Drug abuse scenario in Kashmir

In recognition of the efforts of United Nations Office on Drugs and Crime (UNODC) to eliminate the drug menace worldwide, every year June 26^th is observed as the International Day against Drug Abuse and Illicit Trafficking, which serves as a grim reminder of the need to combat the deleterious hazards to society posed by illicit drugs. As per World Drug Report, 2012 published by UNODC, about 230 million people, or 5 per cent of the world’s adult population, are estimated to have used an illicit drug at least once in 2010. It is also estimated that there were between 99,000 to 253,000 deaths globally in 2010 as a result of illicit drug use, accounting for 0.5 to 1.3 per cent of all-cause mortality among those aged between 15-64 years. Illicit drugs undermine economic and social development and contribute towards crime, instability, insecurity besides negative health consequences including the spread of HIV. Expressed in monetary terms, USD 200-250 billion would be needed to cover all costs related to drug treatment worldwide.

 

India is wedged between the world’s two largest areas of illicit opium production, the Golden Crescent and the Golden Triangle. A joint national survey conducted by UNODC and the Ministry of Social Justice and Empowerment, GOI in 2004 showed that the number of chronic substance-dependent individuals were 10 million (alcohol), 2.3 million (cannabis) and 0.5 million (opiates). In the state of Jammu and Kashmir too drug abuse has assumed alarming and epidemic proportions with large number of school and college going youth falling prey to the scourge including a large number of females. Prescription drug abuse is of particular concern among our population. According to a United Nations International Drug Control Program (UNDCP) sponsored survey, Kashmir division alone had 70,000 drug addicts including 4000 women in the year 2008. However a more recent survey entitled, “Community drug abuse study survey in Kashmir” by valley’s renowned psychiatrist Dr Mushtaq Margoob and his team has revealed that there are 24.32 lakh substance abusers (including tobacco abusers) in Kashmir, which includes 2.11 lakh opioid, 1.37 lakh cannabis, and around 38,000 alcohol abusers. As per this study, around 35% of boys of very prestigious schools from 8th standard to 12th standard use these substances daily.

 

Children and adolescents who suffer from neglect, abuse, household dysfunction, exposure to violence and instability are at particular risk of substance abuse. In Kashmir major causes of drug abuse have been linked to long standing conflict and frequent unrest, large scale unemployment and illiteracy, stressful social life, educational and family stress, lack of sports amenities and recreational avenues, easy availability of scheduled prescription products over-the-counter, select areas turning out to be hot pockets of illicit drug use, lack of enforcement mechanism and government control over substance abuse, mushroom growth of licensed drug stores and large scale corruption in the society. Drug dependence and illicit drug use are associated with health problems, poverty, violence, criminal behavior, and social exclusion. However, drug dependence is a preventable and treatable disease, and effective prevention and treatment interventions are very much possible. Best results are achieved when a comprehensive multidisciplinary approach that includes diversified pharmacological and psychosocial interventions is adopted.

 

Unfortunately in many societies drug dependence is still not recognized as a health problem and many people suffering from it are stigmatized and have no access to treatment and rehabilitation. The notion that drug dependence could be considered a “self-acquired disease”, has contributed to stigma and discrimination associated with drug dependence. However, scientific evidence indicates that the development of the disease is a result of a complex multi-factorial interaction between repeated exposure to drugs, and biological and environmental factors. Attempts to treat and prevent drug use through tough penal sanctions for drug users fail because they do not take into account the neurological changes drug dependence has on motivation pathways in the brain. Supportive families are essential to raising socially, mentally and physically healthy and well-adjusted children and preventing later adolescent problems. Factors such as a lack of security, trust and warmth in parent-child relationships, a lack of structure in family life and inappropriate discipline practices and insufficient limit-setting can render children at greater risk of problematic behaviours and subsequent substance abuse and mental health disorders. Therefore family skills training programmes have been found to be effective in preventing many of these risky behaviours, including substance abuse.

 

Regular awareness and counseling programmes through outdoor camps, open air theatres, dramas, painting competitions, video displays etc need to be conducted in every school and college across the state against drug abuse in order to acquaint the students with the dangers and consequences of such addiction. Each and every educational institute must have a full-time position available for a counselor who could either be a qualified psychiatrist or a trained clinical psychologist, who should entrusted with the job of undertaking student counseling from department to department on regular basis and address their stress management or drug de-addiction needs. Govt. must secure slots for drug awareness campaigns in the middle of most popular and widely viewed television programmes. Each school and college must procure a drug-addiction detection kit that come at an affordable price for regular detection of drug abusers. This will act as a strong deterrent too. Similar kits can be used by the police for truck drivers and drivers of public transport vehicles.

 

State government must come out with a comprehensive and discrete policy against drug addiction and chalk out a robust and time-bound action plan at division, district and block levels. An effective coordination and collaboration between various govt. agencies and multiple stake-holders needs to be fostered. A coordinated response of government and non-governmental organizations can be highly effective for drug abuse prevention. Drug de-addiction centres need to be established at all district headquarters with sufficient trained staff and bed strength besides a full-fledged drug de-addiction and rehabilitation centre at the divisional level. Drug sale licences must not be made free for all. Particularly licences to stock and sell schedule X drugs and psychotropic substances must be restricted to a few chosen chemists with an unblemished track record. Sale and purchase records of such drugs must be checked continuously and severe penalties must be imposed upon the defaulters. OTC sale of prescription drugs must be stopped.

