Kerala High Court
The Principal vs The Pharmacy Council Of India on 17 September, 2021
'CR'
IN THE HIGH COURT OF KERALA AT ERNAKULAM
PRESENT
THE HONOURABLE MR. JUSTICE P.V.KUNHIKRISHNAN
FRIDAY, THE 17TH DAY OF SEPTEMBER 2021 / 26TH BHADRA, 1943
WP(C) NO. 14617 OF 2021
PETITIONER/S:
THE PRINCIPAL
DM WIMS COLLEGE OF PHARMACY, NASEERA NAGAR, MEPPADI
P.O., WYNAD DISTRICT-673577.
BY ADVS.
KURIAN GEORGE KANNANTHANAM (SR.)
THOMAS GEORGE
TONY GEORGE KANNANTHANAM
RESPONDENT/S:
1 THE PHARMACY COUNCIL OF INDIA
REPRESENTED BY ITS SECRETARY, COMBINED COUNCIL
BUILDINGS, TEMPLE LANE, KOTLA, NEW DELHI-110002.
2 THE DIRECTOR OF MEDICAL EDUCATION,
MEDICAL COLLEGE P.O., TRIVANDRUM-695011.
3 STATE OF KERALA
REPRESENTED BY THE SECRETARY TO GOVERNMENT, HEALTH
& FAMILY WELFARE DEPARTMENT, GOVERNMENT
SECRETARIAT, TRIVANDRUM-695001.
BY ADV SHRI.P.VIJAYAKUMAR, ASG OF INDIA
OTHER PRESENT:
SRI.K.B.RAMANAND, SPL.GP
THIS WRIT PETITION (CIVIL) HAVING COME UP FOR ADMISSION
ON 17.09.2021, THE COURT ON THE SAME DAY DELIVERED THE
FOLLOWING:
W.P.(C).No.14617/2021
2
'CR'
P.V.KUNHIKRISHNAN, J.
-------------------------------
W.P.(C).No.14617 of 2021
----------------------------------------------
Dated this the 17th day of September, 2021
JUDGMENT
Petitioner is the Principal of a Self Financing Pharmacy
College. The petitioner's College was established in the
year 2016. The College started with B.Pharm with an intake
capacity of 100. It is stated that the Educational Agency of
the College is running a Medical College. This is situated in
Wayanad District. Since this is a composite program and the
institution had all the infrastructural and instructional
facilities to provide more courses in the field of Pharmacy,
the Educational Agency wanted to add on courses in
Pharmacy, in the College. Therefore, the petitioner applied
to the Pharmacy Council of India for approval to start
Pharm.D, M.Pharm and D.Pharm courses.
2. Pharm.D is an integrated course of six years
W.P.(C).No.14617/2021
leading to doctoral degree. All these applications were
given in 2020. The petitioner was on a bonafide belief that
for grant of approval for the above courses, the NOC or the
consent of affiliation of the examining body was required.
Therefore the petitioner had applied to the State
Government, the Director of Medical Education (DME) and
the University for the consent of affiliation. Ext.P1 is the
representation submitted by the petitioner to the
Government for NOC to Pharm.D and M.Pharm. The
University had issued their consent of affiliation for both the
courses. Ext.P2 is the consent of affiliation by the University
to Pharm.D course and Ext.P3 is the similar consent of
affiliation issued to M.Pharm. Since the matter was getting
delayed as far as D.Pharm is concerned, the petitioner again
gave a representation to the DME on 20.04.2021. This was
so given because the DME is the examining authority for
D.Pharm. Ext.P4 is the representation. The DME rejected
the application as per Ext.P5. In Ext.P5, the only reason
W.P.(C).No.14617/2021
said for rejection of NOC by DME is that NOC from the
Government is essential to start D.Pharm. Subsequently the
matter was considered by the 1st respondent in their
meeting dated 10.06.2021. Ext.P6 is the Minutes of the
meeting dated 10.06.2021. As per Ext.P6, the 1st respondent
rejected the request for D.Pharm course because the
institution has failed to submit consent of affiliation of
Examining Authority. As far as M.Pharm and Pharm.D
courses are concerned, the same was approved and D.Pharm
course alone is rejected. The petitioner filed an appeal to
the Executive Committee. But, as per Ext.P7, the appeal
was also dismissed because of the reason that the institution
has failed to submit consent of affiliation of Examining
Authority for D.Pharm course. Aggrieved by the same, this
writ petition is filed, mainly challenging Exts.P6 and P7.
