Pharmacy Act.pptx

PHARMACY ACT

1. P H ARM A C Y A C T – 1948

2. C O NTENTS Introduction & History O b jecti v e a n d Ame n d me n t s Pharmacy Council of India Registration of Pharmacist Offences and Penalties

3. INTRODUCTION 3 An act to regulate the ‘Profession Of Pharmacy’. The act was promulgated in the year 1948. The Pharmacy Bill, 1947, having been passed by the Legislature received its assent on 4th March, 1948. It came on the Statute Book as THE PHARMACY ACT, 1948 (8 of 1948).

4. HISTORY Great harm t o th e health of people Early 20 th century- No restriction to the practice of pharmacy Poor qu a l i ty of service Absence of recognized curriculum 4

5. The following statement of objects and reasons i.e. pharmacy bill was published in Gaz. of Ind.,1947, Part V, page 469. "It is desirable that, as in most other countries, only persons who have attained a minimum standard of professional education should be permitted to practice the Profession of Pharmacy. It is accordingly proposed to establish a Central Council of Pharmacy, which will prescribe the minimum standards of education, it is further proposed to empower Provincial Governments to prohibit the dispensing of medicine on the prescription of a Medical Practitioner otherwise than by, or under the direct and personal supervision of, a registered pharmacists 5 Chapters and 46 Sections 5

6. OBJECTIVE: Regulating and raising the Status of Profession of Pharmacy in India Providing uniform education and training to the person willing to enter the Profession of Pharmacy Maintaining control over the persons entering the Profession Pharmacy 6

7. LIS T O F AME N DI N G A CT S AND A D A P T A T I O N ORDER S 7 The Adaptati o n of Laws O r d e r , 1950. The Adaptati o n of Laws (No. 3 ) Orde r , 1956. The Phar m acy (A m end m ent) Act, 1959 (24 of 1959). The Phar m acy (A m end m ent) Act, 1976 (70 of 1976). The Phar m acy (A m end m ent) Act, 1982 (22 of 1982). The Delegated Legislation Provisions (A m end m ent) Act, 1985 (4 of 1986). Pharmacy Practice (Amendment) Regulations, 2021

8. CHAPTER-I INTRODUCTORY 1. Short title, extent and commencement: This act may be called as The Pharmacy Act 1948. It extends to the whole of India except the State of Jammu and Kashmir. It shall come in to force at once but chapters III,IV and V shall take effect in a particular state from such date as the state govt.

9. CHAPTER-II 9 THE PHAR M A C Y COUNCI L OF INDIA The PCI was first constituted in the year 1949. Reconstituted for every 5 years. COMPOSITION: Elected members Nominated members Ex-officio members

10. Elected members Six memb e r s - selected by UGC among them at least one from teaching profession One member- elected by MCI One member- elected by State Pharmacy Council Nominated members Six members- nominated by Central govt. One r e pr e s e n t a ti ve each- UGC, AICTE One registered Pharmacist- each state/ union territory E x o f f icio members 10 The Director General of Health Services The Director of Central Drugs Laboratory The Drugs Controller of India

11. The executive committee consists of President Vice president Five members elected by Central Council from its member’s Apart from this, the council also appoints A registrar Other officers and servants for carrying out its statutory functions. 11

12. President- Dr. Montu M.Patel   Vice president- Prof. ( Dr. ) Pramod Yeole   Registrar- Mrs. Archna Mudgal

13. FUNCTIONS OF PCI: 13 Amendment i n 199 1

14. E D U C A T I O N R E GU L A T I ON S : Minimum qualification for admission in to the course. Duration of training and course of study to be covered. Equipments and facilities to be provided by the institutions. Giving practical training. Holding approved examinations. The Educational Regulations shall be published in the Official Gazette and in such other manner as the Central Council may direct. First Education Regulations (E.R) were to be framed by 1952 and effectively implemented within 3 years of their framing. 14

15. A PP R O V A L O F Q U A L I F I C A T I O N GRANTED OUTSIDE INDIA: 15 Qualification in pharmacy granted outside India can be rec o g ni z e d b y PC I . This is a pplic a ble to I ndi a n c i t i z e n s . Citizens of foreign nationality can be eligible for registration when an Indian national holding the same qualification is allowed to enter an practice in that country.

16. A PP R O V A L / W I T H D R A W A L O F I NST I TU TIONS APPROVAL – Procedure to be followed for approval for an i n s tit u ti o n p r ov i d i n g c ou r s e of s t ud y i n Ph ar m ac y : A pp li ca ti o n b y i n s tit u ti o n t o PC I Inspection Approval Declaration WITHDRAWAL – Non compliance with EducationRegulations N o ti c e i ss u e d t o t h e I n s tit u ti o n b y t h e P C I . 3 month window for the Institute to make its representation. F i n a l Dec i s i o n re s t s wit h t h e P C I .

17. CENTRAL REGISTER 17 U n d e r the p r ovision of ph a r m ac y ac t(19 7 6 ) , the PCI of India is required to maintain a Central Register. The register has to: a. Maintained by the Registrar council of India b. Has to be revised suitably from time to time c. Published in the gazette of India.

