In every country a “prescription drug” can be sold by a chemist to a patient only if he produces an authentic prescription issued by a licensed medical practitioner (a drug is a substance intended for use in the diagnosis, treatment, or prevention of disease).
There are several differences between OTC (over- the-counter) drugs and “prescription drugs”. In addition to what has been stated above, Prescription drugs are prescribed for one person and intended to be used only by that person.
In America their sale is regulated by FDA (Food and Drug Administration) through the New Drug Application (NDA) process. This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. The drug company makes available all data in respect of the drug, such as how the drug is manufactured and how it behaves in the body. Results of trials on animals and humans and an analysis of the data, are also provided. The procedure in most countries, including India is similar, with marginal variations.
OTC drugs do NOT require a doctor’s prescription. They are bought off-the-shelf in stores? Their sale is regulated by the FDA through “OTC Drug monographs”. OTC drug monographs are a kind of “recipe book” covering acceptable ingredients, doses, formulations, and labelling. Monographs will continually be updated adding additional data if any regarding ingredients. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not, must undergo separate review and approval through the “New Drug Approval System.”
The legal provision is clear and unambiguous and but in our country as in many other developing countries, and under-developed countries one can obtain even a prescription drug from a drugstore without producing a prescription, because the rules regulating dispensing of drugs are honoured in the breach. Unscrupulous pharmacists, and slack supervision by enforcement agencies, have reduced the necessity of having to produce a prescription to mockery. The medical community should also take a blame, for such a state of affairs, as many doctors are often hand-in-glove with pharmaceutical companies, hospitals, and diagnostic centres. In order to ensure brisk sale of a drug, the pharmaceutical companies have to depend on doctors to prescribe only drugs manufactured by them. The pharmaceutical companies compete with each other to cultivate a particular doctor targeted by them. To cite an extreme example a beta-blocker called Atenolol is manufactured by many pharmaceutical firms under 291 brand names e.g Atenolol, Tinormin, Presten , otenol etc. The doctor can for example prescribe anyone of these brands. The companies that manufacture these brands will offer all sorts of incentives to make the practitioner prescribe their drug. Each company will generously distribute large quantities of drugs as free samples to the doctor (of course no doctor has the necessity to buy medicines for his family members), and expensive household gadgets as gifts.
The kind of lavish gift depends on the stature or the number of patients of a particular practitioner. Of late the drug companies are even arranging trips to foreign countries. The tickets are purchased by the pharmaceutical company which also meets all the expenditure incurred by the medical practitioner, including hotel accommodation and transportation, in the cities he visits. The margin of profit by sale of drugs is so astronomical, that drug companies are prepared to pay for everything. The doctor merrily enjoys the lavish hospitality, for all that he has to do is to prescribe that particular drug manufactured by the pharmaceutical company in question.
Another malpractice arises from the fact that the cost of production of a particular drug may be only a few rupees, but it is sold for an exorbitant price by the pharmacies. To cite an example again, let us take a drug like erythropoietin
, which is administered for curing anaemia in kidney patients; it costs less than twenty or thirty rupees to manufacture but is sold as an injection cartridge for two or three thousand rupees by pharmacies. So is the case with many antibiotics, like penicillin and amoxicillin, anti-depressants like Mirtazapine and Fluvoxemine, drugs prescribed to combat hypertension like Ramapryl, and Prazopres, and drugs prescribed to lower cholesterol like Atervostatin. Irrespective of the financial status of the patient the doctor will deliberately prescribe a drug manufactured by a particular multinational drug company which in turn bestows all sorts of favours on him. The margin of profit runs to thousands of rupees in the case of drugs given for chemotherapy to cancer patients.
It would come as a surprise that many Indians who are citizens of the US or Green card holders, and who are on a short visit to India request their hosts to get them an antibiotic though they don’t possess a valid prescription from an Indian physician. These are the very same people who make a great fuss if you request them to give an antibiotic or some other drug when you are on a short visit to the US, and flatly refuse to oblige you.
There is also another malpractice. A few doctors form a sort of chain, a well-knit team. A general physician will send his patient to a particular specialist e.g a urologist or a skin specialist or a throat specialist even when there is no necessity. The specialist in turn recommends a battery of unnecessary tests like CAT scan, MRI (costing thousands of rupees) to enable a particular diagnostic laboratory to make money at the expense of the poor patient who gets tossed to and fro.
Big hospitals also have a major share of the profit. The patient is usually directed to a particular hospital by the doctor who is in league with that hospital. Thus every member in the team or chain is benefited, doctor, the pharmaceutical company, the pharmacy, the diagnostic centre and the hospital. Only the poor patient is robbed to the point of bankruptcy. No person of moderate means can afford to stay in these hospitals which charge higher tariff for their rooms than five-starred hotels. It is one vicious cycle which cannot be broken even by the most efficient investigating agency, in the country.
The moral of the story—what cannot be cured (pun intended) has to be endured.