SELECTION OF ESSENTIAL DRUGS:
Draft Drug Policy approved by the cabinet of ministers in JandK envisages that the Department of Health and Medical Education shall appoint an Expert Committee known as the State Drug Committee which would be responsible for initially preparing and subsequently updating the essential drug list every two years for the hospitals in public sector. The Committee will comprise of Clinicians, Pharmacologists, Microbiologists, qualified Pharmacists and independent experts in the field besides senior functionaries of the Department like the Principals of Medical and Dental Colleges, Directors of Health Services, Controller of Drug and Food Control Organization etc. The Committee shall be headed by the senior-most Principal of Government Medical Colleges in the State. Further a separate drug committee with appropriate composition would be constituted in respect of drugs pertaining to Indian Systems of Medicine. The drugs selected by this committee shall be identified and listed by their generic names or International Non-proprietary Names (INN) only. The State essential drug list will be subsequently categorized according to the levels of health care facilities like primary, secondary and tertiary and will be revised after every two years so as to reflect therapeutic advances and changes in cost, resistance pattern and public health relevance.
However there is one discrepancy in this key feature of the approved policy. Memorandum for approval of drug policy for JandK prepared for submission to the cabinet by the Commissioner/Secretary to Government, Health and Medical Education Department clearly reads at S.No. 8, page 4 that “two working groups, one each for Jammu and Kashmir division were constituted under the chairmanship of the respective principals of Government Medical Colleges to prepare a draft drug policy besides a state level committee under the chairmanship of then Commissioner/Secretary to Government, Health and Medical Education Department with members from each division to finalize the draft drug policy for the state. Memo reads that these working groups also prepared a draft State Essential Drugs List and Complementary Drugs List. This Essential Drugs List comprised of 383 drugs.”
Pertinently, Civil Society Forum (CSF) Kashmir in its meeting with senior functionaries of the health department had pointed out that since the draft drug policy of 2009 envisaged that state essential drug list will be revised after every two years so as to reflect therapeutic advances and changes in cost, resistance pattern and public health relevance and given the fact that two years have already passed eversince state essential drug list appended to the draft drug policy 2009 was prepared, a new state essential drugs list must be prepared in tune with National List of Essential Medicines (NLEM), 2011 for the purpose of this policy. However it was not suggested that EDL prepared by the experts keeping in view local requirements of the state should altogether be replaced by the NLEM 2011. Consequently NLEM, 2011 appended with the approved drug policy is the one that caters to the whole country in general and not to the JandK state in particular. It would have been more pertinent to revise the state EDL in consonance with diseases endemic to this region and the local needs of our hospitals.
PROCUREMENT OF ESSENTIAL DRUGS:
Owing to the friction between Health Ministry and the Ministry of Medical Education in the state, the idea of having an autonomous corporation on the pattern of Tamil Nadu Medical Supplies Corporation (TNMSC) as was mooted in the draft drug policy of 2009 has been skipped in the final approved draft. Unrevised draft had endorsed that the drugs included in the essential drug list shall be centrally procured through an autonomous, transparent, accountable and free from constraints mechanism on the pattern of TNMSC which has achieved unprecedented success in ensuring timely availability of quality drugs and has therefore been recommended to be adopted for procurement of drugs, not only by the Government of India but by the World Health Organization too. Unrevised draft had envisioned that the procurement, storage and transportation becomes easier, more transparent and more accountable when it is done through an autonomous Corporation and also reduces the tendency to invest funds in unutilized and slow moving stocks because the Corporation was expected to invest in drugs which have a good take off. This model was believed to facilitate the minimization of stock outs and expired stocks, and ensure availability of essential drugs throughout the year as per the actual requirements of the health institutions. Under such a dispensation, the Health and Medical Education Department was supposed to advise on medicines to be procured but the decisions on procurement would have completely rested with the corporation.
Ignoring all these assertions made in the unrevised draft, state govt. has finally declared in the approved draft that the existing procurement mechanisms of drugs and supplies shall be improved with a view to ensuring timely availability of quality drugs. Approved policy also envisages to make the detection of pilferages/wastages/expired stocks easier and for this purpose, an appropriate Management Information System shall be evolved and a web-based e-procurement model developed. It reaffirms that the objective is to put in place an effective system of procurement of essential drugs by generic names to ensure timely availability, good quality and reasonable cost. However existing procurement mechanisms are too flawed and inefficient to improve so drastically overnight as required under approved drug policy provisions. Existing system has completely failed so far in keeping quality drugs available at hospital drug counters throughout the year.
