Pharmaceutical Education Policy

About Author
Dr. R. S. Thakur
Chief Editor
Journal of Pharmaceutical Research
Krupanidhi College of Pharmacy
Bengaluru-560035.
Email: drramsthakur@gmail.com

Preamble
There is long overdue need to evolve a pragmatic, futuristic pharmaceutical education policy with visionary inputs that could transform the teaching learning process and respond to global aspirations and expectations of provisions of advanced pharmaceutical care. Producing empowered professionals, fully equipped with latest knowledge, skills and professional practice etiquette is a gigantic task. The vast canvas of critical educational complexities needs skillful exploration to draw transformational policies for educational reform. In view of the National Education Policy 2020’s emphasis on forward-looking vision for India’s higher education system and advocacy for catalyzing quality academic research in all fields through a new National Research Foundation, the precinct of pharmaceutical education needs special attention to produce world class pharmacists and pharmaceutical technologists to further strengthen India’s position as Pharmacy of World.
The distinguishing features of pharmaceutical education must accommodate dynamic system for knowledge generation, dissemination and utilization for welfare of society and nation as a whole. Rational use of medicines, economic availability and accessibility to quality medicines and safeguarding public health from the effects of improper use or misuse of modern medicines deserves special attention. No other healthcare professional fits well in this important role. This gigantic task deserves appropriate redressal by Pharmacy Council of India in view of the Statement of Object and Reasons of Pharmacy Act, 1948. Appropriate curricular approach, closely monitored pedagogical performance assessment, and foolproof evaluation system are backbone of sound education system. Education must help individuals to polish their best potential and thrive in their professional endeavour. This paper analyses the aforesaid objectives for guidance of present day professionals, educationists and policy makers.

Introduction
Genesis of Pharmacy Act
Wednesday, 9th March, 1927 is red letter day in history of Pharmacy in India, because on this day, for the first time on the floor of the Council of State (Upper House) of British India’s legislature, the word ‘Pharmacy’ was mentioned by the then Director General, Indian Medical Service while taking part in a debate on the resolution regarding control of the craze for medicinal drugs. During the 3rd session of the Second Council of State on 9th March, 1927 after question answer, The Honourable Sir Haroon Jaffer (Bombay Presidency) moved the following Resolution:
“This Council recommends to the Governor General in Council to urge all Provincial Governments to take immediate measures to control the craze for medicinal drugs by legislation for the standardisation of the preparation and sale of such drugs”
While taking part in debate on this resolution, Director General of Indian Medical Service, the Hon’ble Major-General, T. H. Symons inter alia spoke:-
“In Great Britain and in America there exist Acts which control the standard of drugs manufactured. May I deal with America first? The law in America particularly, I may say, deals with all these proprietary drugs. There are other drugs like the ordinary drugs found in the British Pharmacopoeia which fully satisfy a certain standard and as such are recognised, but there are a large number of proprietary drugs especially in America, and these in the interests of the public are safeguarded by what is called the Food and Drugs Act. Also there is what is called the Council Pharmacy of the American Drugs Association, which puts forward the truth as regards new preparations. It investigates all put upon the market and publishes annually a publication which is called “New and Old Non-official Remedies”. In Great Britain we have what is called the Therapeutic Act. But unfortunately the terms of that Act are not nearly as comprehensive as the Food and Drugs Act of America. The Therapeutic Act deals with biological products, such as toxins and serums and digestive ferments, glandular products and insulin. Now in India there are no safeguards against the manufacturing, advertising and selling of these patent drugs. You have been given to understand from the early part of my remarks that there are many firms in India putting on the market drugs in uncertain proportions inasmuch as they have not been standardised in India and no one except the manufacturer knows their correct composition. Therefore, I am with the Honourable the Mover of the amendment when he says that it is desirable that some steps should be taken whereby drugs manufactured in India should be standardised in some form or other. And I am therefore in favour of the amendment proposed which I will read, if I may, namely: “That this Council recommends to the Governor General in Council to urge all Provincial Governments to take such steps as may be possible to control the indiscriminate use of medicinal drugs and to legislate for the standardisation of the preparation and for the sale of such drugs.”

