## Policy Analysis Report: Notifications Regarding Statutory Certificates for Drugs and Medical Devices
**1. Executive Summary:**
This report analyzes two notifications issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, Government of India, published on May 16, 2025. These notifications relate to the authorization of Dr. Rakesh Kumar Rishi, Director Incharge of Central Drugs Laboratory, Kolkata, to sign statutory certificates of test or evaluation for both medical devices and drugs & cosmetics. This authorization applies to samples sent by Courts of Law under the Drugs and Cosmetics Act, 1940. One notification concerns medical devices (S.O. 2208 E), and the other focuses on drugs and cosmetics (S.O. 2209 E) excluding specific categories of drugs. The key finding is a temporary measure to ensure continued certification of samples for legal proceedings.
**2. Introduction:**
This report provides an overview and analysis of two official notifications published in the Gazette of India regarding the signing of statutory certificates for medical devices and drugs & cosmetics samples sent by Courts of Law. The analysis is based solely on the information presented in the provided policy text.
**3. Policy Overview:**
These are amendments to existing policies regarding the authorization of personnel to sign statutory certificates. Specifically, they supersede notification S.O. 3758 E, dated August 10, 2022 (for medical devices) and S.O. 3757E, dated 10th August, 2022 (for drugs & cosmetics). The core objective of both notifications is to ensure the continuity of the statutory certification process for samples sent by Courts of Law under the Drugs and Cosmetics Act, 1940, by temporarily authorizing a specific individual to sign these certificates.
**4. Background and Rationale:**
The amendments appear to be prompted by a temporary vacancy or absence of a regularly appointed person to fulfill the Director Incharge role at the Central Drugs Laboratory, Kolkata. The amendments provide a temporary solution to prevent any disruption in the legal processes that require statutory test certificates for medical devices and drugs & cosmetics.
**5. Key Provisions / Changes:**
Both notifications detail very similar changes focused on personnel.
* **Original Policy Change:** The original policies, which authorized someone to sign certificates, are temporarily superseded.
* **New Rule/Provision:** Dr. Rakesh Kumar Rishi, Director Incharge of Central Drugs Laboratory, Kolkata, is *temporarily* authorized to sign statutory certificates of test or evaluation of samples.
* **Difference/Effect:** This change ensures that the Central Drugs Laboratory can continue to fulfill its legal obligation of providing test certificates for samples sent by Courts of Law, despite the absence of a permanently appointed individual. This authorization is valid "with effect from the date of publication of this notification in the Gazette of India till the regularly appointed person takes charge of the post or until further orders, whichever is earlier."
**For the Drugs and Cosmetics notification (S.O. 2209E), the following specific exclusions apply**:
The change *specifically excludes the authorization for signing statutory certificates related to the following classes of drugs*:
1. Sera
2. Solution of Serum Proteins intended for injection
3. Vaccines
4. Toxins
5. Antigens
6. Antitoxins
7. Sterilized surgical ligature and sterilized suture
8. Bacteriophages
9. AntiSera for Veterinary use
10. Vaccines for Veterinary use
11. Toxoids for Veterinary use
12. Diagnostic Antigens for Veterinary use
13. VDRL Antigen
14. IntraUterine Devices and Falope Rings
15. Human Blood and Human Blood Products
16. Blood Grouping reagents and diagnostics kits for Human Immunodeficiency Virus, Hepatitis B Surface Antigen and Hepatitis C Virus
17. Condoms
**6. Target Audience and Stakeholders:**
The primary target audience includes:
* **Courts of Law:** Relies on statutory certificates for legal proceedings involving drugs, cosmetics, and medical devices.
* **Central Drugs Laboratory, Kolkata:** The laboratory where the authorized person is located.
* **Dr. Rakesh Kumar Rishi:** The individual temporarily authorized to sign certificates.
* **Manufacturers and Distributors of Drugs, Cosmetics, and Medical Devices:** May be involved in legal proceedings requiring sample testing and certification.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** Ministry of Health and Family Welfare, Department of Health and Family Welfare; Central Drugs Laboratory, Kolkata.
