- Procedure to obtain license for manufacturing of Cosmetics - August 22, 2021
- Procedure to obtain license for manufacturing of drugs - July 22, 2021
- Procedure to obtain license for Medical Store / Pharmacy - July 18, 2021
Last Updated on April 6, 2021 by The Health Master
Record keeping for Medical Store / Pharmacy
The Act: Drugs and Cosmetics Act 1940, and Rules framed thereunder
RSDL: Retail Sale Drugs License
WSDL: Whole Sale Drugs License
RP: Regd. Pharmacist
EP: Experience Person
NSQ: not of std. quality
CS: Civil Surgeon
DCO: Drugs Control Officer
All the medical stores / pharmacies (Retailers / Wholesalers) have to maintain the various records as per Drugs and Cosmetics Act 1940, and Rules framed thereunder. Here are list of records / documents all the medical stores / pharmacies (Retailers / Wholesalers) have to maintain / keep in the premises. They have to produce the said records / documents before the notified Inspector when asked:
- Drug file: Maintain a drug file Keep all the correspondence in the drug file. Correspondence with drug authorities. License retention fee record Records of change in constitution or change in premises, if any. Inspections records
- Correspondence file: Maintain a correspondence file and keep all correspondence with dealers in this file.
- Drug license: Keep copies of all the documents submitted while grant of license. Keep copy of the retail sale drugs licenses / whole sale drugs licenses in the file.
- Inspection record: Keep copies of all inspection done by Drugs Control Officer of your area.
- Registered Pharmacist (RP): Keep copies all the documents of Registered Pharmacist i.e. Regn. Certificate, Qualification Certificates, address proof.
- Change of Registered Pharmacist (RP): Keep copies of all the documents regarding change of RP . i.e Application to Drug Department having the details and dates of relieving of previous RP and joining of new RP, Copy of Regn. Certificate, Qualification Certificates, address proof.
- Refrigerator: Purchase invoice of refrigerator
- Purchase record of drugs: Maintain a purchase files and keep all the purchase invoices of drugs in chronological order. Keep payment records of drugs. Keep Transportation record of drugs.
- Sale records of drugs: Maintain sale records of drugs by means of invoice book having all the details as per the Act. Sale of scheduled drugs must be in the personal supervision of Registered Pharmacist. Maintain sale records in legible manner.
- Schedule-H1 register: Maintain schedule-H1 register for Schedule-H1 drugs
- TB Drugs record: Keep all the sale records of the TB drugs, as per the directions of Drug department. Or Health authorities. i.e details of the patients and detail of drugs given. Send the required details to authorities time to time.
- NDPS Drugs record: Keep all the sale records of the NDPS drugs, as per the directions of Drug department.
- Expiry drugs: Keep record of expiry drugs i.e correspondence with dealer for returning the expired drugs
- Returned drugs: Keep record of drugs returned i.e correspondence with dealer for returning the expired drugs
- Suspension of licenses: Keep records of suspension of licenses, if any.
- NSQ drug: Keep records of NSQ drugs (sampled from the medical store and declared by Govt. Analyst) if any.
- Always stock the drugs properly in racks and avoid direct sun light.
- Always purchase the drugs with invoice from license dealer.
- Don’t stock and sell Physician samples.
- Don’t stock and sell hospital supply drugs.
- Don’t misuse of intoxicating drugs.
How to obtain retail drug license, click here
How to obtain Jan Aushadhi License, click here
How to change pharmacist at medical store, click here
Good storage practice of medicines at Medical Store, click here
Record keeping for Medical Store / Pharmacy, click here
Self inspection of Medical Store :105 points, click here