FDC Ban: Supreme Court Relief to Saridon, Piriton and Dart
Supreme court lifted the ban on the sale of Piramal Healthcare's Saridon, GlaxoSmithKline's Piriton, Juggat Pharma's Dart and another drug, banned FDCs combination by Health Ministry.
New Delhi: Painkiller Saridon will be available at medical stores across the country, with the Supreme Court on Monday allowing the sale of the drug, along with three other banned fixed-dose combinations (FDCs). This, however, is an interim relief company said, as the apex court is yet to take a final decision on the matter.
A Bench of Justices R F Nariman and Indu Malhotra issued a notice to the Centre and sought its reply on the plea filed by some drugmakers and pharma associations.
The medicines whose sale was allowed were Piramal Healthcare's Saridon, GlaxoSmithKline's Piriton, Juggat Pharma's Dart and another drug, the details of which could not be immediately known.
"The court has passed an interim order permitting us (and other pre-1988 manufacturers who were excluded from the exempt list) to continue manufacturing and sale of the product, subject to its final decision on our application," said a GSK Pharmaceuticals spokesperson.
The top court, however, did not grant any relief to the other medicines in the list of 328 FDC drugs, which were banned by the Health Ministry by its September 7 notification. FDCs are two or more drugs combined in a fixed ratio into a single dosage form.
Read also: 328 FDC Medicines banned over safety concern: Health Ministry Notification
The Delhi High Court had earlier allowed Indian pharma major Wockhardt to sell its Ace Proxyvon tablets, which is a mixture of three salts — aceclofenac, paracetamol and rabeprazole — a combination that is banned.
The pharma company, which claimed to have been manufacturing and selling the drug for over 11 years, had contended that it has not been provided with the Drugs Technical Advisory Board (DTAB) report, based on which the decision was taken.
Read Also: Ace Proxyvon Banned: Wockhardt moves Court against a ban on Aceclofenac, Paracetamol, Rabeprazole Combo
It had claimed that the only reason given in the September 7 notification was that the combination had no therapeutic value. The medicine is reportedly prescribed for people with painful rheumatic conditions, such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
The health ministry had, through a notification of March 10, 2016, prohibited 349 FDCs for manufacture, sale and distribution under Section 26A of the Drugs and Cosmetics Act, 1940. The notification was then contested by pharma companies in the Delhi High Court and the Supreme Court.
The high court in December 2016 had quashed the ban on the FDCs, which was challenged by the Centre in the apex court.
The top court had in December last year set aside the high court order and referred the banned FDCs to DTAB for re-examination.
Complying with the apex court direction, an expert panel set up by DTAB, in its report to the Centre, had stated that there was no therapeutic justification for the ingredients contained in 328 of the 349 FDCs, which may also involve risk to humans.
The board had recommended that it was necessary to prohibit the manufacture, sale or distribution of these FDCs under the Drugs and Cosmetics Act, 1940 in larger public interest.
Read Also: Health Ministry bans 328 FDC Banned Drugs, check out the complete list
New Delhi: Painkiller Saridon will be available at medical stores across the country, with the Supreme Court on Monday allowing the sale of the drug, along with three other banned fixed-dose combinations (FDCs). This, however, is an interim relief company said, as the apex court is yet to take a final decision on the matter.
A Bench of Justices R F Nariman and Indu Malhotra issued a notice to the Centre and sought its reply on the plea filed by some drugmakers and pharma associations.
The medicines whose sale was allowed were Piramal Healthcare's Saridon, GlaxoSmithKline's Piriton, Juggat Pharma's Dart and another drug, the details of which could not be immediately known.
"The court has passed an interim order permitting us (and other pre-1988 manufacturers who were excluded from the exempt list) to continue manufacturing and sale of the product, subject to its final decision on our application," said a GSK Pharmaceuticals spokesperson.
The top court, however, did not grant any relief to the other medicines in the list of 328 FDC drugs, which were banned by the Health Ministry by its September 7 notification. FDCs are two or more drugs combined in a fixed ratio into a single dosage form.
Read also: 328 FDC Medicines banned over safety concern: Health Ministry Notification
The Delhi High Court had earlier allowed Indian pharma major Wockhardt to sell its Ace Proxyvon tablets, which is a mixture of three salts — aceclofenac, paracetamol and rabeprazole — a combination that is banned.
The pharma company, which claimed to have been manufacturing and selling the drug for over 11 years, had contended that it has not been provided with the Drugs Technical Advisory Board (DTAB) report, based on which the decision was taken.
Read Also: Ace Proxyvon Banned: Wockhardt moves Court against a ban on Aceclofenac, Paracetamol, Rabeprazole Combo
It had claimed that the only reason given in the September 7 notification was that the combination had no therapeutic value. The medicine is reportedly prescribed for people with painful rheumatic conditions, such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
The health ministry had, through a notification of March 10, 2016, prohibited 349 FDCs for manufacture, sale and distribution under Section 26A of the Drugs and Cosmetics Act, 1940. The notification was then contested by pharma companies in the Delhi High Court and the Supreme Court.
The high court in December 2016 had quashed the ban on the FDCs, which was challenged by the Centre in the apex court.
The top court had in December last year set aside the high court order and referred the banned FDCs to DTAB for re-examination.
Complying with the apex court direction, an expert panel set up by DTAB, in its report to the Centre, had stated that there was no therapeutic justification for the ingredients contained in 328 of the 349 FDCs, which may also involve risk to humans.
The board had recommended that it was necessary to prohibit the manufacture, sale or distribution of these FDCs under the Drugs and Cosmetics Act, 1940 in larger public interest.
Read Also: Health Ministry bans 328 FDC Banned Drugs, check out the complete list
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