CHANGES SUGGESTED BY CSF ACCEPTED FOR INCLUSION IN DRAFT DRUG POLICY OF J&K

           
CHANGES SUGGESTED BY CIVIL SOCIETY FORUM ARE GIVEN IN RED:

            To provide cost-effective and efficient procurement and supply management system for drugs. (ACCEPTED)

Although, there may be about 20,000 medicines/ combinations available in the market, with about 300 drugs recommended by the World Health Organization and 348 drugs in the National List of Essential Medicines, 2011 adopted by the Government of India, it would be possible to tackle almost all disease conditions. (ACCEPTED)

State Drug Committee which would be responsible for initially preparing and subsequently updating every two years the essential drug list for the public sector.  The Committee will comprise Clinicians, Pharmacologists, Microbiologists, qualified Pharmacists and independent experts in the field besides senior functionaries of the Department...(ACCEPTED)

         In some cases the choice may be influenced by other factors such as pharmacokinetic properties or by local considerations such as the availability of facilities for storage. Other local considerations as listed below shall be considered for this purpose:

a.                Effects of local diseases or conditions and food habits on drug effectiveness (e.g., malnutrition, liver diseases etc).

b.                Local differences in sensitivity and resistance of micro-organisms.

c.                 Differences in climate, topography and other environmental factors. (ACCEPTED)

Medicines selected must be available in a form in which adequate quality, including bioavailability and stability can be ensured. (ACCEPTED)

 

    The warehouses/stores shall be managed by appropriate number of skilled and qualified personnel (which will include qualified pharmacists) in line with the principles of good store management.

a.       Drugs shall be stored as per good storage practices and in accordance with FEFO (first-expiring-first-out) and FIFO (first-in-first-out) fashion.

b.       Cold chain storage shall be maintained, wherever required.

c.        Procurement of bulk/loose drugs shall be avoided to prevent contamination and pilferage due to manual handling.

d.       Transport facilities will have to be strengthened for proper and timely distribution to all districts and blocks.

e.        Appropriate disposal of banned, expired and recalled drugs shall be effected in accordance with well-   established norms e.g., WHO guidelines and special care shall be taken for the disposal for antibiotics. (ACCEPTED)

       The said organization needs to be strengthened through a capacity building process by augmenting infrastructure, manpower and financial resources. Adequate communication, transportation, accommodation, and legal assistance facilities shall be provided to the inspectorate staff in all districts. All provision of Drugs and Cosmetics Act relating to AYUSH medicines shall be enforced. Necessary laboratories for testing of Cosmetics shall be established. (ACCEPTED)

      The drug testing laboratories would be accredited with national and, where possible, international accreditation bodies to ensure the reliability of tests as per national/international standards.  Annual testing load and average testing time of the existing drug testing laboratories shall be fixed for greater accountability. (ACCEPTED)

       Private sector laboratories may also be involved to ensure the quality of drugs in the State. However, these would need to be approved, accredited and supervised by the State or central authorities, as the case may be. (ACCEPTED)

     Therefore a statistically designed, scientifically managed, statewide survey shall be conducted collecting samples from every nook and corner of the state and testing them for their quality and authenticity, to measure the extent of spurious drug menace in J&K state. (ACCEPTED)

     Creation of  intelligence cum legal cell to facilitate busting of spurious drug rackets and their prompt prosecution respectively will receive thrust. (ACCEPTED)

     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.  (ACCEPTED)

      Proliferation of drug distribution outlets will not be encouraged.  (ACCEPTED)

      A separate policy for drugs belonging to AYUSH systems of medicine shall be framed. (ACCEPTED)

      In-house Quality Control cells will be established in every major hospital as part of their comprehensive Quality Assurance system. Services of qualified pharmacy graduates in all division, district and sub-district level hospitals shall be made available. (ACCEPTED)

       Clinical Pharmacy and Pharmaceutical Care Services shall be established in all hospitals for maximizing the clinical outcomes of drug therapy and bridge the communication gap between doctors and patients. (ACCEPTED)

      Sale, storage and use of drugs specified under Schedule X of the Drugs and Cosmetics Act, 1940 shall be regulated with a greater vigil by the inspectorate working under Drug and Food Control Organization, J&K. Record-keeping of such drugs shall be made indispensable and the same shall be checked regularly by the inspectorate. Special checking squads under the leadership of deputy drugs controllers will be framed and authorized to undertake periodic necessary inspections in this regard along the length and breadth of the state. License to sell, stock and distribute drugs pertaining to Schedule X shall be restricted to dealers with absolutely spotless track record and should not be issued to those indulging in any sort of unlawful activities. (ACCEPTED)

      J&K Pharmacy Act 2011 (samvat) will be updated and strengthened and the J&K Pharmacy Council shall 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. (ACCEPTED)

       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. (ACCEPTED)

November 2: An important day in the history of Pharmacy profession in J&K

So November 2nd will henceforth be a big day in the history of Pharmacy profession within J&K state for on this day many long-pending demands of pharmacy professionals were accepted and incorporated in the draft drug policy of J&K. It was a marathon, three hour long brainstorming session with senior bureaucrats/officials of health department of J&K and even though many people from other fields were on my side too, but I was the only technical person speaking for the required change, it was so hard to convince them, but we drove the nail in with our perseverance and performance. Meeting was unofficial because there was no scope for an official meeting at this juncture since memo had already been issued for clearance of the previous, half-baked draft drug policy during the recently held cabinet meeting at Srinagar. Hope you've read health minister informing GK that policy will be through in a week's time. It was withheld only on our insistence. Therefore we were told not to make the issue public. I was very eager to share this good news with my students and couldn't hold it back on the eve of Eid. That doesn't mean I broke my commitment because they didn't tell us not to share it even with my students and it struck my mind that I can confine this status update to my students only, and that is exactly what I did. Only my students are able to see this.

