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Pharma industry opposes the move to weed out irrational drug combinations
Joseph Alexander, New Delhi | Tuesday, July 17, 2007, 08:00 Hrs  [IST]

The Union Health Ministry is under intense pressure from pharmaceutical industry bodies after DCGI issued the order to the State drug authorities to act tough on irrational combinations. The state drug authorities are likely to be asked now to act in phases, it is learnt.

"There were a few informal representations from the industry on the issue, after the DCGI issued orders to withdraw licences of irrational combination drugs. We are studying the matter. But at the same time, we are determined to curtail the toxic effects of these drugs can cause in the long run,'' said a senior official from the Ministry.

The DCGI has recently written to the State Drug Controllers asking them to withdraw the licenses of over 1000 irrational combination drugs, prompting the industry to take up the issue with the authorities. The DCGI is reportedly following up the order further by assessing the actions taken by each State in this regard.

Sources in the Ministry however, said that the massive mission of taking the irrational drug combinations off the shelves of chemists across the country would now be done in a phased manner. The government may now categorise the combinations in three parts and only those which would be assessed toxic would be banned.

In the past, government used to identify the combination drugs which were not supported with clinical trials. They would be exempted on the grounds that they are safe. The second category will have the combination drugs which require further investigations to prove the safety and the action would be deferred till the final observation on safety is made. And the axe would thus fall only on those who have been defined toxic.

If the current plans are implemented, the number of irrational combination drugs, which need to be banned from the market, would come down drastically in effect, much to the cheers of the industry which has been stalling similar attempts by the authorities for many years now. It is reliably learnt that the authorities and the industry have already reached some understanding in this regard.

Authorities, who tried to act on the issue many times in the past, realized that withdrawal of combination drugs from the market at a go would be impossible and they would be inviting the wrath of some large companies.

But the officials at the DCGI office admitted that many companies were making irrational combinations to maximize their profit and it should be changed. This would also mean check on the proliferation of untested medicines.

After the order of the DCGI came, the industry associations were planning to put the onus of proving the irrationality of the drug combination on the drug control department of the state government.

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