The government is planning to approach Chennai High Court to allow marketing of 50 of the 294 fixed dose combinations (FDCs) drugs that it had ordered to be withdrawn in July 2008.

The drug regulator, drug controller general of India (DCGI) has evaluated the 50 FDCs and has found them effective without any side effects. The list includes medicines for diarrhoea, antibiotics and anti-hypertension drugs.

The 294 FDCs of medicines withdrawn from the market were meant for the treatment of diseases including tuberculosis, hepatitis and normal fever.

Before they were withdrawn from the market these 294 FDCs of

drugs contributed about

Rs 3,500 crore in the domestic market. The 50 FDCs that the DCGI office is planning to make available through Chennai High Court’s intervention are estimated to be worth over 550 crore, an official at DCGI office told Financial Chronicle.

“The sub-committee on FDCs headed by DCGI has given approval to over 50 FDCs. The proposal has been approved by Drug Technical Advisory Board (DTAB),” the official said.

The committee would continue to assess other drugs that were withdrawn after the court order and if found safe without significant side effects, it would appeal to the court to allow them to be sold in the domestic market.

“It is a welcome move especially for small scale drug manufacturers. The FDCs sold under different brand names have been there is the market for quite some time and have not been reported for adverse drug reactions,” Lalit Jain vice-chairman SME Pharma Industries Confederation said.

FDC drugs are combinations of two or more medicines with a fixed single dosage. Combination products have advantages of combination therapy as well as advantages related to reducing number of pills to be taken. It also reduces the number of prescriptions and hence the cost.

The DCGI has asked drug inspectors to review remaining combination drugs that were earlier given marketing approval. There are no standard guidelines for state drug regulators or the Centre to grant marketing approvals of FDC drugs.

Medical experts, however, advocate caution while allowing FDCs in the market for sale saying that combining drugs would alter the safety profile of established drugs. "The safety of the combination drugs has to be thoroughly evaluated. One cannot mix two drugs whose dosage schedules are not same," CM Gulati, editor of a medical journal said.