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Core Purpose

Notification authorizing the Director In-charge of Central Drugs Laboratory, Kolkata, to sign statutory certificates for samples of Medical Devices and certain Drugs and Cosmetics sent by Courts of Law under the Drugs and Cosmetics Act, 1940.

Detailed Summary

The Central Government, in exercise of powers conferred by section 6 of the Drugs and Cosmetics Act, 1940, read with rule 19(1)(a) of the Medical Devices Rules, 2017 (vide S.O. 2208(E) dated 16th May, 2025) and read with rule 8 of the Drugs Rules, 1945 (vide S.O. 2209(E) dated 16th May, 2025), and in supersession of previous notifications S.O. 3758(E) dated 10th August, 2022 and S.O. 3757(E) dated 10th August, 2022 respectively, has authorized Dr. Rakesh Kumar Rishi, Director In-charge of Central Drugs Laboratory, Kolkata. This authorization is for signing statutory certificates of test or evaluation on samples of Medical Devices sent by Courts of Law under section 25(4) of the 1940 Act or in Form MD-30 of the 2017 Rules (S.O. 2208(E)), and for signing statutory certificates of test or analysis on samples of Drugs and Cosmetics sent by Courts of Law under section 25(4) of the 1940 Act or in Form 1 of the 1945 Rules (S.O. 2209(E)). The authorization is for the whole of India, effective from the date of publication until a regular appointment is made or further orders, whichever is earlier. S.O. 2209(E) explicitly excludes seventeen classes of drugs/items from this authorization, including Sera, Vaccines, Toxins, Antigens, Anti-toxins, Sterilized surgical ligature and suture, Bacteriophages, Veterinary use products (Anti-Sera, Vaccines, Toxoids, Diagnostic Antigens), VDRL Antigen, Intra-Uterine Devices and Falope Rings, Human Blood and Human Blood Products, Blood Grouping reagents and diagnostic kits for HIV, Hepatitis B Surface Antigen and Hepatitis C Virus, and Condoms. These notifications were issued by the Ministry of Health and Family Welfare.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-19052025-263206 EXTRAORDINARY PART II-Section 3-Sub-section (ii) PUBLISHED BY AUTHORITY No. 2158] NEW DELHI, FRIDAY, MAY 16, 2025/VAISAKHA 26, 1947 3228 GI/2025 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi the 16th May,2025. S.O. 2208 (E).β€”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). NOTIFICATION New Delhi, the 16th May, 2025 S.O. 2209(E).β€” 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. Bacteriophages 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.

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