As a matter of fact, provisions relating to generic drug prescribing cannot be a success or even a reality unless and until procurement procedures are very well defined in the policy. Unfortunately, dropped idea of having an autonomous corporation on the pattern of TNMSC could have helped a great deal in streamlining the drug procurement process and ensuring round the clock availability of quality generics at hospital counters. Drug policy approved by the state govt. specifies no detailed procedures for drug procurement and their quality assurance and unless that part is settled between the two squabbling ministries of Health and Medical Education, generic drug prescribing cannot work on expected lines. Selvaraj and Nabar have suggested in India Health Report 2010 that an efficient procurement supply chain is based on the fundamental principle of transparency in the process of selection and quantification of drugs and the procurement process – which includes tendering process, bid opening process, award conditions, payment mechanisms and quality control procedures. Lack of efficiency in any one of these areas can lead to sub-optimal procurement, resulting in a shortage of supply. Further it is likely to produce uncompetitive behavior among suppliers, leading to fewer choices of suppliers and higher prices of drugs. Therefore in larger public interest, govt. must decide on this issue as soon as possible so that the approved drug policy does not remain confined to the shelves of the government secretariat.
GENERIC DRUG PRESCRIBING:
There are widespread myths and misconceptions among common masses, pharmacists, chemists as well as doctors regarding generic drugs and these misgivings have only been compounded by the spate of misinformed newspaper columns against generic drug use published after clearance of the drug policy by the state cabinet. After years of research and worldwide consultation, World Health Organization (WHO) has clearly recommended generic drug prescribing as one of the core strategies to promote rational use of medicines across the globe. Percentage of medicines prescribed by their generic names is in fact one of the primary/ core drug use indicators used by WHO for assessing quality of drug utilization in any country. In fact there is a separate Department for Essential Medicines and Pharmaceutical Policies at WHO. Using an essential medicines list makes medicine management easier in all respects; procurement, storage and distribution becomes easier with fewer items; prescribing and dispensing becomes convenient for professionals if they have to know about fewer drugs and on top of all, availability and affordability of drugs to poor patients visiting government health facilities will drastically improve upon generic prescribing. Concept of Essential Drugs List as a whole is aimed at making the best use of limited resources particularly in resource-poor countries like India. Procurement of fewer drugs in larger quantities results in more price competition and economies of scale and also to better supply of drugs, rational prescribing, reduction in costs and finally to better health outcomes.
Worldwide, developing as well as developed nations are shifting to generic prescribing and this is showing phenomenal gains in every aspect of drug use, that is why more than 75% prescriptions in US and more than 50% prescriptions in UK contain generic drugs at present. However it is understandable that situation in our part of the globe is no match to that in US or UK, which results in numerous apprehensions about the success and implications of generic drug prescribing. Even though generics have proved to be a big success everywhere else, in our part of the globe where there is large scale corruption and drug markets are poorly regulated showing little compliance with norms, enforcing genuine generic prescribing and sale is a huge challenge for the govt agencies. To address such predicaments, examples of several Indian states like Delhi, Tamil Nadu, West Bengal, Rajashthan, Himachal Pradesh, Chatisgarh, Kerala, Karnataka, Uttarakhand can be cited that have shifted to generic prescribing in govt hospitals successfully and tremendous benefits have been recorded in every aspect of drug use. Same is the case with another resource-constrained country like Bangladesh that has also made good progress in this direction. Initially there is skepticism but with effective implementation of the policy, all problems are gradually sorted out. However necessary pre-requisite is that there has to be effective and foolproof implementation of the policy by the government agencies, devoid of any corrupt practices. If proper implementation of the policy fails, generic prescribing cannot be of any help.
Ensuring high quality of generic drugs purchased by the govt. is an inherent component of the approved drug policy outlined under procurement provision. If the govt. follows standard guidelines of pre-qualification and post-qualification of suppliers and strictly adheres to the technical specifications as has successfully happened in case of Tamil Nadu Medical Supplies Corporation, there is no reason why govt. can't procure good quality drugs. However the controversy surrounding the autonomous corporation V/S procurement directorate in JandK has a potential to mar the entire spirit of the rational procurement policy.
