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drugs. Clinical trials are a must for these drugs for verifying their safety/efficacy profile, as also specified documentation. In practice, however, state licensing authorities routinely give approvals for new FDCs. A move is on to shift the licensing powers to the Centre under the Central Drug Authority Bill, which is pending in Parliament.
“There are doubts about the rationality of the FDC drugs (regarding which directions have been issued) and they may not be of any use to patients,” a health ministry official said.
The Central Drugs Standard Control Organisation (CDSCO) in March this year issued a comprehensive list of FDC drugs approved by DCGI which includes a total of 1,125 FDCs covering all therapeutic categories. This list is meant to be a ready reckoner for state regulators as well as doctors and patients.
A recent report in the International Journal of Basic & Clinical Pharmacology on "the irrational fixed-dose combinations in the Indian drug market" states that out of 278 FDCs (the report studied), only 5.4% were rational, and rest of the FDCs were irrational. Moreover, the most commonly prescribed FDCs were B complex, pantoprazole plus domperidone and amoxicillin plus clavulanic acid, said the report.
In 2007, the DCGI had come down heavily against sale of irrational combination medicines and states were asked to withdraw 294 FDCs that were licensed without the regulator's approval. However, the industry got a stay order on these FDCs from the Madras High Court. The matter is still sub judice, and a decision on these 294 FDCs will be taken after the outcome of the case, said the DCGI.
Recently, a parliamentary panel on health had also rapped the government on approving drugs without clinical trials and harmful fixed dose combinations. It had said "this inaction has led to unhindered marketing of these drugs with unknown and unspecified risks to unsuspecting people".