After hectic lobbying and advocacy, Govt. of J&K agreed among other things during the meeting to engage pharmacy graduates in all hospitals of the state, start clinical pharmacy services and establish quality control cells in all major hospitals, make serious efforts towards restricting drug sale licences to diploma and degree holders in pharmacy only by framing education regulations, update and ammend J&K Pharmacy Act, fix annual testing load and average testing time of our drug testing laboratories, make necessary accomodation, communication, transportation and other facilities available to drug inspectorate of the state. These things and many others were incorporated in writing into the draft drug policy of the state which is likely to be declared in the next cabinet committee meeting later this month. Many other changes were made which I can't elaborate upon over here. However we are more interested in the points mentioned above because this is what we pharmacists have been dreaming for so many years now. Finally our long-cherished dream seems to be getting realized. Regarding gazetted cadres of DIs, I tried to push it through but due to resistance from some unexpected and unwanted quarters, couldn't materialize this time. Some people simply can't accept positive changes just for the sake of their big egoes, what to do. So after two months of hectic lobbying and advocacy through meetings, seminar etc we finally achieved our goal, during which we undertook a series of meetings with Governor, CM, Health Minister and six other ministers besides senior bureaucrats to get the necessary changes incorporated in the draft. Thanks to other office bearers and members of CSF (Civil Society Forum) without whose relentless efforts nothing would have moved. Now we need to have lot of patience and perseverance to translate the policy into action because you know how long it takes in govt to get things done. Last time in 2003 we framed and moved a proposal for creation of 90 posts of drug inspectors which got materialized only recently in 2009. We (alongwith J&K pharmacy graduates association) had to move the file literally from table to table during the six long years. Let us hope it won't take so long this time. I have sown the seed, now it is for others to nourish it so that it changes into a sapling, than a plant and finally a big tree that can provide shade to so many aspirants of our profession. Let everybody reap the fruits in the end.God Bless.

25 Grave Deficiencies in the Draft Drug Policy of J&K State

1. Draft drug policy does not lay out the standards of quality that the drugs procured by proposed J&K Medical Sales Corporation have to comply with. Standards of quality and purity of drugs have to be in accordance with Indian Pharmacopoeia, 2010 and National Formulary, 2010.
2. Draft policy just mentions that the drugs will be centrally procured by J&K Medical Sales Corporation and does not specify the policy and procedures of the proposed sales corporation required for tendering, supplier selection, pre-qualification, post-qualification, quality assurance, ordering, payments etc. Thus it is a half-baked policy.
3. No Drug Recall Policy has been specified in the draft. Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.
4. Draft policy of the govt. does not put forth any policy parameters required to curb the menace of spurious drugs or on the need for introducing WHO-IMPACT approved anti-counterfeiting technologies in the drug procurement system. There is no mention of constituting legal and intelligence cells for speedy launch of prosecutions and busting of fake drug rackets respectively.
5. There is no roadmap for countering the menace of drug abuse/addiction. This aspect has been blatantly neglected in the draft. Drug licences for selling Schedule X drugs have to be limited only to those retailers with spotless track- record in dealing with such drugs.
6. There is no clarity in the draft as to how drug price control mechanism will function when the available field staff, the drug inspectors are not authorized to take action in cases of overcharging on drugs since as required under law, they are not notified under Essential Commodities Act because of falling under non-gazetted cadre.
7. There is no policy outlined for licensing, monitoring, regulation and control of drugs belonging to AYUSH systems of medicines in absence of which anybody can carry on with illegal business of such drugs with impunity. Provisions relating to such drugs as provided under Chapter-IV A of the Drugs and Cosmetics Act, 1940 need to be enforced and adequate powers need to be delegated to the inspectorate staff.
8. Need for having Drug Inspectors at block level in the state instead of present district level for greater and effective control and vigil has not been emphasized in the draft.
9. Draft talks about Quality Control system but fails to outline the importance of a comprehensive Quality Assurance System that includes perpetual surveillance besides testing and includes not only technical activities but managerial aspects too.
10. Draft mentions about developing human resource in pharmaceutical science but how is that possible in absence of central Pharmacy Act and in absence of any Education Regulations. In absence of pharmacy education regulations anybody can run a pharmacy college without following rules and anybody can enter this profession without earning a legal qualification.
11. Draft drug policy makes no mention of the J&K State Pharmacy Council whose constitution and functioning has been kept restricted and not all-inclusive. There is no representation of academia, hospitals or drug industry in the council. It hasn’t framed its executive committee even after more than a decade of its constitution. Council is responsible for mushroom growth of drug stores along the length and breadth of the state that are sans qualified pharmacists by offering a never ending process of registration.
12. No minimum qualification required for the issuance of drug licences in the state has been specified in the draft policy since at present any Tom, Dick and Hary can get a licence by first registering himself as a pharmacist with the J&K Pharmacy Council.
13. Draft lays down no roadmap for providing medicines free of cost to poor patients living below the poverty line by strengthening and implementing Rashtriya Swastha Bhima Yogna and by constituting State/District Illness Assistance Fund, District Drug Banks and Revolving Funds for BPL families and other central schemes.
14. Annual testing load and average testing time of the drug testing laboratories shall have to be fixed for greater accountability.
15. Draft drug policy while emphasizing upon involving private sector laboratories in ensuring quality of drugs in the state, does not realize the importance of getting such private testing laboratories approved by CDSCO, in absence of which their test reports will not be held valid in the court of law.
16. There is no policy for disposal of expired and unwanted drugs which has of late proved to be a grave environmental concern worldwide owing to their potential to pollute underground water reserves and return back to our bodies.
17. Draft policy does not lay down any policy for establishing in-house Quality Control cells within hospitals and providing clinical pharmacy and pharmaceutical care services to patients within hospitals with a view to maximize clinical outcomes.
18. Draft drug policy does not specify drug budget requirements of the state nor does it fix a minimum per capita per annum expenditure on drugs out of our hospital budgets.
19. Draft drug policy is silent about the provisions of Drugs and Cosmetics Act dealing with regulatory control over sale, storage and distribution of Cosmetics since lack of any regulatory control has led to the flooding of markets with cosmetic products that are either spurious or are not of standard quality.
20. Draft drug policy is also silent about the specific choice of formulations, packaging and labeling requirements to be fulfilled by the suppliers of drugs. While procuring drugs preference must be given to tablets over capsules, reconstitutable powders over injectable solutions and to strip and blister packaging over loose/bulk packaging. Special labeling requests like “only meant for sale by J&K Medical Sales Corporation” have to be accepted by the suppliers.
21. Draft policy does not emphasize upon the need to have a robust system for reporting and recording quality problems at various sites throughout the year.
22. No pre-qualification criteria to be met by the drug suppliers has been outlined in the draft policy that leaves room for wrongful selection of suppliers during tendering process. Other criteria for vendor selection like their ORG rankings, GMP standards, market standing, annual turnover etc have also not been specified in the draft.
23. Draft drug policy does not specify whether drugs will be procured by the J&K Medical Sales Corporation directly from the manufacturers for cost-effectiveness or otherwise.
24. Importance of pre and post-shipment analysis/testing of drug consignments has not been emphasized upon in the draft policy.
25. Draft drug policy of the J&K government is not in consonance with the recommendations of Hathi Committee (1975), National Human Rights Commission (1999), Parliamentary Standing Committee on Petroleum and Chemicals (2001) and Mashelkar Committee (2002).

