MODEL ANSWERS FOR MAIN EXAM QUESTION PAPER B.PHARM. Vth SEMESTER-2013; SUBJECT: FORENSIC PHARMACY & ETHICS-V

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1 1 P a g e MODEL ANSWERS FOR MAIN EXAM QUESTION PAPER B.PHARM. Vth SEMESTER-2013; SUBJECT: FORENSIC PHARMACY & ETHICS-V SECTION: A Q I. What is technical education as per AICTE Act? Answer. Programmes of education, research and training in engineering technology, architecture, town planning, management, pharmacy and applied arts and crafts and such other programme or areas as the central government may, in consultation with the Council (AICTE), by notification in the official gazette, declare. Q II. Who is drug inspector as per the Drug and Cosmetic Act and Rules? Answer. The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for such areas as may be assigned to them by the Central Government or the State Government, as the case may be. Every Inspector shall be deemed to be a public servant within the meaning of section 21 of the Indian Penal Code, and shall be officially subordinate to such authority [(Note: Ins. by Act 68 of 1982, sec.18 (w.e.f )), having the prescribed qualifications,] as the Government appointing him may specify in this behalf.] Q III. What is clinical trial, as mentioned under the Drug and cosmetic Act and Rules? Answer. Clinical trial for a new drug, whether for clinical investigation or any clinical experiment by any institution, shall be conducted except under, and in accordance with, the permission, in writing, of the Licensing Authority defined in clause (b) of Rule 21. An application for grant of permission to conduct: (a) human clinical trials (Phase-I) on a new drug shall be made to the Licensing Authority in Form 44 accompanied by a fee of fifty thousand rupees and such information and data as required under Schedule Y. (b) exploratory clinical trials (Phase-II) on a new drug shall be made on the basis of data emerging from Phase I trial, accompanied by a fee of twenty five thousand rupees; (c) confirmatory clinical trials (Phase-III) on a new drug shall be made on the basis of the data emerging from Phase-II and where necessary, data emerging from Phase-I also, and shall be accompanied by a fee of twenty-five thousand rupees. Provided that no separate fee shall be required to be paid along with application for import/manufacture of a new drug based on successful completion of phases clinical trials by the applicant. Q IV. What is coca leaf? Answer. Coca leaf means (a) the leaf of the coca plant except of a leaf from which all ecgonine, cocaine and any other ecgonine alkaloids have been removed; (b) any mixture thereof with or without any neutral material; but does not include any preparation containing not more than 0.1 percent of cocaine. QV. Specify the narcotic drugs. Answer. Narcotic drug means coca leaf, cannabis, opium, poppy straw and includes all manufactured drugs of it. QVI. Define advertisement as per the Drug and Magic Remedies Act. Answer. Advertisement means any notice, circular, label, wrapper, or other documents and any announcement made orally or by any means of producing or transmitting light, sound or smoke. QVII. How will you define establishment as per the prevention of cruelty to animals act. Answer. Means any individual, company, firm, corporations, institutions other than schools up to higher secondary level, which performs experiments on animals. QVIII. Define inspection and its purpose as per AICTE Act. Answer. For the purpose of ascertaining the standard of teaching, examination and research of a technical institutions/ university, or its financial needs, the council may cause and inspection to

2 2 P a g e be made. The results of inspection shall be communicated and after ascertaining the opinion of that technical intuitions/ university, the council shall recommend to that the action to be taken on the recommendations. QIX. What do you understand by university technical department as per AICTE Act? Answer. Means the department of the concerned university conducting technical education, courses or programmes. QX. Define the term adolescent as per factories act. Answer. Means a person who has completed his fifteenth year of age but has not completed his eighteenth year. QXI. Who is worker as per factory act? Answer. "Worker" means a person employed directly or by or through any agency (including a contractor) with or without the knowledge of the principal employer whether for remuneration or not in any manufacturing process, or in cleaning any part of the machinery or premises used for a manufacturing process, or in any other kind of work incidental to, or connected with the manufacturing process, or the subject of the manufacturing process but does not include any member of the armed forces of the Union. QXII. What is pharmacist oath? Answer. I Swear by the code of Ethics of Pharmacy Council of India in relation to the community and shall act as an integral part of health care team. I shall uphold the laws and standards governing my profession. I shall strive to perfect and enlarge my knowledge to contribute to the advancement of pharmacy and public health. I shall follow the system, which I consider best for pharmaceutical care and counseling of patients. I shall endeavor to discover and manufacture drugs of quality to alleviate sufferings of humanity. I shall hold in confidence the knowledge gained about the patients in connection with professional practice and never divulge unless compelled to do so by the law. I shall associate with organizations having their objectives for betterment of the profession of Pharmacy and make contribution to carry out the work of those organizations. While I continue to keep this Oath inviolate, may it be granted to me to enjoy life and the practice of pharmacy respected by all, at all times. Should I trespass and violate this oath, may the reverse be my lot. SECTION B Q 2. Write in detail about the steps for filing of a patent as per patent act. Specify the rights of patentees and co owners of