management of community and hospital pharmacies as per the provisions contained in the Drugs and cosmetics Act and Rules created by M R Pradeep.M.Pharm Retired Deputy Drugs Controller,Kerala for the new comers in the field of retail pharmacy

1. M . R . P R A D E E P . M . P H A R M
D E P U T Y D R U G S C O N T R O L L E R
G O V E R N M E N T O F K E R A L A
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MANAGEMENT OF GENERIC
DRUGS STORES

2. DRUGS
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 All Medicines For Internal Or External Use Of
Human Beings / Animals
 All Substances/Devices Intended/Used For The
Diagnosis,treatment,mitigation Or Prevention Of
Any Disease Or Disorder In Humans/ Animals.
 All Substances(other Than Food) Intended To
Affect The Structure Or Any Function Of The
Human Body.
 Components Used To Make Drugs

3. APPROVED SYSTEMS OF MEDICINE
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 ALLOPATHIC/MODERN MEDICINE
 AYURVEDIC
 YOGA & NATUROPATHY
 UNANI
 SIDDHA
 HOMOEOPATHIC

4. GENERIC & BRANDED DRUGS
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 Any product that can be sold without a brand name
highlighting its chemical name without
advertisement
A proprietary drug with a trade name protected by a
patent(can be produced & sold by one company only)
is its branded one
When the patent protection expires, it can be
converted into the generic version.
less expensive than branded drugs
Generic drug is bioequivalent to the branded product.

5. DISCOUNTED SHOPS IN KERALA
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 KARUNYA COMMUNITY PHARMACY SERVICES
 NEETHI MEDICAL STORES
 MAVELY MEDICAL STORES
 HDC FAIR PRICE SHOPS
 JAN AUSHADHI STORES
 SEVANA MEDICAL STORES
 ASHWAS MEDICAL STORES
 VISWAS MEDICAL STORES

6. LAWS ON DRUGS
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 DRUGS & COSMETICS ACT 1940 & RULES 1945
 PHARMACY ACT 1948
 DRUGS & MAGIC REMEDIES (O.A) ACT 1954
 N.D.P.S ACT 1985
 D.P.C.O.2013(UNDER THE E.C.ACT)
 KERALA POISON ACT & RULES
 KERALA DRUGS & OTHER STORES
(UNLAWFUL POSSESSION ACT) 1971
 MEDICAL DEVICES CONTROL ACT 2013

7. DRUGS CONTROL IN INDIA
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 ENSURE QUALITY,EFFICACY,PURITY,SAFETY AND
AVAILABILITY AT A CONTROLLED PRICE
 REGULATE THE IMPORT,MANUFACTURE,
DISTRIBUTION,STORAGE,ADVERTISEMENT AND
SALE OF DRUGS.
SLA CONTROLS THE MANUFACTURE,SALE AND
DISTRIBUTION
DCGI APPROVES BLOOD BANKS,MFG OF
I.V.FLUIDS,VACCINE,SERA,MEDICAL DEVICES etc.
SLA ISSUES COSMETICS MFG.LICENCE

8. CDSCO
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 UNDER DGHS WITH DCGI AS HEAD AT DELHI
 APPROVE NEW DRUGS,CLINICAL TRIALS,
 FIX STANDARDS FOR DRUGS,CONTROL THE
QUALITY OF IMPORTED DRUGS,
 CO ORDINATES THE ACTIVITIES OF SLAs,
PROVIDE EXPERTISE FOR UNIFORM
ENFORCEMENT IN INDIA.
 ZONAL OFFICES AT
MUMBAI,KOLKATA,CHENNAI ,GHAZIABAD

9. STATE DRUGS CONTROL DEPT
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 HQ AT THIRUVANANTHAPURAM
 ZONAL A D C OFFICES AT
THIRUVANANTHAPURAM,KOLLAM,ERNAKUL
AM,THRISSUR,KOZHIKKODE & KANNUR.
 DISTRICT D I OFFICES AT
PATHANAMTHITTA,ALAPPUZHA,KOTTAYAM
IDUKKI, PALAKKAD,
MALAPPURAM,WYNAD,KASARAGOD
DTLs AT
THIRUVANANTHAPURAM,ERNAKULAM

