Medicines play a crucial role in saving lives, restoring health, and preventing diseases and epidemics, but they need to be safe, efficacious, of good quality, and above all need to be used rationally. When medicines we consume turn out to be spurious, results are counter-productive, they only end up doing harm instead of doing some good to the patient and this goes against the basic ethos of medical practice i.e., “primum non nocere” meaning first of all do no harm. Every day people suffer and sometimes even die because of spurious and substandard drugs. But how many? We will never know because a patient is always presumed to have died from a disease, rather than the drugs.
Genesis of the Debate:
Issue of spurious drugs in J&K has been hogging the limelight in almost all the local newspapers and tabloids right from the day when on November 12th, 2011 Dr Naresh Trehan, a renowned cardiothoracic surgeon descended like a messiah and made a sudden prophetic revelation that “Many deaths in J&K are caused by fake, substandard or expired drugs resold in new packages, and it is known to druggists and medicos that many pharma agencies have been doing so with impunity.” Another cardiologist, Dr Surinder Bazaz added fuel to the fire by stating, “I have been practicing in Kashmir since 1997, and have come across drugs which you can find nowhere else in the country. It seems as if this state has turned into a safe bastion for the trade in spurious and substandard drugs, perhaps, the highest number of fake drugs worldwide, is sold here” 1. Later on, apparently under pressure from some obvious quarters, Dr. Trehan backtracked from his statement and said that he had been misquoted by the press2. However his statement had already caused sufficient ripples in the stagnant waters and was enough to trigger panic waves across J&K and spark a continuing debate on the magnitude and nature of this unscrupulous trade in the state. Ensuing debate was also marked by several unsubstantiated claims and sweeping statements by government officials as well as people from pharmaceutical trade, media and civil society. Amidst all the melodrama, moot question remains as to what is the factual position about the extent and nature of spurious drug trade in J&K and why we only talk of spurious drugs and conveniently brush the larger issue of substandard medicines aside? There is dire need to present an unbiased, factual and dispassionate picture of the whole issue that is of paramount importance given its serious ramifications on the health and well-being of common masses.
Definition of a ‘Spurious Drug’
The term ‘Spurious Drug’ has been defined under Section 17-B of the Drugs and Cosmetics Act, 1940, as amended by the Drugs and Cosmetics (Amendment) Act, 1982. A drug is deemed to be spurious if it is manufactured under a name which belongs to another drug, if it is an imitation of another drug or if it has been substituted wholly or partly by another drug or if it wrongly claims to be the product of another manufacturer. While the above-mentioned Act gives proper definitions for adulterated and misbranded drugs, it does not provide any definitions for counterfeit, fake or duplicate drugs, terms that are frequently used in local parlance. A drug is considered to be “Not of standard Quality” or in simple words, “substandard” if it fails to comply with any of the parameters of the overall standards laid down for it either in a recognized Pharmacopoeia or otherwise pre-declared by the manufacturer. According to WHO3, a counterfeit medicine is one which, is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredient or with fake packaging. Counterfeits are also referred to as SALA (sound-alike-look-alike) drugs. In all cases, contents of counterfeits are unreliable because their source is unknown or vague and always illegal. Such drugs can cause harm to patients and sometimes even lead to his death.
Global and National Scenario
The United States Food and Drug Administration estimates that counterfeits make up more than 10% of the global medicines market and are present in both industrialized and developing countries. It is estimated that up to 25% of the medicines consumed in poor countries are counterfeit or substandard. These figures place the annual earnings from the sales of counterfeit and substandard medicines at over US$ 32 billion globally4. Thus the problem of spurious drugs is reported to be a global phenomenon and India is no exception to this nefarious trade. At national level, 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 as whopping as 35% as per industry claims and the claims made by some independent groups like ASSOCHAM, CII, OECD, EC etc. Within J&K too, on one hand we have hair-raising claims made by common masses and people like Dr Naresh Trehan who believe that vast majority of drugs available in our local markets are spurious and on the other hand we have drug regulatory authorities and the concerned ministry living in a mode of complete denial by saying that spurious drugs do not exist in our markets at all. So these are the two extreme pictures of the problem. Question is whose statement is to be believed by an average consumer and whose claims are based on facts or substantiated by some logical evidence. When we probe and dig a little deeper into the whole matter, we get to know that both sets of claims are themselves spurious and the truth lies somewhere in the middle. So let us dwell into some facts for a better perspective.