patent. What are the related prescribed offences and penalties under the act? Answer. Filing of patents: Subject to the provisions contained in section 134, an application for a patent for an invention may be made by any of the following persons, that is to say, by any person claiming to be the true and first investor of the invention; by any person being the assignee of the person claiming to be the true and first inventor in respect of the right to make such an application; by the legal representative of any deceased person who immediately before his death was entitled to make such an application. An application under sub-section may be made by any of the persons referred to therein either alone or jointly with any other person. Form of application: Every application for a patent shall be for one invention only and shall be made in the prescribed form and filed in the patent office. Every international application under the Patent Cooperation Treaty for a patent, as may be filed designating India shall be deemed to be an application under this Act, if a corresponding application has also been filed before the Controller in India. The filing date of an application referred to in sub-section and its complete specification processed by the patent office as designated office or elected office shall be the

3 3 P a g e international filing date accorded under the Patent Cooperation Treaty. Where the application is made by virtue of an assignment of the right to apply for a patent for the invention, there shall be furnished with the application, or within such period as may be prescribed after the filing of the application, proof of the right to make the application. Every application under this section shall state that the applicant is in possession of the invention and shall name the person claiming to be the true and first inventor; and where the person so claiming is not the applicant or one of the applicants, the application shall contain a declaration that the applicant believes the person so named to be the true and first inventor. Every such application not being a convention application or an application filed under the Patent Cooperation Treaty designating India shall be accompanied by a provisional or a complete specification. Where an applicant for a patent under this Act is prosecuting either alone or jointly with any other person an application for a patent in any country outside India in respect of the same or substantially the same invention, or where to his knowledge such an application is being prosecuted by some person through whom he claims or by some person deriving title from him, he shall file along with his application [or subsequently 5. within the prescribed period as the Controller may allow a statement setting out detailed particulars or such application; and an undertaking that, up to the date of grant of patent in India, he would keep the Controller informed in writing, from time to time, of 8[detailed particulars as required under] clause (a) in respect of every other application -. relating to the same or substantially the same invention, if any, filed in any country outside India subsequently to the filing of the statement referred to in the aforesaid clause, within the prescribed time. At any time after an application for patent is filed in India and till the grant of a patent or refusal to grant of a patent made thereon, the Controller may also require the applicant to furnish details, as may be prescribed, relating to the processing of the application in a country outside India, and in that event the applicant shall furnish to the Controller information available to him within such period as may be prescribed. Provisional and complete specifications: Where an application for a patent (not being a convention application or an application filed under the Patent Cooperation Treaty designating India) is accompanied by a provisional specification, a complete specification shall be filed within twelve ' months i rum the date of filing of the application, and if the complete specification is not so filed, the application shall be deemed to be abandoned. Where two or more applications in the name of the same applicant are accompanied by provisional specifications in respect of inventions which are cognate or of which one is a modification of another and the Controller is of opinion that the whole of such inventions are such as to constitute a single invention and may properly be included in one patent, he may allow one complete specification to be filed in respect of all such provisional specifications: that the period of time specified under sub-section shall be reckoned from the date of filing of the earliest provisional specification. Where an application for a patent (not being a convention application or an application filed under the Patent Cooperation Treaty designating India) is accompanied by a specification purporting to be a complete specification, the Controller may, if the applicant so requests at any time within twelve months from the date of filing of the application, direct that such specification shall be treated, for the purposes of this Act, as a provisional specification and proceed with the application accordingly. Where a complete specification has been filed in pursuance of an application for a patent accompanied by a provisional specification or by a specification treated by virtue of a direction under sub-section as a provisional specification, the Controller may, if the applicant so requests at any time before grant of patent cancel the provisional specification and post-date the application to the date of filing of the complete specification. Contents of specifications: (1) every specification, whether provisional or