There are concerns that generic drugs are not available in open markets and patients living in far-flung areas may face problems in refilling their prescriptions. These issues can be taken care of by the prescribing physicians who may prescribe as per the patient's short-, mid- and long-term needs so that patients are able to keep adequate stocks with them depending on their distance from the healthcare centres. Keeping in view exceptionally low cost of these drugs, it won't be a problem for the patients to purchase a few extra doses. Further all patients with common, speciality or rare diseases have to revisit their physicians for consultation when they can refill their prescriptions. Adequate number of drugs listed in state EDL will have to be kept available at all district level healthcare facilities throughout the state so that patients do not face any difficulty on account of their access and availability. Simultaneously, as per the approved drug policy, the State Essential Drug List will be categorized according to the levels of health care facilities like primary, secondary and tertiary. There are some drugs which though not listed in the essential drug list are required for specific diseases/exceptional cases. Keeping this in view, approved drug policy provides that a supplementary drug list shall be drawn by the State Drug Committee and a provision of grants not exceeding 10% of the allocated budget for drugs shall be earmarked for purchase of drugs in the supplementary drug list.
Having said that, Drug Policy is actually aimed at addressing the medication related needs of majority of population with common ailments, availing govt. health facilities. Number of formulations available in the market at present is more than 20,000 which are mostly needless. For almost all the diseases, 348 drugs are enough to cater to all drug related needs. This number is as per National List of Essential Medicines, 2011 and not as per our local needs. Apprehensions expressed by certain quarters that the generic drug prescribing in govt. hospitals will discredit prescribing physicians from exercising any choice of brands and at the same time it will empower the pharmacist to replace the prescribed generics with any generic of his own choice depending on his profit margins. Such fears can come true if the government machinery fails to make all drugs listed in the state essential drug list available in adequate quantities throughout the year at drug counters within the hospitals. However if govt. can successfully implement the drug policy provisions and never allow stock-outs within hospital pharmacies, then this won't happen. As per the inherent design of the approved drug policy, all prescriptions will be filled at hospital drug counters and none of the prescriptions whether belonging to in- or out-patients will need to be dispensed at drug stores outside the govt. hospitals. This can temporally affect the business of drug stores outside the govt. hospitals but with the passage of time, they will adapt to the changing scenario. Moreover such fears have propped up in other Indian states too when generic drug policies were implemented there, but eventually everything got streamlined on expected lines. Once an ambience of generic prescribing prevails, all hiccups and hurdles will be overcome automatically. For the time being provision of generic prescribing of drugs is applicable only for public sector hospitals because majority of poor people visit these hospitals for treatment and that is where they need quality medicines at affordable prices. Affluent can afford to purchase branded medicines in private sector.
WARE-HOUSING AND DISTRIBUTION:
Unrevised 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 JandK 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 requirement to ensure constant supply of drugs to the healthcare institutions they are feeding. However surprisingly this provision has been dropped in the draft approved by the state cabinet. One fails to understand what was wrong in establishing warehouses at divisional and district levels when the govt. has decided to procure drugs centrally and then distribute to various district level hospitals. Pertinent to mention here that Madhya Pradesh government’s centralized drug procurement policy 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. CSF’s specific suggestion that the drugs should be stored as per good storage practices and in accordance with FEFO (first-expiring-first-out) and FIFO (first-in-first-out) fashion has not been incorporated verbatim, however, approved drug policy envisages that the drugs shall be distributed under proper transportation conditions, ensuring safety and proper delivery and that the distribution will be done in an appropriate and timely manner to maintain availability throughout the State. However CSF’s suggestion that pre- and post-shipment quality control testing/analysis of drugs should be done through random sampling on all stocks has been ignored. Thankfully approved draft has incorporated CSF proposal that the proper recall and disposal procedures shall be followed as per standard guidelines.
FINANCING:
Approved draft of the drug policy envisages that the JandK government will provide allocations for procurement and supply of drugs for all types of institutions – Primary, Secondary and Tertiary and that the Department of Health and Medical Education shall be responsible for projecting the cost of drugs required from time to time. However CSF suggestion that govt. needs to specify how drug budgets will be estimated and what will be the minimum per capita per annum expenditure on drugs has not been considered.