3. Heard the counsel for the petitioner and ASGI who
appeared for the 1st respondent. I also heard the
Government Pleader for respondents 2 and 3.
4. The Senior Counsel who appeared for the
W.P.(C).No.14617/2021
petitioner submitted that the point to be decided is whether
NOC is required for grant of approval for D.Pharm by the 1 st
respondent and if the same is necessary, whether the
reasoning of DME to reject the same is in accordance to law.
The Senior Counsel takes me through Sections 10 and 12 of
the Pharmacy Act, 1948. The Senior Counsel also takes me
through Ext.P9, which is the Education Regulation, 2020 for
Diploma course in Pharmacy. The Senior Counsel submitted
that as per Clause 8 of Ext.P9, there is no stipulation that a
consent of affiliation of the Examining Authority is
necessary. The Senior Counsel submitted that Ext.P10 is the
Scheme for approval of D.Pharm course under Section 12 of
the Pharmacy Act. The Senior Counsel submitted that the
Scheme itself is framed without any source of power. The
Senior Counsel takes me through the Bachelor of Pharmacy
(B.Pharm) Course Regulation, 2014, (hereinafter referred to
as 'Regulation 2014') in which there is a corresponding
provision like Clause 8 in Ext.P9. The Senior Counsel
W.P.(C).No.14617/2021
submitted that in that Regulation, there is a specific
provision enabling to frame a Scheme. But the said provision
is not there in Ext.P9 Regulation which relates to the
Diploma course in Pharmacy. The Senior Counsel also takes
me through Clause 7 in Appendix-C of Ext.P9 Regulation in
which it is stated that the 1st respondent shall grant
recognition if the institution satisfies the conditions laid
down in the Rules. It is the definite case of the Senior
Counsel that the petitioner complied all the conditions in
Ext.P9. Therefore, simply because there is a stipulation in
Clause 3 of Ext.P10 Scheme that consent of affiliation of
Examining Authority is necessary, the same is not applicable
in this case. The Senior Counsel also relied on Ext.P8
judgment of this Court especially paragraph 20 of the
judgment.
5. The ASGI submitted that a reading of Sections 10
and 12 of the Pharmacy Act will clearly shows that a consent
of affiliation of the examining authority is necessary. The
W.P.(C).No.14617/2021
ASGI also relied on the judgment of the Delhi High Court.
That was a judgment dated 26.03.2007 in W.P.
(C).Nos.23665-68/2005. The Government Pleader also
supported the contentions of the ASGI and submitted that in
the light of the specific provisions in the Pharmacy Act,
affiliation from the Examining Authority is necessary. The
Government Pleader submitted that the DME has to find out
infrastructure of the institution and he is the Examining
Authority as far as D.Pharm is concerned and therefore, the
affiliation of DME is necessary.
6. The short point to be decided in this case is
whether the consent of affiliation of Examining Authority is
necessary in the light of Clause 3 of Ext.P10 scheme. For
deciding the same, some provisions of the Pharmacy Act is
to be considered. Firstly I will consider Section 12 of the
Pharmacy Act, which is extracted hereunder:
"12. Approved courses of study and examinations.-
(1) Any authority in a State which conducts a
course of study for pharmacists may apply to the Central
W.P.(C).No.14617/2021
Council for approval of the course, and the Central
Council, if satisfied, after such enquiry as it thinks fit to
make, that the said course of study is in conformity with
the Education Regulations, shall declare the said course
of study to be an approved course of study for the
purpose of admission to an approved examination for
pharmacists.
(2) Any authority in a State which holds an
examination in pharmacy may apply to the Central
Council for approval of the examination, and the Central
Council, if satisfied, after such enquiry as it thinks fit to
make, that the said examination is in conformity with the
Education Regulations, shall declare the said examination
to be an approved examination for the purpose of
qualifying for registration as a pharmacist under this Act.
(3) Every authority in the States which conducts an
approved course of study or holds an approved
examination shall furnish such information as the Central
Council may, from time to time, require as to the courses
of study and training and examination to be undergone,
as to the ages at which such courses of study and
examination are required to be undergone and generally
as to the requisites for such courses of study and
examination."