Generics for greater affordability of medicines

There are two types of drug molecules: innovator molecules and generics. Innovator molecules are the branded products, originally developed by some multinational pharmaceutical company through exorbitant R&D activity. These companies own patents and proprietary rights on such molecules for at least 20 years and therefore sell them on their own brand names. Because of huge expenditure on R&D, hefty marketing expenses and patent royalties, such drugs are costly. On the other hand generics are the pharmaceuticals, on which patents have got expired and nobody holds proprietary rights anymore. Such drugs are sold on their basic chemical names instead of brand names and are much cheaper due to the savings on R&D, royalty and marketing expenditure. These drugs are similar in strength, dosage, appearance, quality and other characteristics to branded drugs but do not bear a brand name. Before allowing them to be marketed, local FDA checks their bioequivalence with branded drugs and then only accords approval to them. Hence there is no cause for worry regarding their quality, safety and efficacy. However since a motley collection of struggling mom-and-pop companies have jumped into the generic trade, it has led to numerous cheap quality me-too products too from every TOM DICK AND HARY. Hence strict regulatory control and in-house quality assurance within hospital is essential to ensure their quality.

It is important to note that at present generic drugs make 75 percent of the prescription medicines sold in the United States and vast majority of these drugs are supplied either by China or India. Currently, Indian pharmaceutical companies produce between 20 and 22 percent of the world’s generic drugs, making it world leader in export of generic drugs but unfortunately its benefits are not proportionately percolating down to poor local masses who cannot afford to pay heavily out-of-pocket for branded drugs, due to several myths attached to their use. Just to cite an example one vial of generic 1gm cefoperazone + 1gm sulbactum costs Rs. 140 as against Pfizer's Rs. 500, BIPL's 458 and CMG Biotech's 456 rupees. The widely held belief that generic medicines are sub-standard is not based on facts because this notion has been nullified by a substantial number of BA/BE (Bioavailability/Bioequivalence) studies on generics. Indian generics marketed in US have also been found to be bioequivalent, having similar quality, safety and efficacy as branded drugs, by the USFDA and then only given marketing approval within US. From 2003 to 2008, in programmes supported by donor organizations like the Global Fund, Indian generic drugs accounted for more than 80% of the drugs used to treat AIDS, including 91% of paediatric antiretroviral products, and 89% of the adult nucleoside and non-nucleoside reverse transcriptase inhibitor markets. India is also the most important source of generic drugs for cancer, heart disease, and other diseases and conditions.

Almost all drugs marketed within India are generics and not innovator molecules because none of the Indian pharmaceutical companies has actually developed them through indigenous costly R&D work. Nearly 97 percent of India’s drug market consists of second-and-third generation (generic) drugs no longer subject to patent protection in the developed world. In 1970, India eliminated patents on drug products. The new intellectual property framework enabled India to develop a strong generic drug industry and positioned India as the “Pharmacy of the developing world”. In 1994 the World Trade Organization negotiated the controversial Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). India was required to extend patent protection to drugs and to implement other new obligations. In 2005 India implemented the changes required by the World Trade Organization. In doing so, India limited patents on new uses or new formulations of drugs unless they differ greatly in properties related to efficacy. Thus when India re-instituted “product” patents, it effectively ended 36 years of protection for Indian companies and terminated legal reverse engineering or copying of patented foreign pharmaceutical drugs. For all these years Indian companies had been using copied or reverse engineered versions of original patented drug molecules of MNCs until Patents Act amendment was brought in force in 2005.

The introduction of product patents in India is actually severely constraining generic competition and supply, particularly for newer medicines. Now, there is a threat that the limited policy space that remains will be further constricted by bilateral or regional free trade agreements. Unfortunately, many free trade agreements that have been concluded or are being negotiated between industrialized and developing countries contain measures that restrict access to medicines. Current free trade agreement negotiations between the European Union and India include measures that delay or restrict competition from generic medicines, including: patent term extensions beyond the 20 years required by TRIPS; data exclusivity (that could delay the registration of generic medicines); and border enforcement measures that could block international trade in generic medicines when they are suspected of infringing patents in the countries through which they transit.

Drugs manufactured in India are classified as Branded-Generics (those generics bearing a brand name) and Generic-generics (those generics sold on their chemical names), both of which are available to the patients at the same cost, but there is huge cost difference in the two for a retailer. Therefore if hospitals purchase generic-generics directly from the manufacturer there will be cost saving for the patient to the extent of 70-80% and drugs will become available to them at as low as 10-20% of the market prices. At present only branded drugs are available in our hospital drug stores. Therefore it is high time to promote use of generics. Drug Policy of every Indian state including that of J&K clearly envisages that all drugs must be identified, listed, prescribed and dispensed only by their generic names.

One important thing to be borne in mind is that just procuring generic or branded drugs from some reputed pharmaceutical companies does not guarantee full quality, safety or efficacy. It is necessary to have stringent regulatory framework besides in-house quality control/assurance system within the hospital that can test the quality of all branded or generic drugs. Further there are some studies that have advised against using generic substitutions in case of drugs having narrow therapeutic/safety index like anti-epileptics, digoxin, warfarin, levothyroxine etc. There are also some studies contesting the therapeutic equivalence of some generics. However quality of all generic drugs cannot be simply rubbished on the basis of false beliefs and perceptions.

