Food and Drugs Administration, Haryana, India |
Email ID: naripengoyal@gmail.com
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Last Updated on January 19, 2021 by The Health Master
INSPECTION of a Sale & Distribution Premises
Under the Drugs and Cosmetics Act 1940 and Rules hereunder, a Drugs Inspector who has been appointed and notified under section 21 of the Act is authorized to carry out inspection of a premises where drugs & Cosmetics (as defined in the Act ) are being, imported, manufactured for sale and / or being sold, distributed exhibited for sale, offered for sale. The premises may be licensed or not licensed under the Act, in the area under his Jurisdiction.
The purpose of such inspection by Drugs Inspector is to discharge the duties (legal) cast upon him to enable the Government to regulate the import, manufacture, distribution and sale of drugs and Cosmetics.
The powers to regulate import drug / cosmetics under Chapter III of the Act have been retained by the Central Government but when these are in sales premises in India, then State as well as Central Government Drugs Inspector can exercise their power under the Act in their respective Jurisdictional area.
Inspection involves, examining and investigating, anything or matter.
Essentially visit of site is required.
How to obtain drug sale license, click here
Pre- requisites to inspection
-Notification of the Inspector under section 21 of the Act and its publication in official Gazette.
-Defined area of Jurisdiction
-Planned and unbiased approach
Equipped with accessories and aids to carryout inspection, to take samples of drugs/cosmetics, to seize materials including drugs/cosmetics/ documents and any other material, machine, equipment, vehicles connected with the offence and essential as evidence to be produced in court of law and to prevent continuation of offences under the Act.
Blank but printed stationery to document the activity at the site of inspection which are given in Schedule A under Rules to the Act. Normally Form 35 for inspection, Form 15, From 16, Form 17, form 17A must be available with the Drugs Inspector. Sealing wax is indispensable while taking samples or seizing drugs/cosmetic or any article or premises.
An energetic personality, knowledge and keen desire without any bias attitude are the strength of drugs inspector authorized under the Act. Cool and balance mind always lead to success.
HOW TO CARRY OUT INSPECTION OF A DRUG / COSMETICS SALE PREMISES.
Be conversant with law that licences are granted to legal entity on a premises or vehicle.
Be conversant the Drugs Inspector is empowered to enter any premises and search without any issue warrant from a Magistrate. Restriction of timings and places with in his jurisdictional are with reasons of belief of fact that some offence is being committed in that premises.
For inspection of licensed premises no such reason or belief is required and inspection of such premises at regular intervals but at least once in a year is part of duty. There is no bar as to the frequency of inspection yet it must always be either part of duty under the Act or Instruction of Controlling Authority or his personal knowledge regarding any contraventions under the Act.
INSPECTION OF A LICENSED SALE PREMISES: –
Approach to a premises be made in a cool confident manner suitable to the responsibility and authorization under the Act.
Take note of location, surrounding shops or ground, any heaps or discarded carons, etc. Also note the board of display of name of the premises and take note any obnoxious display.
Approach sale counter and address to person appearing to be in-charge or employee but not the customer as revealed by verbal enquiry. Determine the person in-charge and disclose own (Drugs Inspector) identity. Introduce identity of any Superior Officer or member of team accompanying. Tell purpose of visit.
Use Form 35 prescribed for noting down Observations (adverse) systematically revealing any contraventions under section 18(c), under Rule 65 and any other provisions of the Act and Rules. Prepare three copies. One copy to be delivered to the in-charge of premises after inspection is completed along with form 17, Form 17A, Form 16 and Form 15 if prepared as per Act. Second copy is to be sent to Licensing Authority. Third Copy is to be retained by the Drugs Inspector in his office record.
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Look for Displayed licenses which should be visible without asking for it. Check the presence of Registered Pharmacist or Competent person. There can be Licenses for Retail sale or for wholes of drugs licenses with respect to Modern drugs (API & Medicines) (allopathic) or Homoeopathic medicines.
No sale licenses are required for Ayurvedic drugs and Cosmetics. For Inspection sampling and seizure related to Ayurvedic drugs separate authorization by the Government under Chapter IVA is required.
Check validity date as revealed by license or license retention certificate. Check name and identity of Registered Pharmacist and observe his supervision over retail sale of schooled drugs and sale on prescription. Corroborate with sales record. Look for contraventions as per Rule 65.
