Drug controllers of southern states not acting on DCGI order on FDCs
Ramesh Shankar, Mumbai

Even as the state drug authorities of northern and central states of the country have started taking actions to withdraw manufacturing licences of irrational combination drugs, the four southern states are found to be hesitant in this regard.

The state drug authorities of Rajasthan, Maharashtra, Himachal Pradesh, etc have either started or contemplating actions on the DCGI directive on weeding out irrational combinations from the domestic market. In fact, they are waiting for the full list of irrational combinations from the DCGI who had held a meeting of northern state drug authorities in Simla recently.

Whereas Kerala, Karnataka, Andhra Pradesh and Tamil Nadu are yet to take any concrete steps on the DCGI directive. After all his pulls and pressures fell on deaf ears of the authorities, the DCGI had conducted a meeting of state drug authorities of the southern states in Chennai to convince them on the need to weed out irrational combinations. The DCGI is said to have made an emotional appeal to the state drug authorities in the Chennai meeting.

According to sources, the state drug authorities of Kerala and Tamil Nadu have not initiated any steps to withdraw licences issued to the irrational combinations. "So far no industry has received notice from the drug department in Tamil Nadu. But we are all ready to move court the moment we receive it," a senior industrialist from Chennai told Pharmabiz. The same is the case with Kerala and Andhra Pradesh also. In Karnataka, the authorities have reportedly taken some action.

The DCGI had verbally directed the state drug controllers to withdraw licenses issued by them to the irrational combination drugs in the Drugs Consultative Meeting held in Delhi in the first week of June this year. As the state drug controllers insisted on a written directive in this connection, the DCGI sent a detailed list of more than 1000 combination drugs to be withdrawn from the market.

As the state drug authorities conveniently sat over the file, the DCGI started a regional level meeting of state drug controllers to keep the pressure on them. Now, the DCGI is to meet the state drug controllers at NIPER on October 25 to review the entire exercise.

Source: www.pharmabiz.com
11th October 2007

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