Optimizing Clinical Outcomes Through Pharmaceutical Care

Geer Mohammad Ishaq* Ph.D., Mir Javed Iqbal* B.Pharm., Parvaiz A. Koul** M.D.
*Deptt. of Pharmaceutical Sciences, University of Kashmir
**Deptt. of Internal and Pulmonary Medicine, SKIMS, Srinagar

Pharmaceutical Care is a patient-centered, outcome-oriented pharmacy practice that requires the qualified pharmacist to work in concert with the patient and the patient's other healthcare providers to promote health, to prevent disease, and to assess, monitor, initiate, and modify medication use to assure that drug therapy regimens are safe and effective. The goal of Pharmaceutical Care is to optimize the patient's health-related quality of life and achieve positive clinical outcomes. The pharmacist in the contemporary template is one who provides a vital connect between the health sciences and the pharmaceutical world. Their work in the medical field has become multifaceted, extending from the manufacturing of quality medicines, to the delivery of pharmaceutical care to patients. Pharmaceutical care entails the work of addressing a patient's medication related needs. The involvement of the pharmacist in India in this regard has been somewhat restricted, contrary to trends in developed countries. While seeking medical help, people think of a doctor or a nurse or a medical technician, but seldom does a pharmacist come to mind. This needs correction. Nowadays medicine options have multiplied manifold thus raising the complexity of therapies. Pharmacists have a unique role to play in evaluating these options. Within the team of healthcare professionals, trained pharmacists would have the knowledge and skills to prevent, detect, monitor, and resolve medicine related problems. As the public demands more information on medicines and their effects, to make more informed decisions, pharmacists will have to take on a more pro-active role in patient counseling1.
Defining Pharmaceutical Care

Hepler and Strand2 defined Pharmaceutical care in 1990 as the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life. These outcomes include cure of disease; elimination or reduction of a patient's symptomatology; arresting or slowing a disease process; or preventing a disease or symptomatology. Thus Pharmaceutical Care involves four major functions by a pharmacy practitioner on behalf of the patient viz., identifying potential and actual drug-related problems; addressing needs and resolving actual drug related problems; preventing potential drug-related problems and optimizing patient therapy outcomes.

Of late Cipolle and his colleagues3 have redefined Pharmaceutical Care as “a practice in which the pharmacy practitioner takes responsibility for a patient’s drug-related needs and is held accountable for this commitment”. The pharmaceutical care practitioner assures that all of a patient's drug therapy is used appropriately for each medical condition; the most effective drug therapy available is used; the safest drug therapy possible is used, and the patient is able and willing to take the medication as intended. The Pharmacotherapy Workup is the rational thought process that is used by pharmaceutical care practitioners to make drug therapy decisions.

Definition given by Cipolle et al has three components viz. a philosophy of practice; a patient care process, and a practice management system. Most major pharmacy organizations in developed countries e.g., the American Pharmaceutical Association (AphA)4 and the American Society of Health- System Pharmacists5 have since adopted the pharmaceutical care philosophy. ASHP believes that, to ensure proper coordination of patients’ medication therapies, health care systems must be designed to enable, foster, and facilitate communication and collaboration among health care providers.

More recently, in the year 2009, International Pharmaceutical Federation (FIP)6 defined Pharmaceutical Care as, “the responsible provision of pharmacotherapy for the purpose of achieving definite outcomes that improve or maintain a patient’s quality of life. It is a collaborative process that aims to prevent or identify and solve medicinal product and health-related problems. This is a continuous quality improvement process for the use of medicinal products”. Thus Pharmaceutical Care management is a modern approach towards providing seamless and integrated health care through collaboration with pharmacy practitioners.

What is it all about?

Pharmaceutical care is a ground-breaking concept in the practice of pharmacy which emerged in 1990s. It stipulates that all practitioners should assume responsibility for the outcomes of drug therapy in their patients. It encompasses a variety of services and functions – some new to pharmacy, others traditional – which are determined and provided by the pharmacists serving individual patients. The concept of pharmaceutical care also includes emotional commitment to the welfare of patients as individuals who require and deserve pharmacists’ compassion, concern and trust. However, pharmacists often fail to accept responsibility for this extent of care. As a result, they may not adequately document, monitor and review the care given. Accepting such responsibility is essential to the practice of pharmaceutical care7.

Over the past four decades there has been a trend for pharmacy practice to move away from its original focus on medicine supply towards a more inclusive focus on patient care. The role of the pharmacist has evolved from that of a compounder and supplier of pharmaceutical products towards that of a provider of services and information and ultimately that of a provider of patient care. Increasingly, the pharmacist’s task is to ensure that a patient’s drug therapy is appropriately indicated, the most effective available, the safest possible, and convenient for the patient. By taking direct responsibility for individual patient’s medicine-related needs, pharmacists can make a unique contribution to the outcome of drug therapy and to their patients’ quality of life.

The practice of pharmaceutical care is new, in contrast to what pharmacists have been doing for years. Because pharmacists often fail to assume responsibility for this care, they may not adequately document, monitor and review the care given. Accepting such responsibility is essential to the practice of pharmaceutical care. In order to fulfill this obligation, the pharmacist needs to be able to assume many different functions. The concept of the seven-star pharmacist, introduced by WHO and taken up by FIP in 2000 in its policy statement on Good Pharmacy Practice, sees the pharmacist as a caregiver, communicator, decision-maker, teacher, life-long learner, leader and manager8.

What are its objectives?

Main objectives of Pharmaceutical Care revolve around four areas of drug therapy management viz., Indication, Effectiveness, Safety and Compliance to drug therapy and include:

 To evaluate drug related needs of the patients
 To identify actual and potential drug-related problems among the patients.
 To resolve the actual drug-related problems and prevent potential problems from becoming actual problems.
 To work with physicians and patients in designing, implementing and monitoring
an appropriate care plan.
 To make suggestions for any interventions about drug use, whenever required.
 To offer education and counseling services to patients with a view to
optimize therapeutic outcome.

Global Scenario

Pharmaceutical care started in the nineties in the United States and has rapidly extended in many other countries. The present meaning of pharmaceutical care evolved from a term, defined in 1975 by Mikeal et al10 as a subset of medical care, using an analogous definitional format as medical care. It was Brodie11, who developed this concept by including in it the drug needs for a given patient and the provision, not only of the required drugs but also of the services needed for safe and effective therapy, in an environment of changing societal purpose of pharmacy12 and in 1990, Hepler and Strand2 defined pharmaceutical care as “the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life”

Pharmaceutical care is a generalist practice which has evolved from many years of research that can be applied in all settings: community, hospital, long-term care, and the clinic. It can be used to care for all types of patients with all types of diseases taking any type of drug therapy. Pharmaceutical Care practitioner is not intended to replace the physician, the dispensing pharmacist, nurse or any other health care practitioner. Rather, the pharmacy practitioner is a new patient care provider within the health care system2.

