Sunday, August 12, 2018

CAN WE GET RID OF SPURIOUS AND SUBSTANDARD MEDICINES?


Once again sale of spurious and substandard drugs in the valley is grabbing headlines in the local newspapers, occupying prime slots in current affairs programmes on the electronic media and taking the social media like Facebook and WhatsApp by storm with heated exchanges, hard hitting videos, allegations and counter-allegations. We have earlier witnessed all this in 2013 when spurious drug scam was unearthed and the Union Health Minister and Drugs Controller General of India had to land in the valley in person only to make several tall promises that were never ever fulfilled. Given the fact that the Drug Control Organization is in complete mode of denial about the existence of spurious medicines both in the state as well as at the centre, does the menace exist in reality at the first place and if it does, big question is will we ever get rid of this scourge? If yes, when and how? These are some of the intriguing questions lurking in every citizen’s mind that this write-up would seek to answer in spite of the fact that scores of articles have been written and published earlier by this author on this very topic.

While people are fast losing patience on this issue and blaming the government and drug regulatory authorities for not doing enough to curb this menace, in its defense drug control authorities have been citing the results of various national quality testing surveys besides the outcome of drug testing done by govt. testing laboratories over years which reveal the percentage of spurious medicines anywhere between 0.01 – 0.025% and that of the substandard (NSQ) drugs anywhere between 3.4 – 8.37% only both at the state and national level. Thus official data is in a complete denial mode vis-à-vis spurious medicines whereas there is some acknowledgement of drugs that are not-of-standard-quality (NSQ) though nowhere near to the level general public perceives them to be below the prescribed standards of quality. Truth lies somewhere in the middle. Neither all the medicines available in our markets can be labeled to be altogether spurious or substandard nor can all of them be declared to be of paramount standard quality. Without challenging the reports furnished by drug testing laboratories public perception about quality of drugs can also not be rubbished as completely untrue since common masses consume these medicines themselves and they have got a first-hand experience about their quality and effectiveness. So if they are not satisfied with the quality of drugs, something is wrong somewhere that needs to be addressed rather than adopting an ostrich approach and burying our head in the sand saying that nothing is wrong at all.

global meta-analysis study published in JAMA recently reports that the prevalence of substandard and falcified medicines is 13.7% in Asia. So the problem is there that needs to be studied well and addressed in time rather than adopting an ostrich approach and living in a complete mode of denial. This study concludes that "poor-quality essential medicines are a substantial and understudied problem. Methodological standards for prevalence and rigorous economic studies estimating the burden beyond market size are needed to accurately assess the scope of the issue and inform efforts to address it. Global collaborative efforts are needed to improve supply-chain management, surveillance, and regulatory capacity in low- and middle-income countries to reduce the threat of poor-quality medicines".

If drug regulatory authorities have not been able to detect any spurious drugs in our markets they need to rethink about their drug sampling and drug testing procedure, strategy, designs, quantities and schedules and accordingly devise innovative methods to track down these sourly bitter pills. Have our drug inspectorate been equipped enough to bust spurious drug rackets through intelligence networking cells that provide lucrative incentives to the informers? Are they sufficiently trained in such skills? Do they have the requisite technological and logistic support in terms of mobile drug testing vans laced with sophisticated equipments like Raman Spectrophotometer, Near-infrared and X-Ray Fluorescence Analyser etc that could enable them to test the quality of drugs on spot instantly. In 2013 when spurious drug scam was exposed, Drugs Controller General of India had himself promised an additional drug testing laboratory and two mobile drug testing vans for the state that still continues to remain a distant dream. However as per news reports state government is in the process of setting up a drug testing laboratory at Lakhanpur with a central assistance of Rs 34 crores. 