10. LICENSING AUTHORITIES
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 DC FOR MANUFACTURING FIRMS, APPROVAL
OF BLOOD STORAGE CENTRES,DRUGS
TESTING LABORATORIES, RMIs FOR DEALING
NARCOTICS,E.C FOR NARCOTICS etc.
 ADC FOR DISTRIBUTION,STORAGE,SALES
,ISSUE OF NARCOTICS ALLOTMENTS TO
HOSPITALS,ISSUE OF POISON LICENCES AND
PERMITS etc.
 VISIT www.dckerala.gov.in for Details

11. MAJOR SALE LICENCES ISSUED
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 FOR RETAIL SALES IN FORM 20 & 21.
 FOR WHOLESALE IN FORM 20B & 21B
 FOR RESTRICTED DRUGS IN FORM 20A
 FOR WHOLESALE IN VEHICLES IN FORM 20BB
 FOR DEALING SCHEDULE X DRUGS
IN FORM 20 F (Retail) & 20 G (For Wholesale)

12. COMMUNITY PHARMACY
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 RETAIL SALES TO PATIENTS BASED ON THE
PRESCRIPTION OF RMPs.
 Must comply conditions in rule 64
 Must be under the control of A RP
 Must preserve the properties of the drugs with
adequate storage facility
 Must not dispense/compound drugs without
compliance of schedule N

13. MINIMUM REQUIREMENTS
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 A COMMERCIAL ROOM WITH A MINIMUM AREA
OF 10 m2 (OWNED/RENTED)
 ADEQUATE FLOORING & CEILING
 FULL TIME AVAILABILITY OF A REGISTERED
PHARMACIST
 COLD STORAGE FACILITY WITH MINIMUM 165
LITRE REFRIGERATOR
 STORAGE VOLUME OF 1.5 m3 EACH WITH
SHELVES WITH GLASS AND WOODEN SHUTTERS
 PERMANENT ELECTRIC CONNECTION

14. APPLICATION DOCUMENTS
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 CHALAN FOR Rs 3000/-
 APPLICATION FORM 19 /19A/19AA
 QUESTIONNAIRE,DULY FILLED IN.
 NOTARISED AFFIDAVIT IN Rs 50/-STAMP PAPER
 OWNERSHIP CERTIFICATE
 RENT AGREEMENT/RENT RECEIPT
 LATEST BUILDING TAX PAID RECEIPT

15. LIST OF DOCUMENTS (CONTD)
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 DECLARATION OF RP
 COPY OF PRC OF THE RP,DULY RENEWED.
 OPTION LETTER,TO MAINTAIN SALES BILLS
 COPY OF PHOTO I D CARD OF THE APPLICANT
 2 PP SIZE PHOTO OF APPLICANT
 DECLARATION OF PREVIOUS ACTIVITY
 COVERING LETTER WITH COURT FEE STAMP
 CONSTITUTION DETAILS,IF ANY.

16. PROCEDURE OF GRANT OF DL
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 SUBMIT APPLICATION ONLINE- in the site
xlnfda.kerala.gov.in
 Remit Fee in Head of Account -0210-04-104-99 for
grant/renewal of Drugs Licence
 SUBMIT HARD COPY THROUGH DI TO ADC for
verification & Site Inspection
 OBTAIN Firm I.D & PASSWORD FROM THE
OFFICE
 FURNISH ROOM AS SPECIFIED
 SITE INSPECTION BY DI & GRANT BY ADC