QUALITY ASSURANCE AND REGULATION:
Draft drug policy approved by the state cabinet duly recognizes that Controller, Drugs and Food Control Organization in the State is responsible for implementing the legislation and regulations on pharmaceuticals to ensure quality, safety, efficacy of drugs and accuracy of product information and therefore said organization needs to be strengthened through a capacity building process by augmenting infrastructure, manpower and financial resources. Drug Testing Laboratories would also be strengthened by providing equipment, qualified analysts and other requirements as may be consistent with the workload. Approved drug policy has accepted CSF suggestion that average testing time and annual testing load of govt. laboratories shall be fixed for greater accountability and the rules relating to cosmetics shall be enforced and laboratories notified for their testing purpose. However following important proposals put forth by Civil Society Forum to strengthen DFCO, JandK have not been included in the approved draft:
a. Adequate communication, transportation, accommodation, and legal assistance facilities should be provided to the inspectorate staff in all districts besides according them gazetted cadre and proper authorization for inspecting AYUSH drug stores. All provisions of Drugs and Cosmetics Act relating to AYUSH medicines listed under Chapter IV-A should be enforced.
b. JandK Government should mobilize all necessary resources to make Drug Inspectors available at Block level rather than at tehsil level in the state.
MEASURES TO CURB SPURIOUS MEDICINES:
In regard to curbing the menace of spurious/counterfeit/sub standard/misbranded/ adulterated drugs in the state approved draft of the drug policy includes CSF suggestions that an intelligence-cum-legal cell shall be established in the office of Drug and Food Control Organization, J and K to facilitate busting of spurious drug rackets and their prompt prosecution and that the efforts shall be made to provide incentives to informers giving information about spurious drugs. It also mentions that adequate steps shall be taken to ensure proper implementation of drug regulations especially with regard to offences related to adulterated or spurious drugs. However further suggestions put forth by CSF in this regard as shown below have not been included in the approved draft:
- Special courts shall be designated to try the cases of spurious drugs
- Effective networking system between neighbouring states shall be developed.
- Necessary changes in law shall be made to award severe and deterrent punishments as afforded under law to those dealing with spurious drugs, making the offences cognizable and non-bailable in the light of similar provisions in Narcotic Drugs and Psychotropic Substances Act.
- A distance of at least 500 meters shall be maintained between two successive shops.
- Drug sale licences shall be issued only to persons holding diploma or degree in pharmacy from a recognized/duly approved university/institution. Necessary amendments shall be made in the relevant Acts to enforce this provision.
- Preparation of dossiers of suspected dealers and manufactures shall be a perpetual exercise. Such dealers will be black-listed and their licences cancelled.
- Manufacturers shall be encouraged to have their own anti-counterfeit drug strategies like RFID, QRC etc, better surveillance and efficient complaint handling system.
- Effective interaction between the stakeholders i.e. industry and regulators, industry and consumers, trade and regulators and medical professional and regulators, will be developed
Further in light of the fact that several conflicting yet alarming reports about the magnitude of spurious medicines in Indian markets ranging from as low as 0.25%, as per govt. claims upto a whopping 35% as claimed by several independent groups like ASSOCHAM, CII, OECD, EC etc, it is difficult to hazard a guess about the extent of this unscrupulous trade in JandK. Therefore CSF had suggested that a statistically designed, scientifically implemented, statewide survey should be conducted by collecting samples from every nook and corner of the state and testing them for their quality and authenticity, to measure the extent of this menace in JandK state. Govt. of JandK has not deemed it worthwhile to consider and accept this proposal on the grounds that drug inspectorate of the Drug and Food Control Organization, JandK as part of their routine duties regularly lift drug samples for testing and there is no need for a separate survey in this regard. Approved draft does make a mention that the surveillance on the quality of drugs available in the market shall be maintained by collecting samples and taking further action according to law. However CSF suggestion that in-house quality control cells should be established in all hospitals where drugs lifted by random sampling should be tested for their quality has not been considered.
DRUG LICENSING POLICY:
Even though approved drug policy declares that efforts shall be made to rationalize number of drug licences and to strictly enforce the provisions of the JandK Pharmacy Act, Samvat 2011 and the rules framed thereunder, shockingly it makes no commitment that Education Regulations will be enforced in the state and thereafter further registration of unqualified people as Registered Pharmacists will be stopped that has of late turned into a non-stop nuisance in the state. Surprisingly commitment to this effect has been made in the memo for submission to the state cabinet of ministers but the same is missing in the approved draft of the drug policy making the government’s intentions doubtful since illegitimate registration of unqualified people shall continue, as per JandK Pharmacy Act unless and until Education Regulations are not enforced in the state. In this regard following suggestions put forth by the Civil Society Forum have been completely ignored.
