Kerala High Court
All Kerala Pharmacists Union ... vs State Of Kerala on 25 February, 2021
IN THE HIGH COURT OF KERALA AT ERNAKULAM
PRESENT
THE HONOURABLE MR. JUSTICE P.B.SURESH KUMAR
THURSDAY, THE 25TH DAY OF FEBRUARY 2021 / 6TH PHALGUNA,
1942
WP(C).No.33715 OF 2019(L)
PETITIONERS:
1 ALL KERALA PHARMACISTS UNION (AKPU),
REGISTRATION NO.TU19354/2019, REPRESENTED BY
ITS GENERAL SECRETARY, K.P.6/2A,
MALIKAPEEDIKAYIL, MAKKAD POST, KAKKODI,
KOZHIKODE DISTRICT, PIN - 673 611.
2 NOBY C.P.,
AGED 30 YEARS, S/O.GOVINDANKUTTY,
POONTHOTTATHIL HOUSE, KOODATHUMPOYIL, KAKKODI
POST, KOZHIKODE DISTRICT, PIN - 673 611.
BY ADV. SRI.P.K.RAVISANKAR
RESPONDENTS:
1 STATE OF KERALA,
REPRESENTED BY ITS ADDITIONAL CHIEF SECRETARY,
HEALTH AND FAMILY WELFARE DEPARTMENT,
SECRETARIAT, THIRUVANANTHAPURAM, PIN - 695
001.
2 DIRECTOR OF HEALTH SERVICES,.
GENERAL HOSPITAL JUNCTION,
THIRUVANANTHAPURAM, PIN - 695 035.
W.P.(C) No.33715 of 2019 2
3 PHARMACY COUNCIL OF INDIA,
COMBINED COUNCIL'S BUILDING, KOTLA ROAD,
AIWAN-E-GHALIB MARG, NEW DELHI - 110 002.
4 KERALA STATE PHARMACY COUNCIL,
PHARMACY BHAVAN, PUBLIC HEALTH LABORATORY
CAMPUS, THIRUVANANTHAPURAM - 695 037.
*5 ADDITIONAL R5
ASSOCIATION OF SMALL HOSPITALS AND CLINICS -
KERALA, 'NANMA', T.C. 14/573(1) PJRRA-53A,
MEDICAL COLLEGE, THIRUVANANTHAPURAM, KERALA-
695011, REP. BY ITS SECRETARY; DR. SUSHAMA
ANIL, D/O. LATE V. KRISHNAN NAIR, AGED 56
YEARS, 'KRISHNA' HOUSE, CHELANNUR-8/2,PUNNAD
P.O., KANNAKARA, KOZIKODE DISTRICT, PIN-
673616.
ADDL.R5 IMPLEADED AS PER ORDER DATED 14-01-
2021 IN IA 3/2020 IN WP(C) 33715/2019).
R3 BY ADV. SHRI.P.VIJAYAKUMAR, ASG OF INDIA
R5 BY ADV. JACOB SEBASTIAN
R5 BY ADV. SMT.ANU JACOB
R5 BY ADV. SHRI.ANIL KUMAR K.
R5 BY ADV. SRI.K.V.WINSTON
SRI.V.MANU SPL GP
THIS WRIT PETITION (CIVIL) HAVING BEEN FINALLY HEARD
ON 25-02-2021, THE COURT ON 25-02-2021 DELIVERED THE
FOLLOWING:
W.P.(C) No.33715 of 2019 3
C.R.
