CAN WE GET RID OF SPURIOUS AND SUBSTANDARD MEDICINES?

Once again sale of spurious and substandard drugs in the valley is grabbing headlines in the local newspapers, occupying prime slots in current affairs programmes on the electronic media and taking the social media like Facebook and WhatsApp by storm with heated exchanges, hard hitting videos, allegations and counter-allegations. We have earlier witnessed all this in 2013 when spurious drug scam was unearthed and the Union Health Minister and Drugs Controller General of India had to land in the valley in person only to make several tall promises that were never ever fulfilled. Given the fact that the Drug Control Organization is in complete mode of denial about the existence of spurious medicines both in the state as well as at the centre, does the menace exist in reality at the first place and if it does, big question is will we ever get rid of this scourge? If yes, when and how? These are some of the intriguing questions lurking in every citizen’s mind that this write-up would seek to answer in spite of the fact that scores of articles have been written and published earlier by this author on this very topic.

While people are fast losing patience on this issue and blaming the government and drug regulatory authorities for not doing enough to curb this menace, in its defense drug control authorities have been citing the results of various national quality testing surveys besides the outcome of drug testing done by govt. testing laboratories over years which reveal the percentage of spurious medicines anywhere between 0.01 – 0.025% and that of the substandard (NSQ) drugs anywhere between 3.4 – 8.37% only both at the state and national level. Thus official data is in a complete denial mode vis-à-vis spurious medicines whereas there is some acknowledgement of drugs that are not-of-standard-quality (NSQ) though nowhere near to the level general public perceives them to be below the prescribed standards of quality. Truth lies somewhere in the middle. Neither all the medicines available in our markets can be labeled to be altogether spurious or substandard nor can all of them be declared to be of paramount standard quality. Without challenging the reports furnished by drug testing laboratories public perception about quality of drugs can also not be rubbished as completely untrue since common masses consume these medicines themselves and they have got a first-hand experience about their quality and effectiveness. So if they are not satisfied with the quality of drugs, something is wrong somewhere that needs to be addressed rather than adopting an ostrich approach and burying our head in the sand saying that nothing is wrong at all.

A global meta-analysis study published in JAMA recently reports that the prevalence of substandard and falcified medicines is 13.7% in Asia. So the problem is there that needs to be studied well and addressed in time rather than adopting an ostrich approach and living in a complete mode of denial. This study concludes that "poor-quality essential medicines are a substantial and understudied problem. Methodological standards for prevalence and rigorous economic studies estimating the burden beyond market size are needed to accurately assess the scope of the issue and inform efforts to address it. Global collaborative efforts are needed to improve supply-chain management, surveillance, and regulatory capacity in low- and middle-income countries to reduce the threat of poor-quality medicines".

If drug regulatory authorities have not been able to detect any spurious drugs in our markets they need to rethink about their drug sampling and drug testing procedure, strategy, designs, quantities and schedules and accordingly devise innovative methods to track down these sourly bitter pills. Have our drug inspectorate been equipped enough to bust spurious drug rackets through intelligence networking cells that provide lucrative incentives to the informers? Are they sufficiently trained in such skills? Do they have the requisite technological and logistic support in terms of mobile drug testing vans laced with sophisticated equipments like Raman Spectrophotometer, Near-infrared and X-Ray Fluorescence Analyser etc that could enable them to test the quality of drugs on spot instantly. In 2013 when spurious drug scam was exposed, Drugs Controller General of India had himself promised an additional drug testing laboratory and two mobile drug testing vans for the state that still continues to remain a distant dream. However as per news reports state government is in the process of setting up a drug testing laboratory at Lakhanpur with a central assistance of Rs 34 crores. 

At present Drug and Food Control Organization carries the testing of drug samples at its Srinagar and Jammu based laboratories that reportedly have a total testing capacity of around 4000 samples annually. For a state that is consuming medicines worth more than 1000 crores monthly, this capacity is too insufficient and meager.  We need to upscale our drug testing capacity to more than 10000 drug samples per year. JKMSCL should establish its own drug testing facilities and rope in accredited private drug testing laboratories from across the country so that each and every drug procured by them gets tested before distribution to the hospitals. Guidelines also prescribe one drug inspector for every 100 drug sale outlets but in our state each drug inspector is on an average looking after almost 300 outlets. First of all we don’t have drug inspectors available at the Block level. Secondly drug inspectors working at Tehsil level at present do not have sufficient accommodation, communication, transportation, legal counsel, security and clerical support available to them for carrying out their duties smoothly in a timely and hassle-free manner and they have not been accorded gazetted cadre too as required under Essential Commodities Act for monitoring drug pricing.

