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Industry puts onus on state drug depts to prove combination drugs as irrational
Ramesh Shankar, Mumbai | Monday, June 25, 2007, 08:00 Hrs  [IST]

Even as the government is going ahead with its plan to order state governments to withdraw licenses to more than 1000 'irrational' combination drugs in the country, the pharmaceutical industry is taking up the matter first with the health ministry, it is learnt.

According to industry sources, if the government starts acting on license withdrawal, the industry will put the onus of proving irrationality of the drug combination on the drug control department of the state government which had issued licenses to the pharma companies. "If that fails, the industry will be left with no other option but to move court," a senior industry association leader said.

"It is the government which had given us the license to manufacture the combination drugs. One morning, if the government says these drugs are irrational, the concerned government department has to prove that it is irrational," Confederation of Indian Pharmaceutical Industry (CIPI) chairman TS Jaishankar fumed adding, "Several crore of investments are at stake".

Refuting the theory that the increase in spurious drugs has anything to do with the combination drugs, he said the combination drugs have proved its efficacy as doctors are increasingly prescribing these products. It has been there in the market for many years. There has never been any case of adverse effect of combination drugs on the patients. In fact, it is becoming popular in other countries also. "If these drugs were irrational, the government should not have given the license then. The government is taking the industry for a ridem," Jaishankar said.

As per a conservative estimate, there are more than 5000 combination drugs in the market in the country which were introduced to the market as a cost effective measure. The combination drugs are doing well in the market, not only in India but also several poor countries. But, the combinations drugs are not accepted in US, Europe and other developed nations as the people of these countries frown upon the combination drugs as they suspect its efficacy and safety.

Concerned over the increasing reports of counterfeit drugs in the market, the Drug Control General of India (DCGI) Dr M Venkateswarlu recently sent a directive to state drug controllers to withdraw license to irrational combination drugs. The DCGI is learnt to have bracketed more than 1000 combination drugs as irrational for removing them from the market.

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