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Chapter- 6

Chapter- 6 Inquiry and Inspection

20. Powers of Inspector to make inquiry and inspection:

(1) The Inspector may inspect, enquire and search any place where a drug is being manufactured, stored ♦ sold, distributed or transported.
(2) If, in making inspection, inquiry or search pursuant to Sub-section
(1), the Inspector suspects that any drug is not safe for public consumption,
efficacious or of quality standard or has a reasonable ground to believe that any

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Amended by the Second Amendment.
♦ Inserted by the Second Amendment.
♦ Inserted by the Second Amendment.

activity is being carried out in contravention of this Act or the Rules framed under this Act, the Inspector may seal the drug which he/she has found, hand over its custody to its owner, receive a receipt from that owner, withhold such drug and give order to immediately stop such activity
(3) If the Inspector makes inspection, inquiry or search pursuant to this Section or stops a drug or sends sample of that drug for testing, he/she shall submit a report thereon to the Administrator within three days.
(4) If the drug, which has been withhold by the Inspector pursuant to Sub- section (2), is proved, from the analysis or test by a research center, laboratory, hospital, pharmacy or clinic, that it is not safe for public consumption, efficacious or of quality standard, such drug may be seized or destroyed by order of the Administrator; and the Administrator may, while issuing such order, order to cancel the recommendation letter, product license, certificate or license issued under this Act.
♦ (4a) If, in carrying out analysis or test pursuant to Sub-section (4), any drug is found to be safe for public consumption, efficacious and of quality standard but the person manufacturing, selling, distributing, storing, transporting, exporting or importing such drug is held to have committed any activity in violation of this Act or the Rules framed under this Act, the Administrator may seize such drug and control the manufacturing, sale, distribution, storage, transportation, export or import of such drug or suspend the license or certificate or recommendation letter of such person for a period not exceeding six months.
(5) The manufacturer shall bear the expenditures incurred in destroying the drug pursuant to Sub-section (4) If the drug seized from the seller and stopped is to be destroyed, the value of such drug received by the manufacture from the seller shall also be got reimbursed by the manufacturer to the seller.
♦ (6) The Department may, as per necessity, depute any expert in the concerned subject to assist in the inquiry and inspection as referred to in this section.

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Amended by the Second Amendment.
♦ Inserted by the Second Amendment.
♦ Inserted by the Second Amendment.

21. Filing complaint against order of Administrator:

(1) A person who is not satisfied with an order issued by the Administrator to cancel or suspend the product license, recommendation letter, certificate or license pursuant to Sub-section (4) and (4a) of section 20 may file a complaint before the Secretary at the Ministry of Health within thirty five days after the date of receipt of such order.

(2) The complaint filed pursuant to Sub-section (1) shall be decided within
three months.

22. Procedures to be followed while making inspection or inquiry :

The methods and procedures, as prescribed, shall be followed while making inspection,
inquiry and search under this Act.

♣ 23. Qualifications of Inspector and Analyst:

(1) The Inspector shall possess the following qualifications:
(a) Graduation in pharmacy ? , or
(b) —– ?
(c) —– ?
? (d) Having passed certificate level or equivalent in pharmacy and gained at least five years of experience in pharmacy related works.
(2) The Analyst shall possess the following qualifications:
(a) Graduation in pharmacy, or ?
♦ (a1) Master’s degree in chemistry, or
(b) Graduation in chemistry and gained at least three years of experiences in drug analysis ? .

________________________________
Amended by the Second Amendment.
♣ Amended by the First Amendment.
Amended by the Second Amendment.
Deleted by the Second Amendment.
Deleted by the Second Amendment.
Amended by the Second Amendment.
Amended by the Second Amendment.
♦ Inserted by the Second Amendment.
Amended by the Second Amendment.

24. Sending sample of drug for test :

The Inspector shall send the sample of a drug, which has been withheld or seized in the course of inspection or inquiry, to the research center, laboratory, hospital, dispensary or clinic, as  rescribed, for test or analysis; and the Analyst shall also carry out necessary test or analysis and send a report thereof to the Administrator, as prescribed.

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