Dr Geer Mohammad Ishaq in his article published by Daily Greater Kashmir for publication dwells upon the measures
needed to be taken by JKMSCL in order to ensure quality and streamline supply
of medicines in the state
J&K Medical Supplies Corporation
Limited has once again been in news albeit for wrong reasons. Several cases of
substandard drugs being supplied by JKMSCL to government hospitals have
surfaced in recent past that includes a spine-chilling case of steroids and
antibiotics being supplied together in the same boxes in large quantities for
use by children at a pediatric hospital. Boxes of antibiotic Vancomycin
injection were found to contain vials of Prednisolone injection, a steroid and
both the injections had same size, labeling and packaging design and even the
same batch number, making it difficult to differentiate between the two without
going through the labeling information. As many as 7000 vials were confiscated
by the drug control officials from the hospital apart from seizing additional
12000 vials from the drug warehouse at Government Medical College, Srinagar. Any
use of steroid in place of an antibiotic would have wreaked disaster among
pediatric patients making them vulnerable to potentially serious health hazards.
Recently it also came to the fore that five out of the six substandard drugs
supplied by the JKMSCL to the state hospitals during past few months had come
from a single Himachal Pradesh based company against which reportedly no
immediate action was taken due to some “procedural formalities”.
The minister for Health and Medical
Education of the state is on record to have admitted on the floor of the House
that 85 drugs were found to be sub-standard including drugs like Amoxicillin
capsules and Ceftriaxone injections supplied by Jammu and Kashmir Medical
Supplies Corporation Limited. Earlier a CAG report tabled in the state legislative assembly had also
brought to light some serious lapses in the procurement processes for
equipments and supplies in J&K Health Department, and had also depicted
gross negligence and apathy on part of the officials in ensuring supply of quality
and safe medicines to patients that can be gauged from the fact that as per
this report, 50.95 lakh sub-standard tablets, capsules and injections had been issued
to patients in various govt. hospitals. CAG report has also revealed acute
deficiency of drugs and disposables for testing in healthcare institutes. All this has led
to soaring mass resentment and anxiety and has further diminished already
plummeted faith and trust of common people upon medicines being issued at
public health facilities.
Local print media particularly GK has
been doing a commendable job in highlighting these crucial issues of high
importance having serious implications on overall public health. However, while
rightly blaming the faulty drug procurement and flawed quality testing
procedures being adopted by JKMSCL at present, for the dismal scenario, some
sections of the pharmaceutical traders as well as medical fraternity have also
been suggesting winding up of the whole JKMSCL and reverting back to previous
mode of decentralized procurement by different institutions and departments in
a fragmented manner. Question is whether dissolution and dismantling of JKMSCL
is the right answer to the miseries of common masses vis-à-vis quality and
availability of medicines at govt. health centres. Answer inevitably is a clear
‘No’ since JKMSCL is a step in the right direction taken on the basis of
premier drug policy of the J&K state that was formulated and adopted by the
state govt. in the year 2012.
Main purpose behind establishing JKMSCL
was to centralize procurement and decentralize distribution of standard quality
medicines on the lines of Tamil Nadu and Rajasthan Medical Services Corporations
which have been successful, WHO-endorsed models in this field and have led to
conservation of 38 to 45% of financial resources meant for drug procurement
that in turn has directly benefited patients of these states for whom
availability and affordability of standard quality generic medicines has
drastically improved. Since getting
good health care is not a privilege but a fundamental right of every human
being, a just and humane society must be able to provide reasonable, universal access
to safe, effective and standard quality medicines to all its citizens
irrespective of their caste, creed, religion or their paying capacity. Universal
access to health care is well recognized as a basic right of the people under the
right to protection of life and personal liberty as enshrined under Article 21
of the Constitution of India as well as under Section 24 of the Constitution of
Jammu & Kashmir state. Therefore main idea behind JKMSCL was to pool all
the previously fragmented and dispersed financial resources meant for
procurement of quality medicines and to utilize them to the best possible
benefits of patients. Hence those who talk of its dismantling or dissolution
cannot be considered as the well-wishers of patients. Then the next
obvious question would be as to where does the actual fault lie and what needs
to be done to rectify the same.
Roots of the problem lie in the fact that JKMSCL is functioning in
the state in absence of proper drug procurement policy framework, there is lack
of adequate, scientific
warehousing and inventory management system that includes state-of-the-art drug storage facilities fully
equipped with Management Information System (MIS) for real-time monitoring of stocks
in all districts and divisions of the state, lack of sufficient, dedicated
transportation vehicles laced with cold-chain facilities, non-availability of
qualified and adequate manpower trained specifically in supply chain
management, paucity of funds for procurement as well as non-procurement
purposes, lack of adequate, sophisticated drug testing facilities and
deficiency of frequent, random drug sampling procedures, non-compliance with
stringent pre- and post-qualification criteria to promote competition and
enforce quality, dearth of scientific demand estimation and forecasting system
to accurately quantify procurement, well defined, precise and localized Essential
Drugs List, protocols for regular inspection of supplier premises and mandatory
multiple external quality testing. A lot can be written about each of these
supply chain management activities, however due to constraints of space only a
couple of important issues shall be briefly discussed in the remaining part of
this write-up.
