Sale of Drugs

*Sale Of DrugsDefinitions: Sale:Sale includes the process of passage of articles from the manufacturer to the consumersWholesale :A dealer or his agent or a stockiest appointed by a manufacturer or an Importer for sale of his drugs to a retailer.

*Retailer: A dealer carrying retail business of sale of drugs for customers.

For the sale of drugs a license is required .

If drugs are sold or stocked for sale at different places, a separate license is required for each place.

*Issuing the sales license of drugs are divided into to 3 categories:Drugs other than those specified in schedules C,C1 and X.Drugs specified in schedule C and C1 but excluding-schedule- X.Drugs specified in schedule-X.

*License for wholesale / retail sale of drugsApplication made together with prescribed fee to licensing authority for wholesale / retail sale of drugs is as follows

The licensing authority issues license for wholesale / retail sale of drugs in different forms for which applications are made in different forms

*20B

21B

20GWhole sale of drugs other than those specified in schedule C,C1 & XWholesale of drugs specified in schedule C & C1Wholesale of drugs specified in schedule XNo or form for issue of applicationType of license

*20

21

20FRetail sale of drugs other than those specified in schedule C,C1 & XRetail sale of drugs specified in schedule C & C1Retail sale of drugs specified in schedule XNo or form for issue of applicationType of license

*Conditions for sale of drugsThe licensed premises are adequate & equipped with facilities of proper storage of drugs .

The pharmacy shall comply with requirements of schedule-N.

*The license should be displayed in a prominent placeAll the compounding &display of drugs shall be made under personal supervision of qualified person i.e. Registered PharmacistThe supply of other than schedule-X drugs on prescription shall be recorded either in prescription register or cash or credit memo book

*The supply of schedule-C drugs shall be recorded either in register or in a cash or credit memo book.The drugs shall be purchased from licensed dealer or a licensed manufacturer. Purchase bills are numbered serially &maintained in order.All the registers & records shall be produced for inspection by inspector, if required

*All the registers &records shall be preserved for a period of two year from date of last entry.Schedule-H & X drugs shall be sold on prescription of registered medical practitioner.The supply of schedule H & X drugs to the RMP Hospitals &Nursing Homes, shall be made only against the signed order in writing Such order should be preserved for 2 years.

*The schedule H & X drugs shall not be supplied more than once, unless it is stated by the prescriber .Only prescribed schedule - H & X drugs shall be dispensed, not the substitutes.Schedule-X drugs shall be stored in cupboard under lock & key separately under control of a responsible person.

*The description of chemist and druggist or pharmacy shall be displayedInspection book in form-35 should be maintained The physician sample drugs & drugs meant for Govt. supply with a distinguishing mark, shall not be sold or stocked

*The drugs for animal treatment shall be stored in separate cupboard, with words Not for human use, For animal treatment only on the cupboard

The supply of schedule-X drugs shall be recorded in separate register & pages should be allotted for other drugs

*Restricted licenseRestricted licenses are issued for retail sale of drugs to:Dealer or persons in respect of drugs whose sale does not require the supervision of qualified person.Where they do not have fixed premises A vender who purchases drugs from licensed dealer for distribution sparsely populated areas where other channels of distribution of drugs are not available.

PH204.27*Restricted license is issued to traveling agent of firm for special purpose of distribution to medical practitioner or Dealer for supply of biological & other special products in schedule -C.Restricted licences for retail sale are issued for Drugs other than those specified in schedule C / C1 & XFor drugs specified in schedule C1

PH204.27

*This license is issued for drugs other than those specified in schedule-C ,C1 and X in form -20-A on application made in Form-19A.

For drugs specified in schedule C1 in Form-21 A on application made in 19A

Itinerant vendors in exceptional cases for bonafide traveling agents of firms dealing in drugs

*ConditionsThe license should be displayed in prominent place in a part of premises open to public place or kept on the person of vendor Shall produce the same on demand by inspector or other officer authorized by state Govt.Drugs should be purchased only from a duly licensed dealer or manufacturer.

*The licensee can deal only in such drugs as can be sold without a supervision of a qualified person Drugs should be sold in original container.If the Licensee be a vendor having no fixed place of businessHe should buy drugs only from such dealers as may be specified in his license

*Distribution Of Drugs From Motor VehiclesLicenses are issued for sale of drugs from motor vehicles Separate license are issued forDrugs other than schedule C & C1 Drugs specified in schedule C& C1.License issued in form 20BB for drugs other than schedule C and C1 where application is made in form 19AA License issued in form 21BB for drugs specified in schedule C and C1 where application is made in form 19AA

*Conditions:The drugs can be distributed to only such persons who hold license for retail sale of drugs.

The license should be displayed in a prominent place in the vehicle.

Any change in ownership of vehicle or constitution of the firm should be informed to licensing authority with in week of change.

*In case of change in constitution of the firm fresh license should be requested to be issued with in 3 months of the change.

For distribution of schedule C & C1 drugs the licensee should provide proper facilities for storage of drugs.

*Cancellation & Suspension of LicensesThe licensing authority may cancel or suspend the license either wholly or in respect of substances to which it relates.

If the licensee fails to comply with the conditions of license or with any provisions of Act.

*He or his employee had not guilty of any similar act or omission with in 12 months before the date on which act or omission in question took place orIf the offence was committed and licensee could not reasonably have had knowledge of previous offence

Cancellation & Suspension of Licenses:

*Licensee whose license has been cancelled / suspended may appeal with in 3 months from date of cancellation or suspension of license to the state Govt. Procedure for disposal of drugs if the licence is cancelledThe licensee should apply to the licensing authority giving the particularsName & address of the person to whom the drugs are proposed to be sold and his licence number.Cancellation & Suspension of Licenses:

*Procedure For Disposal Of Drugs If License In CancelledNames of drugs together with quantities, batch number, name and address of the manufacturer & date of expiry, and person to whom proposed to be sold.The licensing authority after examination of the particulars furnished If necessary, after inspection by inspector of the premises, where the drugs are stocked, grant required permission for disposal.

*a) Any adulterated or spurious drug not of standard qualityImprisonment for minimum 5yrs extending up to life imprisonment &fine not less than Rs:10,000Imprisonment up to 10yrs or fine up to Rs. :20,000 or bothOffences and penalties Offences penalties

PH204.26

PH204.28*c) Spurious drugs but not mfg under name of any other drugs. Imprisonment for NLT 3 to 5 yrs & fine NLT Rs:5,000.The court many award Imprisonment for lesser time but not less than 1year.Imprisonment for NLT 6to 10 years & fine NLT Rs. :10,000.b) Adulterated drugs but not containing any toxic or harmful substances which may be injurious to healthImprisonment from 1to 3 years. And fine< Rs 5,000Imprisonment from 2 to 4 years & fine not less than Rs:10,000

PH204.26

PH204.28*2) Not disclosing the name of Mfg. of the place where the manufacture drugs kept.Imprisonment up to 3 years or fine up to Rs:1,000 or both.same as the Ist conviction.Not keeping records of manufacturer or sale of drugs in specified manner.Imprisonment up to 3years or fine up to Rs:1,000or both.Same as Ist conviction4) Using the report of Govt. analyst for advertising any drugFine up to Rs. 5,000Imprisonment up to 10 yrs or with fine or both

PH204.26