The drugs and food are essential components of the health care of the public. The recovery of ailing patients from illness is directly related to the quality of drugs they consume. The proliferation of spurious drug in India is a serious problem.In the state of Jammu & Kashmir ,the menace of spurious drugs is growing as an issue of grave concern in the current times there by deteriorating the health of the people to large extent. However, there is a lack of awareness of the existence of spurious and adulterated medicines by a large section of people and therefore the people, doctors and hospitals are not adequately alert. The public administration lacks the competence and the will to deal with the menace and moreover unless the moral standards of administration and politicians are high one cannot depend upon them. Therefore the public is required to be more alert in this regard and device their own methods of safeguard themselves.
CATEGORIZATION OF SPURIOUS/SUB-STANDARD DRUGS
The major categorization of NOT of standard quality of Drugs is given below:
1)Category A (Spurious and Adulterated Drugs):
Spurious or imitation drug products are drug formulations manufactured concealing the true identity of the product and made to resemble another drug, especially some popular brand, to deceive the buyer and cash on the popularity of original product. The product may or may not contain the active ingredients. Spurious drugs are usually manufactured by unlicensed anti-social elements but sometimes licensed manufacturers may also be involved. The adulterated drugs are those drugs which are found to contain an adulterant/substituted product or contaminated with filth rendering it injurious to health.
2)Category B (Grossly sub-standard drugs):
Drugs manufactured by licensed manufacturers and reported to have defects of serious nature to affect the quality of the drug. These defects may broadly be like Tablets/Capsules failing in disintegration test wherever prescribed; liquid preparations showing presence of fungus; and vaccines failing in potency, etc.
3)Category C (Minor defects):
Drugs manufactured by the licensed manufacturers found not of standard quality because of defects arising out of minor variations in quality. Such defects may arise because of inadequate pre-formulation development studies, lack of in process controls exercised by the manufacturer or unsuitable conditions under which drugs are stored or transported. For examples broken or chipped tablets; presence of spot/discolouration/uneven coating; and change in colour of the formulation, etc.
CAUSES OF SPURIOUS/SUB-STANDARD DRUG MENACE
The government institutions like defence,hospitals, dispensaries etc make bulk purchases of drugs through the tender system and settle for the lowest bids. Due to the presence of corrupt purchase officials in these deals and in the absence of any appropriate system of monitoring the quality of drug, spurious and sub-standard drugs find the way into these places. Most of the spurious drug manufacturers do not register their companies with the drug controller and it is difficult to detect them. Some of the licensed manufacturers, which operate the legal business, produce counterfeit drugs and it makes the matter even more complicated.
The manufacturer of spurious drugs are
equipped with the latest techniques like desk-top publishing (DTP) to copy any innovations to reproduce exact replicas of new packaging labels and holograms. The reproduction is so perfect that even the experts cannot tell the counterfeit from the genuine packing. The manufactures and traders use modern communication system like cellular phones and Internet to avoid detection. The production is also carried out at different locations for the same reason.
Due to a high margin of profit the producers of spurious drugs are rich and they are able to pay handsome amount to indulge in corruption. They are using chalk powder, saw dust, salt, jaggery etc for producing spurious drugs. These products may not produce adverse effects on the health of consumers and are being used to reduce the penalty in case they are caught. The counterfeit drugs are no longer restricted to tablets and capsules of antibiotics, antiprotozoa, anti-malarial, hormones, steroids etc but are covering inhalers, sophisticated injections and expensive tablets used for the treatment of cancer. Recently the lifestyle drugs have also come into its fold. They include, health tonics, fairness lotions, pills for body building and impotence drug or erectile dysfunction drug. These drugs are taken by a large number of people and therefore can affect a large population of the world.
Recycling is one of the common practices adopted by small timers engaged in the manufacture of spurious drug. The recycling is mostly used in products like powder injections, e.g., beta-lactam antibiotics, which are expensive,and over-the-counter products like Iodex, Gripewater, cough syrups, pain balms, analgesics, anti-inflammatory tablets etc. An individual having knowledge of marketing of pharmaceuticals carries out this business. The process involves collection of used vials with intact labels, removing the closures, filling the containers with enough material and resealing it by using hand operated sealing machines. The activities are restricted to two or three districts and don’t have a large networking. It’s a cottage level operation involving small quantity of product. The products are sold to hospitals, nursing homes and practicing quacks.
E)REFILLING AND RE-LABELLING
Another method in this trade is refilling and re-labelling. The culprits identify the expensive branded drugs and substitute them with cheaper drugs having the same composition, remove the labels from the recycled bottles or vials, pack the cheaper products and affix the label of the branded product. Sometimes the packing may look similar to the branded or a generic product in appearance, but may contain a cheaper generic drug e.g., Indomethacin capsules relabeled as Chloramphenicol capsules. ‘Phensedyl’, a cough syrup, is a trade mark of Nicholas Piramal. The counterfeit version is sold as ‘Phensedyl plus’ and is supplemented with extra doses of narcotic codeine.
The reuse of drugs past their expiry date is yet another method used by these people .Mostly they are circulated in areas where the people are illiterate. Some of the dispensing chemists are also partners in this racket as they get huge margins of profit from the spurious drug manufacturer. The counterfeiters prey more on the vulnerable semi-literate and illiterate belts where people think that the death is due to the disease and not due to the drug .
