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Drugs (Research) Rules, 1978.

Country/Territory
Pakistan
Document type
Regulation
Date
1978
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Drugs Animal health Research Legal proceedings/administrative proceedings Special fund
Geographical area
Asia, Asia and the Pacific, Indian Ocean, South Asian Seas, Southern Asia
Entry into force notes
These Rules enter into force immediately.
Abstract

These Rules establish the Drugs (Research) regulation. In exercise of the powers conferred by Section 43 of the Drugs Act, 1976 (XXXI of 1976), the Federal Government makes the following rules, the same having been previously published as required by sub-section (3) of the said section. The research in drugs shall be conducted at such place or places and by such person or persons as may be approved by the Federal Government and shall be categorized as under: (i) other than clinical trials; and (ii) clinical trials. Conditions for conducting research on aspects of other than clinical trials: (1) The research on any aspect of drugs other than clinical trial shall be conducted under the supervision of an investigator who possesses post-graduate qualification and experience in the relevant field and has sufficient background knowledge. to conduct scientific investigation. (2) The recipient shall, at regular intervals not exceeding six months, submit the progress report to the Federal Government in respect of the investigation being conducted. (3) No change of an investigator or in the plan for investigation shall be made without prior approval of the Federal Government. (4) The recipient shall allow experts authorized by the Federal Government to visit the premises at which the research is being conducted and to see that the Fund is being utilized in accordance with the approved plan. The Federal. Government shall set up a Committee of Experts on Drug Research to determine the priorities, to give directions in drug research, to evaluate the applications received for the grant and make allocations from the .Fund and to take or propose such actions and measures as may be necessary for ensuring effective and proper use of the Fund.

Full text
English
Website
www.dra.gov.pk

References - Legislation

Implements

Drugs Act, 1976 (Act No. XXXI of 1976).

Legislation | Pakistan | 1976

Keyword: Food quality control/food safety, Residues, Pesticides, Public health, Internal trade, Packaging/labelling, Animal health, Drugs, Transport/storage, Inspection, Authorization/permit

Source: FAO, FAOLEX