7. From Section 12(1), it is clear that any authority in a
State which conducts a course of study for Pharmacists may have
to apply to the Central Council for approval of the course. The
W.P.(C).No.14617/2021
Central Council, if satisfied after such enquiry as it thinks fit to
make that the said course of study is in conformity with the
Education Regulations, shall declare the said course of study to
be an approved course of study for the purpose of admission to
an approved examination for Pharmacists. Therefore, the duty of
the Central Council is to find out after such enquiry as it thinks fit
that the said course of study is in conformity with the Education
Regulations. As far as Section 12(2) is concerned, it is stated that
any authority in a State which holds an examination in Pharmacy
may apply to the Central Council for approval of the examination,
and if the Central Council is satisfied after such enquiry as it
thinks fit to make that the said examination is in conformity with
the Education Regulations, shall declare the said examination to
be an approved examination for the purpose of qualifying for
registration as a pharmacist under this Act. Section 12(2) says
that an authority in a State which holds an examination in
pharmacy has to approach Central Council to get the approval
and Section 12 (1)says any authority in a State which conducts a
course of study for pharmacists has to approach the Central
Council for approval of course. Section 12(3) says that every
W.P.(C).No.14617/2021
authority in the States which conducts an approved course of
study or holds an approved examination shall furnish such
information as the Central Council may, from time to time,
require as to the courses of study and training and examination
to be undergone, as to the ages at which such courses of study
and examination are required to be undergone and generally as
to the requisites for such courses of study and examination. As I
stated earlier, Section 12(1) deals with the approval of a course
by the Central Council based on the application of any authority
in a State which conducts a course of study and Section 12(2)
says about the approval of examination by any authority in a
State which holds an examination in Pharmacy. In Sections 12(1)
and 12(2), the Pharmacy Council has to follow that the course of
study and the examination are in conformity with the Education
Regulations.
8. Section 10 of the Pharmacy Act deals about the
Education Regulations. It will be better to extract Section 10:
"10. 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
W.P.(C).No.14617/2021
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 prescribed-
(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
W.P.(C).No.14617/2021
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."
9. Section 10(1) says that 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. Therefore,
the Education Regulations is to be framed prescribing the
minimum standard of education required for qualification as a
Pharmacist. Section 10(2) (a) to (d) also deals with the other
matters which can be prescribed in the Education Regulations.
Based on Section 10 of the Pharmacy Act, Ext.P9 Regulation is
framed. Ext.P9 is the Education Regulations, 2020 for Diploma
course in Pharmacy. The Regulation which is applicable in this
case is Regulation 8. The same is extracted hereunder:
"8. Approval of the authority conducting the course of
study-
(1) No authority in a State shall start or conduct
Diploma in Pharmacy course of study without the
prior approval of the Pharmacy Council of India.
W.P.(C).No.14617/2021
(2) The course of regular academic study prescribed
under regulation 6 shall be conducted in an
institution, approved by the Pharmacy Council of
India under sub-section (1) of Section 12 of the
Pharmacy Act, 1948.
Provided that the Pharmacy Council of India shall
not approve any institution under this regulation unless it
provides adequate arrangements for teaching in regard
to building, accommodation, equipments and teaching
staff etc. as specified in Appendix-A to these regulations
which may be amended by the Pharmacy Council of India
from time to time."
10. Regulation 8 only says that no authority in a State
shall start or conduct Diploma in Pharmacy course of study
without the prior approval of the Pharmacy Council of India.
Regulation 8(2) says that the course of regular academic study
prescribed under Regulation 6 shall be conducted in an
institution, approved by the Pharmacy Council of India under
sub-section (1) of Section 12 of the Pharmacy Act.
11. In the proviso to Regulation 8 it is stated that the
Pharmacy Council of India shall not approve any institution under
this regulation unless it provides adequate arrangements for
teaching in regard to building, accommodation, equipments and
W.P.(C).No.14617/2021
teaching staff etc. as specified in Appendix-A to the regulations
which may be amended by the Pharmacy Council of India from
time to time. It will also be beneficial to see conditions to be
fulfilled by the institution to be recognised for giving practical
training as per Appendix-C of Clause 7 in Ext.P9 Regulation.
Clause 7 of Appendix-C in Ext.P9 Regulation is extracted
hereunder:
"Having satisfied that the institution shall follow the
conditions laid down in these rules, the Pharmacy
Council of India shall grant such recognition."
12. A reading of clause 7 of Appendix C of Ext.P9 will
show that if an institution satisfy that they are following the
conditions laid down in Ext.P9 Rules, the Pharmacy Council
of India shall grant recognition. There is no clause in Ext.P9
to give a source of power to frame any scheme. As I
observed earlier, Ext.P9 is the Education Regulations, 2020
for Diploma course in Pharmacy. I perused the Bachelor of
Pharmacy (B.Pharm) Course Regulations, 2014. In clause
9.2 of the above Regulation clearly says about a scheme
prescribed by the Pharmacy Council. It will be better to
W.P.(C).No.14617/2021
extract clause 9 of the Regulations, 2014.