After extensive debate the house adopted the above resolution.1

Drugs Enquiry Committee
As a follow up step, the Government of India, Department of Education, Health and Lands, issued Resolution No. 1637, dated the 11th August 1930, appointing a small committee headed by Col. R. N. Chopra to explore and define the scope of the problem, and to make recommendations as to the measures which should be taken.2

The terms of reference to the Committee was follows:-

(1) To enquire into the extent to which drugs and chemicals of impure quality or defective strength, particularly those recognized by the British Pharmacopoeia, are imported, manufactured or sold in British India, and the necessity, in the public interest, of controlling such importation, manufacture and sale, and to make recommendations;
(2) To report how far the recommendations made in (1) may be extended to known and approved medicinal preparations other than those referred to above, and to medicines made from indigenous drugs and chemicals; and
(3) To enquire into- the necessity of legislation to restrict the profession of pharmacy to duly qualified persons, and to make recommendations.

On 2nd September 1930 the Secretary of Drugs Enquiry Committee forwarded Questionnaire to interested individuals and associations soliciting reply by 1st October, 1930. It was also informed that the Committee will also visit important centres in different provinces and will take evidence on the questions. It also enquired about willingness to appear before the Committee to give further information regarding answers.
The questions posed to Dispensing Chemists are reproduced below:-.

1. What precautions do you take to ensure that all drugs and chemicals used are of standard strength and purity?
2.  How many qualified compounders do you employ?
3. What is the average number of prescriptions you dispense a day?
4. What system of check do you employ in dispensing?
5. What difficulties do you experience from the Poisons Regulations?

The various individuals and organisations relating to dispensing and sale of drugs who replied the questionnaire are listed in Table 1.

Table 1. List of individuals and organizations who replied the questionnaire

The Drugs Enquiry Committee toured across the country and gathered oral evidences from various individuals and organisations. At many of those places persons representing medicine shops or trade organisations appeared before the committee for registering oral evidence. A list of such persons and organisations along with the place where they were heard by the committee is presented in Table 2.

Table 2. List of Chemists and Druggists and Trade Organisations who gave oral evidence before the Committee

Drugs Enquiry Committee Report
Volume I of the report, from page 164 to 167 deals with recommendations relating to “The profession of Pharmacy” through paragraphs 429 to 444 on the basis of which, the Pharmacy Bill was drafted and published for general information vide Notification No. F-450144/45-H (1) on 27th November 1945. The recommendations relating to registration as Pharmacist are reproduced below :-

“The profession of Pharmacy
429.  No person .should be eligible for registration as a pharmacist unless he has-
(a) successfully undergone the undermentioned* course of training as laid down by the General Council of Pharmacy; or
(b) taken the degree of a Pharmaceutical Chemist of an Indian University.
430.  Any person may be registered as a pharmacist without further training or qualifying     examination who is-
(a) a duly qualified medical practitioner, registered or recognized, by the Provincial Council of Medical Registration or by the General Medical Council of the United Kingdom;
or
(b) a holder of a British, American or foreign degree in pharmacy;
or
(c) a holder of a diploma of the Pharmaceutical Society of Great Britain;
or
(d) a holder of a degree in science of an Indian University with evidence of sufficient training in Pharmaceutical Chemistry.
* The course of studies and the qualifying examination will be as follows:-
Two years' course leading to Pharmacist's Diploma (minimum basic qualification- Matriculation of any recognized University or any other equivalent examination).
Curriculum
-First year-
(a) Botany as applied to pharmacy;
(b) Inorganic and organic chemistry;
(c) Physics;
(d) Theory and practice of pharmacy (preliminary);
(e) Pharmaceutical arithmetic (weights and measures, etc.).
First qualifying examination-
Second year - After passing the examination at the end of the first year of study, the curriculum will include-
(a) Theory and practice of pharmacy (advanced),
(b) Pharmaceutical chemistry,
(c) Pharmacognosy,
(d) Elementary knowledge of action of drugs,
(e) Pharmacy law.
Final examination for pharmacist's diploma. - Theoretical, oral and practical.
Apprenticeship.- One year in an institution, hospital or dispensary (specified by the Provincial Pharmaceutical Council) to be undergone along with the second year's course.” .…”

PHARMACY BILL 
On 21st January 1946 Pharmacy Bill was introduced in the Legislative Assembly3 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. The discussion could not be concluded till the adjournment of the Assembly and the Bill remained pending.4
On 15th August 1947 India became independent and the Legislative Assembly became Constituent Assembly. The Pharmacy Bill was again introduced vide L. A. Bill No. 52 of 1947 as published in the Gazette of India, Part V Dated 29th November, 1947.
Finally the Bill was taken up in the Constituent Assembly of India (Legislative) on 12th December, 1947 in the very first session of the Constituent Assembly5 after independence and 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 unorganised. 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 organised 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.”