RECOMMENDATIONS TO CURB THE MENACE OF SPURIOUS/SUB-STANDARD DRUGS
(a)Role of CBI: The major hurdles in catching the spurious drug manufacturers and traders are the corruption practices prevailing in administrative set up. Instead of controlling the menace, protection of the culprits is being acknowledged. Moreover the smuggling of spurious drugs out of the borders on such a large scale cannot take place without the help of underground Mafia, custom officials and the importers. The nexus of government officials, administrative officials or custom officials with the manufacturers and traders of spurious drugs can only be exposed by investigative agencies like CBI. If the CBI is able to catch the big fish it will have a direct impact on arresting the illegal trade.
- b) THE GOVERNMENT:
The responsibility to check the menace rests with the Government. Simply enhancement of penalty is not going to trap the culprits. The concerted efforts are required by drug control officers to nab the culprits. Since it is difficult to establish that the spurious drug is responsible for the grievous hurt or death, the introduction of death penalty is not going to make much difference to these criminals. A minimum fine of rupees one crore is suggested. The maximum fine should be calculated further on the basis of the capacity of the plant, the number of drugs manufactured, the type of drugs i.e. whether they are life saving drugs, number of years they are in business and the nature of contaminants used in the drugs. Moreover their whole assets, moveable or immovable should be confiscated and they should be debarred from entering the pharmaceutical business again. The minimum imprisonment should be enhanced to 10 years. The onus of proving that the spurious drugs have not caused grievous hurt or death to a person should lie with the accused. The fine or imprisonment to the corrupt officers should be more severe than suggested to the manufacturers and traders of spurious drugs. The Government should educate people through electronic media regarding the circulation of spurious drugs and the danger they pose to the health. The Government should declare fabulous prizes for the informers, whose information may lead to nab the culprits.
The dispensing chemists are the most important terminal points in the whole chain as the people are duped by them to buy the spurious drugs. The working of the chemists should be modernised. The integrity of the owner should be checked before issuing the licence. A person with a criminal record should be debarred. The information regarding the stock with details of manufacturers, batch numbers and expiry dates etc and the selling should be computerized. The information regarding the supplier with address, gate pass number, date etc should be recorded in the computer. It is very important to establish the link of the whole chain. The use of computer should be made mandatory by a specified period. The chemist shops not issuing cash memo for the sale should be heavily fined. The cash memo should clearly show the manufacturer’s name and the batch number.
d)THE PHARMACEUTICAL COMPANIES:
The genuine pharmaceutical companies should upgrade the technology, from time to time, for packing their products as to have a lead over the spurious drugs manufacturers, which copy the technology as then there will be a lag time before the latter can acquire the innovation. They should use holograms, bar-code, special inks for printing,printed/locked capsules, embossing logo on the tablets, pilfer proof packing etc to make it difficult for the small spurious drugs manufacturers to copy. They should emboss month and year of the date of manufacture or at least the year on glass bottles to stop recycling of the bottles. They should keep proper record of even trusted distributors and test random samples in their stocks to eliminate possible mixing of counterfeit drugs as a matter of routine. They should print a code or serial numbers on the concealed side of tablets/capsules strips or label of bottles so that counterfeit drug manufacturer is not able to print that and the counterfeit drugs are easily detected even without testing.They should write on each label, ‘Caution:Please destroy the container and the label after use so that a spurious drug manufacturer does not use them. This way the people will be educated regarding circulation of spurious drugs.
- e) THE GRIEVANCE CELL OPERATED BY AN NGO:
Since the government organizations, in general, are not run efficiently, a private grievance cell to attend to the complaints of consumers is proposed. The organization shall have a modern laboratory equipped with the latest instruments for quick analysis. The organization is proposed to be financed by the Indian pharmaceutical companies on the basis of certain percentage of their turn over. The infrastructure facility like land, building etc is to be provided by the government on a nominal lease. The project cost and the modalities for working can be planned. The facility would also be helpful in nabbing the culprits of the illegal trade and would activate the government organizations due to the competition. The facility may also have an intelligence wing as suggested above.
(f)THE PROTECTION OF THE CONSUMERS:
It is a long drawn war against the illegal trade and the solution depends on the will and competence of the government authorities, which have not been very promising in the past. Therefore, the consumers have to play an active role in protecting themselves and help nabbing the culprits. They are required to be vigilant and alert while purchasing and using the drugs. Some of the precautions they should observe are given as follows:
- To buy drugs from reputed and well established chemists, which issue cash memo for the purchases.
- To check whether batch number of the medicine is clearly and correctly written on the cash memo
- Don’t buy if the packing looks different
- Don’t buy if the packing looks the same but medicine is other than prescribed
- Don’t buy loose medicine
- Don’t buy if the price on the medicine is lower than the one at which you purchase normally
- Don’t buy if the spelling of name of the medicine is different.
- Don’t buy if there is an additional mark along with the name unless prescribed by your doctor like +, *, ! etc, e.g., in case of Phensedyl and Phensedyl plus, the former is the trade mark of Nicholas Piramal while the latter is not.
- Ensure the doctor who is prescribing medicines shall have proper certificate of registration issued by the State Medical Council. Avoid doctors, who themselves dispense loose medicines and don’t write a prescription.
- Don’t buy if the label looks old or is mutilated.
- Check the expiry date and don’t buy beyond the expiry date.
- In case of an illiterate person get the medicines checked, before opening, by your doctor or a literate neighbour.
- Destroy the label and the container of the medicine after use.
Dr.Tasaduk Hussain Itoo is a Medical Practioner/Activist/Columnist/Educator at Unacademy and can be mailed at firstname.lastname@example.org