At present Drug and Food Control Organization carries the testing of drug samples at its Srinagar and Jammu based laboratories that reportedly have a total testing capacity of around 4000 samples annually. For a state that is consuming medicines worth more than 1000 crores monthly, this capacity is too insufficient and meager.  We need to upscale our drug testing capacity to more than 10000 drug samples per year. JKMSCL should establish its own drug testing facilities and rope in accredited private drug testing laboratories from across the country so that each and every drug procured by them gets tested before distribution to the hospitals. Guidelines also prescribe one drug inspector for every 100 drug sale outlets but in our state each drug inspector is on an average looking after almost 300 outlets. First of all we don’t have drug inspectors available at the Block level. Secondly drug inspectors working at Tehsil level at present do not have sufficient accommodation, communication, transportation, legal counsel, security and clerical support available to them for carrying out their duties smoothly in a timely and hassle-free manner and they have not been accorded gazetted cadre too as required under Essential Commodities Act for monitoring drug pricing.

Jammu and Kashmir state drafted its premier drug policy in the year 2011 that was duly approved by the state cabinet and state legislative assembly in the year 2012 but still awaits implementation even after a lapse of more than six years. This is a major hurdle in making standard quality drugs available to the masses on their generic names at all government hospitals throughout the year without any stock-outs. Though some provisions of the policy like constitution of JKMSCL and procurement of drugs on generic names have been partially implemented, other provisions that emphasize seamless quality assurance, scientific demand estimation, pre-and post-qualification of suppliers following cGMP standards, drug storage and distribution in accordance with latest guidelines issued by WHO, their dispensing by qualified pharmacists alongwith patient counseling and continuous monitoring for any adverse reactions still awaits implementation. It is high time when the present state government should revisit, revise and revamp the state drug policy owing to the fact that it was drafted six years back and therefore needs to be redrafted taking all new challenges and changes into consideration. Population of the state has considerably increased so has the consumption of medicines ever since the draft drug policy was approved in 2012. Therefore there is need to take a fresh look at the draft and devise an updated comprehensive drug policy to streamline and ensure quality, efficacy and safety of medicines available in our private and public sectors.

Another big reason for plummeting quality standards of medicines in our markets is mushrooming of drug retailers and wholesalers in every nook and corner of the state. Eversince J&K Pharmacy Council came into being and opened its First Register of Pharmacists thousands of Pharmacy Registration certificates have been issued to every Tom, Dick and Harry irrespective of their educational qualifications. Matriculates in thousands have been registered as pharmacists without any basic know-how of pharmacy and subsequently they were provided drug sale licences by the Drug Control Organization of the state as a result of which today we can see beelines of drug stores not only outside hospitals but along length and breadth of the state which sometimes gives a notion that people living in the state probably eat medicines in place of food also. Worst part of the story is that matriculates with few years of experience in selling medicines were legally authorized to get registered as pharmacists in our state under J&K Pharmacy Act of 2011 (samvat) and subsequently were licensed to sell drugs. This is because J&K Pharmacy Council never bothered to bring Educational Regulations in time that would have restricted the issuance of drug sale licenses only to diploma and degree holders in Pharmacy. They acted like a business corporation making quick bucks over a period of almost 18 years by registering unqualified people as pharmacists. It can actually be counted among one of the biggest scams of this century in our state. This in turn has led to the deterioration of pharmacy services with drugs manufactured by third rate companies being sold for higher profits and that too in absence of any prescriptions which in turn promoted abuse of prescription drugs and psychotropic substances.

Cutting the long story short and returning back to the main question whether we can get rid of spurious and substandard drugs or not: Yes of course we can provided we have the will, wherewithal and the resolve to change the existing scenario rather than continue to live in a complete mode of denial. Way forward is to revise the state drug policy, implement it in letter and spirit, stop issuing drug licences to non-pharmacy professionals, augment the staff strength and infrastructure of drug control department, upgrade the existing drug testing laboratories and open new ones in each division of the state, streamline the functioning of JKMSCL on scientific lines and ensure availability of standard quality generic drugs in government hospitals throughout the year without any stock-outs, incorporate the professional pharmaceutical care services in all hospitals through qualified pharmacy graduates and post-graduates, mandate prescribing of drugs on their generic names only, revamping J&K Pharmacy Council and appointing Pharmacy Inspectors specifically for inspecting pharmacy stores for ensuring drug dispensing in accordance with established guidelines, pressing mobile drug testing vans into service for instant testing of drugs in far flung areas of the state and establishing a pharmacy practice department with adequate qualified staff in each and every hospital of the state. That alone can bring some semblance of order in the chaotic state of affairs existing at present. If journalists blame doctors, doctors blame pharmaceutical companies and regulatory authorities and they in turn blame pharmacists and common people, that is not going to solve the problem. Concerted and coordinated efforts by all of them towards improvement of the system however will definitely solve it.


