Chief Editor, Journal of Pharmaceutical Research
Krupanidhi College of Pharmacy, Bengaluru-560035.
Email: drramsthakur@gmail.com
Preamble
Pharmacy Act, 1948 (VIII of 1948) regulates the profession of pharmacy in India. Every pharmacist might have seen on the first page of the Act below the caption on the right side [4th March, 1948.]1 is printed. This is a very important date for pharmacists of India. It conveys that on 4th March 1948, the Pharmacy Bill passed by Constituent Assembly of India (Legislative) was assented by the Governor General and was brought on Statute Book as Pharmacy Act, 1948 (VIII of 1948). The existence of this Act is entering 75th year on 4th March, 2022. The year 2022-23 is thus celebration year of Pharmacy Act. Let us plan for it well in time for yearlong celebration across the country and recapitulate the events that led to enactment of Pharmacy Act and its importance in safeguarding public health through assured services of qualified and registered pharmacist in the matter of allopathic medicines. Thanks to all the individuals, the organizations, the Government machinery and the committees, whose incessant efforts and articulations between 1927 and 1947(21 long years) led to promulgation of the Pharmacy Act, 1948. This Act stipulates that only duly qualified pharmacists can be registered and only a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner. The Act also guarantees that contravention of the above provisions shall be punishable with imprisonment for a term which may extend to six months, or with fine not exceeding one thousand rupees or with both. It further provides for appointment of Inspectors to ensure compliance of the above stipulations of the Act.
Introduction
Historical facts and sequence of events between 1927 and 1931that led to drafting of Pharmacy Bill and its introduction in the Legislative Assembly 2 by Mr. S. B. Y. Oulsnam, Secretary Education Department on 21st January 1946 was discussed in detail in my article “Pharmaceutical Education Policy” published in PHARMATUTOR on 7th December, 2021.3
The Drugs Enquiry Committee Report was submitted on 29th March 1931. SECTION VII, CHAPTER II of the report presents Summary of Recommendations.4 From page 164 to 167 paragraph 429 to 446 covers recommendations relating to the profession of Pharmacy, of which 429 and 430 were presented in3 and 431 to 446 are reproduced below for the knowledge of the present generation and the posterity:-
The profession of Pharmacy
“429. xxx
430. xxx
431. Any person may be registered as a pharmacist until the expiration of a period of five years from the date of the passing of the Act- -
(a) if he has successfully undergone the course of 'Chemist and Druggist' of the Madras Medical College, or
(b) if he has obtained a compounder's certificate from the State Medical Faculty, Bengal, after undergoing the revised course of training instituted in July 1928; or
(c) if he is a qualified compounder and has been actively engaged in dispensing work for a period of not less than three years, or
(d) if he has been actively engaged in dispensing work without qualification for the preceding five years.
432. Provision should be made to institute a degree in Pharmaceutical Chemistry in the different Universities in India. Persons taking such degree will be eligible for registration as pharmacists.
433. The course for the degree in Pharmaceutical Chemistry should extend to two years after the Intermediate examination or four years after the Matriculation examination or its equivalent. In addition to training in technical and practical Chemistry and Botany in the laboratory, the candidate should be required to undergo training in a manufacturing establishment in Manufacturing Pharmacy and in the methods of analysis and standardization of drugs.
434. No person should be allowed to use the name or title of a "Pharmaceutical Chemist" unless he has taken such degree.
435. No person should carry on compounding, mixing, preparing, dispensing, or selling any drug in any registered shop or place, unless he is registered as a pharmacist under the Act, but a firm or company or a person who is not properly qualified may keep an open shop for compounding, mixing, dispensing, etc., provided the management is undertaken by or under the supervision of a qualified registered pharmacist.
436. In the case of hospitals, dispensing, etc., must be undertaken under the supervision of a qualified pharmacist. The Provincial Council will have power to exempt from this requirement an institution where the employment of a qualified pharmacist is neither necessary nor practicable owing to the small amount of dispensing. In such an institution, dispensing must be undertaken by or under the supervision of a medical practitioner.
437. No person who is not a registered pharmacist should be allowed directly or indirectly
(a) to use the name or title of 'Registered Chemist,' 'Pharmaceutist,' 'Pharmacist,' 'Chemist and Druggist' 'Dispensing Chemist,' 'Chemist,' or 'Druggist'; or
(b) to use or exhibit any name, title or sign holding out or implying that he is a registered pharmacist.
438. No registration is necessary in the case of -
(a) Persons selling drugs and chemicals in the ordinary course of wholesale dealing;
(b) persons selling drugs and chemicals in unbroken packages; and
(c) persons selling useful household remedies prescribed by the Governor-General in Council.