 

Involvement of all sections of the society and the government officials like police, traffic police, medical health officers, school and college teachers, principals, religious preachers, housing societies, mohalla committees, drug control and excise officials can go a long way in not only creating awareness and preventing abuse but also in identifying magnitude of the problem in each locality and motivating the abusers towards the rehabilitation. Social engineering is of crucial importance in preventing drug addiction. Perpetual sermons through religious preachers during weekly religious congregations can have a durable impact in discouraging drug abuse. Govt. action plan must begin with identification of vulnerable areas that are prone and sensitive to drug trafficking and illicit use and therefore require focused attention and strategic action. Government needs to strengthen its intelligence apparatus for improving collection, collation, analysis and dissemination of operational intelligence regarding illicit drugs. There must be a reward policy for giving information about drug trafficking or abuse.  Let us make health our “New High” in life, not Drugs.

TOWARDS A DRUG-FREE SOCIETY

Of late drug abuse has assumed alarming and epidemic proportions in our Kashmir valley with large number of school and college going youth falling prey to the menace that unfortunately includes a large number of females too. Prescription drug abuse is of particular concern among our population. Drug dependence and illicit drug use are associated with health problems, poverty, violence, criminal behavior, and social exclusion. However it is not something that is incurable. It is a preventable and treatable disease, and effective prevention and treatment interventions are very much possible. Best results are achieved when a comprehensive multidisciplinary approach that includes diversified pharmacological and psychosocial interventions is adopted.

 

The evolution of the contemporary drug problem has been influenced by a range of drivers. Some relate to demographic trends, such as gender, population, age and levels of urbanization, whereas others are socioeconomic, such as levels of disposable income, inequality and unemployment. Children and adolescents who suffer from neglect, abuse, household dysfunction, exposure to violence and instability are at particular risk of substance abuse. In Kashmir valley major causes of drug abuse have been linked to long standing conflict and frequent phases of unrest, large scale unemployment and illiteracy, stressful social life, educational and family stress, lack of sports amenities and entertainment avenues, easy availability of scheduled prescription products over-the-counter, select areas turning out to be hot pockets of illicit drug use, lack of effective enforcement mechanism and government control over substance abuse, mushroom growth of licensed drug stores and large scale corruption in the society.

 

Unfortunately in many societies drug dependence is still not recognized as a health problem and many people suffering from it are stigmatized and have no access to treatment and rehabilitation. The notion that drug dependence is a “self-acquired affliction”, has contributed to stigma and discrimination associated with drug dependence. However, scientific evidence indicates that the development of the disease is a result of a complex multi-factorial interaction between repeated exposure to drugs, and biological and environmental factors. Attempts to treat and prevent drug use through tough penal sanctions for drug users have failed because they do not take into account the neurological changes drug dependence has on motivation pathways in the brain.

 

Based on the approach that drug abuse is a psycho-socio-medical problem that can be handled through community-based interventions, a multi-pronged strategy needs to be adopted to curb the menace that should mainly include measures towards prevention, control and rehabilitation. Such measures lay emphasis upon creating awareness and educating people about ill effects of drug abuse, dealing with addicts compassionately through a programme of motivation, counselling, treatment, follow-up and social reintegration and by imparting drug abuse prevention and rehabilitation training to volunteers with a view to build up a strong cadre of drug abuse control operators.

 

Regular awareness and counseling programmes through outdoor camps, open air theatres, dramas, painting competitions, video displays, street plays etc need to be conducted by every school and college across the state against drug abuse in order to acquaint the students with the dangers and consequences of such addiction. Even CCTV cameras may be installed in vulnerable and addiction-prone educational institutions to monitor sale and abuse of drugs within and outside the premises. Each and every educational institute must have a full-time position available for a counselor who could either be a qualified psychiatrist or a trained clinical psychologist, who should be entrusted with the job of undertaking student counseling from department to department on regular, door-delivery basis and address their stress management or drug de-addiction needs.

 

Govt. through its information and broadcasting wing must secure slots for drug awareness campaigns in the middle of most popular and widely viewed television programmes. Popular television serials based on stories and scripts related to drug addiction and its consequences must also be relayed from local as well as national channels. Drug de-addiction centres must be established at all district headquarters with sufficient trained staff and bed strength besides a full-fledged drug de-addiction and rehabilitation centre at the divisional level. Each school and college must procure a drug-addiction detection kit that comes at an affordable price for regular detection of drug abusers. This will act as a strong deterrent too. Similar kits can be used by the police for truck drivers and drivers of public transport vehicles.

 

State government needs to take several steps towards controlling the menace of drug addiction. Its approach has to be bi-pronged addressing supply side (that includes enforcement activities) as well as the demand side (that includes rehabilitation and de-addiction measures). On the analogy of National Policy on Narcotic Drugs and Psychotropic Substances formulated in January, 2012, it must come out with a comprehensive and discrete policy against drug addiction and chalk out a robust and time-bound action plan at division, district and block levels. An effective coordination and collaboration between various govt. agencies and multiple stake-holders needs to be fostered. A coordinated response of government and non-governmental organizations can be achieved through government funding support to voluntary organisations for setting up/maintenance of counselling and awareness centres, deaddiction-cum-rehabilitation centres, de-addiction camps and for preventive awareness programmes, workplace prevention programme and training of service providers. Drug sale licences must not be made free for all. Particularly licences to stock and sell schedule X drugs and psychotropic substances must be restricted to a few chosen chemists with an unblemished track record. Sale and purchase records of such drugs must be checked continuously and severe penalties must be imposed upon the defaulters. Drug control department needs to conduct regular market checks and ensure sale of prescription drugs only against the prescriptions of registered medical practitioners. OTC sale of prescription drugs must be stopped.

