Drugs Inspector – Qualification, Power, Duties
Introduction
Becoming a drugs inspector is a career path that demands a high level of responsibility and expertise. These professionals play a crucial role in ensuring that pharmaceutical products and healthcare facilities meet the required standards. In this article, we will delve into the qualifications, responsibilities, and the process of becoming a drugs inspector.
Qualification of Drugs Inspector
1. Persons having qualification for appointment as government, as Governmental Analysis for allopathic drugs; or
2. having a degree in Ayurveda, siddha or unani system and not less than three years of post-graduate experience in the analysis of drugs in a laboratory under control of (a) a government analyst, or (b) a chemical examiner, or (c) head of an institution specially approved for this purpose.
Power of Drugs Inspector:
a) Inspect, —
(i) Any premises where in any drug or cosmetic is being manufactured.
(ii) Any premises where in any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed;
Take samples of any drug or cosmetic,–
(i) Which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed;
(ii) 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.
- Appointed by Central and State Governments.
- He should be a person with out any financial interest in the import, manufacture or sale of drugs or cosmetics.
- They are deemed as public servants and are officially subordinate to the Controlling Authority.
Qualifications
For appointment as DI, person must have a degree in Pharmacy/Pharmaceutical Chemistry/Medicine with specialization in Clinical Pharmacology/Microbiology from a recognized University;
For inspection of manufactured substances in Schedule C, the DI must have 1) at least 18 months experience in manufacture of at least one of the substance specified in schedule C 2) at least 18 month experience in testing one of the item in schedule C 3) gained experience of NLT 3 yrs in inspection of firms manufacturing any of the substances of Schedule C during their tenure as services as DI
Powers of DI
He can 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 ;
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;
At all reasonable times with necessary assistance
- search any person, who, he has reason to believe, has secreted about his person, any drug or cosmetic in respect of which an offence relating to manufacture sale or distribution has been, or is being, committed; or
- enter and search any place in which he has reason to believe an offence relating to manufacture, sale or distribution of drugs or cosmetics 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 has been, or is being, committed, and order in writing the person in possession of the drug or cosmetic not to dispose of any stock that of for a specified period not exceeding 20 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
- examine any record, register, document or any other material object with any person or in any place mentioned above and seize the same if it is likely to furnish the evidence as an offence
- require any person to produce any record, register, or other document relating to the manufacture for sale or for distribution of any drug or cosmetic with respect to which an offence has been committed
- exercise such other powers as may be necessary for carrying out the purposes of the Acts or Rules.
Duties of Inspectors
A) Inspection of premises licensed for sale:
- Inspect NLT twice an year all establishments licensed for sale of drugs within the area assigned to him and to satisfy himself that the conditions of license are being observed.
- Procure and send for tests or analysis, if he has reason to think that the drugs are sold in contravention of provisions of Acts or Rules.
- To investigate any complaints made to him in writing & to institute prosecutions in respect to the breaches of the act.
- To maintain all records of inspections made & actions taken by him including taking of samples and seizure of stocks & to submit copies of such records to the Controlling Authority
- To make enquiries and inspections as may be necessary to detect sale of drugs in contravention to the Act.
- When so authorized by State Governments to obtain imported packages which he has reason to suspect to contain drugs whose import is prohibited.
B) Inspection of Manufacture of Drugs
- Inspect NLT twice a year all premises licensed for the manufacture of drugs within the area allotted to him and satisfy himself that the condition of license and provisions of Acts and Rules are observed.
- In establishments licensed to manufacture products specified in Schedule C and C1 inspect the process of manufacture, means employed for standardizing and testing of drugs, methods & place of storage, technical qualifications of staff employed & all details of location, construction & administration of establishment likely to affect the potency or purity of drug.
- To send controlling authority after each inspection a detailed report indicating conditions of license & provisions of Acts & Rules which are being observed & which are being not observed.
- To take samples of drugs manufactured on premises & send them for test or analysis.
- To institute prosecutions in respect of breaches of Act and Rules.
Procedure for Drug Inspectors
- An Inspector taking any samples must pay its fair price & may require written acknowledgement for the same. If price tendered is refused or when Inspector seizes any stock of any drug or cosmetic, he should issue the receipt for the same in prescribed form. (Form 16)
- He should inform the concerned person, the purpose of taking the sample in form 17 & divide the sample to four parts In his presence. Each portion is then sealed & suitably marked. The person from whom the sample is taken must also be allowed to add his mark of seal on the packet. If sample taken from a manufacturing premises, it should be divided to three portions only.
