AWARENESS ABOUT BANNED DRUGS IN INDIA

AWARENESS ABOUT BANNED DRUGS IN INDIA

India has become a dumping ground for banned drug, also the business for production of banned drug is booming. All the formulations are meant for prevention or treatment of ailments and diseases, out of which only a few drugs are lifesaving and essential, rest of the drugs are substitutes of each other. Banned drugs are still available in developing countries like India due to lack of law enforcement physician awareness and the drug control authorizes fails to inform all the hospital of the status of medicine. Some of the dangerous drugs have been globally discarded but are available in India. The most common are like Nimesulide, Furazolidone, Phenylpropanolamine and other over the counter preparation are banned by USFDA due to their side effect on kidney, liver and nerve. Unfortunately analgesic, antidiarrheal and cough preparations which are banned in other countries and are blindly used in India as over the counter drugs because of unawareness, lack of law enforcement and corruption. The Government of India is in the process of developing a regulatory regime designed to ensure the quality, safety and performance of medical devices. The pharmacist should take interest in public information campaigns and educate consumers and thus can play an important role of eliminating the banned drugs from market.

INTRODUCTION

A drug is “a chemical or synthetic substance used in the, cure, prevention or diagnosis of disease or used to otherwise enhance physical or mental well being.

Banned Drugs- banned drugs are drugs that not allowed to intake because they could artificially improve their performance and shows various adverse effects more than therapeutic effects. Whose production or use is prohibited or strictly controlled via prescription.

“Drug Controller general of India” is the highest authority in India to expand the approval of any drug or to ban a drug. Some of the dangerous drugs have been globally discarded but are available in India.The most common are like Nimesulide,Phenylpropanolamine,Furazolidone, etc.

Reason For Banning a Drug -Drugs undergo rigorous testing before they are introduced into the market. The efficacy as well as safety profiles of the drug are tested. In spite of this, some adverse effects of drugs appear only after the drug is released called Pharmacovigilance.

Pharmacovigilance is the Pharmacological science relating to the detection, assessment understanding and prevention of adverse effects, particularly, long-term and short-term side-effects of medicines.

“Drug Controller general of India” is the highest authority in India to expand the approval of any drug or to ban a drug. If any is to have harmful side-effects, the government issues the ban order and all manufacturer and wholesaler are asked not to stock the particular medicine.

“If doctors stop prescribing drugs that are harmful to patients"health, chemists will automatically stop selling since there are no patients asking for it, and hence, manufacturers do not produce it. Certainly, much of the problem can be solved like that, ‘the manufacturers have every reason to sell their products if there are buyers.”

WHY INDIA STILL SELLING BANNED DRUGS

India has become a dumping ground for banned drugs.The irony is that very few people know about the banned drugs and consume them unaware, causing a lot of damage of themselves. The issue is severe and we must not delay in spreading the warning message to the offenders and innocent people.

MOST OF THE DRUGS BANNED IN OTHER COUNTRIES BUT AVAILABLE IN INDIA

Oxyphenbutazon- Oxyphenbutazone, a metabolite of phenylbutazone,is an NSAID. It has been used for episceleritis, osteoarthritis,and rheumatoid arthritis etc. the severe adverse effects of oxyphenbutazone, which give rise to further complications include allergic reactions, abdominal pain, blurred vision. Metamizole: Metamizole (Dipyrone) belongs to a group of drugs that eliminate pain and reduce fever. Metamizole can cause damage to the bone marrow (granulocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia.) ,digestive disorders etc.

Cisapride- Cisapride is a “Prokinetic Agent” that used for treatment of gastroesophageal reflux disease (GERD). There is no evidence it is effective for this use in children. evidence for its use in constipation is not clear. It has been found to cause cardiac arrhythmias (irregular heart rhythms)

Nimesulide- Nimesulide is a non-steroidal anti-inflammatory drug, used for painful inflammatory conditions, back pain, dysmenorrheal, postoperative pain, osteoarthritis and fever. Caution should be exercised in patients with history of stomach problem, high blood pressure, fluid retention, abdominal discomfort, heartburn, abdominal cramps, nausea, vomiting and diarrhea, headache, dizziness and drowsiness, blood in urine and kidney failure.

Phenylpropanolamine- Phenylpropanolamine is a “Prokinetic Agent” that used for treatment of gastroesophageal reflux disease (GERD). But heart stroke and heart attack can cause due to adverse effect of phenylpropanolamine.

Quiniodochlor- Quiniodochlor is a antibacterial agent, used for dermatophytosis, mycosis barbae, seborrhoeic dermatitis, infected eczema, furunculosis, and pityriasisi veriscolor. It caused to nausea, transient loose and green stools, itching and goiter.

