The Delhi High Court has stayed the September 7 government ban on 328 fixed dose combination (FDC) drugs to allow the sale and distribution of already manufactured stock of the banned drugs. This offers an an interim relief to almost ten major pharmaceutical players.
The companies have also been directed to file an affidavit with the court indicating the ‘batches already manufactured by them to ascertain the quantity.
No coercive action would be initiated against the manufacturers, stockists as well as dealers of the banned FDC drugs, as per the court directive which allows the sale of FDC drugs for the time being.
The High Court, however, directed the companies to cease all manufacturing operations with regard to the banned FDC drugs, which was readily agreed to by the companies.
The pharmaceutical companies which were before the High Court today, against the September 7 notification of the Union Health Ministry, are Coral Laboratories Ltd, Lupin Ltd, Obsurge Biotech Ltd, Mankind Pharma Ltd, Koye Pharmaceuticals Private Ltd, Glenmark Pharmaceuticals Ltd, Wockhardt Ltd, Alkem Laboratories Ltd, Macleods Pharmaceuticals and Laborate Pharmaceuticals.
FDCs are two or more drugs combined in a fixed ratio into a single dosage form.
Additional Solicitor General Maninder Kaur Acharya, appearing for Centre, informed the Court that the sub-committee of the Drugs Technical Advisory Board (DTAB) had banned these FDC drugs due to “Pharmacokinetic mismatch” between the drugs.
She explained that each drug is prescribed and its dosage is recommended keeping in mind its reaction with the body, amongst other things. However, in the case of the banned combination drugs, it was not possible to reconcile the adequate dosage for each component drug. Hence, “this would lead to either over-exposure or low-exposure of one of the combined drugs“, she submitted.
At times, Acharya stated, “the body may not even need all the combined drugs simultaneously“.
Justice Vibhu Bakhru, after hearing Wockhardt and Alkem Laboratories at length, directed the Centre to “specifically indicate”, for each ailment and its respective FDC, how its consumption would result in “lower” or “higher” dose. The Court also directed it to submit any material which was relied upon by the Sub-Committee to arrive at a conclusion that an FDC had no therapeutic value, and was instead harmful.
Stating that the Court would not “supplant its own views” over that of an expert body, Justice Bakhru said that the Court would nonetheless inquire if the sub-committee “went into the requisite in-depth examination” while arriving at the conclusion.
All India Drug Action Network (AIDAN) also sought for the Court’s permission to be impleaded as a party to the batch of petitions.
ASG Acharya also informed the Court that given the multiplicity of litigation over the FDC ban across various fora in the country, Central Government may move a transfer application before the Supreme Court.
The matter would be next heard by the High Court on September 27.