39. A Provincial Pharmaceutical Council should be formed in each Province including the Administered Areas and Commissionerships, consisting of eleven members, of whom seven will be elected from among themselves by registered pharmacists and four (who need not necessarily be registered pharmacists) will be nominated by the Local Government. But the first Council will consist entirely of persons nominated by the Local Government from among those who will be eligible for registration as Pharmacists.
440. The period of office of each member will be three years from the date d election or nomination as the case may be.
441. Each Provincial Pharmaceutical Council should hold at least one meeting during a period of three months.
442. The Provincial Pharmaceutical Council will have power-
(a) to maintain a register of all registered pharmacists of the Province and to register the names of Pharmacists on payment of such fees as may be determined by the General Council of Pharmacy; .
(b) to prescribe the educational institutions in which candidates for qualification and registration as pharmacists should undergo training and the places in which and the conditions under which apprenticeship should be served;
(c) to conduct an examination for Pharmacists under the guidance of the General Council of Pharmacy and to grant certificates;
(d) to investigate all complaints regarding registered Pharmacists of the Province and to remove the name of any person convicted of specified offences from the register of Pharmacists, subject to an appeal to the General Council of Pharmacy;
(e) to restore for good and sufficient reasons the names of Pharmacists removed from the register under the preceding clause;
(f) to send to the General Council of Pharmacy an annual report of its proceedings during the last preceding year; and
(g) generally to act under the control and direction of the General Council of Pharmacy.
443. A Central Council known as "The General Council of Pharmacy" consisting of 15 members of whom 12 members will be representatives from the Provincial Pharmaceutical Councils and three nominated, should be formed.
Each of the Provincial Pharmaceutical Councils of Bengal, Bombay and Madras will elect two members from among themselves and each of the Provincial Pharmaceutical Councils of the Punjab, the United Provinces, the Central Provinces and Bihar and Orissa, Assam and Burma will elect one member from among themselves to the General Council of Pharmacy. In case of appeals from the Administered Areas and Commissionerships, the General Council will have power to co-opt for purposes of hearing the appeal, any member from the Pharmaceutical Councils existing in those places.
The Governor-General in Council will nominate three members to the General Council of Pharmacy who need not necessarily be pharmacists.
444. The period of office of each member of the General Council of Pharmacy will be three years.
445. The General Council of Pharmacy should hold at least one meeting during every period of six months.
446. The General Council of Pharmacy will have power-
(a) to correlate and co-ordinate the activities of the different Provincial Pharmaceutical Councils;
(b) to organize the practice of pharmacy by setting up a uniform system of training and education all over India; .
(c) to exercise general disciplinary control over all the registered Pharmacists in India and, in cases where such powers are expressly given to the Provincial Pharmaceutical Councils, to exercise such power only by way of revision or appeal;
(d) to specify the fees and conditions for registration in respect of Pharmacists;
(e) to prescribe the form and contents of the registers to be maintained by the Provincial Pharmaceutical Councils; and
(f) to make such by-laws and regulations as may be necessary for the better control of the profession of pharmacy from time to time.”
Health Survey and Development Committee
On 25th October 1943 Government of India appointed the Health Survey and Development Committee under the Chairmanship of Sir Joseph Bhore to make: -
(a) A broad survey of the present position in regard to health conditions and health organizations in British India, and
(b) Recommendations for future development.
The report of the committee was submitted in 1946. The Committee made specific recommendations on Pharmacy Legislation5 and Pharmaceutical Education6 and those are appended below:
Drafting of the Bill
The recommendations of Drugs Enquiry Committee provided a good deal of content for drafting the Pharmacy Bill. However, the report remained in cold storage for more than 14 long years in so far as Pharmacy Bill is concerned. Pharmacy Bill was drafted in 1945 and published on 8th December, 1945. The step was welcomed by The Indian Pharmaceutical Association, the Bengal Pharmaceutical Association, the Indian Chemical Manufacturers Association, the Private Dispensers Association, Amritsar, and the All-India Compounders and Dispensers Association. These paved way for introduction of the Bill in the legislature.