(Author teaches at the Dept. of Pharmaceutical Sciences, University of Kashmir and has been actively involved in formulation of the first drug policy of J&K state)

Wednesday, April 11, 2018

Use of student feedback in teacher evaluation: need for revalidation


While there is need to ensure academic accountability of teachers working in higher educational institutions and welcome any initiatives and reforms aimed at streamlining teacher performance through student feedback or any other mechanism, it becomes imperative to validate and standardize any such system before invoking it owing to the fact that any biased or prejudiced feedback will seriously dent the career and reputation of teachers involved. Therefore there is need to doubly ensure that there is no element of bias or prejudice in the student feedback mechanism suggested by the institutions of higher learning. The existing student feedback system used by higher educational institutions across India is statistically as well as scientifically inaccurate and needs to be made fool-proof and efficient before utilizing it for the desired purpose. Standard practice proposed by UGC in this regard needs to be converted into best practice first. As per National Assessment and Accreditation Council (NAAC), “a standard practice qualifies to a best practice status if it results in high-value impact on any aspect of educational activity in an institution. Best practice is nothing but value-added standard practice. Continual review and improvement of a current practice becomes necessary to elevate it to the status of a best practice, more so in the present day scenario of fast-paced educational innovations”.

NAAC guidelines also stipulate that “students are supposed to be the most important stakeholders of higher education system. The interest and participation of students at all levels in both internal quality assurance and external quality assurance have to play a central role. Higher education is first and foremost about the enhancement and empowerment of students as participants in a process of learning for transformation. Any higher education institution therefore needs to ensure that students have a voice at various decision-making processes, formulating learning and teaching practices and the views of students are to be considered as the primary evidence on which the quality of teaching and learning is evaluated.”

Having said this, fact of the matter is that the present system of student feedback has a potential to generate many false positive and false negative results that needs attention. Existing system allows students to score teachers on sympathetic, personal, vindictive as well as other stray considerations and not purely on their teaching qualities. For instance in departments where total number of students in a class is less (say 10-20), few bad scores on personal and non-scholastic considerations are sufficient to bring the mean score of the teacher drastically down no matter if all others have rated him/her highly on all parameters. This statistical error needs to be rectified. Furthermore there should be some grading of top ranking and bottom ranking students’ feedback because top ranking students are studious, sincere, serious and forthright in their feedback whereas same cannot be said about the bottom ranking students who mostly remain absent, keep failing in internals and externals, do not complete their assignments in time and lack discipline. Every student cannot be placed at the same pedestal while according weightage or value to his/her score. Few bad scores of few bad students should not be allowed to ruin the hardwork, career and reputation of a sincere and committed teacher.

While students need to be empowered they cannot be allowed to overpower teachers or vice versa. It will never be in the interest of academics. If that happens, instead of bringing some semblance of order and discipline back in our higher education system which the student feedback is understandably aimed it, it will only wreak havoc in the same. A teacher will literally become subservient to students’ sweet will and dictates. Teacher supremacy must sustain in a student-teacher relationship and decision making though there is no denial of the fact that in the changing global scenario it should be more of a mentorship rather than dictatorship. A teacher has to act like a friend, philosopher, counselor and guide of his students rather than a whip flouting master.

Student feedback should be anonymous, external and tamper-proof for if there is any scope of tampering and manipulation of the same, it will only become a tool of vendetta in the hands of those who want to settle personal scores and grudges. All outgoing students of the final semester should be called to an external venue by an external agency for collecting their anonymous feedback or the same can also be collected online by a third party using a fully secure and confidential software system. Those who have failed or have had shortages in their attendance or bad track record should be debarred from this exercise. More weightage should be given to the feedback of top ranking students. Parameters of evaluation should be exhaustive rather than selective in order to remove any scope of ambiguity, lack of clarity and confusion. Five-point feedback criteria being used at present somewhere lacks in reliability, selectivity, specificity and predictive value of teacher quality. A ten-point explicit scale having greater accuracy and precision that takes into account all important attributes of a good teacher needs to be devised for this purpose. Before approving and utilizing the same, its pre-testing/validation must be done by seeking feedback from experts in the field on its clarity, comprehensibility, lucidity and un-ambiguity.
                       
