Pharmacy Council will approve pharmacy courses, not AICTE: Supreme Court

The bench of Honourable Justices Arun Mishra, Vineet Saran and MR Shah held that only Pharmacy Act 1948 will be applicable in relation to the subject of Pharmacy, including approval of courses of study, minimum standards of education required for qualification as a Pharmacist, registration as a Pharmacist, regulation of future professional conduct etc; not any other authority.

The SC was approached to intervene in the conflict over restrictions imposed by the PCI on the intake of students to various Pharmaceutical courses.

Many colleges had moved the various High Courts against these restrictions. Since the Colleges increased the intake of students, based upon the requisite approval obtained from the All India Council of Technical Education (AICTE), the High Courts had allowed the colleges to continue with the increase in intake.

In their decision, the Courts had concluded that AICTE is the supreme authority between the two bodies, namely, AICTE and PCI and the decision of AICTE will prevail over the decision of PCI. Following the same, the present appeal was filed by the PCI before the apex court against these High Courts' orders.

During the hearing, the question that arose before the SC bench was whether the mandate of the PCI or that of the AICTE would prevail on the question of granting approval and related matters to any institution for conducting pharmacy education course, if there were any conflict/contradictions in the opinions of these two bodies. The issue was as to which body, i.e. AICTE or PCI would primarily be responsible for regulation of pharmaceutical regulation in India.

In its observation, the bench went over to contemplate on the certain sections of the Pharmacy Act 1948 as well as the AICTE.

Considering the various provisions of the Pharmacy Act and its regulations, it was stated that the Pharmacy Act is a complete Code in itself in the subject of pharmacy, the bench noted adding that the PCI has been constituted as a body empowered to regulate the education and profession of pharmacy in India.

…the Pharmacy Act exclusively covers all areas inclusive of approval of courses, laying down course content, eligibility conditions for students as well as teachers, evaluation standards of examination, grant of registration, entry of higher qualifications in the same discipline, taking action for infamous conduct etc. It also contains a penal provision. Thus, the legislative intent in enacting the Pharmacy Act seems to be to ensure that there is seamless regulation of the profession. To carry out the objective and purpose for enacting the Pharmacy Act, the Legislature has established under the Statute the autonomous statutory authority i.e. Pharmacy Council of India. Thus it can be said that in the field of pharmacy, the Pharmacy Act is a special law.

On the other hand, the bench reckoned the AICTE Act as a general law applicable to the technical institutions and technical education. The preamble for AICTE clearly mentions:

"An Act to provide for the establishment of an All India Council for Technical Education with a view to the proper planning and co-ordinated development of the technical education system throughout the country, the promotion of qualitative improvements of such education in relation to planned quantitative growth and the regulation and proper maintenance of norms and standards in the technical education system and for matters connected therewith."

Noting that as per the Section 2(g) of the AICTE Act, "technical education" also means "pharmacy", the court wondered whether in the field of pharmacy, the Pharmacy Act would prevail or the AICTE Act? The next question was whether in the profession of pharmacy, the PCI shall have the exclusive jurisdiction or the AICTE?

To decide on the issue, the apex court judges relied on its earlier verdicts where the Supreme Court had considered the conflict between the general legislation and the special legislation and argument of 'implied repeal'.

"The general rule, that prior statutes are held to be repealed by implication by subsequent statutes if the two are repugnant, is said not to apply if the prior enactment is special and the subsequent enactment is general"

"A general later law does not abrogate an earlier special one by mere implication. Generalia specialibus non derogant, or, in other words, 'where there are general words in a later Act capable of reasonable and sensible application without extending them to subjects specially dealt with by earlier legislation, you are not to hold that earlier and special legislation indirectly repealed, altered, or derogated from merely by force of such general words, without any indication of a particular intention to do so. In such cases it is presumed to have only general cases in view, and not particular cases which have been already otherwise provided for by the special Act"

In these backdrops, the apex court observed:

"Pharmacy Act is a Special Act in the field of pharmacy and it is a complete code in itself in the field of pharmacy, the Pharmacy Act shall prevail over the AICTE Act which, as observed hereinabove, is a general statute dealing with technical education/institutions."

Taking the constitutional body of PCI and the AICTE into account, the judges stated:

PCI is the body of experts connected with the subject of pharmacy and related subjects and therefore it will be in the larger interest and more particularly in the interest of education of pharmacy that PCI shall alone have the Jurisdiction in the field of pharmacy, rather than AICTE.

