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Last Updated on January 28, 2023 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 the Drugs and Cosmetics Act 1940, and the Rules framed thereunder.
Here is a list of records/documents all the medical stores/pharmacies (retailers or 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 during the granting of the license. Keep a copy of the retail sale drug licenses / wholesale drug licenses in the file.
- Inspection record: Keep copies of all inspections done by the Drugs Control Officer in your area.
- Registered Pharmacist (RP): Keep copies of all the documents of the Registered Pharmacist i.e. Regn. Certificate, i.e., registration certificate, qualification certificates, and address proof.
- Change of Registered Pharmacist (RP): Keep copies of all the documents regarding the change of RP. 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 the refrigerator
- Purchase records of drugs: Maintain purchase files and keep all the purchase invoices of drugs in chronological order. Keep payment records of drugs. Keep a transportation record of drugs.
- Sale records of drugs: Maintain sale records of drugs by means of an invoice book having all the details as per the Act. The sale of scheduled drugs must be under the personal supervision of a registered pharmacist. Maintain sales records in a legible manner.
- Schedule-H1 register: Maintain schedule-H1 register for Schedule-H1 drugs
- TB Drugs record: Keep all the sales records of the TB drugs, as per the directions of the drug department. or health authorities. i.e., details of the patients and details of drugs given. Send the required details to the authorities from time to time.
- NDPS Drugs record: Keep all the sales records of the NDPS drugs, as per the directions of the drug department.
- Expiry drugs: Keep a record of expired drugs, i.e., correspondence with the dealer for returning the expired drugs.
- Returned drugs: Keep a record of drugs returned, i.e., correspondence with the 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 sunlight.
- Always purchase the drugs with an invoice from licensed dealers.
- Don’t stock and sell physician samples.
- Don’t stock and sell hospital supply drugs.
- Don’t misuse intoxicating drugs.
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