DCGI may move Supreme Court on FDC issue if drug cos resist
Ramesh Shankar, Mumbai

The DCGI is likely to move Supreme Court on the FDC issue if the pharmaceutical companies succeed in bringing any legal hurdles in enforcing the order on irrational combinations. Some of the drug companies have approached the Madras High Court and understood to have obtained a stay against DCGI order last week.

The legal department of the Union health ministry has already been alerted on the issue and is waiting for a copy of the order for taking further decision in this regard.

"I am yet to receive a copy of the order and study the court directive. Now I don't even know whether I am a party to it or not. After carefully studying the order, we will decide the next course of action including the option of moving Supreme Court to take the issue to its logical conclusion", DCGI told Pharmabiz.

Even though the Madras High Court had granted a stay order on November 7 against the DCGI order, the judge is yet to sign the order. There are doubts about the nature of the order, whether the jurisdiction of the order is limited to Pondicheryy state alone or it has extra-territorial jurisdictions. Some lawyers are of the opinion that since the order stayed by the court is of central government, it might apply to all over India.

The Madras High Court was moved by five pharma companies in Pondicherry under the aegis of Federation of South Indian Pharmaceutical Manufacturers Association (SIPMA). These pharma companies, along with others, had received notices from the Pondicherry state drug controllers asking them to stop production of 294 FDCs listed by the DCGI.

Source: www.pharmabiz.com
15th November 2007

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