It is surprising to know that India’s pharmaceutical companies have themselves suggested that in India’s major cities, one in five medicines sold is a fake. They have claimed that 30 per cent of the Rs 22,000 crore pharma market in India in 2001 was constituted by spurious products. Confederation of Indian Industries (CII) has earlier in its report concluded 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. 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% annually5. Similarly, the Organization for Economic Cooperation and Development's figures say that 75% of fake drugs supplied world over have their origins in India. Another report by the European Commission also 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.
On the contrary GOI, health ministry’s estimates are more conservative: it says 5% of drugs in India are counterfeit while only 0.3% are spurious. Based on the samples tested by the State drug testing authorities in India, for the period 1995-2008, the extent of sub-standard drugs varied from 8.19 to 10.64% and of spurious drugs varied between 0.24 % to 0.47%. Details of a 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 Trust6, 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 approximately to Rs. 1000 crore (USD 250 million). These figures are considerably lower than Rs. 4000 crore (USD 1000 million) found in CII report.
Scenario within J&K state:
Last year drug control officials of J&K in a review meeting with Divisional Commissioner Kashmir revealed that medicines worth Rs. 600 crore are being consumed annually in J&K of which Rs. 400 crore are consumed in the Kashmir valley alone. A total of 4912 licensed retailers, 4573 wholesalers operate in Kashmir division and a total of 4539 licensed retailers and 1500 wholesalers operate in Jammu division. Thus we have a total of 9451 licensed retailers and 6073 licensed wholesalers operating in the entire state of J&K7. Out of a total of 614 drugs tested by the Govt. Drug Testing Laboratory of Srinagar, 25 (4.07%) were declared as sub-standard during 2010 whereas 33 and 37 drugs were declared sub-standard in 2008 and 2009 respectively, none was found to be spurious during this entire period of three years. Officials of the Drug Control Department claim that during 2010, they conducted a total of 8185 inspections during which 645 samples were lifted from the government and private drug sale outlets and only six were found to be ‘not of standard quality’8. They further claim that since April, 2011 they have conducted 8549 inspections in Kashmir Valley during which they didn’t find any chemist selling spurious drugs. Further they collected 545 drug samples for testing and didn’t find any spurious drug after analysis by the Govt. Analyst, even though 31 drugs out of these 545 samples were declared to be “not of standard quality”. These claims were made by the Deputy Drugs Controller, Kashmir Division while speaking to the Daily Greater Kashmir9, wherein he defined spurious medicine as a drug in which active ingredient is zero percent, and went on record saying that any such drug was not found anywhere in the Valley.
Interestingly while his deputy was vehemently denying the availability of any spurious drugs anywhere in the drug markets of Kashmir, Drug Controller of the J&K state while confirming the use of spurious and sub-standard drugs in the whole of Jammu and Kashmir, particularly in the valley, on a large scale squarely blamed the doctors for promoting the nefarious trade and expressed his helplessness to take any action against them. Drug Controller confirmed to KNS that doctors were playing a key role in the clandestine operations of unrecognized and unlicensed pharmaceutical companies. “However, we don’t have the powers to tighten the noose around such elements,” he said, adding that the doctors involved in it were driven by an uncontrollable lust for money for which they were playing with people’s lives10.
Claims and Counterclaims:
Amidst all these claims and counterclaims, it becomes difficult to ascertain actual size of the problem in question. Small companies claim their standards are as high as those of big companies; big companies, meanwhile, accuse the small ones of all kinds of nefarious behaviour – yet still do not hesitate to get the same companies to produce medicines for them if there is a financial benefit in doing so. Regulatory bodies apprehend that the industry agenda seems to be to separate the respectable, safe, large producers from the myriad small- and medium-scale enterprise that comprise more than 85% of the entire Pharmaceutical Sector in India, and thus to establish trust in the big Indian companies and enhance their export potential. They suspect that CII representatives wave the flag of ‘danger to patients’, but actually they seem to be more concerned about danger to their own profits. Since everyone blames everyone else, listening to all sides of the argument does not necessarily get one closer to the truth of the matter. Given the lack of reliable evidence in this area, it is not surprising that unsubstantiated claims and rumours drive out harder sources of information.
