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Date: 2019-08-23 Category: Not Applicable State: Union Government Country: India

Additional FAQ on New Drugs and Clinical Trial Rules, 2019

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 gazette clarifies the import license requirements for drugs used in academic clinical trials under the New Drugs and Clinical Trial Rules, 2019.
  • Specifically, it addresses whether an import license under Form 11 is required for importing drugs for academic clinical trials.

Key Changes

  • No import license is required for drugs imported for academic clinical trials if certain conditions are met.
  • The Ethics Committee must have approved the academic clinical trial for a new indication, route of administration, dose, or dosage form of a permitted drug formulation.
  • The clinical trial must be conducted in accordance with Rule 28 of the New Drugs and Clinical Trial Rules, 2019.
  • A copy of the Ethics Committee approval for the clinical trial must be furnished to the concerned Port office at the time of import.
  • An undertaking must be provided, stating that the imported drug quantity will be used exclusively for the academic clinical trial.

Impact Analysis

Stakeholder: Academic Institutions and Researchers

  • Action Item: Familiarize with Rule 28 of the New Drugs and Clinical Trial Rules, 2019, to ensure compliance.

Stakeholder: Ethics Committees

  • Action Item: Continue to thoroughly review and approve academic clinical trial protocols.

Stakeholder: Port Authorities

  • Action Item: Develop a process for verifying Ethics Committee approvals and collecting the required undertakings.

Stakeholder: Pharmaceutical Companies

  • Action Item: If supplying drugs for academic clinical trials, ensure proper documentation is provided to the academic institution to facilitate import.

Key Entities Referenced

New Drugs and Clinical Trial Rules, 2019: The primary regulatory framework governing clinical trials and drug approvals in India. Rule 2(1)(a) of New Drugs and Clinical Trial Rules, 2019: Defines 'academic clinical trial' under the New Drugs and Clinical Trial Rules, 2019. Rule 28 of New Drugs and Clinical Trial Rules, 2019: Specifies requirements for academic clinical trials. Form 11: Form for applying for import license. Ethics Committee: Committee responsible for reviewing and approving clinical trial protocols to ensure ethical conduct and participant safety. Port office: The government office at the port of entry responsible for customs and import regulations.
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Additional FAQ on New Drugs and Clinical Trial Rules, 2019 Q. Whether import license under Form 11 is required for import of drugs for conducting ‘academic clinical trial’? The definition of “academic clinical trial” has been prescribed under Rule 2(1) (a) of New Drugs and Clinical Trial Rules, 2019. In case, the Ethics Committee has granted approval for conduct of academic clinical trial of a permitted drug formulation for a new indication or new route of administration or new dose or new dosage form and the drug is to be imported for conducting the academic clinical trial in accordance with Rule 28 of the said Rules, no import license is required, if copy of the ethics committee approval for the said clinical trial of the drug to be imported is furnished to the concerned Port office at the time of import along with an undertaking mentioning the quantity of the drug being imported will be used exclusively for the academic clinical trial.

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