“Central Pharmacy Act of 1948 should be enforced in the state to replace JandK Pharmacy Act 2011 (samvat) and the JandK Pharmacy Council should endeavour to constitute its executive committee and frame Pharmacy Education Regulations and implement them as soon as possible so that minimum standards can be prescribed for colleges and institutes offering diploma or degree courses in Pharmacy. This will make sure that nobody enters the profession of pharmacy without earning a legal qualification. Further the constitution and scope of JandK Pharmacy Council shall be broadened, making it all-inclusive by enrolling professionals from academia, hospitals, industry and trade as its members”. Some kind of sabotage by certain vested interests in this regard cannot be ruled out.
POLICY IN RELATION TO AYUSH DRUGS:
Approved draft provides that the regulatory laws related to quality control of AYUSH drugs shall be examined and suitable amendments in the said regulations shall be made, wherever necessary. However following additional measures suggested by CSF in respect of drugs belonging to AYUSH systems of medicine have been dropped on the pretext that a separate policy for such drugs shall be devised by the govt. in due course of time:
a. A committee comprising of traditional health practitioners and healers, and experts in pharmacognosy, toxicology and related fields should be constituted to study and guide the various activities with respect to AYUSH drugs.
b. The health conditions that can be treated with these traditional systems of medicine should be identified.
c. An appropriate methodology and technology for the identification, development and production of medicinal items used by the traditional systems of medicine should be developed.
d. Scientific studies to evaluate the quality, safety and efficacy of traditional and herbal medicines should be fostered and promoted.
e. All practitioners of traditional medicine systems as well as the public should be encouraged to remain alert to adverse reactions to traditional and herbal medicines and to notify them to the Drug Information Centres and the nodal centre for drug information in the State.
f. Cultivation and research of medicinal plants, should also be encouraged and promoted.
Had JandK government included these proposals, use of drugs belonging to Alternative System of Medicine would have been streamlined to a very large extent even if govt. had any plans to bring in a separate policy for such drugs.
DRUG ADVERTISEMENT AND PROMOTION:
This particular clause of the approved drug policy envisages that in order to prevent risks of misuse and marketing of drugs by quacks, wherever required, laws would be made and strengthened and that this would also help in regulating commercial advertising and marketing of drugs. Hence any advertisements and promotion of drugs will be required to provide complete drug information. However approved drug policy of JandK government does not provide any policy framework in relation to curbing the menace of unethical promotion and marketing practices of drugs by pharmaceutical companies that often lead to unethical prescribing by some unscrupulous doctors. In this regard following suggestions put forth by CSF have been dropped by the govt.
a) All drug promotional practices of pharmaceutical companies and prescribing practices of doctors should be in accordance with Dec.,2010 amendments of the MCI code of Medical Ethics (professional conduct, etiquette and ethics Regulations), 2002 and the prescribers should be made to adhere to these guidelines in letter and spirit.
b) Authorities of government hospitals, particularly teaching hospitals, should ensure that the activities and conduct of medical and pharmaceutical sales representatives are in conformity with standard ethical norms and do not, in any way, hamper routine patient care.
c) Drug Policy should ensure rational prescribing practices by all doctors whether in public or private sector, rational dispensing practices by pharmacists and rational use of medicines by the consumers in an integrated and seamless manner.
d) Promotion-making claims of pharmaceutical suppliers should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste.
e) Product information of all kinds, should be scientifically valid and evidence-based.
f) Offering, soliciting or accepting inducements of any kind, monetary or material (except free samples of product in modest quantity) for promotional purpose should not be indulged in.
g) Prescribing doctors or dispensing pharmacists should not accept support or assistance of any kind conditional upon obligation to promote a medicinal product.
h) Professional societies, educational organizations may accept partial sponsorship from the pharmaceutical companies for holding scientific meetings and symposia, but this should be clearly stated at the meetings and in proceedings. Care should be taken to ensure that the sponsorship in no way affects the quality of scientific deliberations in the meeting.
LOCAL MANUFACTURE OF PHARMACEUTICALS:
In order to promote self-sufficiency, the state government envisages to encourage, promote and support local manufacturers of pharmaceuticals in the approved drug policy however this is not a good drug procurement practice as per international norms and well-established standards since it tilts the balance in favour of the local manufacturers and discourages reputed pharmaceutical concerns from outside the state from participating in competitive bidding process. Moreover we don’t have sufficient manufacturing concerns operating from within the state. On the pattern of Bengal Chemicals and Pharmaceuticals Limited, Rajasthan Drugs and Pharmaceuticals Limited, our state govt. too needs to establish a govt.-owned pharmaceutical manufacturing unit in accordance with cGMP regulations, however, this suggestion put forth by CSF has not been included in the approved draft by the govt.
