Measures to curb the menace of spurious medicines

Shocking news about antibiotic supply from a government hospital testing negative is not only adversely affecting the health and well-being of patients who use such medicines but is also wrecking havoc to the confidence of all other patients and has triggered panic waves all across the state. Confusion and chaos regarding the extent of spurious drugs in our markets is getting compounded by the fact there are no credible and comprehensive studies available to arrive at any firm conclusion regarding the magnitude of this unscrupulous trade in our state. However one thing which is universally accepted by all 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.

 

All these multiple causes notwithstanding, there is need to curb this menace in the right earnest. A series of remedial measures need to be taken by the government and all other stake-holders to get rid of this nuisance that is seriously risking the health of patients who consume such medicines. First and foremost there is need to make necessary changes in the law so that severe and deterrent punishments are awarded to those dealing with spurious drugs, making all medicine related offences cognizable and non-bailable in tune with similar provisions in Narcotic Drugs and Psychotropic Substances Act. Special courts should be designated to try the cases of spurious medicines and all legal assistance must be provided to the drug inspectorate staff to pursue the offences related to substandard medicines.

 

A statewide survey should 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. Creation of intelligence cum legal cells to facilitate busting of spurious drug rackets and their prompt prosecution must receive top priority. There should be a provision of secret funds and incentives for informers giving information about spurious drugs and the drug inspectorate staff must be suitably trained in collecting intelligence inputs and their investigational skills required for probing spurious drug rackets must be honed. Further they must be provided all communication, transportation and accommodation facilities required for this purpose.

 

A fool-proof and effective networking system between neighbouring states should be developed and the preparation of dossiers of suspected dealers and manufactures should be a perpetual exercise. We need to develop effective interaction between all stakeholders i.e. industry and regulators, industry and consumers, trade and regulators, medical professionals and regulators, simultaneously. This will facilitate flow of information regarding substandard medicines.

 

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. Therefore drug sale licences should not be free for all. They should be issued only to persons holding diploma or degree in pharmacy from a recognized/duly approved university/institution. Necessary amendments should be made in the relevant Acts to enforce this provision. Proliferation of drug sale outlets beyond a certain limit must be discouraged. A distance of at least 500 meters should be maintained between two successive medical shops.

 

In government sector, every batch of medicines supplied and kept under quarantine should be tested at initial supply stage through empanelled laboratories. Random samples should be drawn from every warehouse where the batch is supplied. Batch-wise drug sample de-coding should be done through a strictly confidential system and the de-coded samples should be sent for quality checking randomly to any of the empanelled laboratories located across the Country. Only on receipt of "Quality Passed" certificate from the empanelled laboratories that batch should be released for distribution to government hospitals. Further during the shelf life of drugs, random samples should be periodically drawn from warehouses and quality checked to ensure that drugs are of standard quality right till the date of their expiry. Randomly picked control samples should be sent to government laboratories as well as to empanelled laboratories for analysis to compare the accuracy and correctness of testing quality of the empanelled laboratories. If any drug batch subsequently fails in quality upon testing, the remaining stock in warehouses should be frozen and the unused hospital stock of the drug of failed batch should be recalled and returned to the supplier. If three batches of any drug fail during tender period either at the time of initial receipt or during the shelf life of the drug the product as well as the company should be blacklisted. Information of failed batches and black listed companies must be put up on the official website of health department. There should be a provision for pre- as well as post-shipment analysis of all drug consignments received by the govt.

 

Drug manufacturers should be encouraged to have their own anti-counterfeit drug strategies like RFID, QRC etc, better surveillance and efficient complaint handling system. Trade associations should be impressed to have better surveillance on defaulting members and to take strict action against them. On top of them all, creation of better awareness amongst consumers should be accorded top priority. In order to ensure timely and accurate testing of all drug samples, existing drug testing laboratories must be upgraded, accredited and provided all necessary funding to operate in a more effective manner. Establishing drug testing laboratories in private sector must be encouraged too. A new central, fully equipped and dedicated drug testing laboratory must be established for testing drug supplies at Govt. Medical College, its associated hospitals and all hospitals at district level. In-house Quality Control cells need to be established in all major hospitals as part of their comprehensive Quality Assurance system.

 

Many people 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. Some people are demanding scrapping of the approved drug policy which is by no means any solution. In fact a comprehensive drug policy is a remedy to control this problem. Instead of indulging in blame game, all stake-holders need to join hands and ensure speedy implementation of all necessary measures required to the root out the menace of spurious medicines from our markets. Government too needs to accord top priority to this serious public health concern.