Generic Drug Prescribing in J&K - Boon or bane?

Government decision to mandate generic drug prescribing within government hospitals has once again stirred the hornet’s nest and created furore among a section of the medical fraternity who believe that such a move will pave way for sale of drugs by unqualified and inadequately trained pharmacists on profit margin considerations in absence of a stringent quality control mechanism. Draft Drug Policy was approved and adopted by the J&K state legislative assembly way back in 2012 but erstwhile state government miserably failed to implement the same and relegated it to cold storage after there was agitation and resentment among pharmaceutical traders on this very generic drug prescribing clause of the drug policy. Quite surprisingly previous government never bothered to implement other relevant provisions of the drug policy to which nobody had ever expressed any objection and that were aimed at rationalizing drug use, improving prescribing and dispensing practices and ensuring quality, safety and efficacy of drugs procured by government agencies nor did it take any measures to streamline the drug procurement mechanism that was left in doldrums in the state drug policy owing to strong opposition by pharmaceutical corporate lobby.

 

After the spurious drug scam surfaced erstwhile state and central governments repeatedly pledged to upgrade the existing drug testing facilities in the state with a view to silence the huge public dissent against the debacle and had also promised to establish a new, fully equipped and sophisticated state-of-art drug testing laboratory in the state. But again no breakthrough could be achieved on those fronts too till their respective terms ended. Promises to this effect that proved to be hollow were made publicly by none lesser than the Drugs Controller General of India himself. However previous government announced formation of J&K Medical Supplies Corporation which again proved to be a non-starter, a damp squib. Even after a couple of years of its formation it kept craving for funds, manpower, infrastructure, transportation facilities and other necessary logistics without any substantial attention from the powers that be. Contrary to the provisions of the approved drug policy, previous government completely failed to establish intelligence cum legal cells to bust spurious drug rackets, to establish pharmacovigilance and drug information centres, to formulate standard treatment guidelines, to establish Drugs and Therapeutics Committees and to publish customized Essential Drug Lists in all premier health institutions of the state. No warehouses for drug storage were set up at district level nor any dedicated transportation facilities were made available for timely delivery of drug supplies.

 

Soon after new government and new health minister took charge an order was issued banning prescription of branded drugs within government health centres. Though the decision seemed well intentioned to benefit the patients and in accordance with national/international guidelines as well as provisions of the approved drug policy of the state, yet the manner in which order was abruptly issued without taking above mentioned deficiencies into consideration and without laying out a well-organized scientific mechanism towards maintaining unhindered availability of drugs in govt. hospitals throughout the year, fool-proof quality assurance mechanism to ensure quality standards of the drug supplies and robust procurement mechanism to prevent any stock-outs, it has raised many eyebrows forcing people to question the government move. Apprehensions expressed by doctors only get compounded by the fact that we don’t have qualified pharmacy graduates either in public or in private sector. In public sector Medical Assistants having one year MPHW diploma in hand are serving as pharmacists and in private sector matriculates have been registered as pharmacists by the J&K Pharmacy Council on the basis of their experience in drug trade. It is only trained pharmacy graduates who can dispense quality generic drugs alongwith professional counseling services to patients.

 

Fact of the matter is that generic drug prescribing is a need of the hour in order to march slowly towards universal health coverage wherein people at large do not have to pay out of pocket towards medical expenses and consequently face impoverishment on account of catastrophic health expenditures as has been well established in published literature. It is a fact that 78-80% of total health expenditure in India is borne upon medicines alone and out of that around 75% is borne by the people out of pocket since government’s per capita expenditure on drugs in public sector is less than one dollar which is peanuts as compared to what developed nations spend. Therefore making quality generic drugs available throughout the year within government hospitals is a must in order to enhance access to medicines among the 65% population (within India) who as per WHO World Medicines Situation Report lack adequate access at present. Such measures like generic drug prescribing have been hailed and strongly advocated by WHO, UNITAID and other international bodies as a positive step towards achieving Universal Health Coverage. However it is extremely important how generic drug prescribing and other measures envisaged in the drug policy are enforced and implemented. Sometimes a very good move executed in a wrong manner can prove to be a disaster leaving no scope for its revival in future.