4 4 P a g e complete, shall describe the invention and shall begin with a title sufficiently indicating the subject-matter to which the invention relates. (2) Subject to any rules that may be made in this behalf under this Act, drawings may, and shall, if the Controller so requires, be supplied for the purposes of any specification, whether complete or provisional; and any drawings so supplied shall, unless the Controller otherwise directs, be deemed to form part of the specification, and references in this Act to a specification shall be construed accordingly. (3) If, in any particular case, the Controller considers that an application should be further supplemented by a model or sample of anything illustrating the invention or alleged to constitute an invention, such model or sample as he may require shall be furnished 1 before the application is found in order for grant of a patent] but such model or sample shall not be deemed to form part of the specification. (4) Every complete specification shall (a) fully and particularly describe the invention and its operation or use and the method by which it is to be performed; (b) disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection; and (c) end with a claim or claims defining the scope of the invention for which protection is claimed be accompanied by an abstract to provide technical information on the invention: That (i) the Controller may amend the abstract for providing better information to third parties; and (ii) if the applicant mentions a biological material in the specification which may not be described in such a way as to satisfy clauses (a) and (b), and if such material is not available to the public, the application shall be com-*" pleted by depositing 3[the material to an international depository authority under the Budapest Treaty] and by fulfilling the following conditions, namely: the deposit of the material shall be made not later than the date of filing the patent application in India and a reference thereof shall be made in the specification within the prescribed period; all the available characteristics of the material required for it to be correctly identified or indicated are included in the specification including the name, address of the depository institution and the date and number of the deposit of the material at the institution; access to the material is available in the depository institution only after the date of the application for patent in India or if a priority is claimed after the date of the priority; disclose the source and geographical origin of the biological material in the specification, when used in an invention. In case of an international application designating India, the title, description, drawings, abstract and claims filed with the application shall be taken as the complete specification for the purposes of this Act. The claim or claims of a complete specification shall relate to a single invention, or to a group of inventions linked so as to form a single inventive concept, shall be clear and succinct and shall be fairly based on the matter disclosed in the specification. Declaration as to the inventor ship of the invention shall, in such cases as may be prescribed be furnished in the prescribed form with the complete specification or within such period as may be prescribed after the filing of that specification. Rights of patentees: Subject to the other provisions contained in this Act and the conditions specified in section 47, a patent granted under this Act shall confer upon the patentee (a) where the subject matter of the patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing for those purposes that product in India: (b) where the subject matter of the patent is a process the exclusive right to prevent third parties, who do not have his consent, from the act of using that process, and from the act of using, offering for sale, selling or importing for those purposes the product obtained directly by that process in India: Rights of co-owners of patents: (1) Where a patent is granted to two or more persons, each of those persons shall, unless an agreement to the contrary is in force, be entitled to an equal

5 5 P a g e undivided share in the patent. (2) Subject to the provisions contained in this section and in section 51, where two or more persons are registered as grantee or proprietor of a patent, then, unless an agreement to the contrary is in force, each of those persons shall be entitled, by himself or his agents, to 3[the rights conferred by section 48] for his own benefit without accounting to the other person or persons. (3) Subject to the provisions contained in this section and in section 51 and to any agreement for the time being in force, where two or more persons are registered as grantee or proprietor of a patent, then, a licence under the patent shall not be granted and a share in the patent shall not be assigned by one of such persons except with the consent of the other person or persons. (4) Where a patented article is sold by one of two or more persons registered as grantee or proprietor of a patent, the purchaser and any person claiming through him shall be entitled to deal with the article in the same manner as if the article had been sold by a sole patentee. (5) Subject to the provisions contained in this section, the rules of law applicable to the ownership and devolution of movable property generally shall apply in relation to patents, and nothing contained in sub-section (1) or sub-section (2) shall affect the mutual rights or obligations of trustees or of the legal representatives of a deceased person or their rights or obligations as such. (6) Nothing in this section shall affect the rights of the assignees of a partial interest in a patent created before the commencement of this Act. Offences & penalties: Contravention of secrecy provisions relating to certain inventions. If any person fails to comply with any direction given under section 35, 2[or makes or causes to be made an application for the grant of a patent in contravention of section 39] he shall be punishable with imprisonment for a term which may extend to two years, or with fine, or with both. Falsification of entries in register, etc: If any person makes, or causes to be made, a false entry in any register kept under this