Swot analysis of draft drug policyPresentation Transcript
Dr Geer Mohammad IshaqSenior Assistant ProfessorDepartment of Pharmaceutical SciencesUniversity of Kashmir8th J&K Science Congress, University of Kashmir
To promote accessibility of medicines. This wouldmean equitable availability and affordability ofessential medicines including traditionalmedicine. To ensure safety, quality and efficacy of medicines. To promote good prescribing practices, gooddispensing practices and rational use of drugs inthe public and private sectors. To provide cost-effective and efficient procurementand supply management system for drugs.
State Essential Drugs List framed by State DrugCommittee Centralized procurement of drugs. Drugs to be identified, listed and prescribed by theirgeneric names or International Non-proprietaryNames (INN) only. Quantification of drugs with provisions for bufferstocks. Proper inventory control system using appropriateinventory management software. Evidence-based Standard Treatment Protocols (STP) shallbe developed as the basis for training, prescribing and drugsupply.
Distribution of drugs shall be under propertransportation conditions, ensuring safety and properdelivery in a timely manner. Proper recall and disposal procedures for unwanteddrugs shall be followed as per standard guidelines. Drugs & Food Control Organization in the state shallbe strengthened by augmenting infrastructure,manpower and financial resources. Steps shall be taken to ensure proper implementationof drug regulations especially with regard to offencesrelated to substandard or spurious drugs.
Drug Testing Laboratories shall be strengthened byproviding equipment, qualified analysts, adequate spaceand other requirements as may be consistent with theworkload. Efforts will be made for accreditation of the Drug TestingLaboratories as per national standards. Approved private sector laboratories under overallsupervision of the state government shall also be involvedto ensure the quality of drugs in the state. Annual testing load and average testing time of the existingdrug testing laboratories shall be fixed for greateraccountability.
Appropriate drug information shall be provided andmade available to the health professionals as well as topatients. Efforts shall be made to strictly enforce the provisionsof the J&K Pharmacy Act, Samvat 2011 and the rulesframed thereunder. Regulatory laws related to quality control of AYUSHdrugs shall be examined. Suitable amendments in thesaid regulations shall be made, wherever necessary. Rules relating to Cosmetics shall be enforced andlaboratories notified for testing purposes.
Sale, storage, use of drugs and record keepingspecified under Schedule X of the Drugs andCosmetics Act, 1940 shall be supervised andmonitored effectively by the inspectorate workingunder Drug and Food Control Organization, J&K. Schedule-H drugs shall be strictly dispensed on theprescription of Registered Medical Practitioners. An intelligence-cum-legal cell shall be established inthe office of Drug and Food Control Organization, J&Kto facilitate busting of spurious drug rackets and theirprompt prosecution.
Efforts shall be made to provide incentives toinformers giving information about spurious drugs. Efforts shall be made to rationalize number of Druglicences. In order to prevent risks of misuse and marketing ofdrugs by quacks, wherever required, laws would bemade and strengthened. This would also help inregulating commercial advertisement and marketingof drugs. The regulatory agency shall enforce relevant guidelineson manufacture including Good ManufacturingPractices (GMP), and Good Storage Practices (GSP).
In all the hospitals of the State, Drugs and TherapeuticCommittees shall be established and made effectivelyfunctional. These will be responsible for reviewingdrug utilization and promoting rational use of drugs. A state level drugs and therapeutic AdvisoryCommittee shall also be constituted to monitor theactivities of the drugs and Therapeutic Committees ofthe hospitals. Concepts of essential drugs, rational drug use andgeneric prescribing shall be incorporated in thecurricula of health training institutions.
Regular Prescription audits shall be commissioned inpublic hospitals to monitor prescribing of drugs ontheir generic (INN) names only. Drug Information Centre shall be establishedpreferably in the Government Medical Colleges toprovide appropriate drug information. A state level Drug Formulary would be publishedannually in line with the World HealthOrganization/National norms and distributed to allqualified prescribers free of cost or on subsidized rate.
The state would endeavour to conduct training of drugsellers, continuing education of health care providersand consumer education. Pharmacovigilance centres shall be established tomonitor and document adverse drug reactions and tocollect data on substandard drugs, counterfeit drugs,inappropriate use, medication errors etc. from varioushealth professionals. Efforts will be made to establish a system where bothpublic and private sectors shall be involved to providedrugs needed to adequately treat and controlemerging diseases.
To promote the concepts of essential drugs andrational use of drugs, it is necessary to developexpertise and human resources in the pharmaceuticalfield. Drug management system at all levels shall bemanaged by appropriately trained and skilledpersonnel. Necessary steps would be taken, in due course of time,for training of adequate number of pharmacyprofessionals in the state so as to manage the hospitalpharmacies and drug supply system.
Clinical pharmacy services shall be introduced in allmajor hospitals for the benefits of the patients. Government shall encourage development of multi-disciplinary research in areas such as medicine,pharmacy, pharmacology, medicinal chemistry andtraining of research personnel in the relevant areas. The Government shall promote collaborative researchwith recognized research institutes within and outsidethe state for drug research.
Research on use of drugs shall be promoted to provideinformation on attitudes and beliefs that contribute toinappropriate drug use or non-use. Best practices will be followed in Blood Banking andTransfusion of Blood. Monitoring and evaluation of the drug policy shalltake place at regular intervals and complete externalevaluation will be got conducted. Monitoring system for private sector shall also bedeveloped and implemented by the department. Amechanism for redressal of public grievances shall alsobe developed and made effective.