Pharmacy Bill Introduced
On 21st January 1946 Pharmacy Bill was introduced in the Legislative Assembly2 by Mr. S. B. Y. Oulsnam, Secretary, Education Department. On 8th February, 1946 the Bill came up for discussion on the motion to refer to Select Committee. While moving the motion to refer the Bill to a Select Committee7 Mr. S. B. Y. Oulsnam, Secretary, Education Department spoke:-
“This Bill has been brought forward in response to a demand made on several occasions in this House, and by professional organizations outside the House, for legislation to regulate the profession and practice of pharmacy. As the House is aware, at present the practice of pharmacy is largely in the hands of a class known as compounders, some trained and some untrained. The profession is not organised; there is no provision for registration, and untrained persons can undertake the responsible work of compounding and dispensing medicines without restriction. Such training as is given by Provincial Governments, mainly to persons who are to be employed in hospitals, is generally recognized to be inadequate. When the Drugs Bill was before this House, an undertaking was given on behalf of the Government that they would address Provincial Governments on the question of legislation to control the pharmacy profession. Provincial Governments were addressed at that time; but before the drafting of the legislation could be completed, serious war developments occurred and it was decided to postpone further action until the situation improved. All Provincial Governments have now agreed to Central legislation on this subject, and this Bill has been prepared in consultation with them.
In most countries it is now recognized that the compounding and dispensing of medicines and the handling of patent drugs is a responsibility which should not be entrusted to untrained persons. In almost every country there is an organized pharmaceutical profession consisting of members who have been trained and registered according to the requirements of the law. In India the need for such regulation is increasingly urgent owing to the forthcoming institution of a system of control of drug standards. However detailed the legal provisions may be and however stringent the inspection and supervision, the control cannot be fully effective unless there is available a body of pharmacists who can be relied on by reason of their education and training, to exercise care and responsibility in the dispensing and handling of drugs. Rules and regulations are no substitute for a responsible organized profession, with professional standards of conduct and professional control. A committee appointed by the Bengal Government went so far as to describe the present position as a public danger and a crying evil which is sapping the very foundations of public health and medical practice. I think, therefore, that, whatever differences of opinion there may be on matters of detail, the House will agree that in principle this Bill is a necessary and a non-controversial measure.
Turning now to the general provisions of the Bill, it will be observed that it follows generally the lines of similar legislation relating to the medical profession.
It is proposed that there should be an All India Council, which will be responsible for laying down the standards of education for pharmacists, and provincial councils which will be responsible for the maintenance of register and will adjudicate on matters of professional discipline. It will inevitably take some, time to provide the necessary educational facilities for these improvements in education, and the date of enforcement of the new standards of training to be laid down by a new All India Council has been left to Provincial Governments. In the meantime a register will be prepared and persons who have received training as compounders or have acquired a certain standard or competence will be brought on the register. It is proposed to empower Provincial Governments to prohibit the dispensing of drugs by unregistered persons; but the Bill does not place any restrictions on the compounding and dispensing of medicine by a medical practitioner for his own patients.
Finally, the Bill does not apply to the dispensing of medicines under the Indian systems of medicine but only to the dispensing of prescriptions of practitioners having qualifications recognized under the Medical Acts.
There are a number of amendments on the paper suggesting that the Bill should be circulated for eliciting public opinion. The Bill was published on the 8th December and it has elicited a considerable degree of support from professional associations. The Indian Pharmaceutical Association, the Bengal Pharmaceutical Association, the Indian Chemical Manufacturers Association, the Private Dispensers Association, Amritsar, and the All-India Compounders and Dispensers Association are among the bodies who have welcomed the Bill.
If, however, the House feels that it is desirable to give more time to those interested in the measure to formulate their views, Government will have no, objection to such a course. Sir, I move.”
Two members of the Legislative Assembly namely Mr. Ahmed Ebrahim Haroon Jaffer and Dr. G. V. Deshmukh took part in the debate. While the former wanted that the Bill be circulated for the purpose of eliciting opinion thereon by the end of June 1946; the latter moved:
“That the Bill be circulated for the purpose of eliciting opinion thereon by Tuesday, the 30th April, 1946.”
However, the discussion could not be concluded till the adjournment of the Assembly and the Bill remained pending.
On 15th August 1947 India became independent and the Legislative Assembly became Constituent Assembly. The Pharmacy Bill was again introduced in the Assembly vide L. A. Bill No. 52 of 1947 as published in the Gazette of India, Part V Dated 29th November, 1947.
