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India has become a dumping ground for banned drugs, Painkiller, Depression, Pharmaceutical

Many spurious drugs that have been banned, withdrawn or marketed under restrictions in other countries, continue to be sold in India. The pharmaceutical companies and defaulters are playing with the lives of thousands of people who are not aware of the harmful effects of the drugs they sell.

Life, it seems, comes cheap for the health officials of our country. Otherwise how else would you justify the existence of drugs withdrawn elsewhere in the world but still sold and prescribed in India?

"More than 60,000 branded formulations are available in India. These preparations contain either single drug or drugs in fixed dose combination (FDC). All formulations are used for treatment or prevention of diseases. Out of it only few drugs are lifesaving and essential drugs, otherwise maximum of them are available as alternative or substitute to each other."

The safety of the combination drugs has to be thoroughly evaluated and there are considerations for the drugs that are already in the market as individual or single drug entity. However, the safety profile of the established drugs will alter when they are combined together. There was alarming increase in irrational FDCs in recent years and pharmaceutical companies manufacturing these FDCs are luring physicians to prescribe by unethical means. This may be due to the implementation of product patent regime where the mediocre companies find various alternatives to sustain themselves in the market place and combination products for newer indications play a major role. The total number of essential drugs mentioned in the 14th list of essential medicines by WHO is 312, out of which only 18 are fixed dose combinations. But many of the irrational combinations are popular and widely prescribed by physicians in our country.

India has become a dumping ground for banned drugs. The business for production of banned drugs is blooming and because there are more consumers here and all illegalities are duly obeyed. The irony is that very few people know about the banned drugs and consume them unaware, causing a lot of damage to themselves. The issue is severe and we must not delay in spreading the warning message to the offenders and innocent people.

As big time business enterprises and small time defaulters, pharmaceuticals have been growing in every direction. There are few provisions for a proper check and control of spurious drugs in Indian markets. Worst than that is the little knowledge and slapdash attitude of the buyers. Even at this time, a large population takes medicine and drugs without prescribing a doctor, which in fact is a very wrong decision and can be dangerous.

Thanks to a virtually "absent" adverse drug reaction mechanism in the country, drugs like Analgin, Cisapride, Nimesulide and Piperazine, discarded worldwide due to serious side effects are among the bestsellers in India. According to a report of the World Health Organisation, there has not been a single instance of adverse drug reaction reported against any drug in the country.

The business of production of these discarded drugs is booming in India. Some of the most common ones include Nise (Dr Reddy's), Nimulid (Panacea Biotec) that are discarded for reported liver damage, while Vicks Action 500 from the stable of Procter and Gamble is discarded for increasing chances of brain hemorrhage. Anti-depressant drug Droperol (produced by Triokka) has been discarded for irregular heartbeats in patients. Anti-diarrhoeal drug Furoxone (from the house of Glaxo) was withdrawn from the market after reports of cancer in some patients, who were administered the drug.

Eleven drugs - including cisapride, furazolidone, nimesulide and phenylpropanolamine - that have been banned, withdrawn or marketed under restrictions in North America, Europe and many Asian countries, continues to be sold in India.

India's contribution to the worldwide collection of data on the side effects of different drugs is dismal. Countries like Ireland, Switzerland and Italy with a population of about 4 million, 33 million and 57 million, respectively had submitted 25, 33 and 225 adverse drug reaction on nimesulide. However, India, with over 1 billion population did not report any. Another drug Sildenafil (erectile dysfunction drug) had 18 adverse drug reactions reported from Australia but none from India.

According to a health ministry source, monitoring of adverse drug reaction is not followed in the curriculum for medical students in India and majority of doctors do not maintain records on patients. Assessing adverse drug reaction is not an easy task and in a developed country like the US not more than 10% of the side effects are recorded.

"Regulations in India and US vary. In the US, drugs are not banned; they are withdrawn from the market. When a certain drug is found to have side affects, Indian regulatory authorities should also withdraw it from the market. Unfortunately that does not happen".

Whenever a drug is banned by the Drug Controller of India, it should stop being available in the market. But there are times when a drug is banned yet continues to be sold for a few months till stock lasts. "There is a lot grey zone in the field".

Drugs continue to be available over the counter because doctors keep prescribing it. "Till the time the drugs are not banned by regulatory authorities, no doctor can be blamed for prescribing it and as long as doctors keep prescribing, chemists will keep selling these drugs".

Many doctors, experts say, are unaware of the researches being conducted worldwide. "There have been campaigns against various drugs. Noted doctors keep themselves informed of the harmful side-effects of these drugs and do not prescribe them".

Many people have the opinion that "The problem is two-sided. The demand is still there for these drugs and that is why they are supplied. Doctors and patients who are used to prescribing and using the drug should realize that there are better and safe alternatives".

Dangerous Drugs that have been globally discarded but are available in Indian markets include:
 
Analgin
It is a painkiller
Reason for ban: Bone marrow depression
Brand name: Novalgin
 
Cisapride
For acidity, constipation
Reason for ban: Irregular heartbeat
Brand name: Ciza, Syspride
 
Droperidol
Anti-depressant
Reason for ban: Irregular heartbeat
Brand name: Droperol
 
Furazolidone
Anti-diarrhoeal
Reason for ban: Cancer
Brand name: Furoxone, Lomofen
 
Nimesulide
India has become a dumping ground for banned drugsPainkiller, fever
Reason for ban: Liver failure
Brand name: Nise, Nimulid
 
Nitrofurazone
Anti-bacterial cream
Reason for ban: Cancer
Brand name: Furacin
 
Phenolphthalein
Laxative
Reason for ban: Cancer
Brand name: Agarol
 
Pheylpropanolamine
Cold and cough
Reason for ban: stroke
Brand name: D'cold, Vicks Action - 500
 
Oxyphenbutazone
Non-steroidal anti-inflammatory drug
Reason for ban: Bone marrow depression
Brand name: Sioril
 
Piperazine
Anti-worms
Reason for ban: Nerve damage
Brand name: Piperazine
 
Quiniodochlor
Anti-diarrhoeal
Reason for ban: Damage to sight
Brand name: Enteroquinol
 
To ensure maximum safety and security, it is advisable to get only drugs prescribed by a medical practioner. Also, ask for the details like the name of the company that manufactures it. Always buy medicines from a recognized drug store. For more information about banned drugs, please visit the following links:
  1. List of Drugs banned for Marketing in India
  2. Central Drugs Standard Control Organization

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