17. DOCUMENTS TO BE KEPT
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 OWNERSHIP CERTIFICATE FROM LSGD
 RENT AGREEMENT/RENT RECEIPT/BUILDING
TAX PAID RECEIPT
 LSGD LICENCE
 DRUGS LICENCES
 SALES TAX REGISTRATION CERTIFICATE
 LABOUR REGISTRATION
 SEPARATE KSEB CONNECTION
 UPDATED PRC OF THE RP IN ORIGINAL

18. BASIC AMENITIES TO BE ARRANGED
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 LEGAL DOCUMENTS TO RUN A PHARMACY
 PERMANENT ELECTRIC CONNECTION
 DISPLAY BOARDS
 LCD COMPUTERS
 TELEPHONE CONNECTION
 COUNTER
 STEEL ALMIRAH
 CASH CHEST
 DRINKING WATER & WASH BASIN
 PACKING MATERIALS

19. RECORDS TO BE KEPT
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 DRUGS LICENCES & PRC TO BE DISPLAYED
 PURCHASE RECORDS SERIALLY NO.& FILED
 SALES BILLS COPIES SERIALLY No & FILED
 INSPECTION BOOK IN FORM 35
 REGISTER FOR SCHEDULE H1 DRUGS
 PURCHASE REGISTER DATEWISE
 CORRESPONDENCE FILE WITH GOVT.&
OTHERS
 DETAILS OF DRUGS REFUNDED TO DEALERS

20. ESSENTIAL REQUIREMENTS
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 FULL TIME SUPERVISION BY RP
 SALES PERSONNELS WITH EXPERIENCE
 EASY ACCESSIBILITY OF DRUGS FOR ISSUE
 SUITABLE REFRIGERATOR IN WORKING
CONDITION
 ADEQUATE STORAGE FACILITIES WITHOUT
CONGESTION
 NEAT AND TIDY ROOM

21. ESSENTIALS
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 DEVOTED STAFFS FOR PROCUREMENT
STORAGE,INVENTORY CONTROL,
ARRANGEMENT,SALES,CUSTOMER CARE
 SUFFICIENT STOCK AS PER REQUIREMENT
 CAPITAL INVESTMENT TO MEET URGENCY
 ACCESS WITH DOCTORS/WHOLESALE
DEALERS/OTHER CHEMISTS
 GOOD CUSTOMER RELATIONSHIPS
 PRECISE HANDLING OF PRESCRIPTION

22. PERSONS TO CONTACT
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 PATIENTS
 CUSTOMERS
 RMPs
 DEALERS/AGENTS/ MSRs
 GOVT.OFFICIALS,ACCOUNTANTS
 SALESMEN,HELPERS
 FELLOW CHEMISTS
 KSEB/BSNL/COURIER/CHITTY PERSONS

23. MUST DO THINGS
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 Customer Friendly Attitude
 Precise & Speedy Handling Of Prescriptions.
Discourage Self Medication
 Issue Proper Sales Bills
 INSIST Valid PRESCRIPTION FOR SCHEDULED
DRUGS
 Check Present Price List And Printed Price Before
Sales & Storage
 Adopt Fifo/Fefo System Effectively
 Maintain Proper Storage Conditions

24. How to manage patients?
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 By proper handling of prescription
 Enquire about the present condition
 Narrate the contents of the prescription
professionally with knowledge and skill
 Give specific directions based on the prescription
 Label the medicine covers legibly
 Say few words on the safety aspects as per label
 Convince them that the drugs were supplied based
on the contents of the prescription

25. CATERING WITH GENERIC DRUGS
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 Compare the branded version with the generic one
 Convince that there is no change of molecule,
formulation, dosage, route of administration,
precautionary measures possible side effects and
drug interactions
 Calculate the difference in price of the brand and the
generic drug
 Consult a nearby physician if required to substitute a
branded prescription

26. STORAGE OF DRUGS
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 COLD STORAGE IN REFRIGERATOR
 WOODEN STORAGE FOR LABELLED DRUGS
 CONGESTION FREE STORAGE
 REGULAR CLEANING & EXPIRY CHECK
 STORAGE OF CONTROLLED DRUGS UNDER
LOCK AND KEY
 EASY STORAGE OF OTC & COMMON DRUGS
 STORE POTENT/VETERINARY DRUGS AWAY
 STORE VACCINES/SERA AT 2-8 Degree