 

Constitution of block and district level monitoring and vigilance committees with active participation of police, traffic police, medical health officers, school and college teachers, principals, religious preachers, housing societies, mohalla committees, drug control and excise officials can go a long way in not only creating awareness and preventing abuse but also in identifying magnitude of the problem in each locality and motivating the abusers towards the rehabilitation. Social engineering is also of crucial importance in preventing drug addiction. Perpetual sermons through religious preachers during weekly religious congregations can have a durable impact in discouraging drug abuse. Govt. action plan must begin with identification of vulnerable areas that are prone and sensitive to drug trafficking and illicit use and therefore require focused attention and strategic action.

 

Government needs to strengthen its intelligence apparatus for improving collection, collation, analysis and dissemination of operational intelligence regarding illicit drugs. There must be a reward policy for giving information about drug trafficking or abuse.  Inter-state cooperation and coordination in operational intelligence, investigations and legal assistance needs to be improved too. A nodal office of Narcotics Control Bureau must be established in Kashmir division too and in accordance with its guidelines state government has to constitute an anti-narcotics task force headed by an IG level police officer besides a multi-disciplinary coordination committee under the chairmanship of Chief Secretary level officer for regular interaction with central and state agencies. This will make the state eligible to receive grant-in-aid from NCB for infrastructure development in narcotics control. Surveillance and enforcement at entry/import points and land borders of the state needs to be made more stringent and foolproof besides identification and eradication of illicit cultivation as well as wild growth of cannabis and opium poppy.

Best Practices in Pharmaceutical Procurement and Medicines Management

In the wake of government initiative to constitute J&K Medical Services Corporation, streamline procurement and ensure availability and supply of standard quality drugs Dr Geer Mohammad Ishaq enumerates best practices in supply chain management of medicines in tune with international norms and standards

 

Government of Jammu and Kashmir has in its cabinet meeting held on May 21^st, 2013 approved the establishment of J&K Medical Supplies Corporation (JKMSC) with an objective to streamline the terribly derailed drug procurement and supply chain management system for government hospitals in the state. In view of the recently surfaced spurious drug debacle, credibility and faith of patients upon hospital drug supplies has received a serious jolt. Consequently it has turned out to be truly a Herculean task for the state govt. to restore its credibility and peoples’ trust upon the quality of drugs that are supplied at its healthcare centres. Constitution of JKMSC though late, can still be termed as a right step in this direction. As they say, “better late than never”. Civil Society Forum Kashmir had persistently been insisting upon the government to frame JKMSC and replicate TNMSC taking due care of local contexts, sensitivities and requirements.

 

Now that the govt. has made up its mind to establish JKMSC, it is time to set the drug procurement mechanism in order through “Standard Operating Procedures” and highlight best practices in tune with international norms and standards. The effectiveness of the medication management system depends on adherence to policies (broad, general statements of philosophy) and procedures (detailed guidelines for implementing policy). Four strategic objectives of Drug Procurement in the state should be to procure the most effective and safe drugs in right quantities; select reliable suppliers of high quality products; ensure timely delivery, reduce lead time and achieve the lowest possible total cost. Other best practices are as under:

Selection of Drugs:

 

The selection of pharmaceuticals is a basic and extremely important professional function of the JKMSC that may be charged with making decisions regarding products, quantities, product specifications, and sources of supply. It is the JKMSC’s obligation to establish and maintain standards assuring the quality, proper storage, control, and safe use of all pharmaceuticals and related supplies. ABC/VED analysis of past procurement has to be conducted regularly and drugs categorized into basic, supplementary and specialized lists. Drugs should preferably be selected for procurement from the specific Essential Drugs List of the state. While selecting drugs local factors like local diseases, regional differences in sensitivity and resistance of micro-organisms, local climate, topography, environmental factors etc, should be duly considered. While selecting formulation types, stable forms should be chosen, giving preference to tablets over capsules, ointments over creams, powder for reconstitution over injectable solutions and avoiding syrups, to achieve a low-cost, high impact intervention in maximizing the therapeutic lifespan of medicines. Expensive combination drugs should be kept out of the supply list to reduce the actual cost of drugs to the state by as much as half. As far as possible generic drugs should be purchased to reduce the cost.

 

Quantification of Drugs:

 

To avoid wastage through over-stocking or stock-outs of pharmaceuticals, a reliable system of forecasting or quantification of drug needs should be used that includes a combination of past consumption based and morbidity based methods. Accurate quantification of drug requirements, competitive drug procurement based on generic names, prompt payment and regular audits, and efficient distribution are some of the major aspects of effective pharmaceutical management. Budgetary allocations for drugs and pharmaceuticals should be kept anywhere between Rs. 100-200 per capita per annum.

 

Procurement of Drugs:

 

Competitive bid purchasing is an important method for achieving a proper balance between quality and cost when two or more acceptable suppliers market a particular product meeting the JKMSC’s specifications. Drugs should be purchased directly from the manufacturers and not from their agents, stockists or sub-stockists. Drug procurement through brokers and agents has to be avoided since brokers are prone to using corrupt practices such as paying kickbacks to secure their businesses. Economic considerations should be made subordinate to those of quality. A company which does not fulfill the technical criteria of a minimum annual turnover of Rs 50 crores, market standing of minimum five years and adherence to prescribed Good Manufacturing Practices (GMP), should be disqualified from making a price bid. ORG rankings of pharmaceutical companies may also be followed wherever required. 

