Glenmark Pharma files petition against ban on certain FDC drugs: Delhi HC seeks Centre stand
The court observed that the petitioner was manufacturing FDC drugs under various brand names such as Glencoff Q, Ascodex Dx Syrup, Ascoril-C Syrup, and others.
New Delhi: The Delhi High Court has sought the Central government's response on a petition filed by a pharmaceutical company challenging the ban on manufacturing, selling, and distributing certain Fixed Dose Combination (FDC) drugs for human use.On June 2, the government announced a ban on 14 FDC drugs based on recommendations from an expert committee, stating that these medicines had...
New Delhi: The Delhi High Court has sought the Central government's response on a petition filed by a pharmaceutical company challenging the ban on manufacturing, selling, and distributing certain Fixed Dose Combination (FDC) drugs for human use.
On June 2, the government announced a ban on 14 FDC drugs based on recommendations from an expert committee, stating that these medicines had no therapeutic justification and might pose risks to people.
Read also: No therapeutic justification: Central Government bans 14 FDCs for human use
FDC drugs are medications that contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.
A vacation bench of Justices Jasmeet Singh and Vikas Mahajan issued notices for three petitions filed by Glenmark Pharmaceuticals Ltd against the ban.
The court observed that the petitioner was manufacturing FDC drugs under various brand names such as Glencoff Q, Ascodex Dx Syrup, Ascoril-C Syrup, and others.
However, the court directed that the FDC drugs produced by the petitioner, which are already in distribution, should not be withdrawn and no coercive actions should be taken against them.
The court clarified that no fresh manufacturing of these drugs would be permitted until the next hearing.
The petitioner was also asked to provide details about their existing stock and the medicines currently in circulation.
The court gave central government counsel a two-week period to respond to the petitions and posted the matter for hearing next on July 3.
Read also: Glenmark gets CDSCO panel nod for Phase III CT of antidiabetic FDC drug
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