18. STATE PHARMACY COUNCILS -Except where a Joint State Council is constituted in accordance with an agreement made under section 20, the State Government shall constitute a State Council consisting of the following members. E le c t ed m e m b ers Six members- by registered pharmacist of thestate O n e mem b er ele c t ed b y M CI Nominated members Five members nominated by the StateGovernment 4-p o ss e s s i n g a p r e s c r i be d d eg r ee o r d i ploma in p h a r ma c y o r p h a r ma c e u t ica l c h emi st r y E x - o f f ici o m e m b ers C h i ef a d mi n i st r a t i v e M e d i c al Of f i c er Officer in charge of Drugs Control Administration of theState G o v e r n me n t An a l y st . 18 C H APTE R - III

19. JOINT S T A T E PHARM A C Y COUNCI L : 19 Two or more states enter into an agreement to form a joint state pharmacy council . Elected members Registered phar m ac i s t - 3 to 5 from each state Medical counci l - 1 fr om each state. Nominated members Govt. nominees- 2 to 4 from each state. E x- o f f i c io members Chief Administrative Med i c a l O f fi ce r . O f fi c e r i n c h a r g e of Drugs Control Administration. Govt. analyst.

20. The president and vice president are elected by the members from amongst themselves. Period of 5 years Casual vacancy is filled by nomination or election Members are eligible for re-election P ossess a n e x ec u t ive c o m m i t tee s i m i lar t o the c e ntr a l government. 20

21. FUNCTIONS OF STATE COUNCIL 21 INSPECTION: The state council may appoint Inspectors. An inspector may Inspect any premises under dispensing and submit the report to Registrar. Enquire whether the person engaged in dispensing is a registered pharmacist Institute prosecution under the order of the Executive Committee of the State Council.

22. The first and subsequent Registers of Pharmacists in a State– P re p are d a n d m a i n t a i n e d b y t h e S t a t e G ov e r n m e n t . R e g i s t e r of P h ar m ac i s t s P a r ti c u l a r s . 2 . M a i n tena n ce of r e g is t er

23. 3 . E N T R Y AND R E M O V A L O F NAM E S : En tr y: All applicants for the registration should be addressed to the Registrar of SPC. If the applicant has the requisite qualifications for registration, he shall direct his or her name to be entered in the register. a certificate of registration i s is su e d. Upon entry, Removal: R e g i s t ra ti o n by error offence in any professional aspect. If he has been convicted of any 30 day period for appealing Surrender of certificate of registration and publication in the official gazette

24. 4. PRINT I NG O F R E G I S T E R : 1 st d a y o f A pr il sub s e quent to the It is done on the commencement of the Pharmacy (Amendment) Act, 1959 (24 of 1959). 24 first of April, register T h er e a f t e r , e a c h y e a r af ter the wi l l arrange for reprinting showing supplements to the registers. These supplements and registers are deemed to be proof that the persons whose names are contained therein, are registered pharmacists.

25. REGISTRATION OF PHARMACISTS Preparation and maintenance of register The register shall include the following particulars, namely: full name and residential address of the registered person; date of his first admission to the register; the the his qualifications for registration; his professional address, and if he is employed by any person, the name of such person; such further particulars as may be prescribed. 25 CHAPTER-IV

26. Preparation of first register.- (I) For the purpose of preparing the first register, the State Government shall by notification in the Official Gazette constitute a Registration Tribunal consisting of three persons, and shall also a pp o i n t a Reg ist r a r w h o shall act as Secretary of the Registration Tribunal. The State Government shall, by the same or a like notification, appoint a date on or before which applications for registration, which shall be accompanied by the prescribed fee, shall be made to the Registration Tribunal. The Registration Tribunal shall examine every application received on or before the appointed date, and if it is satisfied that the applicant is qualified for registration under section 31, shall direct the entry of the name of the applicant on the register. The first register so prepared shall thereafter be published in such manner as the State Government may direct, and any person aggrieved by a decision of the Registration Tribunal expressed or implied in the register as so published may, within sixty days from the date of such publication, appeal to an authority appointed by the State Government in this behalf by notification in the Official Gazette. The Registrar shall amend the register in accordance with the decisions of the authority appointed under sub-section (4) and shall thereupon issue to every person whose name is entered in the register a certificate of registration in the prescribed form.

27. Q U A L I F I C A T I O N S F O R E N T R Y IN REG I STER: He/ She holds a degree in an Indian University other than pharmacy and has been engaged in the compounding of drugs in hospital or dispensary for a total period not less than 500 hours of practical training (spanning three months) in a pharmacy. 27 He/ She should hold a diploma in pharmacy or pharmaceutical chemistry. ⚫ If the student takes the training from a government hospital pharmacy, it does not need to seek approval of the PCI. passed an examination H a s rec o g ni z e d a s a d e qu a te b y the State Government for commoners or dispensers.