 

A double-envelope system should be used for bidding and the drugs should always be purchased using VFM (Value For Money) criteria instead of Low Bid criteria. Envelope B (price bid) of Companies not fulfilling technical criteria should be returned to them without opening. To eliminate sole dependence on one supplier, the next two lower suppliers willing to match the lowest price should also be approved. To the extent possible, all products should be made available by the supplier in single unit or unit dose packages. Procurement should be effected in the largest possible quantities in order to achieve economies of scale.

 

With the dual objectives of maintaining quality and preventing wastages and pilferages, all tablets and capsules should be procured with only strip or blister packing, as against bulk packing which requires manual handling at the time of distribution. Both inner and outer packages of all items may bear the logo of JKMSC or labeling instructions to show that the drugs are manufactured only for JKMSC and are not meant for sale outside JKMSC. On account of this, the credibility and acceptability of the drugs by the public shall improve immensely. Doctors should be advised to prescribe only products on the procurement list, although anywhere upto 10% of drug budget can be used on unlisted products. The procurement office should have at least one senior qualified pharmacist as part of its senior staff, in addition to having qualified pharmacists’ all along the pharmaceutical procurement chain.

 

Pre-Qualification of Suppliers:

 

Pre-qualification should assess the quality of the manufacturer (respect for Good Manufacturing Practices-GMP); the quality of the product (registration status, Certificate of Pharmaceutical Product) and the quality of the batch (Certificate of analysis, labeling, appearance, packing and shelf life inspection, chemical analysis). It should be the responsibility of the drug supplier, if any, to sell only drugs from GMP-compliant manufacturers and drugs that are duly licensed. Technical specifications should include Analytical control data, Sterility testing data, Bioavailability data, Bioequivalence data, Descriptions of testing procedures for raw materials and finished products, Testing data developed by independent laboratories, and any other information that may be indicative of the quality of a given finished drug product. All information should be supplied at no charge. A Model Questionnaire consisting of four main sections: Business Information, Manufacturing Information, Quality and Product Information should be used for prequalification of suppliers. Pre-qualification should be done continuously as prospective suppliers express their interests and even before tenders are floated.

Evaluation of Bids:

 

Selection of suppliers should be done through a transparent, clear and explicit bidding process. After thoroughly evaluating the bids, a special committee or tender board usually awards the tenders. It is important that a pharmacist or a person with technical knowledge of pharmaceutical products and its manufacture be a member of the tender board. As often the case, the determining factor for awarding a tender is price. Quality must be a more important consideration due to the fact that purchase of cheaper pharmaceuticals without quality assurance invariably result in losses like expiration of stocks soon after delivery because of too short shelf-life; substandard drugs and health hazards. In selecting a vendor, the Corporation must consider price, terms, shipping times, dependability, quality of service, returned goods policy, and packaging; however, prime importance always must be placed on drug quality and the manufacturer’s reputation. Transparency must be maintained throughout the procurement cycle by following formal written procedures. Decisions should be based on explicit criteria. A list of all contracts awarded, specifying the supplier and price for each product, should be made available to all bidders.

 

Monitoring Supplier’s Performance:

 

A continuous supplier performance monitoring system which tracks lead time, compliance with contract terms, partial shipments, quality of drugs, remaining shelf-life, compliance with packaging and labelling instructions of drugs should be evolved. Monitoring should include an annual external audit too. The supplier’s compliance with the terms and conditions of the contract should be recorded, with emphasis on timely delivery, quantities delivered as ordered, shelf life after delivery and quality. A system for reporting and recording quality problems noted by the healthcare professionals throughout the state should be part of the post qualification procedures.

 

Quality Assurance System:

 

A comprehensive Quality Assurance system involving both surveillance and testing of drug quality and including both technical and managerial activities, spanning the entire supply process from drug selection to patient use should be established. Quality should be checked through visual inspection of incoming consignments and randomly drawn samples from different batches should be coded and sent to private approved laboratories to ensure effective quality control. 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 and stability.

 

Proper Storage of Drugs:

 

Correct storage of drugs to avoid deterioration distribution and wastage should be developed through systematic stock inventory control system should be ensured using modern tool of computerization and management information system so that drugs are always available when needed in the state. IT enabled infrastructure is therefore an essential component of the supply chain management of medicines so that real-time monitoring of drug stocks at district and divisional levels could be monitoring round the clock.

 
(Author is senior faculty at the Department of Pharmaceutical Sciences, University of Kashmir and can be reached at ishaqgeer@gmail.com)

J&K Medical Supplies Corporation - Issues at hand and challenges ahead

After immense public and media outcry over the spurious drugs debacle and after four years of sustained lobbying and persistent advocacy by Civil Society Forum, Government of J&K has finally risen to the occasion and decided to constitute J&K Medical Supplies Corporation (JKMSC) with an aim to centralize and ensure the supply of standard quality drugs and other medical supplies to healthcare centres in the state. Proposed Corporation shall function under the chairmanship of Chief Minister, with Ministers of Health and Medical Education serving as its Vice-Chairmen. It may undertake procurement, testing, storage and distribution of human drugs, medical equipments & devices, surgicals & sutures, kits and reagents to the government health institutions of the State. Constitution and other modalities of the Corporation are at present being finalized for getting it approved by the state cabinet.