The principal elements of pharmaceutical care are9 that it is medication related; it is care that is directly provided to the patient; it is provided to produce definite outcomes; these outcomes are intended to improve the patient’s quality of life; and the provider accepts personal responsibility for the outcomes.

The Pharmaceutical care is a much needed service as it has direct impact on quality of healthcare and supports audit of outcome of the treatments. One huge study in America involving approximately 1000 hospitals showed that as the number of clinical pharmacists per occupied bed increased mortality, drug costs, total costs of care and length of stay were reduced13. The adoption of Pharmaceutical Care Practice in clinical and community setting is the need of the hour. There is a tremendous scope for the upcoming pharmacists to practice the profession which not only ensures efficacy but also safety of therapy. The benefits of pharmaceutical care have been illustrated in a number of studies worldwide.

Indian Scenario

India is a country with significant problems in medication use, but until recently Indian pharmacists have not been properly educated for a patient-care role14. Clinical Pharmacy on the whole has so far remained neglected within India and there has been resistance on part of the medical professionals to accept the fact that pharmacists too have a clinical role. There has also been reluctance on part of pharmacists themselves towards assuming such clinical role and responsibilities. However this dismal scenario has started undergoing promising changes in the recent past. Many hospitals across India have of late initiated clinical pharmacy and pharmaceutical care services and this step has already started showing positive results. In a six-month long, prospective, open-label study conducted at three primary health centers of a southern Indian district of Tamil Nadu to evaluate the impact of pharmaceutical care on the clinical outcomes of patients enrolled in a pharmacist-coordinated diabetes management program, effective improvement was seen in the clinical outcome and health-related quality of life of diabetes patients in rural India15. Association of Community Pharmacists of India also took an initiative to establish Pharmaceutical Care Clinic at Chinchwad, Pune, first of its kind in India in the year 200916. In another study that was conducted on 115 patients admitted in General Medicine ward of a 1700 bedded tertiary care teaching hospital in South India, to identify and resolve drug-therapy related problems through pharmaceutical care, it was demonstrated that a pharmacist can identify drug related problems and other pharmaceutical care related issues and resolve them by his timely interventions, thereby playing a pivotal role in promoting patient care17.

Status in J&K

Clinical Pharmacy on the whole is in its infancy in the state of Jammu and Kashmir and the concept of Pharmaceutical Care is completely new to most of the physicians, nurses and even pharmacists presently working at the government health facilities. As a result of the patient overload of physicians and some other reasons, they are not in a position to offer detailed counseling, patient education and pharmaceutical care services on individual basis to all their patients. Therefore it is for the trained pharmacy practitioners to step in and fill the void by offering such services with a view to achieve definite therapeutic outcomes that improve a patient’s quality of life. Overall goal is to optimize the therapeutic outcome management and decrease the burden of five D’s viz, death, disease, disability, discomfort and dissatisfaction among patients. Clinical, economic and humanistic outcomes will also shift towards the positive side as a result of these integrated and seamless healthcare services rendered by a pharmacy practitioner.

Therefore need of the hour is to design, implement and monitor models aimed at providing Pharmaceutical Care services to our patients at primary, secondary and tertiary care level so that there is a transition in the focus of the qualified and pharmacists from bench side to bed side and from product to patient for the greater benefit of the patients at large. Pharmaceutical Care being a patient-oriented service will pave way for pharmacist involvement in providing patient education and counseling services, monitoring drug therapy and suggesting interventions wherever required, reporting ADRs and drug interactions, supplying drug information to physicians and nurses, conducting drug-utilization evaluation studies, preparing monographs and hospital formularies and in providing poison control services. Ultimate aim of all these services is only one and that is to optimize the clinical outcomes and thereby improve patient’s health-related quality of life.

REFERENCES:

1. Excerpts from the speech delivered by her Excellency the president of India, Shrimati Pratibha Devi singh Patil at the inauguration of the National Seminar on Recent Trends in Pharmacy Education and Practice, held at New Delhi on 9th of July 2010. (Accessed at http://presidentofindia.nic.in/sp090710.html, retrieved on 28.05.2011)
2. Hepler C,Strand L. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm 1990;47:533-43.
3. Cipolle RJ,Strand LM,Morley PC.Pharmaceutical Care Practice.McGraw-Hill,New York. 1998.
4. American Pharmaceutical Association.An AphA White Paper on the Role of the Pharmacist in Comprehensive Medication Use Management: The Delivery of Pharmaceutical Care. American Pharmaceutical Association, Washington, DC, 1992.
5. American Society of Hospital Pharmacists. ASHP statement on phamaceutical care. Am J Hosp Pharm 1993;50:1720-23.
6.International Pharmaceutical Federation FIP Statement of professional standards- pharmaceutical care http://www.fip.org (retrieved September 1,2009).
7.Developing Pharmacy Practice-A focus on patient care. FIP Handbook 2006 Edition WHO/PSM/PAR/2006.5
8.The role of the pharmacist in the health care system.Preparing the future pharmacist: Curricular development.Report of a third WHO Consultative Group on the role of the pharmacist,Vancouver,Canada, 27–29 August 1997. Geneva: World Health Organization; 1997.WHO/PHARM/97/599.Availableat:http://www.who.int/medicinedocs/
9.Medication therapy and patient care: organization and delivery of services-guidelines. ASHP guidelines on a standardized method for Pharmaceutical Care,Pharmacist-conducted patient education and counseling and documenting pharmaceutical care in patient medical records. (Retrieved from http://www.ashp.org/Import/PRACTICEANDPOLICY/PolicyPositionsGuidelinesBestPractices/BrowsebyTopic/MedicationTherapyandPatientCare.aspx Accessed on 28.05.2011)
10.Mikeal RL,Brown TR,Lazarus HL,Vinson C.Quality of Pharmaceutical care in hospitals. Am J Hosp Pharm 1975;32:567-74
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Deficiencies in the Draft Drug Policy of J&K government

Government of Jammu and Kashmir is currently in the process of framing a Drug Policy for this state. An exercise that was started a couple of years back by the Ministry of Health and Family Welfare is about to reach its logical conclusion. In this connection a draft of the proposed drug policy was published by the ministry in local newspapers and also uploaded on its official website. Per se the draft looks quite comprehensive but there are several important areas that have been left unattended. Keeping in view the impact of those missing vital policy inputs
\, it is necessary that these deficiencies are adequately addressed in right earnest before a final shape is given to the proposed policy so that the health and welfare of common masses does not get jeopardized in any manner whatsoever.