Cerivastanin- Cericastatin prevents the risk of stroke and heart attack .it functions by blocking away the enzymes in the liver that is responsible in the production of cholesterol inside the body. There are several side effects associated by using Cerivastatin, for example- diarrhea, nasal congestion, constipation, headache and heartburn, muscle damage, sexual problems, fever, difficulty in breathing etc.

Droperidol- Droperidol is an Antidopaminergic drug used as an antiemetic and antipsychotic. It also often used for neuroleptanalgesic anesthesia and sedation in intensive care treatment. but it causes dysphoria, sedation, hypotension resulting from peripheral alpha adrenoceptor blockade, prolongation of qt interval which can lead to extra pyramidal side effects such as dystonic reaction.

Furazolidone-Furazolidone is a Nitrofuran Antibacterial. It is marketed under the brand name furoxone. furazolidon has been used in human and veterinary medicine. in humans it has used to treat diarrhea and enteritis caused by bacteria or protozoan infections. it has been used to treat cholera and bacteremic salmonellosis, and helicobacter pylori infections. it has many side effects, and as with other nitro furans generally, minimum inhibitory concentrations also produce systemic toxicity (tremors, convulsions, peripheral neuritis, gastrointestinal disturbance, depressions of spermatogenesis.)

Nitrofurazone- Nitrofurazone is bactericidal for most pathogens that commonly cause surface skin infections.Topical nitrofurazone is indicated as an adjunctive therapy second and third degree burns. The adverse effects have been selected on the basis of their potential clinical significances are itching, rash and swelling.

Thioridazine- Thioridazine is an antipsychotic medicine called a phenothiazine. It is used to treat schizophrenia. But it can cause a life-threatening heart rhythm disorder, uncontrollable muscle movements of your lips, tongue, eyes, face, arms or legs.

Pergolide- Pergolide is a drug normally used for the treatment of parkinson’s disease. But cardiovascular system can damaged as the adverse effect of pergolide.

Piperazine- Piperazine was introduced to medicine as a solvent for uric acid. PIPERAZINE was first introduced as an anthelmintic. piperazine is used in the treatment of worm infections. following side effects can causes the human body: blurring of vision, clumsiness, crawling or tingling feeling of the skin, fever, irregular, twisting movement, especially of the face, arms and legs, joint pains, and itching or skin rash etc.

Phenolphthalein- Phenolphthalein is a astringent normally used as a laxative. The several adverse effects of phenolphthalein are heart stroke and heart attack etc.

Tegaserod- Tegaserod is a medicine used to treat severe, chronic, irritable bowel syndrome (IBS) in women who have constipation (and not diarrhea) as their main bowel problem. But it causes to new or worsening stomach pain, blood in stools, ongoing diarrhea, severestomach pain or cramps, headache, dizziness, or migraine, back pain or joint etc.

Analgin-Analgin is a medicine of pyrazolone group possessing hard analgesic and antipyretic effects and moderate anti-inflammatory activity and used for the treatment of pains of different origin and variable intensity: toothache, headache, arthralgia, myositis, mild to moderate visceral pain, high fever. After prolong administration very rarely can be observed agranulocytosis, leucopenia, and thrombocytopenia, proteinuria, interstitial nephritis. In sensitive patients rashes, urticaria, quincke’s edema, asthmatic attacks, and very rarely anaphylactic shock are possible.

REGULATIONS & GUIDELINES

Process of banning drug in India is done by DTAB (Drug technical advisory board) which is the final authority on imposing a ban. Drug controller general of India notifies all state drug authorities and manufacturer about ban on the drug. At IPA we understand the problems faced by pharma professionals in accessing requisite information in order to comply withthe regulatory requirements At home and in the regulated foreign markets. We’ve tried to simplify things for you by assembling the important Indian and international guidelines and regulations in this section.

CONCLUSION

Though each country has its own list of banned drugs, it is worrisome that some drugs that are banned in other countries for proven adverse effects are still available in the Indian market. Some of these drugs are available over – the – counter and people may take it without realizing the risk. A note of caution on these drugs could help patients in deciding whether they want to take the drug. Please make sure that patients buy drugs only if prescribed by a doctor. And that also from A reputed drug store. Not many people know about these banned drugs and consume them causing a lot of damage to themselves. For illegal drugs that are not diverted prescription controlled substances, some critics believe that illegal recreational use is inherently irresponsible; due to the unpredictable and unmonitored strength and purity of drugs are the risks of addiction, infection, and other side effects.The Central Drugs Standard Control Organisation run by the government of india has to made a strict guidelines over the list of drugs have been banned by European union and USA.

Link-http://www.arpb.info/Pharma/admin1/user/download/6846ronak.pdf