The Delhi High Court has requested the Centre's position regarding a petition that challenges the ban on fixed dose combination (FDC) drugs. The government, following the recommendations of an expert committee, announced the ban on 14 FDC drugs on June 2 this year. FDC drugs are medications that contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.
Court directs temporary protection for petitioner against ban
A pharmaceutical company, Glenmark Pharmaceuticals Ltd, has challenged the government's decision to ban the FDC drugs. The court has issued notice on three petitions filed by Glenmark Pharmaceuticals against the ban. Furthermore, the court has directed that FDC drugs produced by the petitioners, which are already in the distribution channel, should not be withdrawn. It also ordered that no coercive measures should be taken against them.
Interim measures and response from Centre
The court noted that the petitioner was manufacturing FDC drugs under various brand names such as Glencoff Q, Ascodex Dx Syrup, and Ascoril-C Syrup. It has been directed that the drugs already in the distribution channel should not be withdrawn, but no fresh manufacturing of the drug will be allowed until the next hearing.
"It is directed that the drugs which are already in the distribution channel shall not be withdrawn. However, no fresh manufacture of the drug will take place till the next date of hearing. In addition, no coercive steps will be taken against the petitioner for the drugs which are already in the distribution channel," ordered a vacation bench of Justices Jasmeet Singh and Vikas Mahajan last week.
The court also noted it had granted interim protection in 2018 to another pharmaceutical company for the drugs already in the distribution network in "somewhat similar circumstances".
The central government counsel has been given a two-week period to file a response to the petitions.
Petitioner challenges notification citing lack of specific reasoning
The petitioner claims to have manufactured the FDC drugs in question for over 30 years. It argued that the notification banning the FDCs only states that they may pose a risk to human beings without providing specific reasons, extent, or nature of the risk.
Experts Banned drugs and expert committee's findings
The banned drugs include combinations used for treating common infections, cough, and fever. Examples of these combinations are Nimesulide Paracetamol dispersible tablets, Chlopheniramine Maleate Codeine Syrup, Pholcodine Promethazine, Amoxicillin Bromhexine, and Bromhexine Dextromethorphan Ammonium Chloride Menthol, Paracetamol Bromhexine Phenylephrine Chlorpheniramine Guaiphenesin, and Salbutamol Bromhexine.
The expert committee had said there is "no therapeutic justification for this FDC (fixed dose combination) and the FDC may involve risk to human beings. Hence, in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act, 1940. In view of the above, any kind of regulation or restriction to allow for any use in patients is not justifiable".
"And whereas, on the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition the manufacture for sale, sale and distribution for human use of the said drug in the country," the government notification said.
Ban on 344 drug combinations & connection to currently banned FDCs
In 2016, the government announced a ban on the manufacture, sale, and distribution of 344 drug combinations. This decision was made after an expert panel, established at the request of the Supreme Court, concluded that these combinations were being sold to patients without sufficient scientific data. The manufacturers challenged this order in court. The currently banned 14 FDCs are part of the previously banned 344 drug combinations.