Need for intelligence and legal cells

At present inspectorate staff working under Drug and Food Control Organization (DFCO) is not only levied with the task of conducting inspections, lifting samples of drugs for analysis, recommending cases for grant or renewal of various licenses but also have to investigate rackets of spurious and sub-standard drugs operational in their jurisdiction areas, launch prosecutions in the courts of law against breach of any provisions of the Drugs and Cosmetics Act, 1940 and even plead their cases themselves in absence of any adequate legal assistance. Consequently they have to spend most of their time in court hearings thus adversely affecting their devotion towards main duties assigned to them. As such need of the hour is to establish intelligence cells in every district of the state to assist the inspectorate in investigating and busting any rackets of spurious/sub-standard drug trade flourishing in their jurisdiction areas with provision of lucrative incentives for informers. Similarly establishment of legal cells will allow the inspectorate to devote maximum time to their main duties of enforcing provisions of the Drugs and Cosmetics Act, 1940 effectively. Additionally court cases will be better pleaded by legal experts and the conviction rate will rise steeply which is otherwise at its lowest ebb at present due to lack of suitable expertise in courts. As such this provision needs to be included in the proposed Drug Policy of the J&K state.

Delegation of powers under Essential Commodities Act

In order for the drug inspectorate staff to be able to book the culprits found overcharging patients on sale of medicines, they need to be notified under Essential Commodities Act, without which they cannot enforce the provisions of Drug Prices Control Order, 1995. However it is mandatory to accord them gazetted status in order to make them eligible to be notified as authorized officers under Essential Commodities Act. At present any prosecution in respect of overcharging on drugs has to be instituted by an officer of the rank of an Assistant Controller or Deputy Controller of DFCO, J&K which delays the matters inordinately since Drug Inspectors are not in a position to take necessary action as warranted under rules against any breach of the Drug Price Control Order. Therefore the upcoming drug policy should ensure that the required cadre is accorded to the inspectorate staff so that they are notified under EC Act and are suitably empowered to enforce the provisions of DPCO, 1995 failing which some unscrupulous chemists will continue to charge the patients as per their own whims and fancies thus putting an additional burden on the already straining pockets of poor patients.

Implementation of provisions relating to AYUSH drugs

Over the past few years, use of drugs belonging to indigenous systems of medicine like Ayurveda, Unani, Siddha and Homeopathy (AYUSH) has gained wide popularity among masses and a large chunk of population is resorting to these forms of treatment for seeking a cure to their ailments. J&K State too has witnessed a massive growth of sale outlets dealing with drugs belonging to one or more of these systems of medicine. However surprisingly there are absolutely no legal or statutory frameworks and mechanisms in place to control, govern, monitor and regulate the sale, storage or distribution of such drugs including licensing of such drug sale outlets. Even the necessary powers to enforce these provisions have not been delegated to the inspectorate staff available at present with the DFCO of J&K. At present DFCO issues a few limited licenses only in respect of Unani drugs and there are no provisions for other systems of medicine.

As a result mushroom growth of unlicensed Ayurvedic drug sale outlets has become a big nuisance along the length and breadth of the state. Anybody feels free to open an Ayurvedic or Homeopathic drug store in any part of the state and sell, store or distribute such drugs without any license, regular monitoring and supervision from Drug Control authorities. Therefore it should be a priority of the state govt. to immediately enforce provisions relating to the manufacture, sale, storage and distribution of such drugs as provided under chapter IV-A of the Drugs and Cosmetics Act of 1940 and thereby bring drug sale, storage and distribution of alternative systems of medicine also under the ambit of Drug and Food Control Organization. Adequate powers should be vested upon the existing staff in this regard until further augmentation is made possible. Draft Drug Policy is surprisingly silent about this issue and lays no stress on enforcement of these provisions and delegation of necessary powers to the available staff. Therefore this aspect needs to be revisited in the draft drug policy of the J&K govt., otherwise the sorry state of affairs will continue even after a new drug policy is promulgated in the state.

Implementation of provisions relating to Cosmetics

Similarly provisions of Drugs and Cosmetics Act, 1940 dealing with manufacture, sale, storage and distribution of cosmetics also need to be enforced to the possible extent in due course of time, since at present there is no regulatory framework or apparatus in place that could govern these aspects of trade in Cosmetics which is a flourishing industry and lack of any regulatory control has led to flooding of markets with spurious and sub-standard cosmetics.

Strengthening of infrastructure for enforcement of NDPS, 1985

Reports of widespread drug addiction and abuse of prohibited medicines have been pouring in from various parts of the state over the last few years. A tough and stringent piece of legislation namely Narcotic Drugs and Psychotropic Substances (NDPS) Act has been enacted in 1985 to help curb the scourge of drug abuse. Act is a central Act and extends to the state of Jammu and Kashmir too. Most significant feature of the Act is the exemplary punishment provided for most of the offences. The Act is however chiefly enforced by the Narcotics Control Bureau (NCB) whose workforce is very meager and needs expansion. Though this Bureau has a nodal centre at Jammu, there is none in the valley making its activities imperceptible. More people possessing degrees in Pharmaceutical Sciences need to be appointed as enforcement officers under the Act for an efficient and foolproof administration of its provisions. Further a multi-disciplinary level Coordination Committee under the Chairmanship of Chief Secretary or a senior Secretary has to be established for regular interaction with various Central and State agencies, to receive support and grant-in-aid assistance from the Narcotics Control Bureau of India. Additionally our state also has to set up an Anti Narcotics Task Force under an IG level officer with duties and responsibilities duly demarcated. In absence of such a committee and task force, this state will not be eligible to receive financial assistance and other support from NCBI. Thus this aspect too needs to be attended to in the Draft Drug Policy of the state.