* **Timelines:** The authorization is effective from the date of publication (May 16, 2025) and continues until a regularly appointed person takes charge or until further orders.
* **Procedures:** The process of submitting samples to the Central Drugs Laboratory and the issuance of certificates remains as per the Drugs and Cosmetics Act, 1940, and related rules (Medical Devices Rules, 2017, and Drugs Rules, 1945). Dr. Rishi is now authorized to sign off on the certificates.
**8. Expected Outcomes / Impact of Changes:**
The intended outcome is to maintain the integrity and efficiency of the legal processes that depend on statutory test certificates for drugs, cosmetics, and medical devices. The specific amendments ensures no disruption in these processes during the interim period while a permanent Director Incharge is appointed. For the Drugs and Cosmetics notification, the excluded categories mean certificates for those specific drugs will need alternative authorization during this interim period, potentially causing delays if no other arrangements are in place.
**9. Conclusion:**
The two notifications represent a temporary measure to address a personnel gap at the Central Drugs Laboratory, Kolkata, ensuring the continuation of essential services related to the legal oversight of drugs, cosmetics, and medical devices. While the change is intended to maintain continuity, the specific exclusions for drugs and cosmetics listed in notification S.O. 2209E may require further contingency planning to avoid potential delays in the certification of those specific products. The notifications highlight the importance of maintaining a robust system for statutory certification in the interest of public health and safety.
Key Entities Referenced
INDIA: Country issuing the Gazette notification.
NEW DELHI: Location of publication of the notification.
FRIDAY, MAY 16, 2025: Date of the Gazette notification.
Ministry of Health and Family Welfare: The ministry of the Government of India responsible for health policy.
Department of Health and Family Welfare: A department within the Ministry of Health and Family Welfare.
Central Government: The Government of India.
Drugs and Cosmetics Act, 1940: Indian legislation related to the regulation of drugs and cosmetics.
Medical Devices Rules, 2017: Indian regulations concerning medical devices.
Government of India: The governing authority of India.
Gazette of India: The official journal of the Government of India.
Central Drugs Laboratory, Kolkata: A laboratory authorized to test and evaluate samples of medical devices and drugs.
Dr. Rakesh Kumar Rishi: Director Incharge of Central Drugs Laboratory, Kolkata authorized to sign statutory certificates.
Courts of Law: Judicial bodies that may send samples for testing.
Form MD30: A form related to the Medical Device Rules, 2017.
DR RAJIV WADHAWAN: Adviser Cost.
Drugs Rules, 1945: Indian regulations concerning drugs.
Sera: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
Solution of Serum Proteins intended for injection: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
Vaccines: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
Toxins: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
Antigens: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
Antitoxins: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
Sterilized surgical ligature and sterilized suture: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
Bacteriophages: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
AntiSera for Veterinary use: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
Vaccines for Veterinary use: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
Toxoids for Veterinary use: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
Diagnostic Antigens for Veterinary use: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
VDRL Antigen: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
IntraUterine Devices and Falope Rings: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
Human Blood and Human Blood Products: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
Blood Grouping reagents and diagnostics kits for Human Immunodeficiency Virus, Hepatitis B Surface Antigen and Hepatitis C Virus: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
Condoms: A class of drugs excluded from Dr. Rakesh Kumar Rishi authorization.
