Major
ills that have been plaguing the pharmaceutical procurement and quality assurance system in the state are lack of
foolproof quality assurance system and inappropriate procurement mechanism that
has led to frequent complaints of non-availability of medicines and that of substandard
quality of medicines being supplied by the Corporation. Areas that need immediate attention include drug selection, forecasting and demand estimation, supplier selection, fixing and adherence to pre- and post-qualification criteria and robust quality control mechanism. Roots of the problem
lie in the fact that J&K Medical Supplies Corporation (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.
Establishment of a comprehensive Quality Assurance system
involving both surveillance and testing of drug quality, involving both
technical and managerial activities, is needed 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. 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. Drugs Controller
General of India had promised a couple of such vans in 2015 but the promise remains unfulfilled till date.
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. It is high time when the J&K State Essential Drugs List needs to be
updated and modified in tune with changes in new drug development and new
morbidity patterns surfacing from different parts of the state.
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