Quality Control of drugs and Pharmacy Services in hospitals

Though draft drug policy envisages to upgrade and modernize the govt. drug testing laboratories of the state and involve private sector laboratories too, it ignores the importance of establishing in-house quality control cells within hospitals for testing the hospital drug supplies on regular basis by a qualified pharmacist. Similarly no thrust is given to other clinical pharmacy services that could be rendered by qualified and trained pharmacists in the hospitals to further the cause of better pharmaceutical care of the patients. Medical Council of India has put forth certain guidelines with regards minimum requirement of qualified pharmacists in hospitals that have been ignored altogether in the draft policy and need to be implemented. National Human Rights Commission in its report on hospital pharmacy services submitted in January, 1999 has also recommended that, “every hospital should organize the pharmaceutical activities in regard to purchase, storage, testing, compounding, dispensing and distribution of drugs under the charge of a competent and experienced persons possessing at least degree in pharmacy”. In accordance with these guidelines and the recommendations made vide Hathi Committee Report (1975), it is imperative that the requirements as per MCI guidelines be fulfilled and necessary mechanism devised in the draft drug policy.

Further services of at least one pharmacy graduate should be made available at every primary health centre, sub-district and district hospital of the state. Draft drug policy of the state must make it mandatory to engage qualified pharmacy personnel at all primary, secondary and tertiary care hospitals of the state. It is only professionally trained and legally qualified pharmacy personnel who could assist the doctors in counselling and disseminating information to patients on matters like indications of the drug, its contra-indications, adverse effects, precautions, dosage etc and could also play their legitimate and pivotal role in procurement, testing, storage and dispensing of standard quality drugs in every hospital and primary health centre.

Enforcement of central Pharmacy Act, 1940

Draft drug policy of the J&K state makes no mention of enforcement of central Pharmacy Act in the state. Just the way central Drugs and Cosmetics Act, 1940 has been enforced in the state, central Pharmacy Act of 1948 too needs to be promulgated in place of J&K Pharmacy Act 2011 (samvat). Draft drug policy of the J&K govt. is silent about this issue too. This will bring all pharmacy academic institutions of the state under the purview of the Pharmacy Council of India, help our pharmacists get registered in the Central Register and practice pharmacy profession anywhere in India. Besides it will also enable our pharmacy institutions seek financial assistance from central councils, organize and participate in their continuing education programmes, seminars etc and achieve national and international level standards in our pharmacy and health education. At present no educational institution imparting degree or diploma course in Pharmacy within the state of J&K falls under the purview and influence of the Pharmacy Council of India due to this lacuna that has been brazenly ignored in the draft policy.

Constitution and functioning of the J&K Pharmacy Council

Draft drug policy of the J&K state makes no mention of enforcement of Education Regulations or framing Executive Committee in the state. The Jammu and Kashmir Pharmacy Council has been constituted a few years ago. So far, Council has prepared the first and subsequent registers of those pharmacists who have been carrying on the business or profession of pharmacy in J&K. As a next step, it has to frame an Executive Committee and regulate pharmacy education in the state by way of enforcement of Education Regulations as provided under section 10 of the J&K Pharmacy Act 2011 (samvat). Thereunder it can prescribe the minimum standards of education required for qualification as a pharmacist and can also prescribe the nature and period of study and of practical training to be undertaken before admission to the qualifying examination for a degree or diploma in pharmacy. In absence of Education Regulations there is no binding at present on pharmacy educational institutions to observe and follow any set standards.

Once Education Regulations come into force, no person other than a diploma or a degree holder in pharmacy should be designated or registered as a pharmacist and a target date should be fixed beyond which drug trade should be strictly restricted to diploma or degree holders in pharmacy only. In order to cater to the requirement of qualified pharmacy personnel for such endeavor, diploma course in pharmacy may be commenced at govt. polytechnics in Jammu and Srinagar after appointing teaching staff and making other necessary facilities available for the purpose.

Furthermore wider participation of the pharmacy professionals drawn from various sections like academia, clinical set up, regulatory affairs, industry as well as sales and marketing in the affairs of the J&K Pharmacy Council shall pave way for its better functioning, improved outcome and greater acceptance of its policies. Its working should not be confined to any one department of the state administration. Since its decisions affect the entire profession, it calls for a broader representation to all concerned as is true with state pharmacy councils of all other states.

Other issues not addressed by the draft drug policy:

Draft drug policy published by the J&K government is also silent about many other issues like the modalities of training of Human Resource in Pharmaceutical field in absence of Education Regulations and central Pharmacy Act; necessity of the involvement of qualified Pharmacists in Pharmacovigilance and other activities related to quality control and rational use of medicines. Draft does not lay out the modalities for establishment of Drug Information Centres and the qualifications of personnel to be engaged for this purpose since it is very important as to who will provide drug information to the medical and non-medical staff and how. It has not been specified as to where Pharmacovigilance centres will be established because there is need to establish such centres in every large hospital of the state. Therefore it will be in the larger interests of patients of this state if these issues are adequately and appropriately addressed in the proposed drug policy of the state govt.

Magnitude of Spurious Drug Trade in India

There are several conflicting yet alarming reports about the extent of spurious medicines in Indian markets ranging from as low as 0.25%, as per govt. claims to a whopping 35% as claimed by several independent groups like ASSOCHAM, CII, OECD, EC etc. As per WHO reports spurious drugs now represent 10-12% of $735 billion global market of medicines. Sales of counterfeit drugs worldwide are estimated at $32 billion, causing $46 billion annual loss to the global pharmaceutical industry, recent reports have said. The New York based Centre for Medicines in the Public Interest has predicted that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005. Thus the problem of spurious drugs is reported to be a global phenomenon and India is no exception. India’s pharmaceutical companies have suggested that in Indian major cities, one in five medicines sold is a fake. They have claimed a loss in revenue of between 4% and 5% annually. The industry also estimated that illegal drugs had grown from 10% to 20% of the total market.

According to industry claims, 30 per cent of the Rs 22,000 crore pharma market in India is constituted by spurious products, which translates to an over Rs six-crore trade. About 40% of drug products tested for quality in Nigeria and found to be outside the British Pharmacopoeia limits for drug assay were actually manufactured in India. ASSOCHAM estimates that the lethal market is growing at 25% annually. In fact, the Organization for Economic Cooperation and Development's latest figures say 75% of fake drugs supplied the world over have their origins in India. A recent report by the European Commission said that India is the biggest source of counterfeit drugs in the world, followed by the United Arab Emirates, China and Switzerland. Together, these countries are responsible for more than 80% of all counterfeit medicines, the report said. The GOI, health ministry’s estimates are more conservative though: It says 5% of drugs in India are counterfeit while 0.3% are spurious. Based on the samples tested by the State drug testing authorities in India, for the period 1995-2003. the extent of sub-standard drugs varied from 8.19 to 10.64% and of spurious drugs varied between 0.24 % to 0.47%.