W.P.(C) No.33715 of 2019
-----------------------------------------------
JUDGMENT
The first petitioner is a trade union of pharmacists
and the second petitioner is a member of the first petitioner
trade union. On 24.06.2016, the second respondent, the
Director of Health Services of the State Government issued
Ext.P6 communication to the District Medical Officers under him
to resume distribution of medicines for Non-Communicable
Diseases (NCD medicines) through the Sub Centres functioning
under the Primary Health Centres in the State. It is stated by
the petitioners that there are no facilities in the Sub Centres for
diagnosis and treatment of patients; that the Sub Centres are
manned by Junior Public Health Nurses engaged in field works
concerning the various health programmes and that distribution
of NCD medicines through Sub Centres would therefore
contravene Section 42 of the Pharmacy Act, 1948 (the Act)
which provides that no person other than a registered
pharmacist shall dispense medicine on the prescription of
medical practitioners. It is also stated by the petitioners that
the second respondent has issued Ext.P7 circular later on
28.10.2016, authorising the Junior Public Nurses in the Sub
Centres to distribute NCD medicines prescribed by doctors to
the patients within their jurisdiction. Ext.P6 communication and
Ext.P7 circular were challenged by one Sabira M. before this
Court in W.P.(C) No.37156 of 2016 and the said writ petition
was disposed of holding that the Junior Public Health Nurses
shall not be permitted to dispense drugs, and directing the
State Government to take necessary steps to dispense drugs
through qualified pharmacists through the Sub Centres. Ext.P8
is the judgment in W.P.(C) No.37156 of 2016. It is stated by the
petitioners that after Ext.P8 judgment, the second respondent
has issued Ext.P9 order on 11.01.2018 prescribing the
procedure to be followed for distribution of medicines to
patients. In Ext.P9, it is directed that the pharmacists shall
dispense NCD medicines directly to the patients for a period of
three months in a labelled envelope and the same shall be
entrusted to the Junior Public Health Nurses in the Sub Centres
for safe keeping and periodic distribution. It was also directed in
Ext.P9 order that in hospitals, in the absence of pharmacist, the
Medical Officers may arrange dispensing of drugs under his/her
supervision. Later, on 12.01.2018, the second respondent
issued another order clarifying Ext.P9 order to the effect that
arrangement for dispensation of drugs in the hospital
pharmacies shall be under the direct supervision of the Medical
Officers. Exts.P9 and P10 orders are under challenge in the writ
petition. The case set out by the petitioners in the writ petition
is that the authorisation given to the Junior Public Health Nurses
in terms of Ext.P9 order to distribute drugs to patients and the
authorisation given to the Medical Officers in Exts.P9 and P10
orders to dispense drugs under their direct supervision would
contravene Section 42 of the Act.
2. A counter affidavit has been filed by the second
respondent. The stand taken by the second respondent in the
counter affidavit is that the arrangement made in terms of
Exts.P9 and P10 orders does not contravene Section 42 of the
Act. The stand aforesaid was explained by the second
respondent in the counter affidavit pointing out that a drug
dispensed by the pharmacist can be entrusted to a third person
for administration to patients and drugs can be administered by
the staff nurse in the ward in the case of inpatients, and
bystanders or relatives in the case of outpatients. It is also
pointed out by the second respondent that if the dispensation
of drugs and its administration are not understood separately,
inpatient wards in the hospitals cannot be run, as the
pharmacist cannot be expected to administer drugs to each and
every patients admitted in the hospital. Similarly, it was pointed
out that if dispensation of the drugs and its administration are
not understood distinctively, drugs which are dispensed for
outpatients in the hospitals cannot be administered to them by
their bystanders or relatives. It is also pointed out in the
counter affidavit that administration of drugs is contemplated
to be made through field staff for implementing the various
National and State Level Health Programmes such as
Tuberculosis Control, Leprosy Control, Anaemia Control for
Antenatal women, children etc. and the said programmes
cannot be implemented, if dispensation and administration are
not understood distinctively. It is specifically stated that NCD
medicines are distributed through Sub Centres in terms of the
operational guidelines issued by the Central Government for
implementation of the Scheme of the Central Government viz,
Prevention, Screening and Control of Common Non-
Communicable Diseases and the purpose of such distribution is
to ensure administration of drugs at the field level for patients
who have inaccessibility to reach the Primary Health Centre due
to their ill health, inconvenience or geographical reasons and
to ensure that unavailability of the drug shall not lead to
complications like heart attack, stroke, renal failure etc. It is
also stated that when distribution of NCD medicines was
stopped for sometime pursuant to Ext.P8 judgment, there was a
huge attrition of patients, especially elderly people with limited
mobility as they had to travel long distances to reach their
concerned Public Health Centres for getting medicines. It is also
stated by the second respondent that since monitoring of
health parameters like blood pressure and blood glucose level
is mandatory at regular intervals for continuation and also for
modification of drugs as per the prescribed protocol, long term
issue of medicines is not practical and it is with a view to tide
over this situation that Ext.P9 order has been issued. It is also
stated by the second respondent that as per the practice in
place, NCD medicines dispensed by the pharmacists to the
patients will be entrusted to Junior Public Health Nurses at the
Sub Centres and he/she will distribute the same, after
monitoring the blood glucose level, blood pressure etc. It is
stated that in so far as the distribution of NCD medicines is
concerned, the Junior Public Health Nurses in the Sub Centres
are acting only as care givers like immediate relatives for
ensuring the drug compliance as per the protocol. As regards
the dispensation of the drugs by Medical Officers, it is stated in
the counter affidavit that dispensation of medicines under the
direct supervision of the Medical Officers does not contravene
Section 42 of the Act.