On the issue of supremacy, the bench held that the fight of supremacy between both the regulators is unhealthy for the education sector as well as the institutions to permit two regulators to function in the same field. Therefore also and more particularly when the PCI is consisting of the experts in the field of pharmacy and other related subjects, it is in the larger interest in the field of pharmacy that the PCI must be given the power to regulate in the field of pharmacy.

in the field of Pharmacy Education and more particularly so far as the recognition of degrees and diplomas of Pharmacy Education is concerned, the Pharmacy Act, 1948 shall prevail. The norms and regulations set by the PCI and other specified 46 authorities under the Pharmacy Act would have to be followed by the concerned institutions imparting education for degrees and diplomas in Pharmacy, including the norms and regulations with respect to increase and/or decrease in intake capacity of the students and the decisions of the PCI shall only be followed by the institutions imparting degrees and diplomas in Pharmacy.

The court went on to observe that conflict and the dispute arose because despite refusal by the PCI, the AICTE increased the intake capacity in the respective institutions, which were not approved by the PCI. For the sake of students, the bench the present decision shall not affect those students admitted in the increased intake capacity and/or pursuant to the interim orders passed by this Court and/or final judgments and orders passed by the respective High Courts.

"PCI is therefore directed to give consequential benefit of registration to such students. However, at the same time, all pending applications for increase in intake capacity and/or for recognition and/or approval of course/institutions in the pharmacy shall be as per the provisions of the Pharmacy Act, 1948 and the regulations, if any, thereunder and as per the norms and regulations fixed by the PCI. It is further directed the concerned institutions who increased their intake capacity as approved by AICTE and their increase in intake capacity was not approved by PCI, shall apply afresh for increase in intake capacity and/or evening shift for the next academic year within a period of four weeks from today and their cases for increase in intake capacity and/or applications for recognition and/or applications for approval of the course or evening shift shall be considered by the PCI in accordance with the Pharmacy Act, 1948 and rules and regulations framed therein and the norms prescribed by the PCI."

Attached is the detailed judgment below:

https://medicaldialogues.in/pdf_upload/pdf_upload-125315.pdf

What does the Pharmacy Act 1948 say?

Section 10 of the Pharmacy Act empowers the PCI to frame Education Regulations prescribing the minimum standard of education required for qualification as a pharmacist.

As per sub-section (2) of Section 10, such 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. As per Section 12 of the Pharmacy Act, any "authority" in a State that is empowered to conduct a course of study in pharmacy may apply to the Central Council for approval of the course in accordance with the Education Regulations. Likewise, any authority which conducts an examination of a State for pharmacy may apply to the PCI for approval of such examination. A student who has passed/completed an approved course and passed an approved examination can only be registered as a Pharmacist subject to meeting other requirements.

Section 13 of the Pharmacy Act empowers the Central Council to withdraw approval accorded to the 'course of study' and 'examination' for failure to comply with the prescribed norms.

Section 16 of the Pharmacy Act empowers the Executive Committee to appoint inspectors to inspect any institution which provides an approved course of study or those institutions which apply for approval of course of study or examination.

Section 29 deals with preparation and maintenance of a register of pharmacists.

Section 35 provides for entry of additional qualifications in the register in relation to any registered pharmacist.

Section 36 provides for the removal of any person from the register, either permanently or for a temporary period.

As per Section 42 of the Pharmacy Act, a person may not practice the profession of pharmacy unless he or she is registered as a pharmacist in accordance with the Pharmacy Act.

Sub-section (2) of Section 42 is a penal provision which states that any person who is not a registered pharmacist and contravenes subsection (1) of Section 42 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.

In exercise of powers vested in the Pharmacy Act, PCI has framed a number of Regulations for prescribing minimum standards of education as well as regulating the subject of pharmacy in India, including:

a. Education Regulations, 1991;

b. Pharm. D Regulations, 2008;

c. Minimum Qualifications for Teachers in Pharmacy Institutions Regulations, 2014;

d. Bachelor of Pharmacy (B.Pharm) Course Regulations, 2014;

e. Master of Pharmacy (M.Pharm) Course Regulations, 2014;

f. Bachelor of Pharmacy (Practice) Regulations, 2014;

g. Pharmacy Practice Regulations, 2015.