Confusion and chaos regarding the extent of spurious drugs in Indian markets is compounded by the fact there are not much credible and comprehensive nationwide or even regional studies available to arrive at any firm conclusion. 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. 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. 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.
Countrywide Survey on Spurious Drugs:
Under pressure from various national and international quarters, government of India launched a pan-India survey a couple of years back. The move was expected to help the health ministry to collect some authentic data on the problem of fake medicines. 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/authentication, 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 report11 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 [Bihar(5), West Bengal(3) U.P(2) & Gujarat (1)] and the extent of substandard drugs among the branded items was found to be only 0.1 %. In this survey 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 covered under this survey, though it is mentioned that a total of 5665 samples were collected from the entire North Zone including the state of J&K. Further it has been mentioned in the final report that a Jammu-based NGO named Swasthya Sansar under the headship of Sh. Nigham Gupta assisted in collection of samples from the J&K state. Interestingly Sh. Nigham Gupta himself runs a pharmaceutical and medical device distribution agency under the corporate name of J. K. Healthcare Services Group, J&K (Further details at www.jkhealthcareservices.com). That makes the veracity and reliability of sampling procedure adopted at least in J&K under this survey doubtful. Little is known about other NGOs that helped in sampling from other states. As such there is need to conduct an independent statewide survey on scientific lines to measure the magnitude of spurious drug trade in the state, lifting samples from every nook and corner of the state in a statistically designed unbiased manner.
Etiology of the Problem:
One thing universally accepted by all the stakeholders is that trade in counterfeit/spurious drugs is prevalent internationally and affects both developing and developed countries. Some of the possible factors that contribute towards proliferation of spurious drugs are also universal and include lack of enforcement of existing laws, weak penal action, very remunerative trade, large scale sickness in small scale pharmaceutical industry, availability of improved printing technology that helps in counterfeiting, lack of coordination between various agencies, too many retail & whole sale chemist outlets, inadequate cooperation between stakeholders, lack of control by importing/exporting countries, wide spread corruption and conflict of interests - although appropriate legislation and regulatory systems exists, there is a considerable non-uniformity of enforcement standards followed by state drug control authorities. However in addition to these factors one major factor is the inadequate and weak drug control infra-structure in states as well as centre.
Uncontrolled Proliferation of Drug Stores:
In our state one of the most important factors that contributes largely towards sale of spurious or substandard drugs is the uncontrolled proliferation of drug sale outlets along the length and breadth of the state. Various reasons and solutions for this mushrooming of drug stores in J&K have been discussed at length in an earlier issue of Physicians Academy12. Here it is noteworthy to mention the statement given by the state’s health minister to Daily Greater Kashmir wherein he candidly admitted that between 2002-2008 no less than 9000 licenses have been issued by the state govt. He even went to the extent of saying that even the vendors got registration during that period. However he tried to absolve himself and his ministry by stating that since he took over as health minister he has put curbs on it and no more than 150 people have got license during his 3 year tenure13, whereas if actual reports from the reliable sources on ground are to be believed, during the past three years more than 150 people have been registered as pharmacists in each district, irrespective of their academic qualifications. Never ending process of registration of unqualified people as “pharmacists” that was initiated by the J&K Pharmacy Council more than a decade back is still continuing unabated and every Tom, Dick and Hary, irrespective of his academic qualification is being registered first as a pharmacist merely on the basis of matriculation and five year experience in dispensing drugs and subsequently provided with a drug sale licence on the basis of this registration certificate. This has led to the opening up of floodgates for all and sundry to enter the profession of pharmacy and indulge in the most skilful job of dispensing drugs to patients leading to deterioration of standards and services and malpractices of trade.
Unscrupulous activities of the J&K Pharmacy Council:
Ironically President of the J&K Pharmacy Council who is vested with the official responsibility of cleaning this mess, himself admitted to this anomaly in his statement given to Daily Greater Kashmir, wherein he openly accepted that, “As per the Jammu & Kashmir Pharmacy Act the eligibility criteria for registration as a pharmacist is matriculation with 5 years experience or graduation with 2 years experience. That carried sense when those earning their livelihood had no alternative job avenues. I believe as on date subsequent registration of people as pharmacists should have been stopped but we still follow it under Jammu & Kashmir Pharmacy Act. Education regulation has been implemented in every part of India except Jammu & Kashmir. I have given justification that we have 30-35 colleges in the valley and therefore skilled manpower to take care of our needs”13. Now who is going to remind the President of our defunct Pharmacy Council that it is he who has to frame and enforce Education Regulations and take necessary measures to ensure that only qualified people enter the profession by getting registered as Pharmacists. His press statement clearly reveals that either he is himself ignorant of his powers and responsibilities as President of the Council or is deliberately trying to fool the people by giving confusing statements and shifting the onus of responsibility to someone else.