3. As noted, the petitioners are aggrieved by
Exts.P9 and P10 orders to the extent the same authorise the
Junior Public Health Nurses in the Sub Centres of the Primary
Health Centres to distribute medicines to patients under their
jurisdiction and to the extent the same authorise Medical
Officers to arrange dispensing of medicines under their direct
supervision in hospitals, in the absence of pharmacists. The
petitioners do not have a case in the pleadings that they are
directly or indirectly affected by the said orders. They do not
also state that the writ petition is one instituted in public
interest. As the petitioners allege that the provision in Section
42 of the Act is violated flagrantly by the State Government, I
do not want to dispose of the writ petition on any technical
ground and instead, I wish to deal with the case on merits. The
short question that falls for consideration is as to whether
Exts.P9 and P10 would contravene Section 42 of the Act.
4. Heard the learned counsel for the petitioners as
also the learned Government Pleader.
5. The learned counsel for the petitioners
asserted that Ext.P9 order, insofar as it authorises Junior Public
Health Nurses working in Sub Centres to distribute medicines to
patients, contravenes Section 42 of the Act as the same would
amount to dispensing of drugs. The learned counsel relied on
the definition of 'dispensing' contained in the Pharmacy Practice
Regulations 2015 (the Regulations) issued under the Act to
support the said contention. Similarly, it was also asserted by
the learned counsel that Exts.P9 and P10 orders, insofar as it
authorise the Medical Officers to arrange dispensing of drugs
under their direct supervision also violate Section 42 of the Act.
It was pointed out by the learned counsel that the fact that the
words "except under the direct and personal supervision of a
registered pharmacist" which was originally part of subsection
(1) of Section 42 have been removed subsequently would
indicate the legislative intention that dispensing of medicine is
not permissible even under the direct and personal supervision
of the registered pharmacist. According to the learned counsel,
if that were to be the legislative intention, authorising
dispensation of drugs/medicines under the supervision of
medical officers would certainly contravene the requirement
under Section 42 of the Act.
6. Per contra, the learned Government pleader
reiterated the stand in the counter affidavit that dispensing of
drugs/medicines provided for under Section 42 of the Act and
its administration to patients are to be understood distinctively.
According to the learned Government Pleader, there is a clear
distinction between administration of drug to a patient and
dispensing of drug to the patient which a doctor prescribes. It
was argued that if this distinction is rightly drawn, it could be
seen that the impugned orders do not offend Section 42 of the
Act.
7. Sub-section (1) of Section 42 of the Act on
which reliance was placed by the petitioners to substantiate
their case, reads thus:
"42. Dispensing by unregistered persons.--(1) On or after
such date as the State Government may by notification in
the Official Gazette appoint in this behalf, no person other
than a registered pharmacist shall compound, prepare, mix,
or dispense any medicine on the prescription of a medical
practitioner:
Provided that this sub-section shall not apply to the
dispensing by a medical practitioner of medicine for his own
patients, or with the general or special sanction of the State
Government, for the patients of another medical
practitioner.
Provided further that where no such date is
appointed by the Government of a State, this sub-section
shall take effect in that State on the expiry of a period
of eight years from the commencement of the Pharmacy
(Amendment) Act, 1976."
