Prepared by: Nidhi Patel Roll no : 117 College : KBIPER Department: Regulatory Affairs

Definition:

person appointed for the analysis and testing of samples of drugs and cosmetic under sec 20 ( 33-F in relation to ayurvedic , siddha and unani drugs) of the drugs and cosmetics act , in relation to any drug or cosmetic by the central government or state government.

1. This department is the central drug laboratory. 2. Established in 1904. 3. Two divisions 4. Food science- provides services towards public health 5. Forensic science- provides services to law enforcement authorities in the area of crime investigation. 6. Government analysts are specially trained scientists who do analysis and examination of samples.

1. Analyze the samples of drugs and cosmetics sent to him by inspectors. 2. Furnish the reports of the results of analysis. 3. The government analyst is bound to furnish to the inspector the full protocols of the test applied. 4. He should mention the methods of analysis prescribed for the particular drug. 5. Finally conclusion should be there.

FOR ANALYSIS OF OTHER THAN SCH C/C1 :

1. Graduate in medicine or science or pharmacy or pharmaceutical chemistry. 2. He should have not less than 5 years post graduate experience in the testing of drugs in a lab . 3. Possesses post graduate degree in medicine or science or pharmacy or pharmaceutical chemistry or possesses the associate ship diploma of the institution of chemists obtained by passing the exam with Analysis of drugs and pharmaceuticals as 1 of the subject. 4. After obtaining this one should have at least 3 years experience in the testing of drugs in a lab.

: FOR ANALYSIS OF SCH C/C1 DRUGS: 1. Degree in medicine, physiology, pharmacology, and microbiology. 2. He should have experience or training in testing of such products in an institution or lab approved by the appointing authority for a period of not less than 6 months. 3. If a person doesnt have degree in above subjects should have experience or training in testing of schedule C drugs for a period of not less than 3 years or have completed 2 years training on testing of schedule c drugs in central drugs laboratory. 4. No person who is engaged directly or indirectly in any trade or business connected with the manufacturer of drugs shall be appointed as a government analyst.

FOR ANALYSIS OF BIOLOGICAL FOR VETERINARY USE:

1. A graduate in veterinary science or general science or medicine or pharmacy. 2. A postgraduate in veterinary science or general science or medicine or pharmacy or pharmaceutical chemistry. 3. At least 3 years experience of testing.

1. The portion of the sample sent to gov analyst by drug inspector through registered post or by hand in a sealed packet with a memorandum in form 18. 2. Gov analyst examine the condition of the packet. 3. Test or analysis has been done on sample. 4. Report in triplicate in form 13 of the result of the analysis with full protocols of the analysis applied should be submitted to drug inspector.

1. 2. 3. 4.

5.

Pharmacopoeial drug method of test prescribed in pharmacopoeia followed references to the specific tests in the pharmacopoeia should be given. Patent or proprietary medicines method of test prescribed in pharmacopoeia followed references to the specific tests in the pharmacopoeia should be given. Patent or proprietary medicines containing pharmacopoeial drugs method of assays are modified and applied a description of actual method and applied method should be given. Patent or proprietary medicines no pharmacopoeial methods of analysis are available or methods given in standard books or journals are followed description of applied method of analysis with references to the relevant books or journals should be given. Drugs methods of test are not available methods are evolved by the gov analyst description of the applied test should be given.

Application for test or analysis: form 14-A Report of test or analysis : form 14-B

DEFINITION: inspectors appointed under

sec 21 of the ( 33 G in relation to ayrurvedic , siddha and unani drugs) drugs and cosmetic act in relation to any drug or cosmetic by the central government or state government and assign them definite area.

1. Drug inspector trace the persons who market counterfeit pharmaceuticals. 2. Suspected products are sampled and physical properties are examined by drug inspector. 3. If the results are not satisfactory then chemical analysis should be done. 4. Still if conclusive evidence can not get then compendial procedure should be followed. 5. This is done under the supervision of drug inspector. 6. Drug inspectors should have no any financial interest in the import, manufacture or sale of drugs and cosmetics. 7. All drug inspectors are public servants within the meaning of Indian penal code. 8. Inspectors are required to keep all informations confidential and not to disclose.

Classified under two categories:

1. Inspection of premises, licensed for the sale of drugs. (RULE 51) 2. Inspection of premises licensed for the manufacture of drugs and cosmetics.

(RULE 52)

1. To inspect not less than once a year all shops within the area assigned to him. 2. He checks whether the conditions of licences are being fulfilled or not. 3. To obtain and send samples for analysis. 4. To investigate any complaints. 5. To institute prosecution. 6. To maintain records of all inspection. 7. To detain packages of imported drugs. 8. To enter and search where an offence is believed to be committed. 9. To exercise other duties as may be necessary.