After extensive debate the Bill was referred to a select Committee on the very same day. The report of the select Committee was presented to the Constituent Assembly of India (Legislative) on 28th January 1948. The Bill as reported by the Select committee was finally taken up for consideration6 on 5th February, 1948 and after extensive debate it was passed as amended. It got assent of the Governor General on 4th March 1948 and came on the Statute Book as THE PHARMACY ACT, 1948 (VIII of 1948).

STATEMENT OF OBJECTS AND REASONS
It is desirable that, as in most other countries, only persons who have attained a minimum standard of professional education should be permitted to practise the Profession of Pharmacy. It is accordingly proposed to establish a Central Council of Pharmacy, which will prescribe the minimum standards of education and approve courses of study and examinations for Pharmacists, and Provincial Pharmacy Councils, which will be responsible for the maintenance of provincial registers of qualified pharmacists. 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 pharmacist.

National Education Policy 2020 (NEP)7
Vision for Higher Education
NEP envisions the followings as major problems currently faced by the higher education system in India:
“ (a) a severely fragmented higher educational ecosystem;
(b) less emphasis on the development of cognitive skills and learning outcomes;        (c) a rigid separation of disciplines, with early specialisation and streaming of students into narrow areas of study;     
(d) limited access particularly in socio-economically disadvantaged areas, with few HEIs that teach in local languages
(e) limited teacher and institutional autonomy;
(f) inadequate mechanisms for merit-based career management and progression of faculty and institutional leaders;
(g) lesser emphasis on research at most universities and colleges, and lack of competitive peerreviewed research funding across disciplines;
(h) suboptimal governance and leadership of HEIs;
(i) an ineffective regulatory system; and
(j) large affiliating universities resulting in low standards of undergraduate education.”

Revamping Academic Research
On the Research front, NEP advocates exemplary innovations at educational institutions. It emphasizes that the world’s best universities provide the best teaching and learning processes at the higher education level as also a strong culture of research and knowledge creation is properly nurtured. It also records that much of the very best research in the world has occurred in multidisciplinary university settings. Pharmaceutical research is highly rewarding and therefore, needs close collaboration with industry to fetch adequate incentive and funding. Of course none can grow and prosper in isolation! Sooner we rise to the occasion is better for the nation.

Discussion
Pharmaceutical education being highly important for industry, research, academic and professional service in healthcare deserves special attention for revamping curricular and knowledge advancement process. Strong academia-industry bonding and world class professional skill development in pharmaceutical care are the issues that will glamorize India as powerhouse of pharmaceutical education. Let us gear up to tune pharmaceutical education in accordance with the expectations and aspirations of NEP. The points to be debated, documented and addressed in this context may be narrowed down to:

1. Current status of and trends in health care sector vis-a-vis role of pharmacist in global perspective of providing world class pharmaceutical care;
2. Assessment of future needs in pharmaceutical education vis-a-vis emerging role of pharmacist in the context of India emerging as Pharmacy of the World;
3. Devising mechanism for advancing a continuous process of curriculum development, teaching and learning vis-à-vis National Education policy 2020;
4. The role of experiential learning(internship), and practitioner education in professional and technological education; and
5. Visualizing impact of the Commission’s recommendations in view of first such initiative of 21st century for total quality management and dynamic skill accumulation model of continuous changes in Pharmaceutical Education and research initiatives at various levels.

Conclusion
Producing 21st century pharmacists whose super specialist role aims at enhancing efficacy of every prescription by ensuring rational drug use, medication adherence and patient compliance, is a mammoth task. The leadership of Pharmacy Council of India should act promptly to renovate education scenario.

References
1. The Council of State Debates, (8th February 1927 to 29th March 1927), third Session of the Second Council of State, 1927; Vol. 1: 9th March 1927 Page 515-525. Available at https://eparlib.nic.in/bitstream/123456789/762695/1/cosd_02_03_09-03-1927.pdf accessed on 20.08.2020
2. 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. p 3-4.
3. 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. p 67.
4. Ibid. 8th February 1946. p 720-727.
5. The Constituent Assembly of India (Legislative) Debates Official Report Volume III,   1947. (11th December to 21st December, 1947) First Session 1947, p 1817-1824.
6. The Constituent Assembly of India (Legislative) Debates Official Report Volume I,   1948. (28th January to 16th February, 1948) Second Session 1948, p 260-279.
7. National Education Policy 2020. Ministry of Human Resource Development, Government of India.

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