DRUGS FEDERAL INSPECTORS, FEDERAL DRUG LABORATORY Rules 1976

DRUGS (FEDERAL INSPECTORS, FEDERAL DRUG LABORATORY

AND FEDERAL ANALYSIS OF THE GOVERNMENT) RULES, 1976

(Copied from the Drug Law Manual, Pakistan)

SRO 793 (1) 176: In exercise of the powers conferred by Sec. 43 of the Drug Act of 1976 (XXXI of 1976), the Federal Government is pleased to make the following rules, which have been previously published as it is required by subsection (3) of said section, namely

1. Short title and beginning: (I) These rules may be called 'Drug Rules (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts), 1976.

(2) They will take effect immediately.

2. Definitions: in these rules, unless there is something disgusting in the subject or context,

(a) "Law" means the Drug Law, 1976 (XXX1 of 1976);

(b) "Section" means a section of the Law; Y

{c) "form" means a form set out in the Annex.

3. Qualification of federal inspectors: (1) A federal inspector will be a person who

(a) has a pharmacy degree from a Pakistani university or any other institution recognized for this purpose by the federal government; Y

(b) has for a period of, or for periods: adding, not less than ten years of practical experience in, (i) drug manufacturing, testing or analysis, or (ii) in drug administration:

Provided that the condition of the experience can be exceptionally relaxed

deserving cases or for people with higher qualifications or where the candidate; With the required experience they are not readily available:

Whenever the Federal Government can, by notification in the Official Gazette, for the exercise of the powers specified in said notification, designate as ex officio Inspector any official of the medical or public health department who is a registered medical professional or any official who works in the administration of medicines of a government that has a degree in medicine or science or pharmacy or anyone with similar qualifications who works as a teacher in any medical or pharmaceutical educational institution

(2) The Federal Inspector will be under the control of the licensing authority mentioned in Section 18.

Explanation: For the purposes of this rule and rule 4, "licensing authority" means the Director General of Health, the Government of Pakistan, or an official authorized by him on this behalf.

4. Obligations of federal inspectors: (1) Subject to the instructions of the licensing authority, it shall be the obligation of an inspector, within the local limits for which it is located. appointed

(a) to inspect not less than twice a year, all premises licensed for the manufacture of medicines, including the plant and the manufacturing process, the

means used to standardize and test drugs, methods and places of storage, location, construction and administration of the establishment that may affect the potency for product purity, records and records and to ensure that the conditions of the license and they are observing the provisions of the Law and the norms established by virtue thereof;

(b) periodically inspect the establishments authorized for the importation, exportation or sale of medicines and ensure that the conditions of the license are met;

(c) immediately send a detailed report to the licensing authority after each inspection indicating the conditions of the license and the provisions of the Law and the established standards that are being observed and the conditions and provisions, if any, that they are not being observed;

(d) take samples of any medication that has reason to suspect that it is being manufactured, stored, sold or exhibited for sale in contravention of the provisions of the Law or the regulations established thereunder. and send them for test or analysis;

(e) investigate any written complaint that may be made; [..............]

(f) institute, if necessary, prosecutions for breach of the Law and the norms established by virtue thereof. Y

(g) advise the pharmaceutical industry on technical matters related to the manufacture of medicines in accordance with good manufacturing practices in order to improve the industry standard and quality control of medicines;

(h) carry out surveillance of marketed medicines to ensure quality control and compliance with the various provisions of the Law and these standards, and

(i) help organize and conduct the program for monitoring adverse drug reactions.

(2) A federal inspector shall, for the purposes of clause (i) of subsection (l) of Section 18, approve and, for the purposes of clause (ii)