27. ACTS TO REMEMBER
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 SEC:17 -Misbranded drugs
 SEC: 17A -Adulterated drugs
 SEC:17B - Spurious drugs
 SEC:18(a) (1) –prohibition to Mfre
/sell/stock/exhibit for sale
NSQ/misbranded/adulterated/spurious drugs
 SEC:18A-Every person shall disclose to the DI the
name,address & other particulars of the drug
 SEC:18 B-keeping of records,registers& documents
by licensee & shall furnish to DI

28. SAMPLING BY Drugs Inspectors
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 SEC-23 : procedure by DI.
 Issue Form 17
 Tender exact price to the party & get receipt
 Divide the sample into 4 portions, put seal & mark
 One portion return to the dealer
 One portion to Govt Analyst with Form 18
 One portion kept for producing before Court
 One portion to be sent to the party whose name was
disclosed under Sec 18-A.

29. IMPORTANT ACTS TO REMEMBER
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 Sec-26A- power of central govt. to ban a drug
 Sec-27- penalty
 (a)-for adulterated/spurious drugs-10yrs+10 lacs
fine
 (b) –adulterated/without DL-3-5 yrs+1 lac fine
 © - spurious under 17B-7 yrs-life+3 lacs fine
 (d)- other cases-1 yr-2 yrs +Rs 20000/-fine
 Sec 28A- penalty for not keeping records- same
 Sec 28-B-sales of banned drugs-3 yrs +Rs 5000/-

30. RULES TO BE NOTED FOR SALES
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 Rule 64- conditions for grant/renewal
 Area, storage conditions,RP/CP,previous activity etc.
 Rule 65- conditions of licence
 (1) compounding&
 (2)-personal supervision of RP only based on RMPs
 (3) (1)-prescription sales with records
 (a).sl.no (b)-Date,©-name & address of Dr.
 (d)- name & address of patient,(e)-name of drug
 (f)-mfrer name,batch no,expy (g)- signature of RP

31. RULES FOR ATTENTION
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 R-65(4)(1)- for sales of non prescription drugs
 R-65(4)(3)(ii)-keeping carbon copies of sales bills
 R-65 (4) (4) (i)- maintenance of purchase records
 R-65(4) (4) (ii)-Purchase bills in chronological order
 R-65(5)(2)-carbon copies to be kept for 3 yrs
 R-65(6)- supply of records & registers to DI
 R-65(9)(a)-sales without prescription of Sch H/X
 R-65(10)-prescription format with signature & date

32. RULE ON SUBSTITUTION
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 R-65(11) (a)- must not dispense more than once
 R-65(11) (b)- no.of times/intervals for dispensing
 R-65(11-A) no person shall supply any other
preparation than prescribed by a RMP
 R-65(16)- to maintain an Inspection book in Form35
 R-65(17)- no date expired drugs are sold/stocked
 R-65(18)-physicians samples shall not be stocked
 R-65(21)(a)- recording of sch.X drugs in register

33. CONDITIONS OF LICENCE
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 Display Of DL & PRCPromonently
 Report Change Of RP Within A Month
 Purchase Drugs Under Cash/Credit Memo From
Licensed Dealers Only
 Shall Comply The D & C Act & Rules
 Shall Obtain Fresh DL Within 90 Days From Change
Of Constitution
 Apply For Renewal Of DL On Time

34. COMMODITIES SOLD
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 DRUGS
 SURGICALS
 COSMETICS
 MEDICAL DEVICES,
 DIAGNOSTIC CHEMICALS & REAGENTS
 AYURVEDIC /SIDDHA/UNANI DRUGS
 NUTRITIONAL SUPPLEMENTS
 PERSONAL HYGEINE PRODUCTS