Prior to the amendment in terms of Act 24 of 1959, sub-section
(1) of 42 of the Act without its provisos stood thus :
"42(1) On or after such date as the State Government may
by notification in the Official Gazette appoint in this behalf,
no person other than a registered pharmacist shall
compound, prepare, mix, or dispense any medicine on the
prescription of a medical practitioner except under the
direct and personal supervision of a registered pharmacist".
(Underline supplied)
The word 'dispensing' is not defined in the Act. The Regulations
issued under the Act, however, defines the word 'dispensing'
thus:
"Dispensing" means the interpretation, evaluation, supply
and implementation of a prescription, drug order, including
the preparation and delivery of a drug or device to a
patient or patient's agent in a suitable container
appropriately labeled for subsequent administration to, or
use by, a patient."
The Regulations also define the word "distribute" to mean
'delivery of a drug or device other than by administering or
dispensing'. It is thus clear from the aforesaid definitions itself
that the Act draws a clear distinction between dispensation of
drugs, its administration to patients and also distribution of
drugs for the purpose of administration.
8. Reverting to the facts, the operative portion of
Ext.P9 order, which is impugned in the writ petition, reads thus:
"Thus following procedures are to be followed in the
distribution of medicine to patients in the institution and
sub centre level.
1. For NCD drugs the Pharmacist may dispense NCD drugs
for 3 months in a labelled envelope directly to the patient,
which could be entrusted to the sub centre JPHN for safe
keeping and periodic distribution.
2. In the Hospital Pharmacy, in the absence of Pharmacist
or when the Pharmacist leaves the Pharmacy, the Medical
Officer may arrange dispensing of drugs under his / her
supervisions."
Ext.P10 order is nothing but a clarification to the effect that the
arrangement for dispensation of drugs by the Medical Officers
shall be under their direct supervision. The operative portion of
Ext.P10 order reads thus:
"In the light of the ambiguities existing in this regard, it is
clarified that in the hospital pharmacy, in the absence of
Pharmacist, or when the Pharmacist leaves the pharmacy,
the Medical Officer may arrange dispensing of drugs under
his/her direct supervision."
No doubt, Ext.P9 order authorises Junior Public Health Nurses in
the Sub Centres to keep with them NCD medicines prescribed
by doctors and dispensed by the pharmacists for patients within
their jurisdiction and distribute the same periodically for
administration to the patients. If the said order is understood in
the light of the operational guidelines of the Scheme of the
Central Government namely, prevention, screening and control
of common non-communicable diseases, under which NCD
medicines are distributed through Sub Centres, it is evident that
the authorisation aforesaid is given, as monitoring of health
parameters like blood pressure and blood glucose level is
mandatory at regular intervals for continuation and for
modification of drugs as per the prescribed protocol. Such an
authorisation, according to me, would not amount to dispensing
of medicines, but would only amount to distribution for
administration.
9. That apart, the Act is a legislation of the year
1948. It is common knowledge that at that time, drugs were
prepared by mixing or churning different compounds in various
strengths and the said process required special knowledge.
However, things have undergone a sea change. The concepts
of compounding, preparing, mixing etc. of drugs have become
obsolete practices of yesteryears. The drugs are now available
in blister packs. The Act being an ongoing legislation, viz,
intended to apply over a period of time, according to me, the
doctrine of updating construction is to be applied while
interpreting its provisions. The doctrine of updating
construction is premised on the principle that the provisions in
the statute are to be interpreted and constructed with reference
to its contemporary understanding and the constructions should
be continuously updated to allow for changes, for in such
legislations, the Legislature is not expected to intervene every
now and then. [See Bennion on Statutory Interpretation - Fifth
edition - Section 288]. I am fortified in this view by the following
observation of the Apex Court in National Textile Workers'
Union v. P.R.Ramakrishnan, (1983) 1 SCC 228 also.
"We cannot allow the dead hand of the past to stifle the growth
of the living present. Law cannot stand still it must change with
the changing social concepts and values. If the bark that
protects the tree fails to grow and expand along with the tree, it
will either choke the tree or if it is a living tree, it will shed that
bark and grow a new living bark for itself."
