
manufacturing, import, sale, distribution or any other activity covered under the provisions of the Act and the
rules made thereunder.
5. Procedure for compounding.―(1) On receipt of an application under rule 4, the compounding authority
shall call for a report from the reporting authority, under whose jurisdiction offence has been committed, with
reference to the particulars furnished in the application, or any other information, which may be considered
relevant for examination of such application.
(2) Such report shall be furnished by the reporting authority within a period of one month or within such
extended period as may be allowed by the compounding authority, from the date of receipt of communication
from the compounding authority.
(3) The compounding authority after taking into account the contents of the said application may, by order,
either allow the application indicating the compounding amount and grant him immunity from prosecution in
terms of rule 6 or reject such application:
Provided that the application shall not be rejected unless an opportunity has been given to the applicant
of being heard and the grounds of such rejection are mentioned in such order.
(4) A copy of every order under sub-rule (3) shall be sent to the applicant.
(5) The applicant shall, within a period of thirty days from the date of receipt of order under sub-rule (3)
allowing the compounding of offences, pay the compounding amount, as ordered to be paid by the
compounding authority and shall furnish the proof of such payment to the compounding authority:
Provided that the compounding amount once paid shall not be refunded except in cases where the Court
rejects grant of immunity from prosecution.
(6) The applicant cannot claim, as of right, that his offence shall be compounded.
6. Power of Compounding authority to grant immunity from prosecution.―The compounding authority, if
satisfies that any person who has made the application for compounding of offence under these rules has co-
operated in the proceedings before the authority and has made full and true disclosure of facts relating to the
case, grant to such person, subject to such conditions as deemed fit, immunity from prosecution for the offence
with respect to the case covered by the compounding of offence.
7. Withdrawal of Immunity from Prosecution in certain conditions.― (1) An immunity granted to a person
under rule 6 shall stand withdrawn,if such person fails to pay any sum specified in the order of compounding
passed by the Compounding authority, under sub-rule(3) of rule 5 within the time specified in such order or
fails to comply with any other conditions subject to which the immunity was granted and thereupon the
provisions of the Act shall apply as if no such immunity had been granted.
(2) An immunity granted to a person under sub-rule(1) above may, at anytime, be withdrawn by the
Compounding authority, if satisfies that such person had, in the course of the compounding proceedings,
concealed any particulars, material or had given false evidence, and thereupon such person may be tried for
the offence with respect to which immunity has been granted or for any other offence that appears to have
been committed by him in connection with the compounding proceedings and there upon the provisions of the
Act, shall apply as if no such immunity had been granted.[भाग II—खण् ड 3(i)] भारत का राजपत्र : असाधारण 7
FORM
(See rule 4)
(Application for compounding of offences)
1. Full name and address of the applicant:
2. Address for communication:
3. Name and composition of the product:
4. Manufacturing License, Import Licence or Registration Certificate details (including address, email and
contact details):
5. Manufactured or Imported by:
6. Marketed by,if any:
7. Export or Import code No, if applicable:
8. Certificate of Analysis of Manufacturer or National Accreditation Board for Testing and Calibration
Laboratories (NABL) lab, if any:
9. Details of sample, if applicable:
10. Date of sample drawn (Form 17 of Drugs Rules, 1945 or Form COS-10 of Cosmetics Rule 2020 or Form MD-
36 of Medical Device Rules 2017):
11. Date of test report received in Form 13 or Form 2 of Drugs Rules, 1945 or Form COS-14 or Form COS-21of
Cosmetics Rule 2020 or Form MD-32 or Form MD-31 of Medical Device Rules 2017, if applicable:
12. The contravention of the provisions of the Drugs and Cosmetics Act, 1940, against which prosecution is
instituted or contemplated:
13. Date of seizure, if any:
14. Brief facts of the case and particulars of the offence(s) charged:
15. Whether Show Cause Notice or Chargesheet issued:
16. Whether this is the first offence under the Drugs and Cosmetics Act, 1940, if not details of the previous
cases:
17. Whether any proceedings for the same offences contemplated under any other law, if so the details thereof:
Name and Signature of the applicant
DECLARATION:
1. I shall pay the compounding amount, as may be fixed by the compounding authority under the Rule…….. of
the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 there under.
2. I understand that I cannot claim, as of right that the offences committed by me under the Act shall be
compounded.
Name and Signature of the applicant8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
VERIFICATION
I,………………the son/daughter/wife of………………………..residing at………dosolemnly declare that I am
making this application in my capacity as .............. and I am competent to verify it.
That the contents of this application are true to the best of my knowledge and belief and no information relevant to the
facts of the case has been suppressed. The documents accompanying the application are true copies of the originals
and are duly attested by me.
Verified today the ...... day of .......... (month), .......... (year) at .......………. .
Name and Signature of the applicant
[F. No. X 11035/127/2023-DR]
RAJIV WADHWAN, Advisor (Cost)
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.