28. R E N E W A L FE E S: The state g ovt. by not i fi c a t i on in the o f fi c ial g a z e t t e , dir e c t that for the retention of the name in the register. In order to retain the name in the register, renewal fee 28 shall be paid to the state government as may be prescribed. Where a renewal fee is not paid by the due date, the Registrar shall remove the name of the defaulter from the register. On payment of the renewal fee, the Registrar shall [issue a receipt there for and such receipt shall be proof of renewal of registration.]

29. Qualifications for subsequent registration. 1. entitled to have his name entered in the register if he resides or carries on the business or profession of p h a rm a c y i n t h e S t a t e a n d i f h e — satisfies the conditions prescribed with the prior approval of the Central Council, or where no conditions have been prescribed, the conditions entitling a person to have his name entered on the first register as set out in section 31, or is a registered pharmacist in another State, or possesses a qualification approved under section 14: Provided that no person shall be entitled '[under clause (a) or clause (c)] to have his name entered on the register unless he has passed a matriculation examination or an examination prescribed as being e q ui v a le n t to a m a t ri c u l a t io n e x a m i n a t io n . 2. After the Education Regulations have by or under section 11 taken effect in the State, a person shall on payment of the prescribed fee be entitled to have his name entered on the register if he has attained the age of [eighteen years], if he resides, or carries on the business or profession of pharmacy, in the State and if he has passed an approved examination or possesses a qualification approved under section 1 4 ' [ or i s a r eg i s t e r ed p h a rm a c is t i n a n o t h er S t a t e .]

30. SP E C I AL P R O V I SI O NS O F T H E A CT P ha r m a c y A c t , 195 9 ( A m end m en t ) – Pertaining to Pharmacists affected by the Partition of 1947. A l so , t h e R e o r g a n is a ti o n of S t a t e s i n 1956. P r ov i s i on s r e m a i n e d i n e f f ec t f o r a p e r i o d of 2 y ear s . St a t e G ov er n m e n t s we r e e m po we r e d t o e x t e n d t h e p e r i o d of op e r a ti o n u p t o a no t h e r 2 y e a r s .

31. Pharmacy Act , 1976 ( Amendment ) – Pr o v i de d for Registratio n of Pha rm a cis t s b y SPC ’ s w ho : Were eligible for Registration between the closing of the First register and the coming into effect of the Educational Regulations. Approved Qualified Persons, before 31st December 1969, und e r t h e Dr u g s a n d C o s m e ti c s Ac t , 194 a n d R u l e s . Displaced persons from Bangladesh, after 14 th April, 1957 but b e f o r e 25 t h M a r c h , 1971 .

32. OFFENCES PENALITIES 1. F a l s e l y cl a i m s t o b e a r eg i s t e r ed pharmacist. F i n e u p t o R s . 5 00.00 o n f i r s t conviction. F i n e u p t o R s .10 0.00 and or 6 mon t hs i m p r i s onment of a n y s ub s equent c o n v i ct i o n . 2 . D is p ens i n g b y a n un r eg i s t e r e d person 6 months of imprisonment ora fine of up to Rs1000 orboth. 3. F a i lu r e t o s ur r ender t he c e r t i f i c a t e of r eg i s t r at i o n F i n e of R s . 5 4. Obstruction of statepharmacy council inspectors Im p r i s onment of u p t o 6 mon t hs o r a fineup to Rs1000 or both. 32 CHAPTER-V

33. Definitions “Agreement” m e a n s a n a g r e e me n t e n t e r ed i n t o un der section 20 (inter-state agreement regarding constitution of State Councils) “Approved” section 12 means approved by the Central Council under (courses of study and examinations in pharmacy) or section 14 (foreign qualification) for the purpose of qualifying for registration under the act “Central Council” means the Pharmacy Council of India constituted under section 3 “Central Register” means the register of pharmacists maintained by the Central Council under section 15A “Executive Committee” means the Executive Committee of the Central Council or of the State Council, as the context may require “Indian University” m e a n s a U n i v e r sity w it h i n t h e me a n i n g of se c t io n 3 o f t h e U n i v e r s i t y G r a n t s Commission Act, 1956, and includes such other institutions, being institutions established by or under a Central Act, as the Central Government may, by notification in the Official Gazette, specify in this behalf “Register” means a register of pharmacists prepared and maintained under Chapter IV “Registered pharmacist” means a person whose name is for the time being entered in the register of the State in which he is for the time being residing or carrying on his profession or business of pharmacy “State Council” section 19, m e a n s a St a t e C o un c il of P h a rma c y c o n s t i t u t e d un d e r a n d i n c l u d es a J oi n t St a t e C o un c il of P h a rm a c y constituted in accordance with an agreement unde r se c t io n 20 ; “University Grants Commission” means the University Grants Commission established under section 4 of the University Grants Commission Act,1956 (3 of 1956).]

34. The ph a r m ac y ac t w a s c ommen c e d in 194 8 und e r A c t8. Ph a rm a c y ac t provid e d the Pro f e ss ion of Ph a rm a c y in I ndia with framework. It regulates and raises the status of the Profession of Pharmacy. I t rec o g ni z e s the qu a l i f ic a t i on g ra nt e d outside I ndia a nd e x te n ds the Ph a rm a c y A c t. It helped the govt. to obtain some control over the professionals engaged in this field. 34