Lack of an effective Drug Policy:
Another important factor that is contributing towards worsening scenario is the absence of a comprehensive, effective and fool-proof drug policy in J&K state. Pros and cons of this issue have also been discussed in an earlier issue of Physicians Academy in detail14 alongwith the gross deficiencies in the govt draft15 that has been prepared three years back and is still to see the light of the day. Draft prepared by the govt. in 2009 had completely ignored almost all key issues of public importance like spurious and substandard drugs, drug addiction, irrational prescribing and dispensing of drugs, unethical promotion of drugs by pharmaceutical companies, scientific drug storage, drug recall and disposal of unwanted drugs, clinical pharmacy and drug testing services in hospitals, drug licensing policy, revamping and streamlining the affairs of J&K Pharmacy Council, AYUSH drugs and cosmetics control system, drug price control mechanism, system for reporting and recording quality problems, drug budget requirements etc. It was after Civil Society Forum held a series of marathon meetings with senior functionaries of the health department clubbed with hectic parleys for lobbying and advocacy with senior cabinet ministers of the govt., that some of the deficiencies in the draft were duly addressed and the Commissioner-Secretary Health of the state pledged to incorporate all the suggestions made by the CSF in the final draft. In order to curb the menace of spurious and substandard drugs, author of this article through CSF made several suggestions to the govt. that were mostly based on the remedial measures suggested by several well-known committees of experts like Hathi Committee (1975), National Human Rights Commission (1999), Parliamentary Standing Committee on Petroleum and Chemicals (2001), Mashelkar Commmittee (2003) and National Commission for Macroeconomics and Health (2005).
Remedial Measures to tackle the problem:
Some of the remedial measures suggested to the government were as under:
- Special courts should be designated to try the cases of spurious drugs.
- Creation of intelligence cum legal cells in all districts to facilitate busting of spurious drug rackets and their prompt prosecution respectively.
- Provision of secret funds and incentives to informers giving information about spurious drugs.
- Training manpower particularly drug inspectorate staff in investigational skills.
- Monitoring of drugs through supply chain management with proper control on the allied supply industries and transporters.
- Effective networking system between neighbouring states has to be developed apart from identifying and notifying nodal officers in state and central drug control organizations as well as manufacturers for effective and speedy communication.
- Creating central registry for formulations under the brand names and their compositions.
- Necessary changes in law should be made to award severe and deterrent punishments 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.
- Proliferation of drug distribution outlets should not be encouraged. A distance of at least 500 meters should be maintained between two successive shops to avoid agglomeration.
- Drug sale licences should be issued only to persons holding diploma or degree in pharmacy from a recognized/duly approved university/institution. Necessary amendments have to be made in the relevant Acts to enforce this provision.
- Preparation of dossiers of suspected dealers and manufactures should be a perpetual exercise. Such dealers will have to be black-listed and their licences cancelled.
- Manufacturers should be encouraged to have their own anti-counterfeit drug strategies like RFID, QRC etc, better surveillance and efficient complaint handling system.
- A statewide survey has to be conducted to measure the magnitude of spurious drug trade in the state, lifting samples from every nook and corner of the state in a statistically designed scientific manner.
- Effective interaction between the stakeholders i.e. industry and regulators, industry and consumers, trade and regulators and medical professional and regulators, should be developed.
- Creation of advisory bodies at district level with NGOs and Consumer Associations.
Pertinently Health Minister of J&K while talking to Daily Greater Kashmir on October 4th, 2011 admitted that some reasonable suggestions have come from the civil society and some of these suggestions will be incorporated since we have to draft a policy for the next half a century. However in the same interview, towards the end, he contradicted his own statement and went on to say, “We will sharpen the teeth, let the policy first come subsequently we will incorporate the suggestions of civil society. Let the document come, then we can add the provisions by taking suggestions from the civil society. Amendments can be made afterwards8”. So there seems to be a total disconnect in the commitments, policies, priorities and actions of the health ministry. It is high time they realize the gravity of the situation and incorporate the remedial measures suggested above to tackle the menace of spurious and substandard drugs.