It is very important that teachers who receive poor student feedback must be immediately informed about the same for taking corrective measures and intensive in-house training sessions should be conducted to orient such teachers for improving their performance. Anonymous students’ feedback should also be given due weightage in the promotion of teachers so that those receiving poor feedback will get automatically penalized leaving little scope for any additional penalties. However teachers who fail to improve their score beyond a certain threshold level for three consecutive years must be penalized, for instance by withholding their annual increments, for upholding academic accountability. Entire feedback system needs to be made fully transparent while at the same time maintaining confidentiality of students.

Furthermore it is high time when the new Vice-Chancellors of our universities should stop ruling from the ivory towers, deviate from conventional bureaucratic ways and means and connect with their staff and students directly. They should act like field commanders by sparing one hour daily or alternately for making surprise visits to the departments and centres to physically check teaching and research activities, talk to students, staff, HODs and teachers regarding their issues and concerns, themselves sit in the classrooms randomly to witness teaching quality and suggest improvements instantly, counsel the staff and students persistently and even take action wherever needed. This will act as a big deterrent and automatically improve the system. They should prefer a conciliatory and restorative approach over an aggressive or punitive one.

Apart from seeking feedback from students about teachers and their teaching quality, written or online feedback should also be sought on regular basis from them in tune with NAAC recommendations about their courses, departments, HODs, university and its administration on the whole. That will make the feedback all-inclusive and help in overall improvement of the system. A Students Council should be constituted in every university that has a President and a Vice-President from final or pre-final semesters and a Secretary and Joint Secretary from 2nd or 3rd semesters duly elected by the General Council of class representatives who in turn are elected through secret ballot by the students in their respective classes under the supervision of a teacher who acts as student coordinator. President of the Students Council must have a say in all student related matters at every forum and decision-making body of the university and the student grievance cell must also be constituted and made fully functional in every university.

Dean Students Welfare of every university apart from organizing student welfare activities must maintain a close rapport with Students Council and Students’ Grievance Cell for an overall supervision of the related activities. This will ensure student participation in quality assurance in a democratic manner and pave way for their active role in decision making and grievance redressal system of the university. It will also foster and promote cordial relationships between students and teachers and among students themselves. Furthermore each and every department must convene regular open-house meetings of all students of a class with all teachers of that department to facilitate open discussions between students and teachers regarding all matters which are important for both the parties.

Teachers on their part also need to connect with the society directly by establishing a community centre where common people can throng once in a week with their problems, issues and needs so that we can address the same through our teaching, innovation and research.  A state-of-art innovation incubation centre can also be established in the University for this purpose. There is a huge gap between us and our society that has resulted into some trust deficit and alienation.  People don't seem to be thinking too high about the quality of our teaching and research. While all that a few people say about us might not be true, somewhere we are failing in living up to the expectations of our society.  We need to bridge the gap and connect with them like agricultural scientists do and probably that is the reason why nobody takes potshots on them on the social media. Worldwide universities are establishing innovation rooms, social shops and community centres to connect with their society and address their needs.

Dr Geer M Ishaq

Tuesday, March 20, 2018

No college versus university teachers issue at all


This bears reference to a couple of articles published in GK in response to the joint press statement issued by KUTA and JUTA against the order issued by Principal Secretary, Higher Education, Govt. of J&K authorizing all college teachers to act as guides and co-guides for supervising M.Phil. and Ph.D. scholars. Pointed references have been made to the joint statement of KUTA and JUTA in these articles vehemently criticizing the same and taking jibes at their stand on the issue. While constructive criticism is the life and soul of any democracy, undue criticism not based on reason and facts is not only unwarranted and distasteful but divisive too. While putting across their point authors have used some choicest invectives to describe KUTA, University Teachers in general and University Research which is highly unbecoming owing to the fact that use of such language does not help in any manner to promote collaborations and foster inter-institutional relationship rather it only dents any such advancements.

