In the wake of startling revelations regarding the supply and detection of substandard and spurious medicines, Dr Geer Muhammad Ishaq suggests some remedial measures required to restore the confidence of common masses on medicines supplied at government hospitals.
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 for 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 Jammu and Kashmir police’s 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.
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.
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 along with 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, the state government 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 & 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 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.
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 equipment 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 Government 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.
In government sector, every batch of medicines supplied and kept under quarantine should be tested at initial supply stage through empanelled laboratories. The government needs to establish warehouses for drug storage in every district on modern lines and ensure timely supply of only standard quality drugs to all government 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 should that batch 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 government.
The government must involve genuine retailers, wholesalers, working government 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.
Regulating Drug Trade
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 government 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.
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, the 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 stakeholders including retailers, wholesalers, distributors, doctors, government 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.
(The 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 2011. He can be reached at [email protected])