Sales of drugs. Jurisprudence Bpharm .pptx

Sales of drugs

1. Sales of drug Whole sale and retail sale

2. Sale of drugs Sale may be defined as the process of passage of articles from the manufacturer to the consumer. There are two general types of sale: Wholesale and Retail sale

3. Wholesale: (sale by way of wholesale dealing) It means a sale to a person for the purpose of selling again & also includes hospital or a dispensary or medical Retail Sale: It means a sale whether to a hospital or a dispensary or medical, educational, or research institute or to any other person other than a sale by way of wholesale dealing.

4. Layout of retail and whole sale drug store

5. Retail sale a. From shop drug store chemist and druggist Pharmacy b. Venders

6. Retail sale Drug store: It means a licensed premises for the sale of drug who do not require the services of a qualified person. Chemist & druggist: It means a licensed premises for the sale of drug who requires the services of a qualified person but where the drugs are not compounded against prescription Pharmacy: It means a licensed premises for the sale of drug who requires the services of a qualified person but where the drugs are compounded against prescription.

7. Retail sale from shops facilities as per schedule N Purchased only from licensed wholesaler No sale of specified drugs Separate license for sch. C, C1 and X drugs Sale under qualified supervision

8. Retail sale from shops Records Licensee should maintain records related to all purchase & sale of drugs, with particular such as date of purchase & sale name & addresses of the person from whom purchased &to whom sold. names & quantities of drugs & their batch no.

9. e. Drug should be purchased from dully signed wholesaler. inspection

10. Pharmacy The license granted subject to the following conditions. The licensee must have adequate premises & facilities for proper storage of drugs & under the supervision of competent person for sale & distribution of drugs

11. Must fulfill the requirements as per sch. N. Licensee must maintain records of drugs. Licensee must allow an inspector to inspect the premises & to check the records. Licensee must inform to the licensing authority about any change in qualified staff. Must obtain the permission to sale additional categories of drugs. Precaution must be taken during storage of sch C , C1 poisonous and X drugs

12. Sale of sch X & sch X drugs Drugs specified in schedule H & X should be sold only on prescription of RMP. In case of sch. X drugs, the prescription should be in duplicate & should be retained for 2 years. The cash or credit bill should bear a signature of customer with his address.

13. Separate bound & paged registers should be maintained for supply in which separate sheets should be allotted for each drug. The following particulars should be enter at the time of supply date of supply opening & closing stocks of drugs on that day & relevant bill number. name of the drug, its manufacturers name & batch no. name & address of the purchaser date of prescription & name & address of RMP

14. f) signature of Registered pharmacist under whose supervision supply is made Supply of drugs to medical practioner & other institution should be preserve for at least 3 years from the date of supply.

15. wholesale a. From shop License for wholesale of sch. C and C1 License for drugs other than sch. of C and C1 b. Venders License for wholesale of sch. C and C1 License for drugs other than sch. of C and C1

16. License for wholesale of sch. C and C1 Following conditions are to be satisfied by the licensee having wholesale of schedule C&C1 drugs The license should be displaced in a prominent part of premises opened to the public. The licensee must have adequate premises which should not be less than 10 sq. meters, equipped with facilities for the proper storage of drugs.

17. Licensee should maintain records related to all purchase & sale of drugs, with particular such as date of purchase & sale name & addresses of the person from whom purchased &to whom sold. names & quantities of drugs & their batch no. names of manufacturers of drugs Properly sign (Valid Sign). Drug should be purchased from dully signed manufacturer. Drug should be sold only to those persons who are licensed to retail them .

18. License for drugs other than sch. of C and C1 Drugs should not be sold to any person who do not hold the license for the retail sale or distribution of drugs of these class. The general conditions as mentioned in previous slide

19. Wholesale from motor vehicle The license should be displaced in the prominent place in the vehicle. Separate license is necessary for schedule C&C1 drugs & other than those specified in schedule C&C1 The general conditions as mentioned in previous slide

20. GENERAL LICENSE: general license is granted to a person who have premises for business & who have engage the services of qualified person to supervise the sale of drug & do the compounding & dispensing. Restricted license: restricted license is granted to those dealer who do not engage the services of qualified person

21. Offenses and Penalty for sale of drugs Sale, stocking, exhibition or offer for sale of drugs likely to cause death or grievous hurt as per sec. 320 , 5 years- life imprisonment & not less than Rs. 10,000 fine. Sale, stocking, exhibition or offer for sale of adulterated drug 1-3 years imprisonment & not less than Rs. 5,000 fine on first conviction & 2-6years imprisonment & not less than Rs. 10,000 fine on subsequent conviction

22. Sale, stocking, exhibition or offer for sale of spurious drugs 3-5 years imprisonment & not less than Rs. 5,000 fine on first conviction & 6-10 years imprisonmen t & not less than Rs. 10,000 fine on subsequent conviction Failure to keep records or disclosed required information Imprisonment upto 1 year & or fine up to Rs. 1000 False warranty to purchaser Imprisonment upto 1 year & or fine upto Rs. 5000 on first conviction & 2 years imprisonment or fine or both on subsequent conviction. Use of govt. analyst report or CDL report for advertising Fine upto Rs 500 on first conviction & imprisonment upto 10years imprisonment or fine or both on subsequent conviction

23. DRUGS AND MAGIC REMEDIES ACT Drugs and magic remedies act ( DMR ) 1954 and 1955 or objectionable advertisement DMR is an act of the parliament of India which controls advertising of drugs and remedies that claim to have magical properties, and makes doing so a cognizable offence

24. Advertisement : Advertisement includes any notice, circular, label, wrapper, or other document , and any announcement made orally or by any means of producing or transmitting light , sound or smoke . Magic remedy : Magic remedy includes a talisman , mantra , kavacha and any other charm of any kind which is alleged to possess miraculous power for or in the diagnosis , cure , treatment and prevention of any disease .

25. Section 3 prohibition of advertisement of certain drugs for treatment of certain diseases and disorder For the procurement of miscarriage in women or prevention of conception in women; or the maintenance or improvement of the capacity of human beings for sexual pleasure, or the correction of menstrual disorder in women; or d) the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule, or any other disease, disorder

26. any part in the publication of any advertisement relating to a drug if the advertisement contains any matter which- directly or indirectly gives a false impression regarding the true nature or character of the drug; or makes a false claim for the drug; or c) is otherwise false or misleading in any material particular are prohibited.

27. The following classes of Advertisements are not prohibited under this Act: Any advertisements relating to the drugs printed or published by the Government or any other person with prior permission of the Government. Advertisements including any book or treatise (a written or printed composition) dealing with any matter relating to the diseases, disorders or conditions which are otherwise prohibited, provided published from bonafide scientific

28. Advertisement relating to the drugs which comply with the required conditions as follows : Advertisements of drugs in medicinal, pharmaceutical, scientific and technical journals. Therapeutic index or price list published by licensed manufacturer, importer, or distributor of drug (under the Drugs and Cosmetic Act, 1940 and the rules

29. With the conditions that: The advertisement should contain only the information, required for the guidance of registered medical practitioner regarding ( a)therapeutic indications; (b)route of administration; (c) dosage and side effects of such drug or drugs; and (d) the precaution to be taken in treatment with the drug. (ii) The distribution of such literature should be given to registered medical practitioner dispensaries, hospitals, medical and research institutions, chemists and druggists or pharmacies .