Even as the Health Ministry in India had not yet flagged off its ambitious study to ascertain the extent of spurious drugs in India, details of a recent WHO-sponsored study showed that only 0.3 per cent of samples were found spurious in lab tests, though over 3.1 per cent were found to be counterfeits during visual inspections. The study, held by SEARPharm Forum (South East Asian FIP-WHO Forum of Pharmaceutical Association) in collaboration with Delhi Pharmaceutical Trust, reported that the anti-infective category and those drugs priced below Rs 20 were most prone to counterfeiting. During visual inspection, the extent of counterfeit suspects was to the tune of 3.1 per cent. This was assumed due to striking registration differences in the packing. Based on the domestic sales of Rs. 31,500 crore (7 billion USD) in 2006, the extent of suspected counterfeit medicines would be extrapolated to approximately to Rs. 1000 crore (USD 250 million). These figures are considerably lower than Rs. 4000 crore (USD 1000 million) in earlier reports.

The data showed the Bihar has the highest probability of spurious suspects, with 5.65per cent of samples turning spurious. On a region basis, Central region had more counterfeit suspects. The extent of prevalence was 4.21 per cent while the West had 4per cent, East 3.2 per cent, North 3 per cent and South with 2.8 per cent. Sale of fake and spurious drugs in the NCR region to the extent of Rs.300 crore annually continues to be unabated as, according to the latest ASSOCHAM survey, it has gone upto 20-25% of the total medicines sold in the region. The concentration of fake drugs manufacturers can largely be found out in locations such as Bahadurgarh, Ghaziabad, Aligarh, Bhiwadi, Ballabhgarh, Sonepat, Hisar and Punjab. The analysis of suspected samples showed that even from the states perceived to be strongly regulated, the percentage of counterfeit suspects is almost same as weakly regulated. Confederation of Indian Industries (CII) has concluded that spurious drugs cause a revenue loss of over Rs. 4000 crore to the Indian Pharmaceutical Industry. They have further asserted that in 2001, out of a total production of Rs. 22, 887 crores, 18 % was spurious amounting to Rs. 4112 crores. They have revealed that a majority of medicines supplied under government orders fail necessary quality control tests.

Ex-Union minister for health and family welfare Anbumani Ramadoss is reported to have said in the Lok Sabha that the government of India has never conducted any study to find out the actual extent of spurious medicines in Indian markets. However, two pilot exercises have evaluated the extent of counterfeit drugs in India, one by the office of deputy drugs controller (DDC), Western Zone, and the other by an independent forum known as SEARPharm. A total of 3,246 samples were drawn in the combined exercise. The results of the samples tested revealed only five drugs as counterfeit and two samples not complying to the standards,Ramadoss said. The drive undertaken in two months by the western zone office of the Central Drug Standard Control Organisation (CDSCO) which tested 800 samples from various parts of the region, could find only one counterfeit drug, while it detected no spurious ones. This has been claimed by ex-Deputy Drugs Controller of India (West Zone) Dr. Venkateswarlu, who later on assumed charge as the Drugs Controller General of India. Samples in this study were collected from rural areas in Madhya Pradesh and Orissa. According to the Maharashtra Food and Drug Administration, spurious drug trade is only one per cent of the total marketed formulations in the state.

To ascertain the extent of counterfeit drugs produced in India, the government of India launched a pan-India survey a couple of years back. The move was expected to help the health ministry to collect an authentic data on the problem of fake medicines before taking action against the culprits. The ministry had initially aimed at collecting 3-4 lakh samples during the survey in which the volunteers were expected to pick drug samples from the medical stores even in remote places. However only 24780 samples were collected from across India during November-December, 2008. The drug samples were then sent to drug makers (who have procured the license to produce the packs) for verification, while the doubtful packs were sent for further investigation. In 2009, Union Ministry of Health and Family Welfare made the report of this survey public through Central Drug Standards Control Organization (CDSCO). Survey report revealed that the extent of spurious drugs in retail pharmacy is much below the projections made by various media, WHO, SEARO, and other studies i.e. only 0.046 %. Only 11 samples out of a total of 24,136 samples collected were found to be spurious and the extent of substandard drugs among the branded items is only 0.1 %. Out of a total of 2976 unsuspected samples, only 03 samples did not conform to claim with respect to Assay on chemical analysis.

In this survey a total of 24,780 samples were collected by visiting around 40,000 pharmacy outlets. Samples of popular brands of oral solid dosage (OSD) formulations, belonging to 9 therapeutic categories of anti-infective, anti-malarial, anti-T.B.Drugs, steroids, antihistaminic, cardiovascular drugs, anti-diabetics, NSAIDs, and multivitamin preparations, were collected between November & December 2008 from all across the country. It is not clear from the survey report published by the Central Drug Standards Control Organization (CDSCO) in 2009 as to how many samples were collected from the state of Jammu and Kashmir and which all districts of the state were included in the survey, though it is mentioned that a total of 5665 samples were collected from the entire North Zone including the state of J&K.

With most of the fake drug manufacturing units being based in neighbouring Punjab, Haryana and U.P, Jammu and Kashmir for its proximity to these states has been receiving a fair share of the drugs and medicines manufactured there. In the absence of any robust studies for estimating the magnitude of spurious drug trade on scientific lines in the state it is difficult to hazard a guess on the exact percentage of counterfeit medicines in the state and on the exact impact of such drugs on the health of people at large. There is need to conduct a comprehensive statewide survey on spurious drug trade wherein large number of samples need to be picked from every nook and corner of the state to arrive at a firm conclusion about the extent of the problem prevalent in our state. Further remedial measures suggested by the World Health Organization, IMPACT group, USFDA and Mashelkar Committee like Rapid Alert System (RAS) and Radiofrequency Identification Technique (RFID) need to be implemented in toto to put an early end to the problem.

At present drug inspectorate staff of this state have to spend most of their time in courts pleading for various prosecutions launched by them and are left with very little time to conduct probe against spurious drug rackets operating in their jurisdiction areas. There is urgent need to create separate intelligence and legal cells in the state as well as central offices with adequate provisions of secret funds and incentives for informers. In addition special courts need to be designated to exclusively try the cases of spurious drugs. Severe and deterrent punishments as afforded under law should be imposed on persons dealing with spurious drugs. Exemplary penalties need to be awarded to those found guilty of perpetrating such a heinous crime against humanity.