35. DRUGS INSPECTORS
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 APPOINTED U/S 21 OF THE D & C ACT 1940
 THROUGH A GAZETTE NOTIFICATION
 INSPECTION OF LICENSED PREMISES
 SAMPLING OF DRUGS & COSMETICS
 ENTER & SEARCH ANY PLACE
 STOP & SEARCH ANY VEHICLE
 INITIATE PROSECUTION ACTION UNDER CODE
OF CRIMINAL PROCEDURE

36. COMPLIANCE AFTER DL
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 FULL TIME PRESENCE &SUPERVISION OF RP
 MAINTAIN PROPER PURCHASE,SALE
RECORDS.check batch no.before stocking.
 KEEP BILLS SERIALLY NUMBERED & FILED
 KEEP REGISTERS & RECORDS FOR 2 YRS
 MAINTAIN INSPECTION BOOK IN FORM 35
 DO NOT KEEP DATE EXPIRED,BANNED,NOT
OF STANDARD,SPURIOUS DRUGS IN SHOP
 DO NOT KEEP ANY PHYSICIANS SAMPLES/
drugs without proper records of purchase.

37. PUNISHMENTS FOR NON COMPLIANCE
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 Departmental actions
 Issue warning after issuing a show cause notice
 Suspension of drugs Licences for a certain period
 Cancellation of drugs licences
 Appeal petition to Govt & Court
 Legal actions
 Seizure of drugs and documents
 Filing of case against the offenders
 Punishments awarded by the Hon.Court

38. REGISTERED PHARMACIST MUST
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 Supervise The Sales Full Time
 Endorse All Sales Bills Issued
 Ensure Proper Storage Of Drugs
 Verify Prices Of Lifesaving Essential Scheduled
Drugs Frequently
 Keep Only Drugs With Purchase Bills
 Stock Veterinary Drugs Separately
 Keep Controlled Drugs In Custody
 Ensure Proper Handling Of Prescription &
 Patient Counselling

39. IDEAL PHARMACY
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 AVAILABILITY OF ALL ESSENTIAL DRUGS
 SCIENTIFIC WAY OF ARRANGEMENT
 CLEAN AND TIDY, UNCONGESTED PREMISES
 PROPER STORAGE OF DRUGS AS PER LABEL
 TRANSPARENT,UNIFORM BILLING SYSTEM
 UPTO DATE REGISTERS & RECORDS
 PRECISE HANDLING OF PRESCRIPTIONS
 ADEQUATE KNOWLEDGE,SKILL AND
ATTITUDE IN MANAGING PRESCRIPTIONS

40. PATIENT COUNSELLING
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 The RP must take care of the drugs dispensed
 Handle prescriptions with knowledge
 Inform the usage, dosage, precautions, interactions,
possible side effects, period of use, investigations if
any to do, next consultation with the physician etc.
 Update the medicine usage of the patient in the
medical records after dispensing
 ADRs to be monitored and informed to AMCs
 Change the dosage form if necessary

41. HANDLE DRUGS
WITH DIVINITY
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THANK YOU

42. SOME QUESTIONS ?
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1.Period of Validity of a drugs licence
2.Minimum area needed for a retail DL
3.Difference between
pharmacy & drug store
spurious & banned drugs
Regd.Pharmacist & competent person
Retail and Wholesale dealings
Cold storage & cool storage
4.Minimum trade margin for retail dealers
5.Symbols XRx and NRx stands for ?
6.Name 3 schedule X drugs
7.Name an orally administered narcotic drug
8. Minimum period in which the carbon copies of sales bills are to be kept
9.How many drugs are included under DPCO 2013
10.How many drugs are included in the NLEM2012
11.How many diseases are included in the DMR(OA) Rules
12.What are the poisons licensed under Kerala poison ACT
13.Cabinet Minister for Health & Family welfare in the Centre
14.Nearest Zonal office of CDSCO
15.Schedule N is indicated for which purpose