- The sample if made into small volume is likely to deteriorate, Inspector can take three or more containers when necessary after suitably marking it.
- One portion of sample is to be restored to the person, second part send to Government analyst and third one is preserved for production before the court, if required & fourth is sent to warrantor if any.
- Inspector should sent sample to Government Analyst by registered post or by hand in sealed packet enclosed together with memorandum in Form 18 in an outer cover addressed to Government analyst.
- If the confiscated drug is not of standard quality, it should be reported to court accordingly & court may order destruction of drug under the supervision of Inspector in presence of such authority that the court may prescribe.
- If confiscated drug is of standard quality, Inspector may report court accordingly and court may order sale of drugs by public auction to any party holding a requisite license.
- Any record, register or any other document sized by the Inspector should be returned to the persons from whom they where seized or who produce the same within a period of 20 days of such seizure or produce.
- When an Inspector seizes any record, register or document, or any other material object, he should as soon as inform the same to the judicial magistrate & take his orders to the custody thereof.
- Every person for time being in charge of any premises where any drug or cosmetic is manufactured or is kept for sale or distribution, on being required by the Inspector is legally bound to disclose to the inspector the place where drug or cosmetic is being manufactured or kept.
- Willfully obstructing the Inspector or refusing to provide any record or register is punishable with imprisonment up to three years, or with fine or both.
frequently asked questions (FAQs)
What is the role of a Drugs Inspector?
A Drugs Inspector plays a vital role in monitoring and regulating pharmaceutical products to ensure they meet safety and quality standards. They safeguard public health by enforcing regulations in the pharmaceutical industry.
What are the educational qualifications required to become a Drugs Inspector?
Typically, you need a bachelor’s degree in pharmacy, pharmaceutical sciences, or a related field to qualify for the role. Some candidates also pursue postgraduate degrees for a competitive advantage.
Is training and certification necessary for a career as a Drugs Inspector?
Yes, specialized training and certifications are usually required. Training equips you with the skills and knowledge needed for the job, and certifications from relevant regulatory bodies validate your expertise.
What are the primary job responsibilities of a Drugs Inspector?
Drugs Inspectors inspect pharmaceutical manufacturing facilities, review drug production processes, and ensure that quality control measures are adhered to. They also assess product labeling, packaging, and storage conditions.
Which regulatory bodies employ Drugs Inspectors?
The employing regulatory bodies may vary by country. In the United States, for instance, the Food and Drug Administration (FDA) employs Drugs Inspectors. Other countries have their own regulatory agencies.
What is the work environment like for Drugs Inspectors?
Drugs Inspectors work in diverse settings, including pharmaceutical manufacturing plants, laboratories, and regulatory agencies’ offices. They often need to travel for on-site inspections and investigations.
What is the typical salary and benefits package for Drugs Inspectors?
Salary can vary based on factors like experience and location. However, it is generally considered a well-paying profession. Benefits often include health insurance, retirement plans, and opportunities for professional development.
What challenges do Drugs Inspectors face in their work?
Working as a Drugs Inspector can be challenging due to the need to enforce strict regulations. This may lead to conflicts with pharmaceutical companies. Additionally, the job can involve long hours, travel, and exposure to hazardous materials.
What are the career prospects for Drugs Inspectors?
The demand for Drugs Inspectors remains steady. With the growth of the pharmaceutical industry, there are ample career opportunities for those who meet the qualifications.
Why are Drugs Inspectors important for public health?
Drugs Inspectors play a pivotal role in ensuring the quality and safety of pharmaceutical products. Their work prevents the distribution of substandard drugs, which could have severe consequences for patients.
How can I become a Drugs Inspector?
To become a Drugs Inspector, you should start by meeting the educational requirements, gain relevant experience, and apply for positions with regulatory agencies.
What is the application process for becoming a Drugs Inspector?
Aspiring Drugs Inspectors should monitor job openings on the relevant regulatory agency’s website or government job portals. The application process typically involves submitting a resume and cover letter.
What should I expect during the interview and selection process for a Drugs Inspector role?
The interview assesses your knowledge of pharmaceutical regulations and your suitability for the role. Successful candidates are then selected for specialized training.
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