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Prepared by: Nidhi PatelRoll no : 117College : KBIPERDepartment: Regulatory

Affairs

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Definition:person appointed for the analysisand testing of samples of drugs and cosmetic undersec 20 ( 33-F in relation to ayurvedic , siddha andunani drugs) of the drugs and cosmetics act , inrelation to any drug or cosmetic by the centralgovernment or state government.

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1. This department is the central druglaboratory.

2. Established in 1904.3. Two divisions4. Food science- provides services towards public

health5. Forensic science- provides services to law

enforcement authorities in the area of crimeinvestigation.

6. Government analysts are specially trainedscientists who do analysis and examination ofsamples.

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1. Analyze the samples of drugs and cosmeticssent 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 analysisprescribed for the particular drug.

5. Finally conclusion should be there.

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1. Graduate in medicine or science or pharmacy orpharmaceutical 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 possessesthe associate ship diploma of the institution of chemists

obtained by passing the exam with Analysis of drugsand pharmaceuticalsas 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 OTHER THAN SCH C/C1 :

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: 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 appointingauthority for a period of not less than 6 months.

3. If a person doesnt have degree in above subjects shouldhave experience or training in testing of schedule C drugsfor a period of not less than 3 years or have completed 2years training on testing of schedule c drugs in centraldrugs laboratory.

4. No person who is engaged directly or indirectly in any tradeor business connected with the manufacturer of drugs shallbe appointed as a government analyst.

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1. A graduate in veterinary science or generalscience or medicine or pharmacy.

2. A postgraduate in veterinary science orgeneral science or medicine or pharmacy orpharmaceutical chemistry.

3. At least 3 years experience of testing.

FOR ANALYSIS OF BIOLOGICAL FORVETERINARY USE:

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1. The portion of the sample sent to gov analyst

by drug inspector through registered post orby hand in a sealed packet with a

memorandum in form 18.2. Gov analyst examine the condition of thepacket.

3. Test or analysis has been done on sample.

4. Report in triplicate in form 13 of the resultof the analysis with full protocols of theanalysis applied should be submitted to druginspector.

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1. Pharmacopoeial drug method of test prescribed in pharmacopoeiafollowed references to the specific tests in the pharmacopoeiashould be given.

2. Patent or proprietary medicines method of test prescribed inpharmacopoeia followed references to the specific tests in the

pharmacopoeia should be given.3. Patent or proprietary medicines containing pharmacopoeial drugs method of assays are modified and applied a description of actualmethod and applied method should be given.

4. Patent or proprietary medicines no pharmacopoeial methods of

analysis are available or methods given in standard books orjournals are followed description of applied method of analysiswith references to the relevant books or journals should be given.

5. Drugs methods of test are not available methods are evolved bythe gov analyst description of the applied test should be given.

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Application for test or analysis: form 14-A

Report of test or analysis : form 14-B

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DEFINITION:inspectors appointed undersec 21 of the ( 33 G in relation toayrurvedic , siddha and unani drugs) drugsand cosmetic act in relation to any drug or

cosmetic by the central government or stategovernment and assign them definite area.

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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 financialinterest in the import, manufacture or sale ofdrugs and cosmetics.

7. All drug inspectors are public servants within themeaning of Indian penal code.

8. Inspectors are required to keep all informationsconfidential and not to disclose.

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Classified under two categories:

1. Inspection of premises, licensed for the sale of

drugs.

2. Inspection of premises licensed for themanufacture of drugs and cosmetics.

(RULE 51)

(RULE 52)

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1. To inspect not less than once a year all shops within thearea 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.

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1. To inspect not less than once a year allmanufacturing premises within the area allottedto him.

2. If the manufacturer manufacturing biologicaldrugs, inspect plant, process, standardizing, andtesting of drugs and method of storage andtechnical 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.

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(RULE 49)

1. A degree in pharmacy or pharmaceutical science ormedicine ( clinical pharmacology or microbiology).

2. Not less than 18 months experience in themanufacturing or testing of the substances specified

in sch C.3. Not less than 3 years experience in the inspection offirm manufacturing any of the substances specifiedin sch C.

TO INSPECT PREMISES MANUFACTURE OTHER THANBIOLOGICAL AND PREMISES MANUFACTURE BIOLOGICAL.

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TO INSPECT PREMISES MANUFACTURE BIOLOGICAL (VETERINARY)

1. A graduate in veterinary science or medicineor general science or pharmacy and 18 months

experience in the manufacture or testing ofveterinary biological. OR

2. A graduate in veterinary science or medicineor general science or pharmacy and 3 yearsexperience in the inspection of firmmanufacturing veterinary biological.

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The aim of this course is to provide trainees with:

- an awareness of methods for the detection of counterfeitpharmaceuticals

- an understanding of the difference between counterfeit andsubstandard pharmaceuticals

- the ability to evaluate the test data

- the ability to distinguish between normal and suspectpharmaceuticals on the basis of physical aspects the ability toidentify reports of adverse effects or lack of efficacy that mightresult from the use of counterfeit pharmaceuticals

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- the ability to justify their actions in the legal context ofdetection and prosecution including the prosecution of offenders,

independently, if so authorized, or by the appropriate authority

- an awareness of methods of making the legitimate distributionsystem secure, e.g. by a system of warranty or, for internationaltrade, by compliance with the WHO Certification Scheme on the

Quality of Pharmaceutical Products Moving in InternationalCommerce (76)

- a knowledge of how to share information, coordinate andcollaborate with all concerned in combating counterfeitpharmaceuticals.

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The aim of this course is to provide trainees with:- an awareness of the importance of examining suspectpharmaceuticals in order to facilitate the inspector's

decision whether or not to act- sufficient knowledge and skills to examine counterfeitpharmaceuticals- an understanding of the difference betweencounterfeit and substandard drugs

- knowledge of the value and limitations of techniquesfor rapid examination, and the ability to make rationaldecisions about their use- the ability to justify legal action in the context ofdetection and prosecution.

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1.Theoretical and background informationby lecturers.

2.Practical and field work.3.Discussion of case studies.4.Organoleptic inspection of products.

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Training on inspection depends on local situation andit 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, ifnecessary on various dosage forms (4 days)

- preparation of a summary and reporting (2 days).

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1. Inspect any premises where drugs or cosmetics beingmanufactured or sold.

2. If biological product then he should check plant, processand testing.

3. Take samples of drugs or cosmetics which are beingmanufactured 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 hassecreted about any drug or cosmetic in respect of whichan offence is being committed, stop and search anyvehicle, vessel, or other conveyance used for carryingany drug or cosmetic in respect of which an offence is

being committed.

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1. Whenever inspector take samples of drugs, he should informthe 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 inprescribed 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 maytake 3 or 4 such containers.

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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 thegovernment analyst, 2nd is reserved for the court, 3rdis sent to warrantor and 4th returned to person fromwhom sample is taken.

8. Sample sent to government analyst by registeredpost or personally.

9. After the report of analysis has been received fromgovernment analyst, dug inspector will decide anyfurther action.

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For import : central government

For manufacture and sale : stategovernment

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1. A graduate in pharmacy or

pharmaceutical chemistry or medicine(clinical, pharmacology, microbiology.

2. 5 years experience in manufacture ortesting of drug or enforcement of the

act.

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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.

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