Mayapuri, New Delhi110064: Location of Dte. of Printing at Government of India Press
Delhi110054: Location of the Controller of Publications
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-19052025-263206
CG-DxLx-xEG-I1D9H0x5x2x0 25-263206
xxxGIDExxx
असाधारण
EXTRAORDINARY
भाग II—खण्ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 2158] नई दिल्ली, िुक्रवार, मई 16, 2025/विै ाख 26, 1947
No. 2158] NEW DELHI, FRIDAY, MAY 16, 2025/VAISAKHA 26, 1947
स्वास््य और पररवार कल्याण मत्रं ालय
(स्वास््य और पररवार कल्याण ववभाग)
अविसचू ना
नई दिल्ली ,16 मई, 2025
का.आ. 2208 (अ).— केन्द्रीय सरकार, ओषवि और प्रसािन अविवनयम 1940 (1940 का 23) की िारा
6 के अिीन प्रित्त शवियों का प्रयोग करते हुए, वचदकत्सा युवियां वनयम 2017 के वनयम 19 के उप-वनयम (1) के खंड (क)
के साथ परित, भारत सरकार के स्वास््य और पररवार कल्याण मंत्रालय की अविसूचना संख्याक का.आ. 3758 (अ) तारीख
10 अगस्त 2022 म ेंभारत के राजपत्र, असािारण, भाग 2, खडं 3, उप खंड (ii) म ेंप्रकावशत हुए थ,े को उन बातों के वसवाय
अविक्रान्द्त करत े हुए, वजन्द्ह ें ऐसे अविक्रमण स े पूवव दकया गया ह ै या करन े का लोप दकया गया ह,ै डॉ. राकेश कुमार ऋवष,
वनिेशक-प्रभारी, केन्द्रीय ओषवि प्रयोगशाला, कोलकाता को संपूणव भारत के वलए प्रभारी वनिेशक, उि प्रयोगशाला, के रूप
म,ें भारत के राजपत्र म,ें इस अविसूचना के प्रकाशन की तारीख स े उस पि पर वनयवमत रूप स े वनयुि व्यवि के प्रभार लेन े
तक या आगामी आिेश तक , जो भी पूववतर हो, उि अविवनयम की िारा 25 की उपिारा (4) के अिीन म ेंन्द्यायालयों द्वारा
भेजी गई वचदकत्सा युवियों के नमूनों की जांच या ववश्लेषण के कानूनी प्रमाण पत्रों या वचदकत्सा युवियां वनयम, 2017 के
प्ररूप एम डी -30 पर हस्ताक्षर करन े के वलए प्राविकृत करती ह।ै
[फा.स.ं एक्स-11014/2/2025-डीआर]
राजीव विावन, सलाहकार (लागत)
3228 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi the 16th May,2025.
S.O. 2208 (E).—In exercise of the powers conferred by section 6 of the Drugs and
Cosmetics Act, 1940 (23 of 1940) read with clause (a) of sub-rule (1) of rule 19 of the Medical
Devices Rules, 2017 and in supersession of the notification of the Government of India in the
Ministry of Health and Family Welfare number S.O. 3758 (E), dated the 10th August, 2022
published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii), except as
respects things done or omitted to be done before such supersession, the Central Government hereby
authorises Dr. Rakesh Kumar Rishi, Director In-charge of Central Drugs Laboratory, Kolkata, to
sign statutory certificates of test or evaluation of samples of Medical Devices sent by Courts of Law
under sub-section (4) of section 25 of the said Act or in Form MD-30 of the Medical Device Rules,
2017, as the Director In-charge of the said laboratory, for the whole of India with effect from the
date of publication of this notification in the Gazette of India till the regularly appointed person
takes charge of the post or until further orders, whichever is earlier.
[F. No. X.11014/2/2025-DR]
RAJIV WADHAWAN, Adviser (Cost).
