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Panels to decide on combo drugs (1) 17-May-08 20:43

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Posted by: stox & more on ( 17-May-08 20:43 )

The controversial fixed dose combination (FDC) drugs issue may soon see an end. Drug companies and the government have formed separate technical committees to jointly decide which of the 294 combination drugs can be phased out and how many can remain in the market. A series of discussions may be held next week. Confederation of Indian Pharmaceutical Industry (CIPI) has agreed to voluntarily stop manufacturing and selling 11 drugs which the government wants to ban. It will now sort out through �a product by product examination of each FDC medicine by the two technical committees� to check their efficacy and safety. Combination drugs essentially combine two drugs to provide multiple thereupatic treatment in the same dosage form. They account for about 10% of the total Rs 32,000 crore domestic retail market. Drug Controller General of India, Dr Surinder Singh told ET: �The government will have an internal assessment of these drugs by a technical team headed by Dr YK Gupta of AIIMS and follow it up with a series of discussion with the industry. We will allow the industry to sell those drugs which are scientifically effective and safe.� CIPI secretary general Jai Shankar said: �We have formed a four-member technical committee of pharmacists. The industry will try to establish the efficacy and the safety of each medicine to the government.� For those drugs which need clinical trials, the industry will seek six months time to prove their efficacy. However, in the meantime, they should be allowed to remain in the market, he added. CIPI, a body of around 7,000 small scale drug manufacturers, has been spearheading the fight against the Indian drug regulator attempt to completely weed out the FDC drugs. It had moved the Chennai High Court last year against the government�s order and subsequently received a stay order. One could expect a large number of drugs to stay in the market. The former DCGI Dr M Venkateshwarlu had earlier hinted at allowing companies to sell 78 combo drugs, if they can prove that the individual drugs in the combo drugs have the same efficacy and safety in the combined form as they do independently. While the industry has maintained that these combination drugs have been in the market for a long time without any adverse effect, the government says that these drugs were approved by the state drug regulators without the requisite clearances from the central drug regulator. Khomba Singh, TNN - ET

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