While initially KUTA didn’t deem it necessary to respond to these articles since our initial press statement was self-explanatory wherein we had made our stand amply clear. Furthermore the arguments made in these articles were based on faulty premise and ill conceived conclusions. However since a wrong impression and incorrect message was being passed on to the readers it was deemed needful to clear the haze and set the record straight. It is quite surprising that while authors seem to be reasonably well-read, articulate as well as eloquent in putting forth their point, they seem to have willfully chosen to ignore the assertion made in our joint statement that reads, “It needs to be clarified that KUTA and JUTA are not against authorizing college teachers to act as research guides but against the way it is sought to be done. KUTA never had any problems with that as long as it is done within the purview of statutes and regulations in vogue at present. But if attempts are made to circumvent and override the existing norms and guidelines, overstepping one’s authority, undermining the statutory bodies and usurping the autonomy of the institutions of higher learning, KUTA will oppose any such move,”. There was hardly any need to say anything more after having said that in so clear and unambiguous terms. Nowhere in this statement has JUTA and/or KUTA opposed the recognition of college teachers as research guides/co-guides following codal procedure and statutes in vogue. Even the subsequent clarification issued by the Kashmir University authorities emphasized upon the fact that UGC regulations and statutes in vogue at present shall be followed while recognizing college teachers as guides and co-guides for supervising M.Phil. and Ph.D. scholars. It is beyond one’s comprehension as to what makes the authors doubt the intentions of KUTA and JUTA and not believe their assertion. It is not clear as to what makes them believe that the University teachers somehow feel threatened or insecure by this govt. order and that they vie to have a monopoly on research. These apprehensions are totally ill-founded and baseless. University teachers have never at any point of time stated or done anything that remotely points towards these conclusions.

It is really astonishing how unsolicited motives are being attributed to KUTA and how sweeping judgments are being passed on the quality of research being done at KU as well as on the competence of university teachers while it has never been a case of university versus college teachers even though the authors in question have tried their level best to make it appear like one. At least KUTA never intended it to be that way. There is absolutely no point in pitching college teachers against university teachers for we consider both as the pivots of higher education sector in the state. Both have to work shoulder to shoulder for taking the higher education system of the state to all new heights. No sane and seasoned individual, group or association can ever seek or claim a monopoly or fiefdom on research. Research is a collective means of creating knowledge and evolving solutions to the most intriguing problems faced by the society. All stakeholders have to work in tandem to achieve these goals.

University teachers will be among the happiest lot if government allocates sufficient funds from its kitty for the upliftment of facilities and development of world-class infrastructure in colleges that is necessary to make them capable of conducting high quality research. College teachers should actually press for that rather than going gungho about an order issued from an office of the secretariat that has little significance owing to the fact that college teachers have to anyhow fulfill criteria laid out in the existing statutes and regulations and follow the proper procedure laid out in rule books before getting recognized as guides and co-guides. Kashmir University has been recognizing college teachers as co-guides since its inception several decades back and there is nothing new about it. This government order can only serve as opium for those who want to thrive upon its euphoria and enter into a mud-slinging match against university teachers. Even the Chancellor of Kashmir University, Governor of J&K state in a recent meeting held with Vice-Chancellors of Jammu and Kashmir University on March 6th, 2018 has made it clear in presence of Education Minister and Principal Secretary Education at Jammu that, “The decisions relating to academic matters such as introduction of new courses, framing rules and regulations for running courses, authorising Professors, Associate Professors and Assistant Professors of the colleges to act as guides, co-guides for MPhil and PhD scholars should be taken strictly in terms of Jammu and Kashmir University statutes”.