10. Coming to the authority given in Exts.P9 and
P10 orders to the Medical Officers to dispense medicines/drugs
under their direct supervision, the petitioners do not have a
case that the Medical Officers are not empowered to dispense
medicines to their patients. Their case, however, is only that
dispensation of medicines cannot be permitted under the
supervision of Medical Officers. According to them, if at all
Medical Officers are dispensing drugs/medicines, they should
dispense them by physically delivering the same to the patients
and if dispensation is permitted under their supervision,
dispensing would be done by others and such dispensation
would contravene Section 42 of the Act. I do not agree. True,
that portion of Section 42 of the Act authorising dispensation of
medicines under the direct and personal supervision of
registered pharmacists has been removed by way of
amendment to the Act, but that does not mean that the word
'dispense' in Section 42 of the Act is to be construed so
narrowly to mean that either the Pharmacist or the Medical
Practitioner should deliver the drugs/medicines personally to
the patients or to the agents of the patients. As indicated
above, Section 42 being only an ongoing provision intended for
the safety of patients, having regard to the various
developments took place in the field of medicines during the
last several decades, it cannot be said that dispensing of
medicines which now come in blister packs under the direct
supervision of the Medical Officer would contravene Section 42
of the Act in any manner.
In the said view of the matter, there is no merit in
the writ petition and the same is, accordingly, dismissed.
Sd/-
P.B.SURESH KUMAR, JUDGE.
YKB
APPENDIX
PETITIONER'S/S EXHIBITS:
EXHIBIT P1 TRUE COPY OF THE CERTIFICATE NO.44318
DATED 17/1/2012 ISSUED BY THE 4TH
RESPONDENT TO THE 2ND PETITIONER.
EXHIBIT P2 TRUE COPY OF THE CIRCULAR NO.MSA3-
28696/12/DHS DATED 2/5/2013 ISSUED BY
THE 2ND RESPONDENT.
EXHIBIT P3 TRUE COPY OF THE CIRCULAR
NO.251991/F1/2015/H&FWD DATED
20/10/2015 ISSUED BY THE 1ST
RESPONDENT.
EXHIBIT P4 TRUE COPY OF THE ORDER DATED 18/2/2013
IN H.R.M.P.NO.5139 OF 2011 KERALA
STATE HUMAN RIGHTS COMMISSION.
EXHIBIT P4A TRUE COPY OF THE ORDER DATED 4/3/2013
IN H.R.M.P.NO.28 OF 2014 KERALA STATE
HUMAN RIGHTS COMMISSION.
EXHIBIT P5 TRUE COPY OF THE QUESTIONS AND ANSWERS
DATED 8/1/2014 GIVEN IN THE 13TH
KERALA LEGISLATIVE ASSEMBLY.
EXHIBIT P6 TRUE COPY OF THE LETTER NO.PH2-
43243/16/DHS DATED 24/6/2016 ISSUED BY
THE 2ND RESPONDENT.
EXHIBIT P7 TRUE COPY OF CIRCULAR NO.PH2-
43243/16/DHS DATED 28/10/2016 ISSUED
BY THE 2ND RESPONDENT.
EXHIBIT P8 TRUE COPY OF THE JUDGMENT DATED
23/8/2017 IN W.P.(C) NO.37156 OF 2016.
EXHIBIT P9 TRUE COPY OF THE ORDER
NO.PH2/96525/17/DHS DATED 11/1/2018
ISSUED BY THE 2ND RESPONDENT.
EXHIBIT P10 TRUE COPY OF THE ORDER
NO.PH2/96525/17/DHS DATED 12/1/2018
ISSUED BY THE 2ND RESPONDENT.
EXHIBIT P11 TRUE COPY OF THE LETTER NO.250/17
DATED 4/11/2017 ISSUED BY MEDICAL
OFFICER IN CHARGE, PRIMARY HEALTH
CENTRE, ELAVALLY, THRISSUR DISTRICT.
EXHIBIT P11A TRUE COPY OF THE LETTER NO.29/18 DATED
15/2/2018 ISSUED BY MEDICAL OFFICER IN
CHARGE, PRIMARY HEALTH CENTRE,
AVANNUR, THRISSUR DISTRICT.
EXHIBIT P11B TRUE COPY OF THE LETTER NO.255/17
DATED 21/11/2017 ISSUED BY MEDICAL
OFFICER IN CHARGE, PRIMARY HEALTH
CENTRE, PARALAM, THRISSUR DISTRICT.
