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Date: 2019-08-08 Category: Not Applicable State: Union Government Country: India

Advisory on labeling requirements for combi kit of Misoprostol and Mifepristone tablets for Medical Termination of Pregnancy (MTP)

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • This is an advisory from the Central Drugs Standard Control Organisation (CDSCO) to all State/UT Drugs Controllers regarding the labeling requirements for combi kits of Misoprostol and Mifepristone tablets used for Medical Termination of Pregnancy (MTP).

Key Changes

  • The CDSCO approved the combi kit of Misoprostol and Mifepristone tablets (1 mifepristone 200 mg tablet + 4 misoprostol 200 mcg tablets) for MTP on 24.12.2008.
  • The approved combi-kit had a warning stating it should only be used under the supervision of a service provider and in a medical facility as specified under the MTP Act 2002 & MTP Rules 2003.
  • The 56th Drugs Consultative Committee (DCC) meeting on 01.06.2019 discussed the labeling requirements for the combi kit.
  • The DCC suggested that CDSCO issue a letter to all State Drugs Controllers about the labeling requirements and ensure effective implementation as per MTP provisions.
  • The advisory requests State/UT Drugs Controllers to ensure effective implementation of labeling requirements for the combi kit as per the Drugs and Cosmetics Act, 1940 & Rules, 1945 and MTP Act, 2002 & MTP Rules, 2003.

Impact Analysis

State/UT Drugs Controllers

  • Action Items: Review current labeling practices, disseminate information to manufacturers and distributors, conduct inspections to verify compliance, and take necessary action against non-compliant entities.

Manufacturers and Distributors of Misoprostol and Mifepristone Combi Kits

  • Action Items: Review and update product labeling, train staff on labeling requirements, and implement quality control measures to ensure compliance.

Medical Professionals and Service Providers

  • Action Items: Ensure adherence to the MTP Act and Rules, provide appropriate counseling to patients, and maintain accurate records.

Patients

  • Action Items: Seek guidance from qualified medical professionals and adhere to their instructions.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. State/UT Drugs Controllers: Regulatory authorities responsible for enforcing drug regulations at the state and union territory level. Drugs and Cosmetics Act, 1940 & Rules, 1945: Legislation governing the import, manufacture, distribution, and sale of drugs and cosmetics in India. MTP Act, 2002 & MTP Rules, 2003: Medical Termination of Pregnancy Act, 2002 and Rules, 2003, legislation governing abortion in India. DCC: Drugs Consultative Committee
Official Source Record View Original Source →
See Full Document Text
File No. 15-35/2019-DC Government of India Directorate General of Health Services Central Drugs Standard Control Organisation (DTAB-DCC Division) FDA Bhawan, Kotla Road, New Delhi-110002 Date: 03 . 0§.Zo\$ To All State/ UT Drugs Controllers Subject: Advisory on labeling requirements for combi kit of Misoprostol and Mifepristone tablets for Medical Termination of Pregnancy (MTP) -Reg. Combi kit of Misoprostol and Mifepristone tablets (1 uncoated mifepristone 200 mg tablet + 4 uncoated misoprostol 200 meg tablets) for MTP was approved on 24.12.2008 by CDSCO with following warning: “Warning: product is to be used only under the supervision of a service provider and in a medical facility as specified under MTP Act 2002 & MTP Rules 2003” The issue of labeling requirements for combi kit of Misoprostol and Mifepristone was deliberated in 56th Drugs Consultative Committee (DCC) meeting held on 01.06.2019. In meeting, the DCC suggested that a letter should be issued by CDSCO to all State Drugs Controllers about the labeling requirements and also to ensure the effective implementation of labeling requirements as per MTP provisions. You are therefore, requested to ensure the effective implementation of labeling requirements for Combi kit of Misoprostol and Mifepristone tablets as per the provisions of Drugs and Cosmetics Act, 1940 & Rules, 1945 and MTP Act, 2002 & MTP Rules, 2 0 0 3 - (Dr.S.Eswara Reddy) Drugs Controller General (I) Copy to: 1. Joint Secretary (R), Ministry of Health and Family Welfare, Government of India, Nirman Bhawan, New Delhi. 2. All Zonal/ Sub-Zonal/ Port Offices of CDSCO. 3. CDSCO Website.

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