"9. Approval of the authority conducting the course
of study.-
1. xxx xxx
2. Any person or pharmacy college for the purpose
of obtaining permission under sub-section (1) of
section 12 of the Pharmacy Act, shall submit a scheme
as may be prescribed by the Pharmacy Council of
India."
13. The corresponding provision to the above clause in
Ext.P9 is clause 8, which I already extracted earlier. In
Ext.P9, there is no regulation empowering the Pharmacy
Council to frame a scheme as far as D.Pharm course is
concerned. But, in Regulations, 2014, there is power to the
Pharmacy Council to frame a scheme. Therefore, the source
of power to the Pharmacy Council to frame Ext.P10 scheme
is not available in Ext.P9 Regulations. The consent of
affiliation of Examining Authority is prescribed in clause 3 of
Ext.P10 scheme. First of all, there is no source of power to
the 1st respondent to frame a scheme as evident by Ext.P10,
W.P.(C).No.14617/2021
based on Ext.P9 Regulations. I make such an observation
because in Regulations, 2014, clause 9 clearly says about a
scheme that may be prescribed by the Pharmacy Council of
India.
14. Assume for argument sake, the 1st respondent has
got inherent power to frame Ext.P10 scheme, the question is
whether there can be a condition for consent of affiliation of
Examining Authority for considering approval of D.Pharm
course under Sec.12 of the Pharmacy Act. There is no such a
ladder in Sec.12 of the Pharmacy Act, 1948 or in Ext.P9
Regulations, which stipulate that consent of affiliation of
Examining Authority is necessary for considering an
application for approval of D.Pharm course under Sec.12 of
the Pharmacy Act. Therefore, according to me, the consent
of affiliation of Examining Authority is not necessary for
considering an application under Sec.12 of the Pharmacy
Act. Moreover, Ext.P8 is a judgment delivered by this Court
on 8.2.2019 in W.P.(C.) No. 26571/2018 and connected cases.
W.P.(C).No.14617/2021
Admittedly, the above judgment became final. Ext.P8 is a
judgment, which considered clause 9.2 of Regulations, 2014.
This Court considered the similar question in detail in
paragraph Nos.19 and 20. Paragraph Nos.19 and 20 of
Ext.P8 judgment is extracted hereunder:
"19. The next point to be considered is the validity of
stipulation of No Objection Certificate from the State
Government in the scheme framed under regulation 9.2 of
B.Pharm Course Regulations, 2014. In the scheme, it is
stipulated as follows :
3. "NOC/approval of the State Govt. for
starting B.Pharm course for the session applied
for by the institution.
a) This document shall be submitted by the
institution as soon as possible but without fail
before making admissions.
b) In case institution is not able to submit
NOC/approval of the State Govt. at the time for
applying to the Council with SIF, the institution
shall submit duly notarized affidavit on court
paper to the effect that-
• institution will without fail obtain and
submit NOC/approval of the State Govt. to
the PCI before making admissions.
• in case the institution fails to submit
W.P.(C).No.14617/2021
the NOC/approval of the State Govt. before
making admissions and comply with the
prescribed norms, the approval of the PCI if
granted shall be deemed to be withdrawn".
20. The power given to the Pharmacy Council under Section
10 is only in regard to the standard of education. That
means, to approve the course of study and also to approve
the examination for qualification for registration as a
pharmacist. Therefore, it cannot make any scheme not
relatable to the power given under Section 10. When a
condition is stipulated and it has no nexus with the object for
which the power is given, that condition becomes arbitrary.
The State has no role as far as for prescribing standards for
education for Pharmacy Council of India. Absolutely, no
reasons have been stated in the counter affidavit justifying
the stipulation of No Objection Certificate."