EXHIBIT P11C TRUE COPY OF THE LETTER NO.46/18 DATED
12/2/2018 ISSUED BY SUPERINTENDENT,
COMMUNITY HEALTH CENTRE, KADAPPURAM,
ANCHANGADY, THRISSUR DISTRICT.
EXHIBIT P11D TRUE COPY OF THE LETTER NO.1/18 DATED
15/2/2018 ISSUED BY PUBLIC INFORMATION
OFFICER, FAMILY HEALTH CENTRE,
MUNDOOR, THRISSUR DISTRICT.
EXHIBIT P11E TRUE COPY OF THE LETTER NO.8/18 DATED
5/2/2018 ISSUED BY PUBLIC INFORMATION
OFFICER, PRIMARY HEALTH CENTRE, ALOOR,
THRISSUR DISTRICT.
EXHIBIT P11F TRUE COPY OF THE LETTER NO.1156/17,
DATED 10/11/2017 ISSUED BY PUBLIC
INFORMATION OFFICER, COMMUNITY HEALTH
CENTRE, ALAPPAD, THRISSUR DISTRICT.
EXHIBIT P11G TRUE COPY OF THE LETTER NO.191 DATED
19/12/2017 ISSUED BY MEDICAL OFFICER
IN CHARGE, HEALTH CENTRE,
VILVATTAM,THRISSUR DISTRICT.
EXHIBIT P11H TRUE COPY OF THE LETTER NO.243/17
DATED 27/11/2017 ISSUED BY PUBLIC
INFORMATION OFFICER, PRIMARY HEALTH
CENTRE, VANIAMPARA THRISSUR DISTRICT.
EXHIBIT P11I TRUE COPY OF THE LETTER NO.RTI589/17/9
DATED 4/1/2018 ISSUED BY PUBLIC
INFORMATION OFFICER, K.KARUNAKARAN
SMARAKA COMMUNITY HEALTH CENTRE, MALA,
THRISSUR DISTRICT.
EXHIBIT P11J TRUE COPY OF THE REQUEST DATED
5/6/2019 ADDRESSED TO PUBLIC
INFORMATION OFFICER, DISTRICT MEDICAL
OFFICE, KOZHIKODE.
EXHIBIT P11K TRUE COPY OF THE LETTER NO.226/2019
DATED 22/6/2019 ISSUED BY PUBLIC
INFORMATION OFFICER, PRIMARY HEALTH
CENTRE, KAVIL, KOZHIKODE DISTRICT.
EXHIBIT P11L TRUE COPY OF THE LETTER NO.30/17 DATED
29/1/2018 ISSUED BY PUBLIC INFORMATION
OFFICER, PRIMARY HEALTH CENTRE,
AYYANTHOLE, THRISSUR DISTRICT.
EXHIBIT P11M TRUE COPY OF THE REQUEST DATED
5/6/2019 ADDRESSED TO PUBLIC
INFORMATION OFFICER, DISTRICT MEDICAL
OFFICE, KOZHIKODE.
EXHIBIT P11N TRUE COPY OF THE LETTER NO.106/2019
DATED 26/6/2019 ISSUED BY MEDICAL
OFFICER, PRIMARY HEALTH CENTRE,
KOTTOOR, KOZHIKODE DISTRICT.
EXHIBIT P12 TRUE COPY OF THE COUNTER AFFIDAVIT
FILED THE 3RD RESPONDENT IN W.P.(C)
NO.37156 OF 2016.
EXHIBIT P13 TRUE COPY OF THE PETITION DATED
20/11/2019 TO THE CHIEF SECRETARY OF
THE GOVERNMENT OF KERALA.
EXHIBIT P14 TRUE OF THE NOTE NO.M.S.A3/83501
/2016/DHS DATED 22.02.2017 ISSUED BY
THE 2ND RESPONDENT
RESPONDENT'S/S EXHIBITS:
EXHIBIT R2(A) COPY OF THE GUIDELINES ISSUED BY THE
GOVERNMENT OF INDIA
EXHIBIT R2(B) A COPY OF THE GOVERNMENT ORDER DATED
20.03.2020
//TRUE COPY//
PA TO JUDGE
