SPURIOUS DRUG DEBACLE IN J&K STATE: LESSONS TO BE LEARNT

Startling new revelations are coming to the fore with each passing day in the local press regarding the supply and detection of substandard and spurious medicines particularly in the government run hospitals. A lot has already been written and said about this intriguing problem fraught with disastrous consequences on public health and safety. Mute question remains whether this issue that received enormous media coverage will die down with the passage of time and pass off as just another controversy or some important lessons will be learnt by the powers that be, from this fiasco that enraged and unnerved all sections of our society equally. Even though preliminary enquiry report has been made public by the fact-finding committee constituted by the Ministry of Health and the crime branch has been entrusted with the job of further investigation into the matter, Government of J&K needs to put its act together, ensure adequate checks and balances in its healthcare system and undertake a series of remedial measures in order to curb this menace that has assumed alarming and deleterious proportions. This article proposes a few such steps that need to be taken without any delay in order to prevent the recurrence of such ugly episodes in future.

Impartial enquiry by an empowered committee

Since the preliminary enquiry report has candidly admitted failures on part of Central Purchase Committee and Drug Verification Board members in verifying authenticity of the manufacturer and ensuring quality of the drugs supplied, first and foremost there is dire need to reach out to the roots of this problem. It will be in the fitness of things that a high level, empowered committee of experts should not only expose all the people involved directly or indirectly in the shady spurious drug deal that has shaken the entire healthcare system and damaged its credibility considerably but also make an in-depth investigation into the functioning of Provincial Medical Stores, Central Purchase Committees, Verification Board, Drug Control Department and Drug Testing Laboratories over the past several years. Such an impartial and thorough enquiry assumes importance in the wake of a series of newspaper reports disclosing gross irregularities in procurement, testing and quality control of drugs in the government sector. That can go a long way in revealing all the rot in the prevailing system and pave way for its sustained improvement.

Streamlining supply chain and medicines management

With State Drug Policy already having been approved by the cabinet of ministers as well as the state assembly, Ministry of Health needs to streamline its procurement and quality control mechanism on the pattern of Tamil Nadu and Rajasthan Medical Services Corporation. Drug policy needs to be implemented in letter and spirit as soon as possible and an order must be passed to review and revise the approved drug policy after every three years as against five years mentioned in the policy, so that any genuine grievances arising out of its implementation can be addressed and necessary amendments made to suit various timely needs. Drug selection, quantification, procurement, storage, distribution and dispensing alongwith necessary counseling, monitoring and drug information services to the patients is a highly sophisticated and professional activity that can only be performed by skilled, well-trained and qualified professionals like pharmacy graduates. However in all major and minor hospitals of the state there are either unqualified (matriculates) or under-qualified (Medical Assistants) people managing these affairs leading to frequent failures of the system besides dissatisfaction among patients. Detection of spurious antibiotics is just a manifestation of such systemic failures. Therefore in tune with Drug Policy provisions state govt. must create adequate number of vacancies for pharmacy graduates in all hospitals of the state. This is highly essential for an efficient supply chain management and scientific medicines management within government hospitals.

Legal and administrative reforms

 

On top of everything else, there is need to make necessary amendments 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 accordance with the amendment of Drugs and Cosmetics Act made in the year 2008. Special courts must be designated to try the cases of spurious medicines on fast-track basis and necessary legal assistance should be provided to the drug inspectorate staff in all districts to pursue the offences related to substandard and spurious medicines. 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. Their investigational skills required for probing spurious drug rackets must be honed through workshops and other training modules. Further they must be provided all communication, transportation and accommodation facilities required for prompt action in such cases.
 

Drug testing facilities

 

Immediate priority of the state government must be to augment and upgrade the drug testing facilities within the state. 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, manpower and equipments 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. Alternatively in-house Quality Control cells may be established in all major hospitals as part of their comprehensive Quality Assurance system. Approved and accredited private drug testing laboratories across India must be empanelled for testing of drug supplies procured by the government. All laboratories must be inspected, audited and validated on regular basis by independent experts from outside 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. Therefore there is need to conduct a statewide survey on scientific lines in order to ascertain the magnitude of spurious drug sale in the state. Till such a survey is conducted people will continue to make conjectures regarding the extent of spurious medicines.

 

Quality control of drug supplies in government sector

 

In government sector, every batch of medicines supplied and kept under quarantine should be tested at initial supply stage through empanelled laboratories. Govt. needs to establish warehouses for drug storage in every district on modern lines and ensure timely supply of only standard quality drugs to all govt. hospitals. For this to happen, 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 testing 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. In order to compare and validate the accuracy and correctness of testing quality of the empanelled laboratories, randomly picked control samples should be sent to government laboratories as well as to empanelled laboratories for analysis simultaneously. There should be a provision for pre- as well as post-shipment analysis of all drug consignments received by the govt.

Interaction and collaboration between stake-holders

 

Govt. must involve genuine retailers, wholesalers, working govt. pharmacists as well as their trade associations in tracking spurious drugs and curbing their distribution and sale. We need to develop effective interaction and collaboration between all stakeholders i.e. traders and regulators, traders and consumers, consumers and regulators, medical professionals and regulators, simultaneously. This will facilitate free flow of information regarding substandard and spurious medicines. Trade associations should be impressed to have better surveillance on defaulting members and to take strict action against them. 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. Constant surveillance needs to be maintained at all entry points into the state including Lakhanpur and Qazigund toll posts. Regular samples need to be drawn from there for testing of drugs and the purchase bills of all drug consignments entering the state need to be checked on daily basis. On top of them all, creation of better awareness amongst consumers should be accorded top priority.

 

Regulation of drug licensing and registration

 

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. It is high time that the govt. streamlines its drug licensing and pharmacist registration process. Necessary amendments should be made in the relevant Acts to enforce this provision that includes enforcement of Central Pharmacy Act and implementation of Education Regulations by the J&K Pharmacy Council. Proliferation of drug sale outlets beyond a certain limit must be discouraged. Illegitimate practice of registering matriculates as pharmacists first and then issuing drug sale licences to them must be abandoned forthwith. Chemists on their part must stop issuing experience certificates to such people.

 

Conclusion

 

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 and many other drug-related problems. More than anyone else, state government needs to accord top priority to this serious public health concern and ensure speedy implementation of all necessary measures required to root out the menace of spurious and substandard medicines from our hospitals and open markets. Instead of indulging in blame game, all stake-holders including retailers, wholesalers, distributors, doctors, govt. pharmacists, medical representatives, manufacturers, regulators and patients need to do some introspection and join hands to ensure manufacture, supply, procurement, sale, distribution, promotion, prescribing and use of standard quality drugs only. Let us build a safe and secure healthcare system for ourselves and our generation next.

 

(Author teaches at the Department of Pharmaceutical Sciences, University of Kashmir and has been a part of committee that reviewed and revised state drug policy in the year 2011. He can be reached at ishaqgeer@gmail.com)

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.