Conclusion:
Many stake-holders are making claims and counterclaims regarding the nature and actual size of the problem of spurious drugs in J&K and are simply passing the buck by shifting the blame on each other. In this debate on spurious drugs, the larger issue of substandard drugs is getting sidelined whereas common people at large who are not aware of the legal intricacies associated with the problem and the jargons involved, perceive substandard drugs too as being spurious. While nothing can be said with confidence about the actual magnitude of the spurious drug trade in J&K since there are no credible, independent, scientific studies available, however based on the causal-effect relationship and the experience gained from their practical use, people at large are not satisfied with the quality of drugs available in the local markets and large scale mass resentment on the issue exists on ground, while the drug regulatory authorities and the concerned ministries continue to be in a continuous mode of denial about the prevalence of spurious drugs in J&K.
Very less percentage of spurious drugs found by the regulatory departments, not only in J&K but across India, upon testing of drug samples lifted by the drug inspectorate cannot be taken as certification or confirmation of their claims that the prevalence of spurious drugs in J&K or across India is negligible for the reason that inspectorate randomly lift drug samples for the purpose of testing from the open shelves of only a few chemists in their jurisdiction areas whereas spurious drugs are stored and sold in a clandestine and surreptitious manner. Surely more vigorous, carefully selected and large scale sampling from every nook and corner of the state by some independent agency would provide a different picture altogether. Those drug samples should receive priority for testing whose purchase records are found to be missing or incomplete at the time of lifting their samples and that look suspicious upon physical examination. Furthermore identity of the manufacturer must be concealed before sending the samples to the laboratory for testing.
Need of the hour is that the issues of spurious and substandard drugs should be viewed in conjunction while assessing the situation or finding a solution, and the two must not be viewed in isolation, for the mere reason that the prevalence of substandard drugs is much more higher than that of spurious drugs and together they pose a similar threat to the health-related quality of life of patients. Secondly govt. must come out of its continuous mode of denial and dispassionately try to address the overall problem of quality control and rational use of medicines in a holistic manner by adopting the remedial measures suggested by the expert committees constituted from time to time in this regard. There are social, economic, administrative, legal and political factors16 responsible for the grave situation we are witnessing and only govt. or regulatory bodies cannot be blamed for the mess. Hence all sections of the society need to stop pointing fingers at each other and play their important role in alleviating the problem. All stake-holders must shun their confrontationist attitude, stop drawing any mileage and join hands together to curb the menace. Then only some credible progress can be made.
Reference:
- Daily Greater Kashmir dated Nov., 13th, 2011.
- Daily Greater Kashmir dated Nov., 20th, 2011.
- http://www.who.int/medicines/services/counterfeit/faqs/count_q-a/en/index.html
- http://www.who.int/mediacentre/factsheets/2003/fs275/en/
- http://articles.economictimes.indiatimes.com/2008-02-11/news/28384280_1_fake-drugs-spurious-drugs-counterfeit-drugs
- http://articles.economictimes.indiatimes.com/2007-11-21/news/27684777_1_spurious-drugs-deputy-drugs-controller-counterfeiting
- http://www.jkhealth.org/newsite/index.php?option=com_content&view=category&layout=blog&id=96&Itemid=146
- Daily Greater Kashmir dated April 27th, 2011.
- Daily Greater Kashmir dated Nov., 20th, 2011.
- Daily Kashmir Observer dated November 24th, 2011.
- http://cdsco.nic.in/REPORT_BOOK_13-7-10.pdf
- Geer MI. Mushrooming of medical stores in J&K state – reasons and solutions. Physicians Academy 2010; 4(7): 74-76.
- Daily Greater Kashmir, “words that matter” dated October 4th, 2011
- Geer MI. Deficiencies in draft drug policy of J&K govt. Physicians Academy 2011;5(2):16-19.
- Daily Greater Kashmir dated October 4th, 2011, “Flaws in govt. draft drug policy”.
- http://kashmiruniversity.academia.edu/GeerIshaq/Papers/935529/Poor_Quality_of_Drugs_-_Mass_resentment_and_factors_responsible