Act, or a writing falsely purporting to be a copy of an entry in such a register, or produces or tenders, or causes to be produced or tendered, in evidence any such writing knowing the entry or writing to be false, he shall be punishable with imprisonment for a term which may extend to two years, or with fine, or with both. Unauthorized claim of patent rights: If any person falsely represents that any article sold by him is patented in India or is the subject of an application for a patent in India, he shall be punishable with fine which may extend to 3[one lakh] rupees. Explanation 1 : For the purposes of this section, a person shall be deemed to represent (a) that an article is patented in India if there is stamped, engraved or impressed on, or otherwise applied to, the article the word "patent" or "patented" or some other word expressing or implying that a patent for the article has been obtained in India; (b) that an article is the subject of an application for a patent in India if there are stamped, engraved or impressed on, or otherwise applied to, the article the words "patent applied for", "patent pending", or some other words implying that an application for a patent for the article has been made in India. Explanation 2: The use of words "patent", "patented", "patent applied for", "patent pending" or other words expressing or implying that an article is patented or that a patent has been applied for shall be deemed to refer to a patent in force in India, or to a pending application for a patent in India, as the case may be, unless there is an accompanying indication that the patent has been obtained or applied for in any country outside India. Wrongful use of words, "patent office" If any person uses on his place of business or any document issued by him or otherwise the words "patent office" or any other words which would reasonably lead to the belief that his place of business is or is officially connected with, the patent office, he shall be punishable with imprisonment for a term which may extend to six months, or with fine, or with both. Refusal or failure to supply information (1) If any person refuses or fails to furnish (a) to the Central Government any information which he is required to furnish under sub-section (5) of

6 6 P a g e section 100, (b) to the Controller any information or statement which he is required to furnish by or under section 146. he shall be punishable with fine which may extend to 1[ten lakh rupees] (2) If any person, being required to furnish any such information as is referred to in subsection (1), furnishes information or statement which is false and which he either knows or has reason to believe to be false or does not believe to be true, he shall be punishable with imprisonment which may extend to six months, or with fine, or with both. Practice by non-registered patent agents If any person contravenes the provisions of section 129, he shall be punishable with fine which may extend to 2[one lakh rupees in the case of a first offence and five lakh rupees] in the case of a second or subsequent offence. Offences by companies (1) If the person committing an offence under this Act is a company, the company as well as every person in charge of, and responsible to, the company for the conduct of its business at the time of the commission of the offence shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly: provided that nothing contained in this sub-section shall render any such person liable to any punishment if he proves that the offence was committed without his knowledge or that he exercised all due diligence to prevent the commission of such offence. (2) Notwithstanding anything contained in sub-section (1), where an offence under this Act has been committed by a company and it is proved that the offence has been committed with the consent or connivance of, or that the commission of the offence is attributable to any neglect on the part of any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly. Q3. Describe education regulations as defined by pharmacy council of India (PCI). Explain the constitution of state pharmacy council. What is registration of a pharmacist and recommended panalties for falsely claiming to be registered as pharmacist? Answer. Education Regulations: (1) Subject to the provisions of this section, the Central Council may, subject to the approval of the Central Government, make regulations, to be called the Education Regulations, prescribing the minimum standard of education required for qualification as a pharmacist. (2) In particular and without prejudice to the generality of the foregoing power, the Education Regulations may prescribe (a) the nature and period of study and of practical training to be undertaken before admission to an examination; (b) the equipment and facilities to be provided for students undergoing approved courses of study; (c) the subjects of examination and the standards therein to be attained; (d) any other conditions of admission to examinations. (3) Copies of the draft of the Education Regulations and of all subsequent, amendments thereof shall be furnished by the Central Council to all State Governments, and the Central Council shall before submitting the Education Regulations or any amendment thereof, as the case may be, to the Central Government for approval under sub-section (1) take into consideration the comments of any State Government received within three months from the furnishing of the copies as aforesaid. (4) The Education Regulations shall be published in the Official Gazette and in such other manner as the Central Council may direct. (5) The Executive Committee shall from time to time report to the Central Council on the efficacy of the Education Regulations and may recommend to the Central Council such amendments thereof as it may think fit. Constitution of 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, (a) six members, elected from amongst themselves by registered pharmacists of the State; (b) five members, of whom at least 1 [three] shall be persons possessing a prescribed degree or diploma in pharmacy or pharmaceutical

