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MEDICINES: IRRATIONAL DRUGS
CROCIN FOR YOUR SOUL
By M H Ahsan
HYDERABAD: Did you know that Dexorange, the top selling formulation for anaemia in India, contained haemoglobin taken from slaughterhouse blood till 2000 when the practice was banned? Ever thought of a cough formulation that contains a combination of cough suppressant and a counteracting expectorant? Or how about a fixed drug combination for fever and a psychiatric condition like anxiety? It may seem shocking, but the Indian pharmaceutical market has been host to many such "irrational" (illogical and harmful) medicines—a fact recently confirmed by the Drug Controller General (DCG) of India.
Last month, the DCG, in response to Kerala-based neurosurgeon and activist Jacob John's rti petition, acknowledged that 294 unapproved fixed drug combinations (FDCS) were being sold in the market for which "the rationality, efficacy and safety are not established". This large category of "irrational" medicines consist of illogical and harmful drug combinations and medicines with little therapeutic value. All state drugs controllers, wrote DCG M. Venkateswarlu, have been instructed to stop the manufacturing of these drugs and to withdraw them from the market. These 294 formulations include commonly used analgesics, antipyretics (fever-reducing drugs), anti-inflammatory drugs, muscle relaxants and antibiotics. They are being sold under more than 1,000 brand names by top firms like Sun Pharma, Cipla, Ranbaxy and Cadila with an annual marketshare of over Rs 8,000 crore.
Spurred by this revelation, groups like All India Drug Action Network (AIDAN) and Jan Swasthya Abhiyan, a Delhi-based NGO, have renewed their efforts to push for a speedy and complete withdrawal of such medicines from the shelves and a ban on their production.
A widely sold illogical drug combination is alprazolam (for anxiety) and paracetamol (for fever). "Why would one combine a drug for fever and anxiety? What is the relation between the two?" asks C.M. Gulhati, editor of Monthly Index of Medical Specialities. "One is a an organic problem and the other psychiatric. This combination is even more irrational because alprazolam is meant to be taken a maximum of three times daily and paracetamol eight times," he says. With the pharmaceutical industry struggling to discover new drugs, a rat race is on between firms to capture marketshares by developing combinations, often irrational, and claiming better results. "This is nothing but fooling the patient and physicians," Gulhati adds. Some feel these combinations are also promoted to escape price control imposed on single drugs such as paracetamol.
Worryingly, these FDCS foster resistance when one of the drugs in the combination is not concurrently required. Like cefixime (used for bacterial infections) combined with ornidazole (used for amoebic infections), which doctors often prescribe to patients who suffer from one of these two infections.
When contacted, an official of the Organisation of Pharmaceutical Producers of India reacted by saying his organisation supported the DCG's move. However, he insisted that manufacturers had licences from state drug controllers to produce the drugs that the DCG now, ironically, terms irrational.
Gulhati counters this, saying the problem arises out of deep-rooted corruption in the drug regulatory mechanism. "When two or more approved drugs are combined, the new combination is considered a new drug and needs to be approved by the DCG. But that does not happen. Many firms get manufacturing licences from a state even without a marketing approval from the DCG's office," he explains.
Irrational drugs are also silently precipitating India's public health crisis. It is common knowledge that a majority of Indian adolescent girls and children suffer from anaemia. But a study earlier this year by Gopal Dabade of Drug Action Forum-Karnataka found that only one of 338 drugs for anaemia conformed to the norm prescribed by the WHO List of Essential Drugs, 2005, and standard pharmacology textbooks. "The only drug found to be rational was ferrous fumarate (200 mg tablet). It was also the cheapest (13 paise), but was unavailable as the profit margin is minimal," says Dabade. "This means anaemia continues to be under-treated with expensive, ineffective drugs," he adds.
Similarly, poor regulation means the use of varying combinations of drug doses to treat TB. "Not following the who norm often results in overdosing or underdosing the TB patient, leading to a rise in drug resistance," says AIDAN joint convenor Anurag Bhargava. The irrational use of such drugs, he feels, has led to a public health disaster. "More so, when these drugs impair access to rational, essential and low-priced ones. In fact, rational and essential medicines are in the minority," Bhargava adds.
Another crucial problem is the absence of an unbiased and continuously updated source of drug information such as the British National Formulary. "Education about drugs in India comes essentially from companies and their agents out to promote their drugs. Why would they say negative things?" asks Mira Shiva, chairperson of the national task force on consumer education on safety of food and medicine. Critics also allege that new findings about drugs' adverse effects often do not reach the consumer, a primary responsibility of the DCG's office. "For example, it has been found that betablockers such as carvedilol, used to treat hypertension, can precipitate diabetes. How will this reach the masses when the authorities continue to sit on such valuable information," questions Gulhati.
The lack of a scientifically rigorous regulatory system also enables hazardous drugs to be sold. Such as in the case of phenylpropanolamine, which was banned in the US and several European countries because of its potential to induce strokes. It is still commonly used in cough and cold remedies in India without any warning. Or analgin, used widely as a painkiller, that is known to reduce the white blood cell count.
In 2005, the National Commission on Macroeconomics and Health shocked many when a chapter in its report claimed 10 of the country's top 25 medicine brands were irrational. These included Digene ("useless antacid"), Becosules ("irrational vitamin combination") and Corex ("irrational cough mixture"). It also noted that the market potential for drugs is largely induced through marketing, advertising and distributional network. "The Indian household, which already spends about 6 per cent of its income on healthcare, ends up spending a lot of this large sum of money on such unnecessary medicines," says S. Sakthivel, a health economist who authored the chapter.
The problem, experts say, will remain till government policy does not explicitly acknowledge and address the presence of irrational medicines. "While the draft of the National Pharmaceuticals Policy, 2006, talks about building India as the preferred global destination of pharmaceuticals, it does not utter a word about these irrational medicines," says Bhargava.And for critics like him, this "anarchy" in the pharmaceutical industry simply does not square with its claim of being as good as the best in the world.
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