While the spirit with which JKMSCL was established is admirable,
the way it is functioning is unscientific and needs some serious thinking. No
such corporation can be a success unless it is fully autonomous, completely
transparent and accountable and functions on well established scientific principles
of pharmaceutical supply chain management. There is need to streamline the
entire system on modern, scientific and professional lines and organize all its
activities in a systematic manner in tune with international standards and norms.
A foolproof quality assurance system needs to be adopted leaving no room at all
for any compromises on the quality of medicines being supplied to patients. Government
needs to engage suitably qualified and adequately trained personnel for the
purpose of drug procurement, demand estimation, quantification,
pre-qualification and post-qualification procedures. At present no such executive
or administrative staff is available in sufficient numbers exclusively for
medicine management activities at any of the government health departments of
J&K state like Departments of Health, Family Welfare, Medical Education,
Provincial Medical Stores or Govt. Medical College, Srinagar that are
adequately trained to serve the purpose. Furthermore JKMSCL needs to fulfill
all necessary pre-requisites like state-of-art warehouses, dedicated
transportation, qualified manpower, adequate funds, sophisticated quality
testing facilities, regular inspections of retail outlets and frequent drug
sampling in order to bring it back on track and fulfill its objectives. In
absence of such a robust mechanism JKMSCL will continue to fail in its
objectives of making standard quality medicines available throughout the year
without any stock-outs in all healthcare facilities of the state.
Establishment of a comprehensive Quality
Assurance system involving both surveillance and testing of drug quality, involving both
technical and managerial activities, helps in ensuring quality of the medicines.
Various national standards suggest that drug quality should be assessed
as compliance with pharmacopoeial specifications concerning a
drug’s identity, purity, potency and other characteristics
like uniformity of the dosage form, bioavailability, bioequivalence and
stability. Basic quality assurance procedures like visual inspection of
labelling carried out by a qualified pharmacist can easily be adopted at
facility level. Random sampling of drug consignments for the purpose of testing
soon after its procurement as well as from district and block level health
facilities after distribution is an important step in ensuring quality of
medicines. However JKMSC must not rely completely upon the insufficient govt.
drug testing facilities available in the state. It must empanel accredited
private drug testing laboratories on the lines of Tamil Nadu Medical Services
Corporation and send coded samples to them for testing after carrying out due
process of their validation. Meanwhile govt. needs to accord top priority to
augmenting drug testing facilities in the state on modern lines by installing
state-of-the-art sophisticated equipments and mobile testing vans laced with
all the modern gadgetry required to test drugs on the spot in far flung areas. Gujarat
FDA has taken lead in this respect by procuring around 30 mobile testing vans
that are able to reach any nook and corner of the state and conduct on-the-spot
testing of drugs without even opening the containers at the first instance. Our
state too needs to follow the suit.
Inappropriate and inefficient medicine procurement system leads to
sub-optimal use of resources with poor value for money. Government
needs to promulgate a robust drug procurement policy and implement the drug
policy in letter and spirit that has already been approved by the state
assembly five years back. It is highly deplorable on part of the government
that even after the lapse of five years drug policy is still awaiting
implementation because of which poor patients are suffering for want of good
quality medicines at government health facilities of the state. In this
direction free drug policy need not be confused with drug policy per se since
they are not one and the same thing. Some time back news reports appeared in the local press revealing that
first ever state level Essential Drugs List (EDL) has been customized and the
same consists of a total of 1200 medicines. Such a huge list kills the basic
aim and objective of formulating an Essential Drugs Lists since a concise list
would have allowed concentration of all efforts vis-à-vis medicines management
activities as well as limited resources on a small number of drugs leading to
better results in terms of conservation of resources, large volume of purchases
and consequently greater availability of essential medicines. Having 1200 drugs
in EDL literally means including almost all drugs available in the market which
would hardly translate into any tangible benefits for the patients. If the
essential list finalized by JKMSC consists of 1200 drugs, it need correction as
the essence of EDL lies in limiting the number of essential drugs based on
individual facility/societal needs.
In conclusion appropriate measures need to
be taken in the form of decisions, actions particularly for proper selection,
quantification, forecasting, procurement, distribution and use of medicines to
make the supply chain more efficient. Moreover disbursement of funds should
also be sufficient and timely to cater to the needs of individual hospitals
across all levels of care. Scattered and sparse budgetary allocations for
medicines available with individual hospitals need to be pooled at the central
level for optimal utilization of available resources resulting into more
efficient procurement since centralized procurement and decentralized
distribution has been found to improve access to medicines in all settings. All
the activities related to medicines management and supply chain need to be
carried out in accordance with standard guidelines and good practices involving
only qualified and professional manpower. Evaluation of supply chain should be
carried out regularly to monitor the performance. Facility specific policies
and procedures with SOPs should be developed and adhered to for better
compliance with existing standards. It is high time that the Govt. of J&K
state starts implementing its premier drug policy that has been gathering dust
over the past five years in the corridors of power, in letter and spirit. That
shall go a long way in alleviating the sufferings and addressing the concerns
of common masses regarding quality of medicines.