7 7 P a g e chemistry or [registered pharmacists], nominated by the State Government; (c) one member elected from amongst themselves by the members of each Medical Council or the Council of Medical Registration of the State, as the case may be; (d) the chief administrative medical officer of the State ex officio or if he is unable to attend any meeting, a person authorized by him in writing to do so (d) the officer-in-charge of drugs control organization of the State under the Drugs and Cosmetics Act, 1940 (23 of 1940)], ex officio or if he is unable to attend any meeting, a person authorized by him in writing to do so; (e) the Government Analyst under the Drugs and Cosmetics Act, 1940 (23 of 1940)], ex officio, or where there is more than one, such one as the State Government may appoint in this behalf: Provided that where an agreement is made under clause (b) of sub-section (1) of section 20, the agreement may provide that the State Council to serve the needs of the other participating States also shall be augmented by not more than two members, of whom at least one shall at all times be a person possessing a prescribed degree or diploma in pharmacy or pharmaceutical chemistry or a [registered pharmacist], nominated by the Government of each of the said other participating States, and where the agreement so provides, the composition of the State Council shall be deemed to be augmented accordingly. Inter-State agreements. (1) Two or more State Government may enter into an agreement to be in force for such period and to be subject to renewal for such further periods, if any, as may be specified in the agreement, to provide (a) for the constitution of a Joint State Council for all the participating States, or (b) that the State Council of one State shall serve the needs of the other participating States. (2) In addition to such matters as are in this Act specified, an agreement under this section may (a) provide for the apportionment between the participating State of the expenditure in connection with the State Council or Joint State Council; (b) determine which of the participating State Governments shall exercise the several functions of the State Government under this Act, and the references in this Act to the State Government shall be construed accordingly; (c) provide for consultation between the participating State Governments either generally or with reference to particular matters arising under this Act; (d) make such incidental and ancillary provisions, not inconsistent with this Act, as may be deemed necessary or expedient for giving effect to the agreement. (3) An agreement under this section shall be published in the Official Gazettes of the participating States. Composition of Joint State Councils: (1) A Joint State Council shall consist of the following members, namely: (a) such number of members, being not less than three and not more than five as the agreement shall provide elected from amongst themselves by the registered pharmacists of each of the participating States; (b) such number of members, being not less than two and not more than four as the agreement shall provide, nominated by each participating State Government; (c) one member elected from amongst themselves by the members of each Medical Council or the Council of Medical Registration of each participating State as the case may be; (d) the chief administrative medical officer of each participating State, ex officio, or if he is unable to attend any meeting, a person authorized by him in writing to do so; the officer-in-charge of drugs control organization of each participating State under the Drugs and Cosmetics Act, 1940, ex officio, or if he is unable to attend any meeting, a person authorized by him in writing to do so; (e) the Government Analyst under the Drugs and Cosmetics Act, 1940 (23 of 1940), of each participating State, ex officio, or where there is more than one in any such State, such one as the State Government may appoint in this behalf. (2) The agreement may provide that within the limits specified in clauses (a) and (b) of sub-section (1), the number of members to be elected or nominated under those clauses may or may not be the same in respect of each participating State. (3) Of the members, nominated by each State Government under clause (b) of sub-section (1),

8 8 P a g e 9[more than half shall be persons possessing a prescribed degree or diploma in pharmacy or pharmaceutical chemistry or 10 registered pharmacists. 22. Incorporation of State Councils. Every State Council shall be a body corporate by such name as may be notified by the State Government in the Official Gazette or, in the case of a Joint State Council, as may be determined in the agreement, having perpetual succession and a common seal, with power to acquire or hold property both movable and immovable and shall by the said name sue and be sued. 23. President and Vice-President of State Council. (1) The President and Vice-President of the State Council be elected by the members from amongst themselves: Provided that for five years from the first constitution of the State Council the President shall be a person nominated by the State Government who shall hold office at the pleasure of the State Government and where he is not already a member, shall be a member of the State Council in addition to the members referred to in section 19 or section 21, as the case may be. (2) The President or Vice-President shall hold office as such for a term not exceeding five years and not extending beyond the expiry of his term as a member of the State Council, but subject to his being a member of the State Council, he shall be eligible for re-election: Provided that if his term of office as a member of the State Council expires before the expiry of the full term for which he is elected as President or Vice- President, he shall, if he is re-elected or re-nominated as a member of the State Council, continue to hold office for the full term for which he is elected as President or Vice-President. Mode of elections. Elections under this Chapter shall be conducted in the prescribed manner, and where any dispute arises regarding any such election, it shall be referred to the State Government whose decision shall be final. 