|
Delhi HC grants two weeks to Centre to file reply related to notification prohibiting certain FDCs
|
|
Gireesh Babu, New Delhi
June 21 , 2023
|
|
|
The Delhi High Court has allowed two weeks to the Central Government to file reply in connection with a writ petition filed by a pharma company seeking the Court’s directions to set aside a notification issued by the Union health ministry prohibiting manufacturing and sale for human use of certain fixed dose combinations.
The order is in the backdrop of the Ministry of Health’s notifications on June 2, 2023, prohibiting manufacturing, sales and distribution of 14 fixed dose combinations (FDCs) licensed prior to the year 1988, including cough syrups, anti allergy drugs and pain relief drugs with immediate effect, following advice from an expert committee that these drugs may involve risk to human beings.
A division bench comprising Justice Jagmeet Singh and Justice Vikas Mahajan, referring to an earlier order, directed that the drugs which are already in the distribution channel should not be withdrawn, but no fresh manufacture of the drug will take place till the next date of hearing. The Court referred to an earlier order by the Delhi High Court on September 14, 2018, which granted interim protection for the drugs already in the distribution network.
“In addition, no coercive steps will be taken against the petitioner for the drugs which are already in distribution channel,” directed the Court, adding that the petitioner should file the details of their stock before the next date of hearing and give the affidavit of stock in circulation. The matter is now listed for hearing on July 3, 2023 before the Roster Bench.
The Central Government Standing Counsel (CGSC) Kirtiman Singh accepted the notice issued by the Court. The CGSC sought two weeks’ time to file a reply and the same was granted by the Court.
The petition was filed by Haryana-based Seagull Laboratories Ltd against the government’s order prohibiting manufacture for sale and distribution for human use, of the FDC of ammonium chloride + sodium citrate + chlorpheniramine maleate + menthol (100mg + 40mg + 2.5mg + 0.9mg), (125mg + 55mg + 4mg + 1mg) , (110mg + 46mg + 3mg + 0.9mg) & (130mg + 55mg + 3mg + 0.5mg) per 5ml syrup.
The petitioner argued that it has been manufacturing cough syrup under the brand name Capex Expectorant for over 40 years containing chlorpheniramine maleate I.P 4mg, ammonium chloride I.P 125mg, sodium citrate I.P 55mg and menthol I.P 1mg, which are all non-narcotic and non-habit-forming ingredients.
The company said that in the notification under challenge, it is only stated that the FDC may involve risk in human beings without specifying the reasons/extent and the nature. Besides, its product has been in the market for more than 40 years, it added.
According to news reports, a Mumbai-based pharma company also approached the Delhi High Court and received similar orders after challenging the Ministry’s order, which would result in prohibition of its multiple products which are in the market for more than 30 years.
The drugs prohibited through the notification include nimesulide+ paracetamol dispersible tablets, amoxicillin+ bromhexine, pholcodine + promethazine, chlorpheniramine maleate + dextromethorphan + guaiphenesin + ammonium chloride + menthol, chlopheniramine maleate + codeine syrup, ammomium chloride + bromhexine + dextromethorphan, bromhexine + dextromethorphan + ammonium chloride + menthol, dextromethorphan + chlorpheniramine + guaiphenesin + ammonium chlorid, paracetamol + bromhexine + phenylephrine + chlorpheniramine + guaiphenesin, salbutamol + bromhexine, salbutamol + bromhexine, phenytoin + phenobarbitone sodium, ammonium chloride + sodium citrate + chlorpheniramine maleate + menthol (100mg + 40mg + 2.5mg + 0.9mg) , (125mg +55mg+4mg+1mg), (110mg+46mg+3mg+0.9mg) and (130mg+55mg+3mg+0.5mg)per 5ml syrup and salbutamol + hydroxyethyltheophylline (etofylline) + bromhexine.
The health ministry in its notification on June 2, said that the matter related to these FDCs was examined by an Expert Committee constituted by the Government of India which furnished its report on April 1, 2022 to the Central Government and the Drugs Technical Advisory Board (DTAB) agreed to this expert committee report.
The expert committee recommended, “There is no therapeutic justification for this FDC 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 26A 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. Therefore, only prohibition under Section 26A is recommended”.
Section 26A provides powers to the Central government to regulate or restrict, manufacture etc. of drugs in public interest, by notification in the Official Gazette.
“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,” said the separate notifications issued on the 14 FDCs by the Ministry.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|