Over the past few years, there has been widespread dissatisfaction among the masses with regard to quality of drugs available in the market. People have been expressing their resentment over the available drug services through newspapers, television and radio programs. In spite of several remedial measures taken by the concerned authorities in this context, public outcry continues to occupy the prime slots in print as well as mass communication media. This emphasizes the need to enhance general awareness among masses in regard to the modalities of drug services and various aspects related to their quality control. At the same time, various factors responsible for the prevailing scenario and necessary measures required for restoration of quality medicare services to the people need to be assessed.
Poor quality of drugs and drug services can be attributed to a host of factors that can be broadly categorized into following three groups:
1) Social factors
2) Legal factors
3) Administrative factors
1) Social factors
Due to lack of general awareness, people do not realize the significance of cash memos and do not bother to demand the same on purchasing drugs. On the contrary, at times customers have been seen refusing to take cash memos when offered by the chemists, as it happens generally when drugs are purchased in quantities larger than usual. Thus the importance of cash memos continues to be under-estimated which could otherwise have served like a “triple antigen” and provided immunity against three dreadful diseases that plague the society we live in, namely, overcharging of taxes, sale of spurious drugs and sale of drugs without a doctor’s prescription.
It is a well-known fact that spurious and substandard drugs are generally purchased without proper purchase invoices/bills and sold without issuing any cash memos. Moreover, it has been observed that chemists charge taxes as per the norms whenever they issue cash memos, in order to save their skin from any legal complications and due to the threat of decoy customers sent by the drug control officials. When a cash memo is issued, it becomes imperative for the chemists to mention the name and address of the doctor who has prescribed the medicine. Thus when an atmosphere of issuing cash memos is generated, sale of drugs only against the prescription of a Registered Medical Practitioner shall automatically precede, thereby putting brakes on the sale of drugs to addicts who do not possess any prescription. Since things have to be proved beyond any reasonable doubt through concrete evidence in the court of law in order to prove anybody guilty and get him convicted, there is a need to understand that it will be difficult to prepare firm legal grounds against a person or firm found indulging in overcharging of taxes or sale of spurious and substandard drugs, in the absence of a cash memo containing all necessary details and duly signed by the qualified person in-charge of the firm. Sale of drugs by unlicensed dealers could also be effectively checked through this fabulous tool since unlicensed dealers generally do not issue any cash memos
It is almost impossible for a drug control official to distinguish between a spurious and a genuine drug merely by its visual appearance. More often spurious drugs look more original than the genuine drug. Such drugs are pumped into the market through intelligently mastered and well-knit rackets which are hard to bust by ordinary means and moreso in absence of any specific informational inputs about the same. It has been found during recent raids outside the state that two of the ten strips of tablets in a box were fake. Under such circumstances mere verification of purchase records of drugs at random and lifting of drug samples for test/analysis cannot suffice in curbing the menace that is eating the very vitals of our society. It is extremely important that whosoever has any information regarding spurious drugs passes it on to the regulatory official for immediate action. Without such tip offs, situation is most unlikely to change for good and it will not be rational to expect much improvement in the overall scenario. However, the general belief that most of the drugs currently available in the market are spurious is not based on facts. Only a few unscrupulous agents are thought to be indulging in this unfair trade and they need to be brought to the book through a united effort.
People at large avoid making complaints to the concerned authorities whenever any drug is found not to bring about desired relief from an ailment. Instead, people choose to gossip around amongst themselves regarding such drugs and fail to realize that any action can be initiated or investigations made only when a complaint is lodged at the proper forum. Complaints received by the Drugs Control Department mostly pertain to so-called Welfare Associations who often do so to fulfil their selfish motives and such complaints are mostly hazy and non-specific in nature. Very few instances are such where any specific charges are attributed to any particular individual or firm. People need to have faith in the system and regulatory machinery and lodge specific complaints with concerned authorities. This is essential because there is no parallel/alternative set-up that could investigate and take necessary action in such cases. Further, whenever any person lodges a complaint, he should ensure its necessary follow-up for the cause of humanity and social welfare. He should not give up until remedial measures, as warranted under rules, are taken by the concerned officials towards redressal of the grievance. Even a few such sincere efforts can have far-reaching consequences and yield remarkable results.
It is no secret that people living in rural as well as urban areas prefer to consult compounders, medical assistants and even nursing orderlies with an intention to save few bucks of consultation fee, who in turn prescribe drugs without proper diagnosis and technical know-how, resulting into ineffectiveness of the medication and even adverse reactions in several cases. Under such circumstances too, patients put the entire blame squarely on the quality of drugs and do not bother to ponder whether they have received the most desired drug therapy. This is the case even in large cities where there is a doctor’s clinic available only next-door. Self-medication by patients is yet another cause of concern which also leads to similar consequences.
2) Legal factors
Drug services to common masses and other related issues are regulated through the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules, 1945 and Drugs Price Control Order, 1995. Drugs and Cosmetics Act, 1940, which was passed with an objective of regulating the manufacture, distribution and import of drugs and cosmetics has undergone its latest and major amendment way back in 1982 and no major amendment has been made thereafter. Though the Act has conferred satisfactory powers upon the inspectorate staff, yet there are loopholes that occasionally pave way for the safe passage of offenders.