Finally on 12th December, 1947 the Pharmacy Bill was taken up in the Constituent Assembly of India (Legislative) in its very first session8 after independence. The Hon’ble Rajkumari Amrit Kaur (Minister for Health) moved a motion to refer the Bill to a Select committee. Her statement on the motion is reproduced below:-
“Sir, in asking the House to accept this motion, I would just like to say a few words about the very unsatisfactory position that exists today. There is no authority whatsoever to regulate the profession and the practice of pharmacy. The practice is largely in the hands of persons known as 'Compounders' and they are both trained and untrained. The profession is unorganized. There is no provision for registration. There is no check to prevent untrained persons from undertaking this very responsible work of compounding and dispensing medicines without any restriction. Compounders are trained today in provinces but the training is not of a high enough standard. A Drugs Act actually exists to control the quality of drugs that are imported and those that are manufactured at home but how can this Act be effective if we have not got an organized and trained profession of pharmacists for dispensing those very drugs. The position in advanced countries is that every pharmacist is required by law to be registered and he cannot be registered unless he has gone through a particular course of studies and passed an approved examination. I submit that it is only right that we also should have such rules in our country. This Bill that has been brought forward is intended to remedy these glaring defects. It is sought to provide Central and Provincial councils that will not, only prescribe minimum standards of training and qualification but will also inspect training institutions and will maintain registers of qualified persons. It is absolutely necessary that dispensing by unqualified persons should be stopped. The Bill was actually introduced in January 1946. It was circulated for opinion to all Provincial Governments and latter circulated again. Replies have been received. The Bill was drafted after consideration of those replies. The measure is long overdue. I, therefore hope that the House will have no hesitation in accepting the motion to refer it to a Select Committee.”
The Honourable members who participated in the discussion included Shri H. V. Kamath, Shri T. T. Krishnamachari, Dr. B. Pattabhi Sitaramayya, Shri Ram Sahai, and Shri Satyanarayan Sinha.
Replying to the debate on the motion to refer the Bill to a Select Committee, the Honourable Health Minister Rajkumari Amrit Kaur stated:-
“Sir, I am very grateful to the House for the kind reception which was given to my motion and for the support that I have had and the recognition from them that a measure of this nature is very necessary. I need hardly assure all the speakers that the suggestions that they have put forward will receive the highest consideration when the Bill is referred to Select Committee. I agree with one of the Speakers who said that unless we properly control all the systems of medicines including our own indigenous medicines we shall not really get very far, I am hoping great, things from the Report which is shortly expected of the Committee on Indigenous systems of Medicine and I hope it will be possible to standardise their practice and profession of pharmacy no less than those who dispense medicines for Allopaths. I do not think I need say any more at this stage except expressing my gratitude once again to the House for accepting the motion.”
After extensive debate the Bill was referred to a Select Committee consisting of Shri L. Krishnaswami Bharathi, Dr. V. Subrahmanyam, Shri Vinayakrao B. Vaidya, Dr. H. C. Mookerji, Mr. R. K. Sidhwa, Pandit Mukut Bihari Lal Bhargava, Mrs. Renuka Ray, Kazi Syed Karimuddin, Shri M. S. Aney, Shri O. V. Alagesan, Shri Bikramlal Sondhi, Prof. Yashwant Rai, Dr. P. S. Deshmukh, Dr. Dharam Prakash and the Honourable Health Minister Rajkumari Amrit Kaur with instructions to report on the opening day of the next session of the Assembly, and that the number of members whose presence shall be necessary to constitute a meeting of the Committee shall be five.
Pharmacy Bill Passed
The report of the select Committee was presented to the Constituent Assembly of India (Legislative) on 28th January 1948. The Bill was finally taken up for debate on 5th February, 1948. While moving the motion for consideration of the Bill by the House 9 the Honourable Health Minister Rajkumari Amrit Kaur spoke:-
“Sir, I do not think there is any necessity for me to reiterate what I said while I asked leave to refer this Bill to a Select Committee in the last session of the Assembly as far as the urgent necessity of bringing a measure of this nature on the Statute Book is concerned. All Honourable Members are aware of the very unsatisfactory position that exists today in the matter of the practice and profession of pharmacy. But perhaps it might be as well for me, from the point of view of informing the House, just to say something about the Drugs Act, which was passed in 1940 and the Drugs Rules framed under it which were brought into force in April 1941. The Pharmacy Bill is really a necessary corollary to the Drugs Act which cannot work effectively until the Bill is on the Statute Book. The Drugs Act and the Drugs Rules prescribe the standard of the quality of drugs that can be imported into, or manufactured, stocked and sold in India. They also provide for the licensing of Import, manufacture and sale in India of drugs under suitable conditions. I would like to inform the House that the necessary machinery for licensing and controlling imports has been set up at the centre. There is also a Central Drugs Laboratory, which has its headquarters at Calcutta, responsible for registering the formulae of patent medicines. The provincial councils enforce the Drug Rules in their respective provinces and the Central Council co-ordinates such action from the centre, to the extent possible. Now, the Drugs Rules regulating the retail sale of drugs stipulate that certain specified poisons and all medicines which are compounded on the prescription of medical practitioners can only be sold by, or under the direct supervision of a qualified person, that is to say, a qualified pharmacist. The Pharmacy Bill, therefore, when passed, will enable us to put the profession of pharmacists on a satisfactory basis. The Central Pharmacy Council, as will be seen from the Bill, will lay down the minimum standards required for the training of pharmacists and the provincial councils will maintain their register and attend to questions of professional discipline. In this sense also the Bill now before the House is really complementary to the Drugs Act which is already functioning.