Check purchase record and any contraventions under Rule 65.
INSPECTING DRUGS / COSSMETICS SAMPLING THEREOF in the premises :-
Take drug sample of drugs within expiry period. However there is no bar if the material is required as evidence in ascertained prosecution to certain point for serious offence, on in case of adulterated drug falling under S 27(a) of the Act. Follow procedure of sample as given under the Act and Rules.
Determine which drug is to be sampled. Read its label completely. Look for manufacturing license no. Expiry date must have sufficient interval of time left to complete testing by Government Analyst, Disclosure under section 18A, Investigation with manufacturer, Handing over of Test report and sample portion of the sampled drug to its disclosed ( u/s 18A) manufacturer and still permitting at least 28 days to manufacturer and further period to launch prosecution and get the second sample portion sent to CDL through Court in case manufacturer notifies his intent to do so under section 25 of the Act.
It will ensure success of the case in the court of law. While taking sample for test ad Analysis its mandatory to write details on prescribe Dorm 17, of which on copy has to be given to the person from whom sample is taken on the spot. Therefore, note any abnormality in label content, container in Form 17 and Inspection report which may support in proving and offence. Every care full sampling ensures that prosecutions in matter of any quality of identity of product manufacturer issues succeed in court.
Quantity of sample to be taken should be as per section 23 and personal technical knowledge defendable by official books. Although not mentioned in the Act but it will not be against law to obtain signature of the person from whom sample is taken, on each document prepared on the spot and acknowledgment of price paid, copy of any document handed over to him. No witnesses of the locality are required to be associated for sampling of drug following procedure given under the Act.
However if sampling is done form a premises or person or vehicle having no licenses issued to them, two persons of the locality near to the shop should be joined in the complete process carried in the premises, with their identity. In case of refusal by natural witness, the fact should be noted in Form 17, Inspection report and every document prepared on the spot. Refusal by the person in- charge of the premises does not obstruct or dilute the prosecution in any way. Drug samples bearing label requiring storage in cold place ( mean temp 2 to 8 degree C) after sampling must be kept and carried in ice pack holding vaccine carrier ( box with thermometer inserted.
It should be stored in office at the above mentioned temperature. Sample portion should also be sent to laboratory through special messenger and a certification should be obtained that it was found to be at cold storage when received by the Government Analyst. Any other drugs be sent and sent protected from any excessive heat. Drug sample can only be sent to Government Analyst by Registered Postal Parcel or by special messenger by hand. It should never be sent by Railway Parcel.
Out of the four portions of single drug sample quantity four portions are made, sealed and marked. One portion is handed over to in charge from whom sample was taken, one portion is sent to Govt Analyst and two portions are retained. Out of two remaining portions with the Drugs Inspector, one portion is given to the last disclosure under section 18A (disclosed Manufacturer).
The last remaining portion which has been termed as Second portion is to be produced before the trial court as evidence and it can be sent to Central Drug Laboratory (CDL) if any of the person in chain (usually and naturally disclosed manufacturer) has notified his intent under section 25 to the drugs Inspector of the court before which the matter is pending.
Inspect storage conditions, orderly storage arrangement, storage or any activity of any material detrimental to the quality drugs. Stacking of drugs box one over the other or any stocking of labels printed cartons, packaging of sellable units to alter original pack, any device to batch code etc should be carefully ruled out.
Look for complete compliance under Rule 65, Rule 96, Schedule P, Rule 105 etc. Special Attention is required for drugs covered under NDPS Act, and Scheduled drugs, un-labelled drugs, short time storage of expired drugs intended to be returned, Physicians Sample Government supplies and orders from Registered Medical Practitioner for supplies to them, sale by retail sale in wholesale shops and vice versa.
In unlicensed shops identity proof of persons involve should be gathered on the spot and evidence collected.
The infrastructure of the shop must be of proper quality s not to affect the quality of the drugs adversely.
THE DRUGS INSPECTOR IS CUSTODIAN OF QUALITY OF DRUGS AVAILABLE IN THE MARKET AND IS UNDER OBLIGATION TO MAKE ONLY QULAITY DRUG PRODUCTS AVAILABLE TO EACH AND EVERY ONE.
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