Delhi HC seeks government view on validity of drug companies' licences
NEW DELHI: The Delhi High Court on Wednesday asked the government whether it
needed to consider the validity of licencesheld by pharma companies producing the
combination drugs that were recently banned, according to a lawyer present during the
proceedings. Justice RS Endlaw asked the government whether the court could proceed on the
premise that legitimacy of approval was not an issue, said the lawyer.
The government banned these drugs because they had no therapeutic justification, not on the
ground of legitimacy of approvals, government's counsel and Additional Solicitor General
(ASG) Sanjay Jain reportedly responded. At the same time, most of these firms did not hold
a valid licence to make the FDCs that the government recently banned, he added, according
to the lawyer. Endlaw has called on the government's counsel to respond to the arguments raised by
Pfizer's counsel, according to another lawyer present in the proceedings. The stay on the
ban has been extended by another day while the judge hears arguments of both sides in this
matter.
"The judge is going to frame questions now, on which both counsels have to argue," said
another lawyer representing a large pharmaceutical company in the proceedings. Following
Sibal's argument, the judge asked for notes of other companies' counsels, added the
lawyer.
"The court is of the view that almost all the points which arise in this matter have been
covered in the arguments on behalf of Pfizer," said a third lawyer. Other counsels have been
told to hold their arguments while the government responds to them.
Pharmaceutical lobby groups are among the petitioners at the Delhi High Court against the
government's FDC ban order. If the decision goes in their favour, even companies that
haven't approached court would get relief for their brands earlier banned for using one of the
344 combinations prohibited by the health ministry.
FDCs, cocktail drugs with two or more therapeutic ingredients in a single dose, are often
administered to treat multiple symptoms of an illness. The health ministry on March 10
banned 344 FDCs it found to be "irrational" and unsafe, which led to many popular medicine
brands being ordered off pharmacy shelves.
The Federation of Pharma Entrepreneurs (FOPE) and the Indian Drug Manufacturers
Association (IDMA) have petitioned the government's ban on all 344 FDCs at Delhi. A similar
petition by the Federation of South Indian Pharmaceutical Manufacturers Association
(FOSIPMA) refused to yield favourable judgement from the Madras High Court, which did
not grant a stay on the FDC ban on March 22.
NEW DELHI: The Delhi High Court on Wednesday asked the government whether it
needed to consider the validity of licencesheld by pharma companies producing the
combination drugs that were recently banned, according to a lawyer present during the
proceedings. Justice RS Endlaw asked the government whether the court could proceed on the
premise that legitimacy of approval was not an issue, said the lawyer.
The government banned these drugs because they had no therapeutic justification, not on the
ground of legitimacy of approvals, government's counsel and Additional Solicitor General
(ASG) Sanjay Jain reportedly responded. At the same time, most of these firms did not hold
a valid licence to make the FDCs that the government recently banned, he added, according
to the lawyer. Endlaw has called on the government's counsel to respond to the arguments raised by
Pfizer's counsel, according to another lawyer present in the proceedings. The stay on the
ban has been extended by another day while the judge hears arguments of both sides in this
matter.
"The judge is going to frame questions now, on which both counsels have to argue," said
another lawyer representing a large pharmaceutical company in the proceedings. Following
Sibal's argument, the judge asked for notes of other companies' counsels, added the
lawyer.
"The court is of the view that almost all the points which arise in this matter have been
covered in the arguments on behalf of Pfizer," said a third lawyer. Other counsels have been
told to hold their arguments while the government responds to them.
Pharmaceutical lobby groups are among the petitioners at the Delhi High Court against the
government's FDC ban order. If the decision goes in their favour, even companies that
haven't approached court would get relief for their brands earlier banned for using one of the
344 combinations prohibited by the health ministry.
FDCs, cocktail drugs with two or more therapeutic ingredients in a single dose, are often
administered to treat multiple symptoms of an illness. The health ministry on March 10
banned 344 FDCs it found to be "irrational" and unsafe, which led to many popular medicine
brands being ordered off pharmacy shelves.
The Federation of Pharma Entrepreneurs (FOPE) and the Indian Drug Manufacturers
Association (IDMA) have petitioned the government's ban on all 344 FDCs at Delhi. A similar
petition by the Federation of South Indian Pharmaceutical Manufacturers Association
(FOSIPMA) refused to yield favourable judgement from the Madras High Court, which did
not grant a stay on the FDC ban on March 22.
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