 

Generic drugs are those that have gone off the patent protection and are sold on the name of their active ingredients but are the same as that of their branded counterparts in terms of dosage, safety, strength, purity, stability, quality, performance, route of administration and intended use. An estimated 24.21 lakh people (21.63% population) in J&K state live below poverty line and it is these people who cannot afford costly branded medicines. Price difference between generic and branded drugs ranges anywhere between 10% to 5000%.That is why National Human Rights Commission, World Health Organization, several expert committees and the National Commission for Macroeconomics and Health have unanimously advocated use of generic medicines in government hospitals.  Most of the apprehensions related to generic drug prescribing in government health facilities of J&K pertain either to quality and efficacy of generic medicines or its impact on pharmaceutical trade. However fact of the matter is that if the govt. follows standard guidelines of pre-qualification and post-qualification of suppliers and strictly adheres to the technical specifications as has successfully happened in case of Tamil Nadu Medical Supplies Corporation, there is no reason why govt. can't procure good quality drugs. If India can supply quality generic medicines to the extent of 22% of entire global generic market and if highest number of USFDA approved generic manufacturing units outside USA are based in India, what makes it impossible to procure world class quality generics from such approved companies within India? It all depends upon the will and intent of procurement and enforcement agencies of the govt. as to what quality standards they can maintain for generics.

 

It is quite possible for the state government to ensure standard quality of generic medicines by having stringent quality control measures, foolproof quality assurance mechanism, well-defined, transparent procurement and tendering policy, by adopting efficient technical specifications, pre-qualification and post-qualification criteria for drug supplier selection, by having in-house quality control cells in all major hospitals, by ensuring pre-shipment as well as post-shipment analysis of drug consignments, by taking samples randomly from all warehouses for testing, by having an effective drug problem reporting and recording mechanism, by making onsite periodic surprise inspections of manufacturing premises, by decoding the drug samples before sending them to government and private empanelled laboratories for testing, by validating the testing quality of these laboratories, by blacklisting the suppliers whose drug samples fail upon testing and putting their names on official website of the health ministry, by adopting a perpetual and seamless quality assurance mechanism in all healthcare institutions of the state.

 

Concept of Essential Drug List can minimize the number of drugs to be procured to just 348 and can thereby ensure economies of scale so that all necessary medicines of standard quality can be made available throughout the year within hospital pharmacies. However for that to happen, an efficient procurement and stringent quality control mechanism has to be in place. Drugs have to be procured through an autonomous, constraint-free mechanism that will function in a completely transparent fashion and will be devoid of any political interference in decision-making. Tamil Nadu Medical Supplies Corporation Model has shown the way how it can be achieved and that is the reason why this model has been appreciated, approved and recommended for all Indian states not only by the Government of India but also by the World Health Organization.

 

Further it is feared that generic drug prescribing will disempower qualified physicians from exercising a choice of brands and empower unqualified chemists to substitute prescribed generics with generics of their own choice on profit basis. However, inherent design of the new drug policy is such that all generic medicines listed in the Essential Drugs List will have to be kept available for distribution among patients on hospital pharmacy counters within all govt. health facilities throughout the year without allowing any stock-outs to occur at any point of time, so that all the prescriptions whether belonging to in-patients or out-patients can be dispensed within the hospitals and there is no need for the patients to purchase branded or generic medicines from outside the hospitals.

 

Bottom-line is that for successful enforcement of generic drug prescribing within government health institutions efficient procurement mechanism is necessary and maintenance of quality standards is extremely important without which this decision can boomerang and adversely affect patients’ health and welfare. Standard quality generic drugs have to be made available at all government health centres throughout the state throughout the year without any stock-outs, failing which prescriptions might be filled by retail chemists as per their own monetary considerations rather than quality parameters. Therefore it is high time that the state government takes adequate measures to streamline drug procurement mechanism in tune with well accepted norms and to upgrade quality control mechanism besides employing qualified and adequately trained pharmacy graduates in all hospitals of the state. All this can be achieved in a time-bound manner following which generic drug prescribing could be made mandatory across the state. Putting the cart before the horse will not serve any purpose other than generating yet another spell of agitation and furore among the medical fraternity and traders community thereby killing the entire spirit of a well-meaning drug policy of the state. At the same time doctors and pharmaceutical traders need to be pro-patient and welcome the generics wholeheartedly once the deficiencies are suitably addressed by the government.