Unlike labour laws, the Act does not provide for imposition of on-the-spot fines as and when any violations like supply of drugs in the absence of approved qualified person, non-display of license, stocking of physicians samples or expired drugs within the premises etc are detected by the field staff. Inspectorate has to approach the court of law for each and every contravention, be it minor or major, and the matters get dragged in lengthy judicial procedures yielding very few results, often acquitting the offender on one or the other grounds.
Whereas section 27 lists out the penalties for various contraventions of the Act and Rules thereunder clause (a), (b), (c) and (d), at the same time it authorises the courts to impose a sentence of imprisonment or fine less than that prescribed under clause (b), (c) and (d) for any adequate and special reasons. Unfortunately such special reasons have not been elaborately defined or specified in the Act. Consequently punishments are often reduced by courts on clumsy and inadequate grounds. Rather only rarely such special provisions are left unutilized by the judiciary, thus letting the offenders go scot free and commit further contraventions with greater conviction. There are very few instances where any deterrent penalties have been imposed upon the accused for violating the provisions of Act and Rules thereunder. Hence there is urgent need to amend section 27 of the Drugs and Cosmetics Act, 1940 and reconsider the special provisions of reduction of penalties prescribed under clause (b), (c) and (d) or otherwise make the circumstances under which punishments are reduced, more specific and well defined so that any kind of misuse of these provisions could be prevented.
Procedure prescribed under section 25 of the Drugs and Cosmetics Act, 1940 for retesting of drugs that have been tested once and declared to be not of standard quality by the Govt. Analyst require a prosecution to be launched against the manufacturer and suppliers of such a drug before it could be sent for retesting by the court. This leads to considerable delay in early disposal of such cases since prosecution can be launched only when other statutory requirements have been compiled with and necessary documentary evidence collected, that often takes time owing to slow pace of work in various departments. Many a times, the drug in question gets date expired even before it is retested or any prosecution is launched against the concerned, resulting into their acquittal. Therefore, section 23 and 25 too need a suitable amendment in such a way that one sample portion of the drug is preserved until its manufacturer’s name is disclosed by the suppliers and the same is utilized for retesting, if required, without prior permission from the court.
2) Adminsistrative factors
Keeping in view the vast number of drug sale outlets along the
length and breadth of the state, the workforce currently available with Drugs Control Department is not sufficient enough to fully cater to the actual field requirements. At present one post of Drug Inspector exists in each district, whereas there ought to be at least one post available for each tehsil in order to ensure strict vigil in every nook and corner. Moreover, those presently in service are also devoid of adequate transportation and communication facilities. They have to rely on local road transport for conducting tours across far-flung and remote areas thus occasionally resulting into lack of instant action and free flow of information.
Licensing to drug manufacturing units by various state governments needs to be made more stringent. Standards of granting such licences need to be upgraded and proper compliance with current Good Manufacturing Practices (GMPs) and other quality standards as prescribed under WHO guidelines need to be thoroughly probed before issuing such licenses. Severe punitive action, be it legal or disciplinary, needs to be taken against the manufacturers whose drugs are declared to be not of standard quality by the Govt. Analyst. It should be made mandatory for every new manufacturer who has been granted license by another state to seek prior approval before launching their products in our state and the approval should be granted only after thoroughly testing the quality of their products. Such an initiative is essential in the wake of steep rise in the number of pharmaceutical brands flowing into the market. At an estimate, every year approximately 600 new drug formulations hit the market. There are about 1800 antibiotic preparations having different brand names made from only a dozen drugs and there is absolutely no control over the inflow of fresh new brands.
Mediocre pharmaceutical companies are offering their brands at cheaper rates with huge margins for retailers and exhorbitant complimentary gifts and commissions for physicians. Consequently, some physicians prescribe their brands most often irrationally in a bid to gain more, without any consideration for patients’ actual needs and quality standards of reputed pharmaceutical companies. The practice needs to be curbed through more frequent lifting of drug samples for testing, modernization and sophistication of drug testing laboratories, more rigid regulations for launching of new brands in the state and evolution of some mechanism by means of which irrational prescribing of drugs by some doctors could be checked and brought under control. At present drug control officials are not suitably empowered to lay their hands on those erring practitioners, who prescribe some drugs ruthlessly and irrationally, notwithstanding the actual requirements of the patients. In the absence of any strategic mechanism to counter such malpractice, Chemists and Druggists Associations need to play their role by taking necessary steps and show resistance towards dispensing of drugs prescribed in such a manner. Moreover such steps on their part could also go a long way in stopping the supply of counterfeit drugs.
In nutshell, the general notion that most of the drugs available in the market are spurious and that Drugs Control Department is solely responsible for the poor quality of drugs is not based on facts. All sections of our society including those who consume; those who sell and those who prescribe drugs equally share the responsibility of making qualitative better medical services available to the masses and all of them need to join hands together towards achieving this goal. These initiatives clubbed with the steps recently taken by Union Ministry of Chemicals and Fertilizers in formulating the new drug policy to be called the Pharmaceutical Policy 2001, wherein focus is likely to shift from sales, import and turnover of drugs to their quality, research and selective price control and the recent nod given by the Drugs Controller General of India for upgradation of drug manufacturing norms in harmony with WHO-GMP standards, are expected to drastically improve the overall situation and restore the faith of common masses.
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