Monday, May 30, 2011

ayush drugs- unfit for human consumption?

Over 100 'traditional' drugs found unsuitable for humans sold openly in India
Neetu Chandra | New Delhi, May 30, 2011 | Updated 09:08 IST
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Many common alternative drugs failed tests for export.
It's shocking, but true. Hundreds of popular ayurvedic, homoeopathic and Unani medicines, which have been declared as either "unfit for human consumption", or have otherwise failed to pass essential quality tests for becoming eligible to be exported, are being freely sold in medical stores in Delhi and elsewhere.

Even more shockingly, these drugs have been certified unsafe by a government testing lab. But the Delhi government authority responsible for ensuring compliance with the rules on the part of manufacturers and sellers - the drug control department - professes to be unaware of the practice! "We have no information of such a practice. We will look into the matter seriously," said Ravi Kant, drug controller of Delhi AYUSH (ayurveda, Unani, Siddha and homoeopathy), department of the ministry of health and family welfare.

Nevertheless, scores of such formulations, which have failed to meet the export quality test, are doing brisk business in Delhi drugstores.

According to documents available, over 100 medicines failed to pass quality tests due to "substandard" quality, presence of heavy metals, or prohibited drugs and/or prescription allopathic drugs in alleged "herbal" medicines, are all being openly sold in the market.

Such prohibited content can have adverse and serious effects on the human body on consumption, health experts confirmed.

For instance, 'Missile Power' capsules and 'Xtra Power' capsules, tested at the government of India's Pharmacopoeial Laboratory for Indian Medicine in Ghaziabad, were found to contain Sildenafil Citrate, the chemical in prescription drug Viagra.

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This is not allowed in Ayurveda products, but both were found to be readily available in medical stores visited by this correspondent.

These capsules are consumed for enhancing sexual performance.

Even drugs meant for children were not spared. 'N Tone' syrup (a paediatric tonic for newborns) manufactured by On Ayurvedics, when tested, was found unfit for human consumption as it contained suspended particles.

The tonic is easily available on the internet and in homeopathic stores.

'Mrit Sanjivani Sura', medicinal syrup manufactured by Dabur India Limited, was found exceeding the legal limit of alcohol content, 16 per cent. The tested sample was found to contain 20.56 per cent alcohol.

Samples from other manufacturers of the same syrup, namely Leo Pharma and Rajan Ayurvedics, also failed to pass alcohol limit test. Woodland's medicated Gripe Water, manufactured by Tilak Pharmaceuticals Delhi, which claims to have 'soya seed', failed as there were no soya seeds in it.

While some like ' Panchskar churna' by Sahay Ayurvedic Pharma, failed as the composition and ingredients were not mentioned on the label, others like 'Doctor's Pudin Hara', manufactured by Bandish Chemicals, and Zinzoxin and Fenu Green by Bajaj Herbocare, failed because of prohibited substances, like Methanol, in them.

'Brahmi Vati' by Universal Medicaments, failed as it contained prohibited concentrations of heavy metals. The popular ayurveda medicine 'Rasayan Vati' was found to have exceeded the limit for Cadmium.

'Metascab' ointment was found exceeding limits of Lead and Arsenic, while Debbix tablets were found exceeding limits of lead and cadmium.

Homeopathic medicines Elixir Vita 8 manufactured by Welmans's Homeopathy Delhi and Gastrocin which are used in gastric disturbances, was found to contain alcohol in excess of permissible limits. Alfalfa Q for tiredness and fatigue also failed in alcohol content. Many homeopathic drugs were found in contravention of the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954, like Gro-T Tablet by Holistic Remedies, Bio force AG and Heightex.

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According to the act, treatment for certain diseases cannot be offered through advertisements. These drugs were found claiming to offer treatment by mere consumption of these drugs.

The authorities only appear to be concerned about preventing such medicines from being exported, since overseas health regulations do not permit such formulations.

"We have strictly issued a circular that herbal medicines found with heavy metals would not be exported to other countries. There is no regulation to curb the practice in India. Other countries refused to accept the India-made Ayurveda medicines with metals," said a senior official with the department of drug controls for alternative medicine, AYUSH. The government has fixed the permissible limits of heavy metals in ayurveda and Unani medicines with only herbal ingredients, which are in line with World Health Organisation and US Food and Drugs Administration norms. These limits are 10 parts per million (ppm) for lead, 0.030 ppm for cadmium, 3.0 ppm for arsenic and 1 ppm for mercury.

The Centre, vide its order dated October 14, 2005, has made testing for heavy metals, namely arsenic, lead, mercury and cadmium, mandatory for export purposes in respect of every batch of purely herbal ayurveda, Siddha and Unani medicines by every licensee.

In view of the regulatory requirements of the importing country, the manufacturer is supposed to submit batch- wise testing reports from approved laboratories certifying that the medicines contains heavy metals within permissible limits.

Only after obtaining the certificate can manufacturers export these medicines to other countries. These tests reports were revealed in an RTI reply to Ramesh Verma an RTI activist. "Someone informed me about this rampant practice. I wanted to expose these manufactures so, I filed the RTI," said Verma.

"Drugs that attract the magic remedies acts are mostly the drugs that claim to increase masculine power. These are easily available in the market and are fooling people.

There should be a proper action against the concerned people," Dr P. N. Varma, former director, Central Council for Research in Homeopathy, said.

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