The Delhi High Court has issued notice to the Centre while dealing with a plea challenging the ban on FDC (Fixed Dose Combination) Drugs and granted a time of 2 weeks to file a reply for the same.

A Division Bench of Justice Jasmeet Singh and Justice Vikas Mahajan directed, “Issue notice. Mr. Kirtiman Singh, learned CGSC accepts notice, seeks and is granted 2 weeks to file a reply. … In somewhat similar circumstances, this Court in WP(C) 9739/2018 dated 14.09.2018 granted interim protection for the drugs already in the distribution network. Hence, it is directed that the drugs which are already in the distribution channel shall not be withdrawn.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.”

The Bench further said that no coercive steps will be taken against the petitioner company for the drugs which are already in the distribution channel.

Senior Advocate Darpan Wadhwa and Advocate Ajay Bhargava represented the petitioner company while CGSC Rakesh Kumar and CGSC Kirtiman Singh represented the Centre.

In this case, a plea was filed seeking writ, order, or direction to set aside the notification dated June 2, 2023, issued by the Central Government prohibiting manufacture for sale and distribution for human use, the FDC of Ammonium Chloride + Bromhexine + Dextromethorphan with immediate effect. The petitioner i.e., Glenmark Pharmaceuticals Limited was engaged in the manufacturing of the said FDC under the brand name ‘Ascodex Dx Syrup’ for over the last 30 years.

As per the petitioner, the aforesaid notification only stated that the FDC may involve risk in human beings without specifying the reasons/extent and the nature. It further contended that the FDC has been in the market for more than 30 years.

The High Court in the above regard noted, “The parties will complete the pleadings and list the matter before the Roster Bench on 03.07.2023.”

The Court observed that the petitioner will file the details of their stock before the next date of hearing and will give the affidavit of stock in circulation.

Accordingly, the Court sought a response from the Centre.

Cause Title- Glenmark Pharmaceuticals Limited & Anr. v. Union of India & Anr.

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