15. This Court clearly stated that the power given to
the Pharmacy Council under Sec.10 of the Pharmacy Act is
only to prescribe minimum standard of education required
for qualification as a Pharmacist. Similarly, Sec.10(2) (a) to
(d) of the Pharmacy Act are the provisions which deals
about the other matters that can be prescribed. This Court
clearly says that to approve the course of study and also to
W.P.(C).No.14617/2021
approve the examination for qualification for registration as
a Pharmacist, there cannot be any scheme not relatable to
the power given under Sec. 10 of the Pharmacy Act. This
Court observed that when a condition is stipulated and it
has no nexus with the object for which the power is given,
that condition becomes arbitrary. This Court also observed
that the State has no role for prescribing standards for
education of Pharmacy Council of India. The same principle
is applicable here also. Clause 3 of Ext.P10 scheme not
relatable to the power given under Sec.10 of the Pharmacy
Act. It has no nexus with the object for which the power is
given. In such circumstances, according to me, the consent
of affiliation of Examining Authority prescribed as a pre-
requisite mandatory document to be submitted by the
applicant for approval under Sec. 12 of the Pharmacy Act is
arbitrary and unsustainable.
16. Coming to the facts of this case, admittedly DME
is the Examining Authority of D.Pharm course. But as per
W.P.(C).No.14617/2021
Ext.P5, DME says that, NOC from the Government is
essential to start D.Pharm course. First of all, even as per
Clause 3 of Ext.P10, consent of affiliation of Examining
Authority alone is necessary and admittedly DME is the
Examining Authority of D.Pharm. Moreover, in the light of
the findings in this judgment, Ext.P5 will not stand. That can
be set aside. Exts.P6 and P7 are the decisions by which the
1st respondent and the appellate authority dismissed the
application of the petitioner solely on the reason that, the
petitioner has failed to submit consent of the affiliation of
Examining Authority for introduction of new D.Pharm
course. This will not stand in the light of the findings in this
judgment. The first respondent has to reconsider the matter
to find out whether the petitioner satisfies the other
conditions prescribed in the Pharmacy Act, 1948 and the
Regulations framed. There can be a time frame to take such
a decision.
Therefore, this writ petition is allowed in the following
W.P.(C).No.14617/2021
manner :
1) Clause 3 of Ext.P10, in so far as it insists on the
production of consent of affiliation of Examining
Authority for approval of D.Pharm course is set aside.
2) It is declared that the 1st respondent is not
competent to insist on the production of consent of
affiliation of the Examining Authority for the grant of
approval of D.Pharm course in the petitioner's College.
3) Exts.P5, P6 and P7 in so far as the same reject the
approval of D.Pharm course in the petitioner's College, is
set aside.
4) The first respondent is directed to reconsider the
application of the petitioner for approval of D.Pharm
course in accordance to law, as expeditiously as possible,
at any rate, within one month from the date of receipt of
a copy of this judgment.
sd/-
P.V.KUNHIKRISHNAN
JUDGE
JV
SKS
W.P.(C).No.14617/2021
APPENDIX OF WP(C) 14617/2021
PETITIONER EXHIBITS
Exhibit P1 TRUE COPY OF THE REPRESENTATION DATED
25.9.2020 FROM THE PETITIONER TO THE 3RD
RESPONDENT.
Exhibit P2 TRUE COPY OF THE CONSENT OF AFFILIATION
DATED 27.3.2021 ISSUED BY THE REGISTRAR,
KERALA UNIVERSITY OF HEALTH SCIENCES IN
RESPECT OF PHARM D.
Exhibit P3 TRUE COPY OF THE CONSENT OF AFFILIATION
DATED 27.3.2021 ISSUED BY THE REGISTRAR,
KERALA UNIVERSITY OF HEALTH SCIENCES IN
RESPECT OF M.PHARM.
Exhibit P4 TRUE COPY OF THE REPRESENTATION DATED
20.4.2021 FROM THE PETITIONER TO THE 2ND
RESPONDENT.
Exhibit P5 TRUE COPY OF THE LETTER DATED 21.5.2021
FROM THE 2ND RESPONDENT TO THE
PETITIONER.
Exhibit P6 TRUE COPY OF THE MINUTES OF THE MEETING
OF THE PHARMACY COUNCIL OF INDIA, ON
10.6.2021.
Exhibit P7 TRUE COPY OF THE RELEVANT PORTION OF THE
MINUTES HELD ON 27.6.2021.
Exhibit P8 TRUE COPY OF THE JUDGMENT DATED 8.2.2019
IN WP(C) NO.18063/2018 OF THIS HON.
COURT.
Exhibit P9 TRUE COPY OF THE ENGLISH VERSION ISSUED
BY THE PHARMACY COUNCIL OF INDIA OF THE
NOTIFICATION DATED 9.10.2020.
Exhibit P10 TRUE COPY OF THE SCHEME FOR APPROVAL OF
D.PHARM COURSE U/S. 12 OF THE PHARMACY
ACT 1948.