This is truly a welcome decision that if executed in a proficient manner shall pave way for an effective implementation of the approved Drug Policy besides streamlining the terribly deranged drug procurement mechanism of the state. While this initiative needs to be applauded and encouraged by one and all, there are several issues and challenges confronting the proposal whose redressal assumes importance for accomplishing the dream of this Corporation in a timely manner and for making it a roaring success. Some of these issues at hand and challenges ahead that have the potential to mar the prospects of realization of this government proposal are discussed here with a sole intention of overcoming all possible hurdles and paving way for an unhindered functioning of the proposed Corporation.

Standard Operating Procedures (SOPs)

 

First and foremost issue is that in relation to procurement of drugs and other medical supplies, the approved Drug Policy of the state just mentions that the existing procurement mechanisms of drugs & supplies shall be improved with a view to ensure timely availability of quality drugs, however it does not put forth any discrete policy framework before the upcoming corporation as required for tendering, supplier selection, ordering, pre-qualification, post-qualification, resource allocation, quality assurance, distribution etc. Therefore there is urgent need to chalk out a comprehensive and robust drug procurement policy framework for the state so that there are “Standard Operating Procedures” available to the Corporation that can serve as its guiding roadmap and devise modalities for its day-to-day functioning. Due to some mutual differences between two erstwhile ministers of Health and Medical Education over the constitution of this Corporation, the procurement part had been left incomplete in the approved drug policy of the J&K state. Unless this deficiency is duly addressed well in time, there will always be a scope for gratification practices and bending of rules for some illegitimate gains. Strong lobby of the drug mafia that has successfully scuttled any moves to establish a drug procurement corporation in the past may once again attempt to sabotage the establishment or working of this Corporation which needs to be fought out with firm conviction through strong policies and stringent procedures.

 

Warehousing and Transportation

 

Second big challenge confronting the upcoming JKMSC is to have adequate, state-of-the-art warehousing facilities for drugs and other medical supplies both at divisional and district levels in the state alongwith sufficient transportation laced with cold chain facilities. Madhya Pradesh government’s centralized drug procurement policy of 2004 failed on account of non-availability of adequate drug storage and transportation facilities at district level and consequently they had to revert back to decentralized procurement in their revised drug policy of 2009. Therefore it is extremely important to have warehouses with enough storage space, fitted with heavy duty racking system to avoid wastage of space alongwith pallets, hydraulically operated hand-trolleys and pedestrian controlled electric stackers to handle the medicines scientifically and efficiently. An earlier draft of the drug policy prepared in 2009 had mentioned that the government shall establish modern warehouses at divisional and district levels under the proposed J&K Medical Supplies Corporation keeping in view the state’s topography, climatic conditions and issues of accessibility and that the capacity of warehouses/stores would be in line with the actual requirement to ensure constant supply of drugs to all healthcare institutions of the state. Surprisingly this provision was dropped in the final draft approved by the state cabinet. Therefore if the govt. has decided to procure drugs centrally and then distribute to various district level hospitals, this clause needs to be incorporated into the procurement part of the policy.

 

Skilled manpower trained in procurement

 

Procurement and supply chain management of medicines is a highly sophisticated and professional activity that can only be satisfactorily and successfully undertaken by suitably qualified, adequately trained, sufficiently skilled manpower both at managerial and ground level. At present no executive or administrative staff is available in sufficient numbers at any of the government departments including Departments of Health, Family Welfare, Medical Education, Provincial Stores or Drugs Control that are amply trained to serve the purpose of the upcoming Corporation. Therefore need of the hour is to create sufficient vacancies in the proposed Corporation for such staff, arrange capacity building workshops for the existing staff of Provincial Medical Stores and impart sufficient training to them regarding modalities of modern drug procurement in tune with international standards and norms. Many international Universities conduct summer schools in Pharmaceutical Procurement and Medicines Management from time to time. Government needs to identify and appoint the managerial staff for the proposed Corporation on priority basis and depute the same to these training courses for gaining required expertise so that they can serve the Corporation better and in an effective manner on their return. Given the impact of procurement activities on the operation and effectiveness of health services, it is essential that these activities be performed by trained staff only using sound procedures. Main activities of drug selection, quantification, procurement, quality assurance, storage and distribution must exclusively be carried out by graduates and post-graduates in Pharmaceutical Sciences, who are best suited and well trained for this purpose.

 

Integrity and transparency in tendering

 

Most of the apprehensions and skepticism of common masses in relation to the functioning and success of the proposed Medical Supplies Corporation are linked with the degree of integrity, openness, transparency and efficiency of procedures adopted for awarding tenders to the drug suppliers that will in turn decide the standards of quality of drugs and equipments procured by the Corporation. Majority of people fear that undue political or bureaucratic interference may mar the prospects of such transparency in tendering and procurement and that may in turn bleak the chances of success of this Corporation. In this regard state government needs to display its writ and throttle any such overt or covert moves to undermine the fairness of the tendering practices. Proposed Corporation has to be an absolutely autonomous, open and constraint-free body with full decision-making powers devoid of any undue political or bureaucratic influences. In this regard JKMSC needs to follow the footprints of Tamil Nadu, Kerala and Rajasthan Medical Services Corporations and ensure transparency in all its dealings. Full authority and autonomy needs to be vested upon its Managers and Board of Directors in making their decisions. No transfers of its managers should be allowed under statutes for a specified period unless there are any proven accusations of impropriety. Transparency and integrity will be the benchmark and the key litmus test for the success of this Corporation that alone will decide its future progress. If it succeeds, it makes history and if it fails it fails forever.