25. Term of office and casual vacancies. (1) Subject to the provisions of this section, a nominated or elected member, other than nominated President, shall hold office for a term of five years from the date of his nomination or election or until his successor has been duly nominated or elected, whichever is longer. (2). A nominated or elected member may at any time resign his membership by writing under his hand addressed to the President, and the seat of such member shall thereupon become vacant. (3). A nominated or elected member shall be deemed to have vacated his seat if he is absent without excuse sufficient in the opinion of the State Council from three consecutive meetings of the State Council, or if he is elected under clause (a) or (c) of section 19 or 21, if he ceases to be a registered pharmacist or causes to be a member of the Medical Council or Council of Medical Registration of the State, as the case may be. (4). A casual vacancy in the State Council shall be filled by fresh nomination or election, as the case may be, and the person nominated or elected to fill the vacancy shall hold office only for the remainder of the term for which the member whose place he takes was nominated or elected. (5) No act done by the State Council shall be called in question on the ground merely of the existence of any vacancy in, or any defect in the constitution of, the State Council. (6) Members of the State Council shall be eligible for re-nomination or re-election. 26. Staff, remuneration and allowances. The State Council may, with the previous sanction of the State Government, (a) appoint a Registrar who shall also act as Secretary and, if so decided by the State Council, Treasurer, of the State Council; (b) appoint such other officers and servants as may be required to enable the State Council to carry out its functions under this Act; (c) fix the salaries and allowances and other conditions of service of the Secretary and other officers and servants of the State Council; (d) fix the rates of allowances payable to members of the State Council: Provided that for the first four years from the first constitution of the State Council, the Registrar shall be a person appointed by the State Government, who shall hold office during the pleasure of the State Government. The Executive Committee. (1) The State Council shall, as soon as may be, constitute an Executive Committee consisting of the President (who shall be Chairman of the

9 9 P a g e Executive Committee) and Vice-President, ex officio and such number of other members elected by the State Council from amongst themselves as may be prescribed. (2) A member of the Executive Committee shall hold office as such until the expiry of his term of office as member of the State Council, but, subject to his being a member of the State Council, he shall be eligible for re-election. (3) In addition to the powers and duties conferred and imposed upon it by this Act, the Executive Committee shall exercise and discharge such powers and duties as may be prescribed. Preparation and maintenance of register. (1) As soon as may be after this chapter has taken effect in any State, the State Government shall cause to be prepared in the manner hereinafter provided a register of pharmacists for the State. (2) The State Council shall as soon as possible after it is constituted assume the duty of maintaining the register in accordance with the provisions of this Act. (3) The register shall include the following particulars, namely: (a) the full name and residential address of the registered person; (b) the date of his first admission to the register; (c) his qualifications for registration; (d) his professional address, and if he is employed by any person, the name of such person; (e) such further particulars as may be prescribed. Preparation of first register. (1) 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 appoint a Registrar who shall act as Secretary of the Registration Tribunal. (2) 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. (3) 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. (4) 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. (5) 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. (6) Upon the constitution of the State Council, the register shall be given into its custody, and the State Government may direct that all or any specified part of the application fees for registration in the first register shall be paid to the credit of the State Council. Qualifications for entry on first register: A person who has attained the age of eighteen years shall be entitled] on payment of the prescribed fee to have his name entered in the first register if he resides, or carries on the business or profession of pharmacy, in the State and if he (a) holds a degree or diploma in pharmacy or pharmaceutical chemistry or a chemist and druggist diploma of an Indian University or a State Government, as the case may be, or a prescribed qualification granted by an authority outside India, or (b) holds a degree of an Indian University other than a degree in pharmacy or pharmaceutical chemistry, and has been engaged in the compounding of drugs in a hospital or dispensary or other place in which drugs are regularly dispensed on prescriptions of medical practitioners for a total period of not less than three years, (c) has passed an examination recognised as adequate by the State Government for compounders or dispensers, Or (d) has been engaged in the compounding of drugs in a hospital or dispensary or other place in which drugs are regularly dispensed on prescriptions of medical practitioners for a total period of not less than five years prior to the date notified under sub-section (2) of section 30.