HOSPITAL PHARMACY SERVICES:
Good news is that govt. has accepted CSF suggestion and declared in the approved draft that clinical pharmacy services shall be introduced in all major hospitals for the benefit of the patients and in all the hospitals of the state, Drugs and Therapeutic Committees shall be established and made effectively functional, which will be responsible for reviewing drug utilization and promoting rational use of drugs. Furthermore a state level Drugs and Therapeutic Advisory Committee shall also be constituted to monitor the activities of the drugs and Therapeutic Committees of the hospitals and evidence-based Standard Treatment Protocols shall be developed as the basis for training, prescribing and drug supply. Approved drug policy also envisages that in order to enhance safety of drugs used in hospitals, to monitor and document adverse drug reactions and other adverse events among patients, pharmacovigilance centres will be established in govt. hospitals. Further expertise and human resource in pharmaceutical field will be developed to support the successful implementation of the policy and appropriate in-service training programmes will be designed and implemented to enhance their skills. Another prospective measure that has been adopted in the approved policy is the establishment of Drug Information Centres in the Govt. Medical Colleges to provide appropriate and unbiased drug information to all stakeholders and to publish a state level formulary annually in line with the WHO/national norms.
However CSF suggestion that all hospitals be directed to devise their own hospital drug management policies for efficient management of their resources and drug supplies and the suggestion that in-house Quality Control cells should be established in every major hospital as part of their comprehensive Quality Assurance system have not been included in the approved draft. Services of qualified pharmacy graduates must be made available in all division, district and sub-district level hospitals of the state.
MEASURES TO CURB DRUG ABUSE:
Government of JandK has endorsed CSF suggestions that sale, storage, use of drugs and record keeping specified under Schedule X of the Drugs and Cosmetics Act, 1940 shall be supervised and monitored effectively by the inspectorate staff working under Drug and Food Control Organization, JandK and special checking squads under the leadership of Deputy Controllers will be constituted to undertake periodic inspections in this regard. Approved draft also mentions that Schedule-H drugs shall be strictly dispensed on the prescription of Registered Medical Practitioners. However following suggestions put forth by CSF to curb the menace of drug abuse have not been considered worth inclusion in the final draft by the govt.
a. License to sell, stock and distribute drugs pertaining to Schedule X should be restricted to dealers with absolutely spotless track record and should not be issued to those indulging in any sort of unlawful activities.
b. Workforce of the Narcotics Control Bureau should be augmented and its nodal centre established at Srinagar.
c. In compliance with NCBI directions, a multi-disciplinary Coordination Committee under the Chairmanship of Chief Secretary or a senior Secretary should be established for regular interaction with various Central and State agencies and to receive support and grant-in-aid assistance from Narcotics Control Bureau of India (NCBI).
d. The state should set up an Anti Narcotics Task Force under an IG level officer with duties and responsibilities duly demarcated.
e. Proliferation of drug stores should be discouraged and easy availability of substances of abuse should be reversed.
BLOOD BANKING AND TRANFUSION POLICY:
Regarding this issue of vital significance approved draft of the JandK govt. has accepted CSF suggestion that the best practices will be followed in Blood Banking and Transfusion of Blood. However following important measures as suggested by CSF have not been discretely mentioned in the approved draft.
a. Procedures of blood banks e.g. blood collection, processing, compatibility testing, storage, component separation, transfusion of blood and blood products and all other related activities shall be practiced as per the rules and regulations under the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945 and in accordance with relevant statutory guidelines.
b. In keeping with the constant needs and constraints, special provisions shall be made to facilitate availability of blood and blood products through a substitute storage system, in peripheral areas where good blood banking system is still in the process of development.
c. An expert Committee shall devise Standard Operating Procedures and oversee the functioning of all blood banks and peripheral storage facilities to ensure and facilitate the above goals.
FUTURE POLICY AMENDMENTS:
Govt. has decided that the approved policy document shall be reviewed and revised at appropriate intervals based on the need but at-least once every five years but it does not make any commitment that all stake-holders from hospitals, academia, regulatory bodies, trade, industry and govt. departments shall be involved in the process of review or amendment of the policy. Approved drug policy provides that the state would endeavour to provide financial incentives to promote rational use of drugs apart from regulatory and managerial strategies. However it has not included CSF suggestion that a state level empowered group of experts should be constituted to overlook rational use of medicines, ethical drug prescribing, dispensing and promotion practices in hospitals as well as in the community at large.