Financial/budgetary allocations

 

Besides divisions for procurement, storage and distribution of drugs and other medical supplies, JKMSC must have a separate department of Quality Control where an in-house QC Laboratory equipped with all sophisticated equipments, staff and infrastructure required to test the quality of drugs, should be a established. Therefore besides sending drug samples for testing to government and empanelled private laboratories, Corporation should itself be able to carry out in-housing Quality Control of some of the supplies on urgent basis. To fulfill this and other needs of the Corporation, it must receive sufficient and liberal finances from the govt. through plan as well as non-plan budgetary allocations. Since healthcare has to be on top of all priorities of any government, no stone should be left unturned to ensure adequate monetary support from internal as well as external resources for smooth functioning of the Corporation. It has come to the fore that inadequate funding has over the years left govt. drug testing laboratories of the state in shambles which in turn has resulted into large scale resentment among masses regarding govt. apathy towards these vital institutions. Therefore there should be no dearth of funds at any stage that may impede effective functioning of the proposed Corporation.

Conclusion

An effective procurement process ensures the availability of the right drugs in the right quantities, at reasonable prices, and at recognized standards of quality. Effective procurement is a collaborative process between the procurement corporation, suppliers, an appropriate management system, and committees which make decisions as to which drugs to buy, in what quantities and from which suppliers. In order to put the existing derailed drug procurement system back on track, government has to move several extra miles at a brisk pace and take bold decisions in making this entire concept a grand success. Let our healthcare not fall prey to corrupt practices prevalent elsewhere and let this sector at least be spared from the monetary lust of human kind. States like Tamil Nadu and Rajasthan have shown how this model can be made a success despite all odds; we just need to replicate their success in our own small world.

 

(Author is a senior faculty at the Department of Pharmaceutical Sciences, University of Kashmir and can be reached at ishaqgeer@gmail.com)

SPURIOUS DRUG DEBACLE IN J&K STATE: LESSONS TO BE LEARNT

Startling new revelations are coming to the fore with each passing day in the local press regarding the supply and detection of substandard and spurious medicines particularly in the government run hospitals. A lot has already been written and said about this intriguing problem fraught with disastrous consequences on public health and safety. Mute question remains whether this issue that received enormous media coverage will die down with the passage of time and pass off as just another controversy or some important lessons will be learnt by the powers that be, from this fiasco that enraged and unnerved all sections of our society equally. Even though preliminary enquiry report has been made public by the fact-finding committee constituted by the Ministry of Health and the crime branch has been entrusted with the job of further investigation into the matter, Government of J&K needs to put its act together, ensure adequate checks and balances in its healthcare system and undertake a series of remedial measures in order to curb this menace that has assumed alarming and deleterious proportions. This article proposes a few such steps that need to be taken without any delay in order to prevent the recurrence of such ugly episodes in future.

Impartial enquiry by an empowered committee

Since the preliminary enquiry report has candidly admitted failures on part of Central Purchase Committee and Drug Verification Board members in verifying authenticity of the manufacturer and ensuring quality of the drugs supplied, first and foremost there is dire need to reach out to the roots of this problem. It will be in the fitness of things that a high level, empowered committee of experts should not only expose all the people involved directly or indirectly in the shady spurious drug deal that has shaken the entire healthcare system and damaged its credibility considerably but also make an in-depth investigation into the functioning of Provincial Medical Stores, Central Purchase Committees, Verification Board, Drug Control Department and Drug Testing Laboratories over the past several years. Such an impartial and thorough enquiry assumes importance in the wake of a series of newspaper reports disclosing gross irregularities in procurement, testing and quality control of drugs in the government sector. That can go a long way in revealing all the rot in the prevailing system and pave way for its sustained improvement.

Streamlining supply chain and medicines management

With State Drug Policy already having been approved by the cabinet of ministers as well as the state assembly, Ministry of Health needs to streamline its procurement and quality control mechanism on the pattern of Tamil Nadu and Rajasthan Medical Services Corporation. Drug policy needs to be implemented in letter and spirit as soon as possible and an order must be passed to review and revise the approved drug policy after every three years as against five years mentioned in the policy, so that any genuine grievances arising out of its implementation can be addressed and necessary amendments made to suit various timely needs. Drug selection, quantification, procurement, storage, distribution and dispensing alongwith necessary counseling, monitoring and drug information services to the patients is a highly sophisticated and professional activity that can only be performed by skilled, well-trained and qualified professionals like pharmacy graduates. However in all major and minor hospitals of the state there are either unqualified (matriculates) or under-qualified (Medical Assistants) people managing these affairs leading to frequent failures of the system besides dissatisfaction among patients. Detection of spurious antibiotics is just a manifestation of such systemic failures. Therefore in tune with Drug Policy provisions state govt. must create adequate number of vacancies for pharmacy graduates in all hospitals of the state. This is highly essential for an efficient supply chain management and scientific medicines management within government hospitals.

Legal and administrative reforms

 

On top of everything else, there is need to make necessary amendments in the law so that severe and deterrent punishments are awarded to those dealing with spurious drugs, making all medicine related offences cognizable and non-bailable in accordance with the amendment of Drugs and Cosmetics Act made in the year 2008. Special courts must be designated to try the cases of spurious medicines on fast-track basis and necessary legal assistance should be provided to the drug inspectorate staff in all districts to pursue the offences related to substandard and spurious medicines. Creation of intelligence cum legal cells to facilitate busting of spurious drug rackets and their prompt prosecution must receive top priority. There should be a provision of secret funds and incentives for informers giving information about spurious drugs and the drug inspectorate staff must be suitably trained in collecting intelligence inputs. Their investigational skills required for probing spurious drug rackets must be honed through workshops and other training modules. Further they must be provided all communication, transportation and accommodation facilities required for prompt action in such cases.
 