Cluster Universities of Jammu and Srinagar have been established under the provisions of Srinagar and Jammu Cluster University Act 2016 as an initiative of the Centrally Sponsored Scheme, RUSA (Rashtriya Uchchatar Shiksha Abhiyan) with an aim to create new universities through upgradation of existing colleges and conversion of these colleges into a cluster. Five prominent and leading colleges of Jammu and Srinagar each have been clustered into these two universities that offer undergraduate, postgraduate, integrated masters and research degrees in humanities, social sciences, natural sciences, applied sciences, management and commerce besides some professional courses. That means they have to anyhow recognize the senior faculty working in their cluster of colleges as research supervisors and co-supervisors in order to enable them to guide M.Phil. and Ph.D. scholars registered with these universities. So when nobody has opposed establishment of these two cluster universities why would anybody oppose the research degrees that they intend to offer and the associated recognition of guides and co-guides from colleges. Only matter of concern could be the availability of adequate facilities, infrastructure, staff and funds to go ahead with research at these colleges. Furthermore as per news reports more cluster universities are in the pipeline (GK dated March 6th, 2018: J&K seeks 6 more cluster universities: Altaf Bukhari) implying that more colleges of J&K state will be clustered together to become part of these upcoming universities paving way for more college teachers to be recognized as guides and co-guides and more infrastructure getting created at these colleges to establish research laboratories. These are all positive developments that are always welcome. This will only pave way for radical developments in the higher education sector of the state provided sufficient funds, manpower and necessary infrastructure is made available to these college and they do not meet the same fate as newly established colleges many of whom were being run in cow-sheds as per news reports. It should not be reduced to just paperwork with no substantial progress on ground and that is what college teachers and their associations should actually push for rather than prowling upon an authoritative order flown like a paper plane from some office and feeling overwhelmed about it. I am sure university teachers and their association will lend all possible support in this endeavour at every stage.

While the college teachers strive to achieve these goals they need to simultaneously protect and preserve the dignity and stature of the office of Vice-Chancellor. It is quite shocking that one of the prime constituent colleges of Cluster University Srinagar is going to organize a conference in the fourth week of March, information brochure of the conference as well as its website shows Principal Secretary higher education as Chief Patron, Principal of the college as Patron and some faculty of the college as members of organizing committee of the conference. Astonishingly name of the Vice-Chancellor of Cluster University Srinagar does not figure anywhere either in the brochure or on the website. He is nobody in the conference. This shows the level of sycophancy that some of the college teachers and principals are resorting to throwing all conventions and norms to the wind. This type of approach will not lead us anywhere. Supremacy of academics in all academic institutions has to be maintained at all costs and that is the prime issue KUTA or JUTA had with the order issued by the Principal Secretary who had marked a copy of his order to all vice-chancellors of the state with directions of immediate compliance thus attempting to reduce the vice-chancellor’s office merely to a post-office that could not have been allowed to go unopposed since no respect had been shown to the office of the vice-chancellor in this very order. Unfortunately authors in question have given the joint statement a totally new and unwanted diversion that was never intended to be the case. Perhaps they found a vent for their victimhood syndrome under the garb of our joint statement and started firing their salvos against us. We are being made a butt of the ridicule for no fault of ours.

Due to constraints of space I am not going into some other debatable issues raised in the articles like quality of teaching and research done in the university, quality and quantum of teaching in our colleges, basic mandate of colleges and universities as per statutes and regulations, contribution of college and university teachers towards the progress and development of higher education sector in the state and promotion of science, technology, social sciences and humanities. Those issues will be discussed in another piece but one thing needs to be emphasized that one-upmanship and self-righteousness will lead us nowhere. Mud-slinging and passing the buck will only push us further into an abyss. Negative campaigns do not serve any purpose other than creating animosities and bad blood among two communities of the same system. Rather we need to join hands and work together to improve our lot and uplift the standards of our education and research that will entail this state on a path of sustainable progress and development and enable us the meet the challenges of globalization of education in twenty first century. Drawing sadistic pleasure out of unduly criticizing an entire community of teachers while blissfully ignoring one’s own shortcomings and lacunae will not serve any ends other than bringing some solace to the hurt egos and complexes. Magnanimity demands working above all levels and sects for the benefit of our student community.

(Author is General Secretary of Kashmir University Teachers Association and can be reached at ishaqgeer@gmail.com)

Sunday, March 4, 2018

Ills plaguing pharmaceutical procurement and quality assurance system of medicines in the state

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.