10 10 P a g e Qualifications for subsequent registration: (1) After the date appointed under sub-section (2) of section 30 and before the Education Regulations have, by or under section 11, taken effect in the State, 3[a person who has attained the age of eighteen years shall on payment of the prescribed fee] be entitled to have his name entered in the register if he resides or carries on the business or profession of pharmacy in the State and if he (a) 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 (b) is a registered pharmacist in another State, or (c) possesses a qualification approved under section 14: Provided that no person shall be entitled under clause (a) of clause (c)] to have his name entered on the register unless he has passed a matriculation examination or an examination prescribed as being equivalent to a matriculation examination. 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 5[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 14 6[or is a registered pharmacist in another State. Special provisions for registration of certain persons. (1) Notwithstanding anything contained in section 32, a State Council may also permit to be entered on the register (a) the names of displaced persons who have been carrying on the business or profession of pharmacy as their principal means of livelihood from a date prior to the 4th day of March, 1948, and who satisfy the conditions for registration as set out in section 31;(b)the names of citizens of India who have been carrying on the business or profession of pharmacy in any country outside India and who satisfy the conditions for registrations as set out in section 31;(c) the names of persons who resided in an area which has subsequently become a territory of India and who satisfy the conditions for registration as set out in section 31;(d) the names of persons who carry on the business or profession of pharmacy in the State, and (i) would have satisfied the conditions for registration as set out in section 31, on the date appointed under sub-section (2) of section 30, had they applied for registration on or before that date; or (ii)have been engaged in the compounding of drugs in a hospital or dispensary or other place in which drugs are regularly dispensed on prescriptions of medical practitioners as defined in sub-clause (iii) of clause (f) of section 2 for a total period of not less then five years prior to the date appointed under sub-section (2) of section 30; (e) the names of persons who were qualified to be entered in the register for a State as it existed immediately before the 1st day of November, 1956, but who, by reason of the area in which they resided or carried on their business or profession of pharmacy having become part of a State as formed on that date, are not qualified to be entered having in the register for the latter State only by reason of their not having passed either a matriculation examination or an examination prescribed as being equivalent to a matriculation examination or an approved examination or of their not possessing a qualification approved under section 14; (f) the names of persons (i) who were included in the register for a State as it existed immediately before the 1st day of November, 1956; and (ii) who, by reason of the area in which they resided or carried on their business or profession of pharmacy having become part of a State as formed on that date, reside or carry on such business or profession in the latter State; (g) the names of persons who reside or carry on their business of profession or pharmacy in an area in which this Chapter takes effect after the commencement of the Pharmacy (Amendment ) Act, 1959 (24 of 1959), and who satisfy the conditions for registration as set out in section 31. (2.) Any person who desires his name to be entered in the register in pursuance of sub-section (1) shall make an application in that behalf to

11 11 P a g e the State Council, and such application shall be accompanied by the prescribed fee. (3.) The provisions of this section shall remain in operation for a period of two years from the commencement of the Pharmacy (Amendment) Act, 1959 (24 of 1959). Provided that the State Government may, by notification in the Official Gazette, extend the period of operation of clause (a), clause (b) or clause (c) of sub-section (1) by such further period or periods, not exceeding two years in the aggregate, as may be specified in the notification. Special provisions for registration of displaced persons, repatriates and other persons ; (1) Notwithstanding anything contained in section 32 or section 32A, a State Council may permit to be entered on the register (a) the names of persons who posses the qualifications specified in clause (a) or clause (c) of section 31 and who were eligible for registration between the closing of the First Register and the date when the Education Regulations came into effect. (b) the names of persons approved as qualified persons before the 31st December, 1969 for compounding or dispensing of medicines under the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder; (c) the names of displaced person or repatriates who were carrying on business or profession of pharmacy as their principal means of livelihood in any country outside India for a total period of not less than five years from a date prior to the date of application for registration. In this subsection, (i.); displaced persons means any persons who, on account of civil disturbances or the fear of such disturbances in any area now forming part of Bangla Desh, has, after the 14th day of April, 1957 but before the 25th day of March, 1971, left, or has been displaced from, his place of residence in such area and who has since then been residing in India;(ii.) repatriate means any person of Indian origin who, on account of civil disturbances or the fear of such disturbances in any area now forming part of Burma, Sri Lanka or Uganda, or any other country has after the 14th day of April, 1957, left or has been displaced from, his place of residence in such area and who has since then been residing in India. (2.) The provisions of clauses (a) and (b) of sub section (1) shall remain