The opinions received on the Pharmacy Bill were carefully considered by the Select Committee. Honourable Members will have noted the amendments that have been made and the more important of them have been tabulated in the Report of the Select Committee that has been circulated. I do hope that these will meet with the approval of the House and that the Bill as amended will be passed. Sir, I move.”
After the speech of the Hon’ble Health Minister the following motion was moved by the speaker:-
"That the Bill to regulate the profession of pharmacy, as reported by the Select committee be taken into consideration."
The members of the Constituent Assembly who took part in the discussion on the above motion included Shri Seth Govinddas, Mr. R. K. Sidhwa, Kazi Syed Karimuddin, Shri Biswanath Das, Mr. Tajamul Husain, Shri H. V. Kamath, and Dr. B. Pattabhi Sitaramayya.
Replying to the debate the Honourable Rajkumari Amrit Kaur spoke:
“Well. Sir, I do not think there has been any opposition to the Bill as it stands and everybody has accepted that a measure of this nature should be on the statute book. I think the speakers want to remind the Government of India once again through the Health Department of the need for turning our attention to the indigenous system of medicine. I had said once before on the floor of this House that we are awaiting the Report of the R. N. Chopra Committee. Owing to his illness that Report has been delayed. When it comes, the question as to how Research in indigenous systems of medicine can be encouraged and how those systems can be brought to give medical aid and relief in a greater measure to the people of this country and all other relevant questions will be considered. As far as the scope of this Bill is concerned Dr. Sitaramayya has quite correctly pointed out that indigenous drugs could not he brought within its scope. The Drugs Act of 1940 deliberately excluded drugs dispensed under indigenous systems of medicine for the obvious reason that drugs under these systems of medicine are not standardized and it is, therefore not practicable to bring them within the scope of such Bill. This Bill therefore could only apply to allopathy. That Government is interested in or will give every consideration to, the development of the Indian systems of medicine as I have already stated. But Members may not be impatient and I do plead with the House in matters of science to get away from thinking in terms of country or race for science knows no barriers of race or country. It is perhaps pertinent to note here that the best research that has been done on indigenous drugs has been done by an allopath. I do not think I have any more to say on the subject.”
Following the reply of the Hon’ble Minister the Speaker moved the following motion:
"That the Bill to regulate the profession of pharmacy, as reported by the Select Committee, be taken into consideration."
The above motion was adopted by the House. Thereafter the Bill was considered clause by clause and passed as amended. The members whose amendments were accepted included Shri K. Santhanam and Shri T. T. Krishnamachari. Finally the Pharmacy Bill was passed on 5th February, 1948.
Pharmacy Bill Assented
The Pharmacy Bill passed by the Constituent Assembly (Legislative) was assented by the Governor General on 4th March 1948 and became Pharmacy Act, 1948(VIII of 1948).
References
1. Pharmacy Act, 1948 (VIII of 1948).
2. The Legislative Assembly Debates. Official Report Volume I, 1946 (21st January to 11th February, 1946) First Session of the Sixth Legislative Assembly, 1946. Monday, 21st January, 1946. Page 67.
3. R. S. Thakur. Pharmacy Education Policy. PHARMATUROR. 7th December, 2021.
4. Report of the Drugs Enquiry Committee, 1930-31. Printed by The Superintendent, Government Press, and Published by -The Government of India, Central Publication Branch, Calcutta. Page 164-167.
5. Report of the Health Survey and Development Committee. Manager of Publications, Delhi. 1946. Page 53.
6. Ibid. page 173-174.
7. The Legislative Assembly Debates. Official Report Volume I, 1946 (21st January to 11th February, 1946) First Session of the Sixth Legislative Assembly, 1946. 8th February 1946. Page 720-727.
8. The Constituent Assembly of India (Legislative) Debates Official Report Volume III, 1947. (11th December to 21st December, 1947) First Session 1947. 12th December, 1947. Page 1817-1824.
9. The Constituent Assembly of India (Legislative) Debates Official Report Volume I, 1948. (28th January to 16th February, 1948) Second Session 1948, 5th February, 1948 p 260-279.
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