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Date: 01-Aug-2023 Category: Extra Ordinary State: Union Government Country: India

Prohibition of Veterinary Drugs Ketoprofen and its formulation and Aceclofenac its Formulation.

Issued by Ministry of Health and Family Welfare · Department of Health and Family Welfare

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Executive Summary & Key Takeaways

What it means

  • The gazette notification prohibits the manufacture, sale, and distribution of Ketoprofen and Aceclofenac, including their formulations, for animal use in India with immediate effect.

Key Changes

  • The Central Government has prohibited the manufacture, sale and distribution of:
  • Ketoprofen and its formulations for animal use.
  • Aceclofenac and its formulations for animal use.
  • The decision is based on the assessment that these drugs pose a risk to animals and safer alternatives are available.

Impact Analysis

Animal Health Industry

  • Action Item: Identify and switch to alternative drugs. Clear existing stock of prohibited drugs.

Veterinarians and Animal Care Providers

  • Action Item: Update treatment protocols to exclude Ketoprofen and Aceclofenac. Educate staff on alternative medications.

Animal Owners

  • Action Item: Consult with vets about alternatives. Dispose of existing medications safely.

Enforcement Agencies

  • Monitoring and surveillance will be required to ensure compliance.

Key Entities Referenced

Ministry of Health and Family Welfare: The central government ministry responsible for issuing the notification. Drugs and Cosmetics Act, 1940: The Act under which the powers are exercised to prohibit the manufacture, sale, and distribution of the specified drugs. Section 26A is specifically mentioned as the source of authority. Drugs Technical Advisory Board: The advisory body consulted before the prohibition was imposed. Ketoprofen: A nonsteroidal anti-inflammatory drug (NSAID) now prohibited for animal use. Aceclofenac: A nonsteroidal anti-inflammatory drug (NSAID) now prohibited for animal use.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 xxxGIDHxxx सी.जी.-डी.एल.-अ.-01082023-247766 xxxGIDExxx CG-DL-E-01082023-247766 असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (ii) PART II—Section 3—Sub-section (ii) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 3298] नई दिल्ली, मगं लवार, अगस्ट्त 1, 2023/श्रावण 10, 1945 No. 3298] NEW DELHI, TUESDAY, AUGUST 1, 2023/SHRAVANA 10, 1945 स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसचू ना नई दिल्ली, 31 िुलाई, 2023 का.आ. 3448(अ).—िबदक केंद्र सरकार इस बात से संतुष्ट ह ै दक केटोप्रोफेन और एजसक्लोफेनाक युक्त िवा सूत्र के उपयोग स ेपिुओं के जलए िोजखम िाजमल होने की संभावना ह;ै और िबदक, उक्त िवाओं के सुरजित जवकल्प उपलब्ध ह;ैं और िबदक, केंद्र सरकार इस बात से संतुष्ट ह ै दक िनजहत म ें िानवरों के उपयोग के जलए जनम्न जलजखत के जनमााण, जबक्री और जवतरण पर रोक लगाना आवश्यक और समीचीन ह।ै (i) केटोप्रोफेन और इसके सूत्रण; और (ii) एजसक्लोफेनाक और इसके सूत्रण, इसजलए, अब, औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 26क द्वारा प्रित्त िजक्तयों का प्रयोग करते हुए, और औषजध तकनीकी सलाहकार बोडा के परामि ाके बाि, केंद्र सरकार एतिद्वारा जनम्नजलजखत िवाओं के जनमााण, जबक्री और जवतरण पर तत्काल प्रभाव से रोक लगाती ह,ै अर्ाात:् - 4957 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] "(i) केटोप्रोफेन और पि ु उपयोग के जलए इसके सूत्रण (ii) एजसक्लोफेनाक और िानवरों के उपयोग के जलए इसके सूत्रण". [फा. स.ं एक्स.11035/65/2023-डीआरएस] आराधना पटनायक, संयक्ु त सजचव MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi the 31st July, 2023 S.O. 3448(E).—Whereas the Central Government is satisfied that the use of drug formulations containing Ketoprofen and Aceclofenac are likely to involve risk to animals; And whereas, safer alternatives to the said drugs are available; And whereas, the Central Government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of–– (i) Ketoprofen and its formulations; and (ii) Aceclofenac and its formulations, for animal use; Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), and after consultation with the Drugs Technical Advisory Board, the Central Government, hereby prohibits the manufacture, sale and distribution of the following drugs, with immediate effect, namely:- “(i) Ketoprofen and its formulations for animal use (ii) Aceclofenac and its formulations for animal use”. [F. No.X.11035/65/2023-DRS] ARADHANA PATNAIK, 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.

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