in operation for a period of two years from the commencement of the Pharmacy (Amendment) Act, Scrutiny of applications for registration: (1) After the date appointed under sub-section (2) of section 30, applications for registration shall be addressed to the Registrar of the State Council and shall be accompanied by the prescribed fee. (2.) If upon such application the Registrar is of opinion that the applicant is entitled to have his name entered in the register under the provisions of this Act for the time being applicable, he shall enter the name of the applicant in the register: Provided that no person whose name has under the provisions of this Act been removed from the register of any State shall be entitled to have his name entered in the register except with the approval of the State Council recorded at a meeting. (3.) Any persons, whose application for registration is rejected by the Registrar, may within three months from the date of such rejection appeal to the State Council, and the decision of the State Council thereon shall be final. (4.) Upon entry in the register of a name under section, the Registrar shall issue a certificate of registration in the prescribed form.9 Renewal fees. (1) The State Government may, by notification in the Official Gazette, direct that for the retention of a name on the register after the 31st day of December of the year following the year in which the name is first entered on the register, there shall be paid annually to the State Council such renewal fee as may be prescribed, and where such direction has been made, such renewal fee shall be due to be paid before the first day of April of the year to which it relates. (2) Where a renewal fee is not paid by the due date, the Registrar shall remove the name of the defaulter from the register: Provided that a name so removed may be restored to the register on such conditions as may be prescribed. (3) On payment of the renewal fee, the Registrar shall 10[issue a receipt therefor and such receipt shall be proof of renewal of

12 12 P a g e registration. Entry of additional qualifications registered pharmacist shall on payment of the prescribed fee be entitled to have entered in the register any further degrees or diplomas in pharmacy on pharmaceutical chemistry which he may obtain. Removal from register (1) Subject to the provisions of this section, the Executive Committee may order that the name of a registered pharmacist shall be removed from the register, where it is satisfied, after giving him a reasonable opportunity of being heard and after such further inquiry, if any, as it may think fit to make, (i) that his name has been entered into the register by error or on account of misrepresentation or suppression of a material fact, or (ii) that he has been convicted of any offence or has been guilty of any infamous conduct in any professional respect which in the opinion of the Executive Committee, renders him unfit to be kept in the register, or (iii) that a person employed by him for the purposes of his business of pharmacy 11[or employed to work under him in connection with any business of pharmacy] has been convicted of any such offence or has been guilty of any such infamous conduct as would, if such person were a registered pharmacist, render him liable to have his name removed from the register under clause (ii): Provided that no such order shall be made under clause (iii) unless the Executive Committee is satisfied (a) that the offence or infamous conduct was instigated or connived at by the registered pharmacist, or (b) that the registered pharmacist has at any time during the period or twelve months immediately preceding the date on which the offence or infamous conduct took place committed a similar offence or been guilty of similar infamous conduct, or (c) that any person employed by the registered pharmacist for the purposes of his business of pharmacy 11[or employed to work under him in connection with any business of pharmacy] has at any time during the period of twelve months immediately preceding the date on which the offence or infamous conduct took place, committed a similar offence or been guilty of similar infamous conduct, and that the registered pharmacist had, or reasonably ought to have had, knowledge of such previous offence or infamous conduct, or (d) that where the offence or infamous conduct continued over a period, the registered pharmacist had, or reasonably ought to have had, knowledge of the continuing offence or infamous conduct, or (e) that where the offence is an offence under the 12[Drugs and Cosmetics Act, 1940 (23 of 1940)], the registered pharmacist has not used due diligence in enforcing compliance with the provisions of that Act in his place of business and by persons employed by him 11[or by persons under his control. (2)An order under sub section (1) may direct that the person whose name is ordered to be removedfrom the register shall be ineligible for registration in the State under this Act either permanently or for such period as may be specified. (3) An order under sub-section (1) shall be subject to confirmation by the State Council and shall not take effect until the expiry of three month from the date of such confirmation. (4) A person aggrieved by an order under sub-section (1) which has been confirmed by the State Council may, within thirty days from the communication to him of such confirmation, appeal to the State Government, and the order of the State Government upon such appeal shall be final. (5) A person whose name has been removed from the register under this section or under sub-section (2) of section 34 shall forthwith surrender his certificate or registration to the Registrar, and the name so removed shall be published in the Official Gazette..Restoration to register: The State Council may at any time for reasons appearing to it sufficient order that upon payment of the prescribed fee the name of a person removed from the register shall be restored thereto: Provided that where an appeal against such removal has been rejected by the State Government, an order under this section shall not take effect until it has been confirmed by the State Government.