Self inspection of Medical Store

Self inspection / audit of Drug sale unit
(Retail and / or Wholesale units)

Abbreviations:
RSDL: Retail Sale Drugs License
WSDL: Whole Sale Drugs License
RP: Regd. Pharmacist
EP: Experience Person
RMP: Regd. Medical Practitioner
DCO: Drugs Control Officer
NSQ: not of std. quality
CS: Civil Surgeon
TB: Tuberculosis

Self inspection / audit of the drug sale units (RSDL and or WSDL) is suggested for the assessment of the working of the firm, whether the firm is working as per the Drugs and Cosmetics Act 1940 and Rules framed thereunder or not.

Self inspection / audit should be conducted periodically by the Prop. / Partners / Directors and / or Regd. Pharmacist or Experience Person of the firm.

The improvement or rectification should be done immediately as per the observations during self inspection / audit. Here is the checklist for self inspection / audit for RSDL and or WSDL:

To read the web news click below link

Self audit of Medical Store :105 points

Checklist for Self inspection / audit of Drug sale unit Retail and / or Wholesale units
Date …………………..
Done by ………………
Sr. No.Checklist pointsObservations
1Distt. 
2Name of the firm 
3Address of the firm 
4License No. of the firm 
5License granted onDated ………..
6Validity of the licenseDated…………
7License Retention fee submitted (If due) (Submit license retention fee within time)Yes / No
8Proof of license Retention fee submission kept (Proof of License retention fee must be kept in record)Yes / No
9Constitution of the firmProprietorship / Partnership / Pvt. Ltd. / Ltd firm
10Any change in constitutionYes / No

.

11Have you applied for new license due to change in constitution in time (If constitution changed) (Apply for change in constitution within 90 days)Yes / No / NA
12Name(s) of Prop. / Partners / Directors of the firm 
13Name of the responsible person of the firm 
14Have you changed the premises without obtaining fresh license (Obtain fresh license before changing the premises)Yes / No
15File regarding correspondence with Drug department is maintained (Maintain file of correspondence drug department. e.g. Letters, Notices and circular etc.)Yes / No
16Whether licenses of the firm ever suspended or partially cancelled (Obey Drugs and Cosmetics Rules)Yes / No
17Whether sign board of name of the firm displayed (Display sign board with name of the frim)Yes / No
18Whether “Chemist and Druggist” written on the sign board (“Chemist and Druggist” must be written on sign board)Yes / No
19Whether Drug License displayed at a prominent place (Display drug license at the prominent place)Yes / No
20Name of Regd. Pharmacist (RP / EP) of the firm 

.

21Regn. Number of RP 
22Validity of Regn. of RP (Validity of Regn. Certificate of RP must be up to date) 
23Whether Regn. Certificate of RP displayed (You should display Regn. Certificate of RP)Yes / No
24Joining date of RP 
25Whether any change in RPYes / No
26Resignation date of RP (If resigned) 
27Whether new RP appointed (If resigned)Yes / No
28Whether information of change in RP has been given to department within one monthYes / No
29If yes, date of appointment of new RP 
30Name of new RP 

.

31Regn. Number of RP 
32Validity of Regn. of RP 
33Whether Gap is there between resigning and joining of new RP, if anyNo, if yes ……days
34If yes, sale /purchase of drugs between gap period (No sale / purchase of drug be done in the absence of RP)Yes / No
35Whether dust free environment is maintained in the premises (Keep your premises neat and clean)Yes / No
36Whether purchase record of drugs is maintained properly (Maintain purchase record of every drug properly)Yes / No
37Whether purchase record  is maintained in chronological order (Maintain purchase record in chronological order)Yes / No
38Whether drugs are purchased from licensed dealers (Always purchase the drugs from licenses dealers only)Yes / No
39Whether purchase invoices bear all the mandatory details (Purchase invoice should have all mandatory details of drug)Yes / No
40Whether drugs are being sold under the personal supervision of RP (Sale of drugs must be in the personal supervision of RP only)Yes / No
41Whether drugs are being sold on the prescription of RMP (Sell the drugs on the prescription of a RMP)Yes / No
42Whether substituting the prescription of RMP (Do not substitute the prescription of RMP)Yes / No
43Selling of drugs on price more than MRP (Do not sell the drugs on the price more than MRP)Yes / No
44Sale records of drugs maintained (Maintain sale record of the drugs)Yes / No
45Sale records maintained in legible manner (Maintain sale record of the drugs in legible manner)Yes / No
46Name and address of prescriber mentioned (Mention name and address of prescriber)Yes / No
47Name and address of patients mentioned (Mention name and address of patient)Yes / No
48Sale record is having all other mandatory details ? (sale record of drugs should have all mandatory details)Yes / No
49Sale invoice signed by RP (sale invoices must be signed by RP)Yes / No
50Schedule-H1 register maintained (Maintain Schedule-H1register)Yes / No

.

51Full time electricity supply (Full time electricity supply must be ensured to maintain desired temperature of the drugs)Yes / No
52If not, Generator maintained (Full time electricity supply must be ensured to maintain desired temperature of the drugs)Yes / No
53Direct Sun light on the drugs (Drugs should not be exposed to direct sunlight)Yes / No
54Refrigerator maintainedYes / No
55Whether adequate gap is there between wall and refrigerator (maintain adequate gap between wall and refrigerator)Yes / No
56Refrigerator is in working condition (Refrigerator must be in working condition)Yes / No
57Temperature of refrigerator is maintained (Temperature of refrigerator must be maintained)Yes / No
58Stocking the drugs in refrigerator which do not require storage of refrigerator (Do not stock drugs in refrigerator which do not require storage of refrigerator)Yes / No
59Stocking the drugs in refrigerator which require storage of refrigerator (Stock drugs in refrigerator which require storage of refrigerator)Yes / No
60Whether food items are stored in refrigerator ? (Do not stock food items in refrigerator)Yes / No

.