The existing procurement mechanisms of drugs &supplies shall be improved with a view to ensuringtimely availability of quality drugs. In order to promote self-sufficiency, the StateGovernment will encourage local manufacturers ofpharmaceuticals in line with the state industrial policy. The drug policy document shall be reviewed andrevised at appropriate intervals based on the need butat-least once every five years. Pharmacy Education Regulations completely ignored. Reconstitution of J&K State Pharmacy Council notpledged. Its scope and constitution limited at present.
National List of Essential Medicines, 2011 appended tothe Draft Drug Policy, State Essential Drugs List notupdated/used. Idea of procuring drugs listed in the essential drug listcentrally through an autonomous, transparent,accountable and free from constraints mechanism onthe pattern of TNMSC dropped. Draft drug policy specifies no policy framework fordrug procurement and their quality assurance. An earlier commitment to establish modernwarehouses at divisional and district levels has beendropped in the approved draft.
Pre- and post-shipment quality control testing/analysis of drugs ignored in the final draft. Govt. needs to specify how drug budgets will beestimated and what will be the minimum per capitaper annum expenditure on drugs. Adequate communication, transportation,accommodation and legal assistance facilities to theinspectorate staff in all districts are lacking besideslack of gazetted cadre and proper authorization forinspecting AYUSH drug stores. Provisions of Drugs and Cosmetics Act relating toAYUSH medicines listed under Chapter IV-A have notbeen enforced.
Drug Inspectors available at Tehsil level ratherthan at block level in the State. In-house quality control cells have not beenestablished within hospitals where drugs procured bythe hospital could be tested for their quality standards. Statistically designed, scientifically implemented,statewide survey to be conducted to measure theextent of spurious drug menace in J&K State. All hospitals to be directed to devise their own hospitaldrug management policies for efficient managementof their resources and drug supplies.
India among world leaders to manufacture and supplystandard quality generic drugs. India stands 3rd inrank, 13th in value in production of Pharmaceuticals. GOI to implement schemes of free generic medicinesin government hospitals soon. Rs. 1200 croresearmarked for the twelfth five year plan. Government will and commitment to draft and enforcedrug policy provisions particularly generic prescribing. Not too big a state to manage healthcare services. Hospital drug budgets not too big to manage. Strong workforce of qualified pharmacy graduates. State assembly elections to be held in 2014.
Indian States like Delhi, Tamil Nadu, West Bengal,Rajasthan, Himachal Pradesh, Chhattisgarh, Kerala,Karnataka, Uttarakhand have shifted to genericprescribing in Government hospitals successfully andtremendous benefits have been recorded in everyaspect of drug use. Another resource-constrained country like Bangladeshhas also made good progress in this direction. If the Government follows standard guidelines of pre-qualification and post-qualification of suppliers andstrictly adheres to the technical specifications just likeTNMSC, there is no reason why Government cantprocure good quality drugs.
Services of qualified pharmacy graduates can be madeavailable in all division, district and sub-district levelhospitals of the State. Special provisions can be made to facilitate availabilityof blood and blood products through a substitutestorage system, in peripheral areas where good bloodbanking system is still in the process of development. All stake-holders from hospitals, academia, regulatorybodies, trade, industry and Government departmentscan involved in the process of review or amendment ofthe policy.
No special measures to curb the menace of spuriousmedicines as outlined by Mashelkar Committee (2003). No specific measures in respect of drugs belonging toAYUSH systems of medicine. No specific measures to curb the menace of unethicalpromotion and marketing practices of drugs bypharmaceutical companies as outlined under MCI Code ofEthics, December, 2011. No specific measures to curb the menace of prescriptiondrug abuse/drug addiction as desired by NCBI. Insufficient measures regarding blood banking andtransfusion policy. Absence of an autonomous corporation for procurement ofdrugs for hospital supply.
Poor infrastructure of healthcare in govt. hospitals Lack of comprehensive health policy Negative attitudes and perceptions among doctors andpatients about generic medicines. Lack of knowledge among healthcare professionalsand common masses about generic medicines. Resistance of vested interests to a positive change,corporate lobby playing spoil sport. Virtually non-existent healthcare services in privatesector. Private practice confined to govt. doctors. Large scale corruption in drug regulatory, drugprocurement, hospital supply departments.
Poorly regulated drug markets with unqualified peoplegetting licences and selling drugs to patients. Lack of awareness among patients about their rights. Poor drug testing facilities in public & private sectors. Meager workforce of drug control department. Virtually non-existent drug manufacturing industry. Too many brands, combinations and companies. Unethical drug promotion practices rampant andunchecked due to lack of regulations. Poor enforcement of drug related laws Poor track record of governments in policyimplementation.
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Generic drug prescribing will make more than 10 lakh peopleassociated with pharmaceutical trade jobless. More than 80% of dependence of trade on govt. sector Will disempower qualified physicians from exercising a choice ofbrands and empower unqualified chemists to substitute withgenerics of their choice on profit basis Existing quality and availability of drugs in govt. hospitalspathetic, will only worsen after introduction of generics Spurious drug trade will flourish due to generics Quality and efficacy of generic medicines doubtful Refilling of prescriptions of patients from far flung areas difficult Generics have high profit margins, retailers benefit. Virtually non-existent local drug industry cannot cater to thegeneric drug demands of the state, preference to localmanufacturers will discourage MNCs from filing bids.