Drug testing facilities

 

Immediate priority of the state government must be to augment and upgrade the drug testing facilities within the state. In order to ensure timely and accurate testing of all drug samples, existing drug testing laboratories must be upgraded, accredited and provided all necessary funding, manpower and equipments to operate in a more effective manner. Establishing drug testing laboratories in private sector must be encouraged too. A new central, fully equipped and dedicated drug testing laboratory must be established for testing drug supplies at Govt. Medical College, its associated hospitals and all hospitals at district level. Alternatively in-house Quality Control cells may be established in all major hospitals as part of their comprehensive Quality Assurance system. Approved and accredited private drug testing laboratories across India must be empanelled for testing of drug supplies procured by the government. All laboratories must be inspected, audited and validated on regular basis by independent experts from outside the state. Confusion and chaos regarding the extent of spurious drugs in our markets is getting compounded by the fact there are no credible and comprehensive studies available to arrive at any firm conclusion regarding the magnitude of this unscrupulous trade in our state. Therefore there is need to conduct a statewide survey on scientific lines in order to ascertain the magnitude of spurious drug sale in the state. Till such a survey is conducted people will continue to make conjectures regarding the extent of spurious medicines.

 

Quality control of drug supplies in government sector

 

In government sector, every batch of medicines supplied and kept under quarantine should be tested at initial supply stage through empanelled laboratories. Govt. needs to establish warehouses for drug storage in every district on modern lines and ensure timely supply of only standard quality drugs to all govt. hospitals. For this to happen, random samples should be drawn from every warehouse where the batch is supplied. Batch-wise drug sample de-coding should be done through a strictly confidential system and the de-coded samples should be sent for testing randomly to any of the empanelled laboratories located across the Country. Only on receipt of "Quality Passed" certificate from the empanelled laboratories that batch should be released for distribution to government hospitals. Further during the shelf life of drugs, random samples should be periodically drawn from warehouses and quality checked to ensure that drugs are of standard quality right till the date of their expiry. In order to compare and validate the accuracy and correctness of testing quality of the empanelled laboratories, randomly picked control samples should be sent to government laboratories as well as to empanelled laboratories for analysis simultaneously. There should be a provision for pre- as well as post-shipment analysis of all drug consignments received by the govt.

Interaction and collaboration between stake-holders

 

Govt. must involve genuine retailers, wholesalers, working govt. pharmacists as well as their trade associations in tracking spurious drugs and curbing their distribution and sale. We need to develop effective interaction and collaboration between all stakeholders i.e. traders and regulators, traders and consumers, consumers and regulators, medical professionals and regulators, simultaneously. This will facilitate free flow of information regarding substandard and spurious medicines. Trade associations should be impressed to have better surveillance on defaulting members and to take strict action against them. A fool-proof and effective networking system between neighbouring states should be developed and the preparation of dossiers of suspected dealers and manufactures should be a perpetual exercise. Constant surveillance needs to be maintained at all entry points into the state including Lakhanpur and Qazigund toll posts. Regular samples need to be drawn from there for testing of drugs and the purchase bills of all drug consignments entering the state need to be checked on daily basis. On top of them all, creation of better awareness amongst consumers should be accorded top priority.

 

Regulation of drug licensing and registration

 

In our state one of the most important factors that contributes largely towards sale of spurious or substandard drugs is the uncontrolled proliferation of drug sale outlets along the length and breadth of the state. Therefore drug sale licences should not be free for all. They should be issued only to persons holding diploma or degree in pharmacy from a recognized/duly approved university/institution. It is high time that the govt. streamlines its drug licensing and pharmacist registration process. Necessary amendments should be made in the relevant Acts to enforce this provision that includes enforcement of Central Pharmacy Act and implementation of Education Regulations by the J&K Pharmacy Council. Proliferation of drug sale outlets beyond a certain limit must be discouraged. Illegitimate practice of registering matriculates as pharmacists first and then issuing drug sale licences to them must be abandoned forthwith. Chemists on their part must stop issuing experience certificates to such people.

 

Conclusion

 

Many people are making claims and counterclaims regarding the nature and actual size of the problem of spurious drugs in J&K and are simply passing the buck by shifting the blame on each other. Some people are demanding scrapping of the approved drug policy which is by no means any solution. In fact a comprehensive drug policy is a remedy to control this and many other drug-related problems. More than anyone else, state government needs to accord top priority to this serious public health concern and ensure speedy implementation of all necessary measures required to root out the menace of spurious and substandard medicines from our hospitals and open markets. Instead of indulging in blame game, all stake-holders including retailers, wholesalers, distributors, doctors, govt. pharmacists, medical representatives, manufacturers, regulators and patients need to do some introspection and join hands to ensure manufacture, supply, procurement, sale, distribution, promotion, prescribing and use of standard quality drugs only. Let us build a safe and secure healthcare system for ourselves and our generation next.

