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Anti-Dumping Norms

Banned Sub-Standard Spurious Medicines

Indian Healthcare sector has come a long way, being almost non-existing during 1970’s to a prominent provider of health care products, meeting almost 95% of country’s pharmaceutical needs and is expected to become a US$280 billion industry by 2020.

Indian market can be divided into bulk drugs segment and formulations. The industry produces more than 60,000 finished medicines and roughly 400 bulk drugs, which are used in the formulations. The pharmaceutical industry has become the 3rdlargest in the world in terms of volume and 14th in terms of value.

Last year, nearly 450,000 foreigners sought medical treatment in India as medical tourists. Medical tourism has been a support for select institutions to strive for the highest international standards. “But the bad news is that the healthcare sector is severely affected by the increasing production and promotion of certain banned, sub-standard and irrational drugs all across the country”.

A number of drugs that are banned internationally, some of them are known for serious side-effects are openly available in India. Last year, Merck (a global pharmaceutical and chemical company) announced a worldwide removal of their molecule “Rofecobix”, branded as Vioxx. However in India the drug was sold and despite the litigation, warnings and media coverage of the adverse affects of the drug, it continues to be sold. (Source: www.expresspharmaonline. com). The union health ministry says around 5% of drugs in India’s one lakh crore pharmaceutical industry are sub-standard drugs. At a conservative estimate, drugs worth 5,000 crore could be sub-standard – popping of such drugs would not result with optimum effect. A committee of the commission, headed by Dr. K Srinath Reddy (President, Public Health Foundation of India), recently said the pharmaceutical industry spent over 25% of their annual turnover on sales promotion alone, as compared to a hollow 7% on research and development in 2008-09. (Source: TNN, Nov. 5, 2011). After knowing these facts, what strikes the mind is – where are we headed?. Is such a scenario causing a setback in the healthcare scenario? Indian pharma regulatuions have become so weak that these drugs despite being banned internationally, are available in India? Due to dearth of adverse drug reaction mechanism in the country (though it is being carried out by various state pharma committees), drugs like Analgin, Cisapride, Nimesulide and Piperazine banned worldwide, are among the best sellers in India. According to a report by World Health Organisation (WHO), there has not been a single instance of adverse drug reaction reported against any drug in the country.

The country has become a dumping ground for discarded and substandard medicines and the business of production of these drugs is flourishing in India. Incidentally, globally too, there is no system to ban these drugs by any regulation. The safety and efficacy of a drug is ascertained as per Schedule Y of the Drug and Cosmetics Rules.

Some common banned

Where does the problem lie?

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 or essential drugs, others at the most 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 an individual or single drug entity. However the safety profile of the established drugs will alter when they are combined together. There was an alarming increase in irrational FDCs (Fixed Dose Combinations) in recent years and pharmaceutical companies manufacturing these FDCs are luring physicians to prescribe them by unethical means. This may be due to the execution of product patent regime, where mediocre companies find various alternatives to sustain themselves in the market 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 World Health Organization, (WHO) is 312, out of which only 18 are Fixed Dose Combinations (FDCs). But many of the irrational combinations are popular and widely prescribed by physicians in our country.

“Drug Controller General of India (DGCI) estimates that about 46 banned FDCs continue to be marketed, irrespective of the ban. About 1,067 FDCs are freely marketed with the state drug controller’s approval, but without the DGCI’s concurrence”. A recent Government survey of drugs reveals that 0.3% of all sample drugs are found spurious, while 6-7% of drugs in the country are found substandard in quality.

In India less than 1% of the drugs manufactured are tested. Each of 26 government labs tests a small amount of drug samples annually and has a backlog of about six-nine months. (Source: TNN, Nov. 5 2011)

The problem is two-sided. The demand is still there for these medicines and that is why they are supplied. Doctors and patients who prescribe and buy the drugs should realize that there are better and safe alternatives. Among the literate consumers, there are substantial number of people who are unaware of such banns, very small number of people consults their doctors about the side-effects and strikingly enough it has been observed that majority of people who know about these banns still consume these medicines as they only want quick relief from disease and many a times they end-up doing self medication.

2nd problem is the pressure from manufacturers of newer drugs, which are very expensive, compared to the banned drugs! In India, if we go on banning drugs because of this pressure, the cost factor can make the treatment unavailable to the weaker section of the society.

(; drugs_sale)

Effect on Common Man:

Poor enforcement and multiple interpretations of the Drugs and Cosmetic Act 1940 have made regulations in the health sector an unviable proposition. Poor drug regulation results in the production and sale of banned, fake and substandard drugs. The deaths of pregnant women in Jodhpur due to contaminated IV fluids have brought this issue to the forefront again. Drug quality has specially become an issue with allegations of hazardous, fake & sub-standard drug production,

leveled against small-scale drug manufacturers.

Barrier to Developing Regulations:

A major barrier to developing regulations to discourage marketing messages that promote banned and spurious drugs is the lack of clarity on the standard and level of evidence available to support the development of regulations. Different stakeholders use different standards of evidence to argue for and against different positions, thereby confusing the debate around regulatory options.

Some Thumb Rules:

Any medicine that has a combination of drugs are best avoided, nearly all of them are also banned.
Never self-medicate, especially if your problem is a recurrent one, even if the same drug is working very well and you are getting better. People with sinusitis, frequent upper respiratory infections, frequent urinary infections, arthritis and other long standing pains elsewhere in their body, headpart aches & of course those suffering from allergies tend to repeatedly use certain medicines as it works on them.
It is best to discuss with your doctor that they are not prescribing drugs which can harm them in the long run.
Nearly all drugs, including supplements have a prescribed dose, duration and more importantly, definite indications. Exceeding the dose, duration, or even taking lesser then required will not do any good but harm.
The latest banned drug list contains several obesity controlling drugs (which are often prescribed for longer durations by beauticians, cosmetologists, or self prescribed are definitely harmful)


India is a vast country with multiethnic population. It is therefore necessary to have a viable Adverse Drug Reaction (ADR) data capturing System. Laxity on the government’s People with sinusitis, frequent upper respiratory infections, frequent urinary infections, arthritis and other long standing pains elsewhere in their body, headpart and the selfish interests of the manufacturers in not banning drugs is a concern. Nevertheless, the main problem is that of irrational doses rather than the availability of banned drugs.

Lack of ADR monitoring centers inthe country leads to little reporting of adverse reactions, as a result some undeserving drugs find a foothold inthe market.

The Indian Central Drugs Regulatory Authority has therefore set up a vibrant pharmacovigilance programme in the country. One of the functions of the programme is to assess the benefit, harm, effectiveness and the risks of medicines. This will help to encourage their safe, rational and proper use and improve patient care and safety in relation to the use of medicines and all medical & para-medical interventions. The establishment of National Pharmacovigilance Commission and other deliberate changes in drug regulation are positive steps, but much more remains to be done.

Consumer VOICE

Consumer VOICE

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