1. To inspect not less than once a year all manufacturing premises within the area allotted to him. 2. If the manufacturer manufacturing biological drugs, inspect plant, process, standardizing, and testing of drugs and method of storage and technical qualification of the staff. 3. To take samples and send for analysis. 4. To check all records and registers. 5. To institute legal proceeding in case of breach of the act. 6. To send detailed report of each inspection.

(RULE 49)
TO INSPECT PREMISES MANUFACTURE OTHER THAN BIOLOGICAL AND PREMISES MANUFACTURE BIOLOGICAL.

1. A degree in pharmacy or pharmaceutical science or medicine ( clinical pharmacology or microbiology). 2. Not less than 18 months experience in the manufacturing or testing of the substances specified in sch C. 3. Not less than 3 years experience in the inspection of firm manufacturing any of the substances specified in sch C.

TO INSPECT PREMISES MANUFACTURE BIOLOGICAL (VETERINARY)

1. A graduate in veterinary science or medicine or general science or pharmacy and 18 months experience in the manufacture or testing of veterinary biological. OR 2. A graduate in veterinary science or medicine or general science or pharmacy and 3 years experience in the inspection of firm manufacturing veterinary biological.

The aim of this course is to provide trainees with: - an awareness of methods for the detection of counterfeit pharmaceuticals - an understanding of the difference between counterfeit and substandard pharmaceuticals - the ability to evaluate the test data - the ability to distinguish between normal and suspect pharmaceuticals on the basis of physical aspects the ability to identify reports of adverse effects or lack of efficacy that might result from the use of counterfeit pharmaceuticals

- the ability to justify their actions in the legal context of detection and prosecution including the prosecution of offenders, independently, if so authorized, or by the appropriate authority - an awareness of methods of making the legitimate distribution system secure, e.g. by a system of warranty or, for international trade, by compliance with the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (76) - a knowledge of how to share information, coordinate and collaborate with all concerned in combating counterfeit pharmaceuticals.

The aim of this course is to provide trainees with: - an awareness of the importance of examining suspect pharmaceuticals in order to facilitate the inspector's decision whether or not to act - sufficient knowledge and skills to examine counterfeit pharmaceuticals - an understanding of the difference between counterfeit and substandard drugs - knowledge of the value and limitations of techniques for rapid examination, and the ability to make rational decisions about their use - the ability to justify legal action in the context of detection and prosecution.

1. Theoretical and background information by lecturers. 2.Practical and field work. 3.Discussion of case studies. 4.Organoleptic inspection of products.

Training on inspection depends on local situation and it lasts for 1 week. Training on examination consists 10 days. - introduction (1-2 days) - theory (1-2 days) - practical work in the laboratory and field, if necessary on various dosage forms (4 days) - preparation of a summary and reporting (2 days).

1. Inspect any premises where drugs or cosmetics being manufactured or sold. 2. If biological product then he should check plant, process and testing. 3. Take samples of drugs or cosmetics which are being manufactured or sold. 4. Enter and search any premises in which an offence is believed to be committed. 5. Examine and seize any records, registers and documents. 6. Search any person, who he has reason to believe has secreted about any drug or cosmetic in respect of which an offence is being committed, stop and search any vehicle, vessel, or other conveyance used for carrying any drug or cosmetic in respect of which an offence is being committed.

1. Whenever inspector take samples of drugs, he should inform the purpose in writing in the prescribed form no 17. 2. He shall tender the fair price in cash or credit. 3. If price is not accepted he should tender a receipt in prescribed form no 16. 4. Divide the sample. a. In 4 parts if sample is taken from sales premises. b. In 3 parts if sample is taken from manufacturing premises. c. If small container is likely to deteriorate, the inspector may take 3 or 4 such containers.

5. Each part or container sealed and marked. 6. Allow the person to add his mark or seal to such parts or containers. 7. 1 part or container of the sample sent to the government analyst, 2nd is reserved for the court, 3rd is sent to warrantor and 4th returned to person from whom sample is taken. 8. Sample sent to government analyst by registered post or personally. 9. After the report of analysis has been received from government analyst, dug inspector will decide any further action.

For import : central government For manufacture and sale : state government

1. A graduate in pharmacy or pharmaceutical chemistry or medicine (clinical, pharmacology, microbiology. 2. 5 years experience in manufacture or testing of drug or enforcement of the act.

Appointed by: 1. State government 2. Central government Qualification: 1. Graduate in pharmacy or pharmaceutical chemistry or medicine or microbiology. 2. 5 years experience in the manufacture or testing of drugs or enforcement of the act.