Jammu and Kashmir state drafted its premier drug policy in the year 2011 that was duly approved by the state cabinet and state legislative assembly in the year 2012 but still awaits implementation even after a lapse of more than six years. This is a major hurdle in making standard quality drugs available to the masses on their generic names at all government hospitals throughout the year without any stock-outs. Though some provisions of the policy like constitution of JKMSCL and procurement of drugs on generic names have been partially implemented, other provisions that emphasize seamless quality assurance, scientific demand estimation, pre-and post-qualification of suppliers following cGMP standards, drug storage and distribution in accordance with latest guidelines issued by WHO, their dispensing by qualified pharmacists alongwith patient counseling and continuous monitoring for any adverse reactions still awaits implementation. It is high time when the present state government should revisit, revise and revamp the state drug policy owing to the fact that it was drafted six years back and therefore needs to be redrafted taking all new challenges and changes into consideration. Population of the state has considerably increased so has the consumption of medicines ever since the draft drug policy was approved in 2012. Therefore there is need to take a fresh look at the draft and devise an updated comprehensive drug policy to streamline and ensure quality, efficacy and safety of medicines available in our private and public sectors.

Another big reason for plummeting quality standards of medicines in our markets is mushrooming of drug retailers and wholesalers in every nook and corner of the state. Eversince J&K Pharmacy Council came into being and opened its First Register of Pharmacists thousands of Pharmacy Registration certificates have been issued to every Tom, Dick and Harry irrespective of their educational qualifications. Matriculates in thousands have been registered as pharmacists without any basic know-how of pharmacy and subsequently they were provided drug sale licences by the Drug Control Organization of the state as a result of which today we can see beelines of drug stores not only outside hospitals but along length and breadth of the state which sometimes gives a notion that people living in the state probably eat medicines in place of food also. Worst part of the story is that matriculates with few years of experience in selling medicines were legally authorized to get registered as pharmacists in our state under J&K Pharmacy Act of 2011 (samvat) and subsequently were licensed to sell drugs. This is because J&K Pharmacy Council never bothered to bring Educational Regulations in time that would have restricted the issuance of drug sale licenses only to diploma and degree holders in Pharmacy. They acted like a business corporation making quick bucks over a period of almost 18 years by registering unqualified people as pharmacists. It can actually be counted among one of the biggest scams of this century in our state. This in turn has led to the deterioration of pharmacy services with drugs manufactured by third rate companies being sold for higher profits and that too in absence of any prescriptions which in turn promoted abuse of prescription drugs and psychotropic substances.

Cutting the long story short and returning back to the main question whether we can get rid of spurious and substandard drugs or not: Yes of course we can provided we have the will, wherewithal and the resolve to change the existing scenario rather than continue to live in a complete mode of denial. Way forward is to revise the state drug policy, implement it in letter and spirit, stop issuing drug licences to non-pharmacy professionals, augment the staff strength and infrastructure of drug control department, upgrade the existing drug testing laboratories and open new ones in each division of the state, streamline the functioning of JKMSCL on scientific lines and ensure availability of standard quality generic drugs in government hospitals throughout the year without any stock-outs, incorporate the professional pharmaceutical care services in all hospitals through qualified pharmacy graduates and post-graduates, mandate prescribing of drugs on their generic names only, revamping J&K Pharmacy Council and appointing Pharmacy Inspectors specifically for inspecting pharmacy stores for ensuring drug dispensing in accordance with established guidelines, pressing mobile drug testing vans into service for instant testing of drugs in far flung areas of the state and establishing a pharmacy practice department with adequate qualified staff in each and every hospital of the state. That alone can bring some semblance of order in the chaotic state of affairs existing at present. If journalists blame doctors, doctors blame pharmaceutical companies and regulatory authorities and they in turn blame pharmacists and common people, that is not going to solve the problem. Concerted and coordinated efforts by all of them towards improvement of the system however will definitely solve it.

(Author teaches at the Dept. of Pharmaceutical Sciences, University of Kashmir and has been actively involved in formulation of the first drug policy of J&K state)