अविसचू ना
नई दिल्ली ,16 मई, 2025
का.आ. 2209(अ).— केन्द्रीय सरकार, ओषवि और प्रसािन अविवनयम 1940 (1940 का 23) की िारा 6
के अिीन प्रित्त शवियों का प्रयोग करत ेहुए तथा ओषवि वनयम, 1945 के वनयम 8 के साथ परित, भारत सरकार के स्वास््य
और पररवार कल्याण मंत्रालय की अविसूचना म ें संख्यांक का.आ. 3757 (अ) तारीख 10 अगस्त 2022 भारत के राजपत्र,
असािारण, भाग 2, खंड 3, उप खंड (ii) म ें प्रकावशत हुए थ,े को उन बातों के वसवाय अविक्रान्द्त करत े हुए, वजन्द्ह ें ऐस े
अविक्रमण स े पूवव दकया गया ह ै या करने का लोप दकया गया ह,ै डॉ. राकेश कुमार ऋवष, वनिेशक-प्रभारी, केन्द्रीय ओषवि
प्रयोगशाला, कोलकाता को संपूणव भारत के वलए प्रभारी वनिेशक, केन्द्रीय ओषवि प्रयोगशाला, कोलकाता, के रूप म ें इस
अविसूचना के प्रकाशन की तारीख स े उस पि पर वनयवमत रूप स े वनयुि व्यवि के प्रभार लने े तक या आगामी आिेश तक,
जो भी पूववतर हो, नीच ेवर्णवत ओषवियों के वगों के वसवाय, ओषवियों के सभी वगों की बाबत, उि अविवनयम की िारा 25
की उपिारा (4) के अिीन न्द्यायालयों द्वारा ओषवि और प्रसािन सामग्री के भेज ेहुए नमनू ों की जांच और ववश्लेषण के कानूनी
प्रमाण पत्रों तथा ओषवि वनयम 1945 के प्ररूप-1 पर हस्ताक्षर करन े के वलए प्राविकृत करती ह,ै अथावत –
1. सेरा
2. इन्द्जेक्शन के वलए सीरम प्रोटीन के समािान
3. टीके
4. जीव ववष[भाग II—खण्ड 3(ii)] भारत का रािपत्र : असाधारण 3
5. प्रवतजन
6. प्रवतजीव-ववष
7. ववसंक्रवमत शल्य बन्द्ि और ववसंक्रवमत टांका
8. जीवाणुभोजी
9. पशु वचदकत्सा उपयोग के वलए प्रवतकारक सीरा
10. पशु वचदकत्सा उपयोग के वलए टीके
11. पशु वचदकत्सा उपयोग के वलए टऑक्सोइड्स
12. पशु वचदकत्सा उपयोग के वलए वनिान संबंिी प्रवतजन
13. वी डी आर एल प्रवतजन
14. अंत: गभावशय युवियां और फैलोप ररंगस
15. मानव रि और मानव रि स ेबने उत्पाि
16. मानव इम्यूनोडेदफवशएंसी ववषाणु, हपे टाइरटस बी सरफेस एंटीजन तथा हपे टाइरटस सी ववषाणु के वलए रि
वगीकरण अवभकमवक और नैिावनक दकटें।
17. वनरोि
[फा.स.ं एक्स-11014/2/2025-डीआर]
राजीव विावन, सलाहकार (लागत)
NOTIFICATION
New Delhi, the 16th May, 2025
S.O. 2209(E).— In exercise of the powers conferred by section 6 of the Drugs and
Cosmetics Act, 1940 (23 of 1940) read with rule 8 of the Drugs Rules, 1945, and in supersession of
the notification of the Government of India in the Ministry of Health and Family Welfare number
S.O. 3757(E), dated 10th August, 2022 published in the Gazette of India, Extraordinary, Part II,
Section 3, Sub-section (ii), except as respects things done or omitted to be done before such
supersession, the Central Government hereby authorises Dr. Rakesh Kumar Rishi, Director In-
charge of Central Drugs Laboratory, Kolkata to sign statutory certificates of test or analysis on the
samples of Drugs and Cosmetics sent by the Courts of Law under sub-section (4) of section 25 of
the said Act or in Form 1 of the Drugs Rules, 1945 as the Director In-charge of Central Drugs
Laboratory, Kolkata for the whole of India with effect from the date of publication of this
notification in the Official Gazette till the regularly appointed person takes charge of the post or
until further orders, whichever is earlier, in respect of all classes of drugs, except the classes of drugs
mentioned below, namely:-
1. Sera
2. Solution of Serum Proteins intended for injection
3. Vaccines
4. Toxins
5. Antigens
6. Anti-toxins
7. Sterilized surgical ligature and sterilized suture
8. Bacteriophages4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
9. Anti-Sera for Veterinary use
10. Vaccines for Veterinary use
11. Toxoids for Veterinary use
12. Diagnostic Antigens for Veterinary use
13. VDRL Antigen
14. Intra-Uterine Devices and Falope Rings
15. Human Blood and Human Blood Products
16. Blood Grouping reagents and diagnostics kits for Human Immunodeficiency Virus, Hepatitis B
Surface Antigen and Hepatitis C Virus
17. Condoms
[F. No. X.11014/2/2025-DR]
RAJIV WADHAWAN, Adviser (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.