How to become a Drug Inspector? Qualifications, Power, Duties etc.

Who is Drug Inspector?

Drug Inspector is a person who are authorized by Central Government or a State Government for purpose of regulating law and order related to the drugs or classes of drugs or cosmetics or classes of cosmetics etc.

How to become Drug Inspector?

For becoming drug inspector you need to passed the qualification in degree in Pharmacy or Pharmaceutical Sciences or Medicine with specialization in Clinical Pharmacology or Microbiology from a University established in India by law. And after that qualification a person should have more than 18 months‘ experience in the manufacturing of pharmaceutical substances specified.

After completing above requirements, you need to pass out test conducted by state or central government time to time depend at availability of post available. After test pass, person has to crack interview part.

After completing that procedure, you can become drug inspection.

Inspectors Definition Under Drug and Cosmetic Act

• Drug Inspector is appointed by the Central Government or a State Government may, by notification in the Official Gazette, such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for such areas as may be assigned to them by the Central Government or State Government, as the case may be.
• The powers which may be exercised by an Inspector and the duties which may be performed by him, the drugs or classes of drugs or cosmetics or classes of cosmetics in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed shall be such as may be prescribed.
• No person who has any financial interest in the import, manufacture or sale of drugs or cosmetics shall be appointed to be an Inspector under this section.
• Every Inspector shall be deemed to be public servant within the meaning of section 21 of the Indian Penal Code (45 of 1860), and shall be officially subordinate to such authority having the prescribed qualifications, as the Government appointing him may specify in this behalf.

Qualifications for Drug Inspectors

A person who is appointed as an Inspector under the drug and cosmetic act shall be a person who has a degree in Pharmacy or Pharmaceutical Sciences or Medicine with specialization in Clinical Pharmacology or Microbiology from a University established in India by law:

Provided that only those Inspectors: 

• Who have not less than 18 months‘ experience in the manufacture of at least one of the substances specified in Schedule C, or
• Who have not less than 18 months‘ experience in testing of at least one of the substances in Schedule C in a laboratory approved for this purpose by the licensing authority, or
• Who have gained experiences of not less than three years in the inspection of firms manufacturing any of the substances specified in Schedule C during the tenure of their services as Drugs Inspectors; 

shall be authorized to inspect the manufacture of the substances mentioned in Schedule C:

Powers of Inspectors.

I) Subject to the provisions of section 23 of drug and cosmetic act and of any rules made by the Central Government in this behalf, an Inspector may, within the local limits of the area for which he is appointed,

 1. Inspect

• any premises wherein any drug or cosmetic is being manufactured and the means employed for standardizing and testing the drug or cosmetic;
• any premises wherein any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed;

2. take samples of any drug or cosmetic

• which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed;
• from any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee;

3. at all reasonable times, with such assistance, if any, as he considers necessary,--

• search any person, who, he has reason to believe, has secreted about his person, any drug or cosmetic in respect of which an offence under this Chapter has been, or is being, committed; or
• enter and search any place in which he has reason to believe that an offence under this Chapter has been, or is being, committed; or
• stop and search any vehicle, vessel or other conveyance which, he has reason to believe, is being used for carrying any drug or cosmetic in respect of which an offence under this Chapter has been, or is being, committed,

and order in writing the person in possession of the drug or cosmetic in respect of which the offence has been, or is being, committed, not to dispose of any stock of such drug or cosmetic for a specified period not exceeding twenty days, or, unless the alleged offence is such that the defect may be removed by the possessor of the drug or cosmetic, seize the stock of such drug or cosmetic and any substance or article by means of which the offence has been, or is being, committed or which may be employed for the commission of such offence;

examine any record, register, document or any other material object found with any person, or in any place, vehicle, vessel or other conveyance referred to in clause (c), and seize the same if he has reason to believe that it may furnish evidence of the commission of an offence punishable under this Act or the rules made thereunder;

require any person to produce any record, register, or other document relating to the manufacture for sale or for distribution, stocking, exhibition for sale, offer for sale or distribution of any drug or cosmetic in respect of which he has reason to believe that an offence under this Chapter has been, or is being, committed;

4. exercise such other powers as may be necessary for carrying out the purposes of this Chapter or any rules made thereunder.

II) The provisions of the Code of Criminal Procedure, 1973 (2 of 1974)] shall, so far as may be, apply to any search or seizure under this Chapter as they apply to any search or seizure made under the authority of a warrant issued under section 94 of the said Code.

Every record, register or other document seized under clause (cc) or produced under clause (cca) shall be returned to the person, from whom they were seized or who produce the same, within a period of twenty days of the date of such seizure or production, as the case may be, after copies thereof or extracts therefrom certified by that person, in such manner as may be prescribed, have been taken.]

III) If any person willfully obstructs an Inspector in the exercise of the powers conferred upon him by or under this Chapter, 2[or refuses to produce any record, register or other document when so required under clause (cca) of sub- section (1),] he shall be punishable with imprisonment which may extend to three years, or with fine, or with both.

Duties of Inspectors of premises licensed for sale.

Subject to the instructions of the controlling authority, it shall be duty of an Inspector authorized to inspect premises licensed for the sale of drugs

• to inspect all establishments licensed for the sale of drugs within the area assigned to him;
• to satisfy himself that the conditions of the licenses are being observed;
• to procure and send for test or analysis, if necessary, imported packages which he has reason to suspect contain drugs being sold or stocked or exhibited for sale in contravention of the provisions of the Act or Rules thereunder;
• to investigate any complaint in writing which may be made to him;
• to institute prosecutions in respect of breaches of the Act and Rules thereunder;
• to maintain a record of all inspections made and action taken by him in the performance of his duties, including the taking of samples and the seizure of stocks, and to submit copies of such record to the controlling authority;
• to make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention of the Act;
• when so authorized by the State Government, to detain imported packages which he has reason to suspect contain drugs, the import of which is prohibited.

Duties of Inspectors specially authorized to inspect the manufacture of drugs or cosmetics

Subject to the instructions of the controlling authority it shall be the duty of an Inspector authorized to inspect the manufacture of drugs

• to inspect, all premises licensed for manufacture of drugs or cosmetics within the area allotted to him to satisfy himself that the conditions of the license and provisions of the Act and Rules thereunder are being observed;
• in the case of establishments licensed to manufacture products specified in Schedules C and C(1) to inspect the plant and the process of manufacture, the means employed for standardizing and testing the drugs or cosmetics, the methods and place of storage, the technical qualifications of the staff employed and all details of location, construction and administration of the establishment likely to affect the potency or purity of the product;
• to send forthwith to the controlling authority after each inspection a detailed report indicating the conditions of the license and provisions of the Act and rules thereunder which are being observed and the conditions and provisions, if any, which are not being observed;
• to take samples of the 1[drugs or cosmetics] manufactured on the premises and send them for test or analysis in accordance with these Rules;
• to institute prosecutions in respect of breaches of the Act and Rules thereunder.