61Whether oily injections are stored in refrigerator ? (Do not stock oily injections in refrigerator)Yes / No
62Switching off the refrigerator in the night (Do not switch off the refrigerator in the night and maintain desired temperature of the drugs)Yes / No
63Air conditioner / Cooler (Do not install cooler, however air conditioner is advisable to maintain the temperature of drugs) 
64Stocking the drugs in its original containers (Always stock the drug in the original container of that drug)Yes / No
65Stocking the drugs in racks (Retail) raised platforms (Wholesale) (Stock the drugs in racks or raised platforms)Yes / No
66Stocking the drugs on floor (Do not stock the drugs directly on the floor)Yes / No
67Homeopathic medicines stocked separately (Stock the homoeopathic medicines separately)Yes / No
68“Homeopathic medicines” written on the rack (write “Homeopathic medicines” on the rack)Yes / No
69Ayurvedic medicines stocked separately (Stock the Ayurvedic medicines separately)Yes / No
70“Ayurvedic medicines” written on the rack (write “Ayurvedic medicines” on the rack)Yes / No

.

71Veterinary drugs stocked separately (Stock the Verinary drugs separately)Yes / No
72 “Veterinary drugs Not for human use” written on the rack (write “Veterinary drugs Not for human use” on the rack)Yes / No
73Expiry drugs found stockedYes / No
74If yes, expiry drugs kept separately (Stock Expired drugs separately away from the trade stock)Yes / No
75“Expired dated drugs Not for Sale” written on the rack (Write “Expired dated drugs Not for Sale” written on the rack)Yes / No
76Correspondence with dealers regarding expired drugs (Correspondence with dealers regarding expired drugs must be done)Yes / No
77Sch-X drugs found stocked (License must be taken before dealing in Schedule-X drugs)Yes / No
78“Physician samples not for sale” found stocked (Do not stock and sell “Physician samples not for sale”)    Yes / No
79“Hospital supply drugs not for sale” found stocked (Do not stock and sell “Hospital supply drugs not for sale”)Yes / No
80Misuse of Intoxicating drugs (Never sell intoxicating drugs without prescription of a RMP, it may be misused)Yes / No

.

81Vet. Oxytocin Injection found stocked (Stock and sell Vet. Oxytocin Injection in single blister pack only)Yes / No
82Diclofenac Injection for veterinary use found stocked (Do not Stock and sell Diclofenac Injection for veterinary use and it should not more than 10ml vial)Yes / No
83MTP Kit (MTP kit is to be used under the supervision of a service provider and in a medical facility as specified under MTP Act 2002 and MTP Rules 2003) 
84Sildenafil Tablets (Sildenafil tablets are to be sold on the prescription of Urologist / Psychiatrist Endocrinologist / Venereologist / Dermatologist only) 
85Are Infant food displayed (Infant food should not be displayed)Yes / No
86‘Banned Nail Polish Remover’ found stocked (Do not stock and sell ‘Banned Nail Polish Remover’)Yes / No
87“Banned drugs” found stocked (Never stock and sell ‘Banned drugs’Yes / No
88Whether you sell TB drugsYes / No
89If Yes, whether you are reporting about TB patient to Civil Surgeon. (You should report details of the TB patient to CS)Yes / No
90“Without invoice drugs” found stocked (Purchase of drugs with invoice only)Yes / No

.

91Whether Essential Narcotics Drugs stocked ?Yes / No
92Whether Essential Narcotics Drugs stocked ?Yes / No
93If yes, whether you have obtained license on Form-24 ? (Obtain license on Form-24 before stocking and selling of Essential Narcotics Drugs)Yes / No
94Dustbin kept for “Clean India Project” (Keep a dustbin and keep India Clean)Yes / No
95Date of last inspection done by Drugs Control Officer 
96Whether samples have been withdrawn by DCOYes / No
97What was the result of sampled drugStandard / NSQ
98Copy of last inspection kept (Copy of inspection report must be kept)Yes / No
99Hydroxychloroquine is in Schedule-H1 now (Maintain schedule-H1 record for this drug)To download the notification, click here.
1002ply, 3ply surgical masks, N95 masks and hand sanitizers are under Essential Commodities Act 1955 up to 30-06-2020To download the notification, click here.

.

101Retail prices of 2ply, 3ply surgical mask and Hand sanitizer are fixed upto 30-06-20202ply surgical mask- not more than Rs. 8/- per piece 3ply surgical mask- not more than Rs. 10/- per piece Hand sanitizer – Rs. 100/- per bottle of 200ml To download the notification, click here.
102Is sale license is required for stocking and selling of hand sanitizer ?Yes
103Is sale license is required for stocking and selling of hand cleanser / Rub / wash ?No
104Door step delivery of drugsGovt of India has issued notification No. G.S.R. 220 (E ) dt. 26-03-2020 regarding the door step delivery of drugs. To download the notification, click here.
105Sale of some drugs without prescription of RMP and without supervision of Registered Pharmacist.Drugs which are not covered under Schedule H, H1, G, X, nRx, can be sold without prescription of RMP and without supervision of Registered Pharmacist.

.

Sign

Date

Name

Prepared by
Rakesh Dahiya
SDCO, FDA Haryana

To download the self inspection performa click below link