 

(Author teaches at the Department of Pharmaceutical Sciences, University of Kashmir and has been a part of committee that reviewed and revised state drug policy in the year 2011. He can be reached at ishaqgeer@gmail.com)

Measures to curb the menace of spurious medicines

Shocking news about antibiotic supply from a government hospital testing negative is not only adversely affecting the health and well-being of patients who use such medicines but is also wrecking havoc to the confidence of all other patients and has triggered panic waves all across the state. Confusion and chaos regarding the extent of spurious drugs in our markets is getting compounded by the fact there are no credible and comprehensive studies available to arrive at any firm conclusion regarding the magnitude of this unscrupulous trade in our state. However one thing which is universally accepted by all is that trade in counterfeit/spurious drugs is prevalent internationally and affects both developing and developed countries. Some of the possible factors that contribute towards proliferation of spurious drugs are also universal and include lack of enforcement of existing laws, weak penal action, very remunerative trade, large scale sickness in small scale pharmaceutical industry, availability of improved printing technology that helps in counterfeiting, lack of coordination between various agencies, too many retail & whole sale chemist outlets, inadequate cooperation between stakeholders, lack of control by importing/exporting countries, wide spread corruption and conflict of interests.

 

All these multiple causes notwithstanding, there is need to curb this menace in the right earnest. A series of remedial measures need to be taken by the government and all other stake-holders to get rid of this nuisance that is seriously risking the health of patients who consume such medicines. First and foremost there is need to make necessary changes in the law so that severe and deterrent punishments are awarded to those dealing with spurious drugs, making all medicine related offences cognizable and non-bailable in tune with similar provisions in Narcotic Drugs and Psychotropic Substances Act. Special courts should be designated to try the cases of spurious medicines and all legal assistance must be provided to the drug inspectorate staff to pursue the offences related to substandard medicines.

 

A statewide survey should be conducted to measure the magnitude of spurious drug trade in the state, lifting samples from every nook and corner of the state in a statistically designed scientific manner. Creation of intelligence cum legal cells to facilitate busting of spurious drug rackets and their prompt prosecution must receive top priority. There should be a provision of secret funds and incentives for informers giving information about spurious drugs and the drug inspectorate staff must be suitably trained in collecting intelligence inputs and their investigational skills required for probing spurious drug rackets must be honed. Further they must be provided all communication, transportation and accommodation facilities required for this purpose.

 

A fool-proof and effective networking system between neighbouring states should be developed and the preparation of dossiers of suspected dealers and manufactures should be a perpetual exercise. We need to develop effective interaction between all stakeholders i.e. industry and regulators, industry and consumers, trade and regulators, medical professionals and regulators, simultaneously. This will facilitate flow of information regarding substandard medicines.

 

In our state one of the most important factors that contributes largely towards sale of spurious or substandard drugs is the uncontrolled proliferation of drug sale outlets along the length and breadth of the state. Therefore drug sale licences should not be free for all. They should be issued only to persons holding diploma or degree in pharmacy from a recognized/duly approved university/institution. Necessary amendments should be made in the relevant Acts to enforce this provision. Proliferation of drug sale outlets beyond a certain limit must be discouraged. A distance of at least 500 meters should be maintained between two successive medical shops.

 

In government sector, every batch of medicines supplied and kept under quarantine should be tested at initial supply stage through empanelled laboratories. Random samples should be drawn from every warehouse where the batch is supplied. Batch-wise drug sample de-coding should be done through a strictly confidential system and the de-coded samples should be sent for quality checking randomly to any of the empanelled laboratories located across the Country. Only on receipt of "Quality Passed" certificate from the empanelled laboratories that batch should be released for distribution to government hospitals. Further during the shelf life of drugs, random samples should be periodically drawn from warehouses and quality checked to ensure that drugs are of standard quality right till the date of their expiry. Randomly picked control samples should be sent to government laboratories as well as to empanelled laboratories for analysis to compare the accuracy and correctness of testing quality of the empanelled laboratories. If any drug batch subsequently fails in quality upon testing, the remaining stock in warehouses should be frozen and the unused hospital stock of the drug of failed batch should be recalled and returned to the supplier. If three batches of any drug fail during tender period either at the time of initial receipt or during the shelf life of the drug the product as well as the company should be blacklisted. Information of failed batches and black listed companies must be put up on the official website of health department. There should be a provision for pre- as well as post-shipment analysis of all drug consignments received by the govt.

 

Drug manufacturers should be encouraged to have their own anti-counterfeit drug strategies like RFID, QRC etc, better surveillance and efficient complaint handling system. Trade associations should be impressed to have better surveillance on defaulting members and to take strict action against them. On top of them all, creation of better awareness amongst consumers should be accorded top priority. In order to ensure timely and accurate testing of all drug samples, existing drug testing laboratories must be upgraded, accredited and provided all necessary funding to operate in a more effective manner. Establishing drug testing laboratories in private sector must be encouraged too. A new central, fully equipped and dedicated drug testing laboratory must be established for testing drug supplies at Govt. Medical College, its associated hospitals and all hospitals at district level. In-house Quality Control cells need to be established in all major hospitals as part of their comprehensive Quality Assurance system.

 

Many people are making claims and counterclaims regarding the nature and actual size of the problem of spurious drugs in J&K and are simply passing the buck by shifting the blame on each other. Some people are demanding scrapping of the approved drug policy which is by no means any solution. In fact a comprehensive drug policy is a remedy to control this problem. Instead of indulging in blame game, all stake-holders need to join hands and ensure speedy implementation of all necessary measures required to the root out the menace of spurious medicines from our markets. Government too needs to accord top priority to this serious public health concern.