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Delhi HC to take up matter related to ban on cough syrup first
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Gireesh Babu, New Delhi
September 05 , 2023
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The Delhi High Court has decided to hear the matter related to the Central government's notification banning chlorpheniramine maleate + codeine syrup to be taken up first when the hearing starts related to the prohibition of 14 fixed dose combinations through orders on June 2, 2023.
The Division Bench of the High Court comprising Chief Justice Satish Chandra Sharma and Justice Sanjeev Narula in an order on August 28, also granted a week's time to the learned counsel appeared on behalf of the Union of India to file reply in all the connected matters on cases filed by the companies against the notifications.
According to the latest data, more than 50 companies have sued the Union government and the Drugs Controller General (India) against the notifications.
Kirtiman Singh, the counsel appearing for the Union of India prayed before the Court that the matters arising out of the notification S.O.2398 (E) be taken up first for hearing and the prayer was not opposed by the other side.
"Accordingly, it is made clear that, when hearing commences in the present matters, matters arising out of Notification S.O.2398(E) will be taken up first," said the daily order issued by the Bench. The matter is listed on September 22, now and the Court said that the interim orders will continue.
Some of the brands that could have an impact of the ban of the FDC mentioned in the particular notification include Dr Reddy's Laboratories' Dialex-DC, Glenmark Pharmaceuticals' Ascoril-C syrup, Glencoff-C syrup and Ascodex-C syrup, among others.
According to the series of notifications issued by the Union Government on June 2, 2023, S.O.2398 (E) prohibits the manufacture for sale, sale and distribution for human use of the FDC of chlopheniramine maleate + codeine syrup as an expert committee recommended that "there is no therapeutic justification for the ingredients contained in this FDC and the FDC may involve risk to human beings."
"Hence in 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," it added. The decision was also based on the recommendations of the Drugs Technical Advisory Board.
The companies approached various High Courts in the country against the ban and the Delhi High Court, directed in separate petitions filed by the companies that the order passed by a Coordinate Bench in Lupin Ltd and another vs Union of India and another in a similar matter on June 28, 2023 shall apply mutatis mutandis in respect of the drugs which are subject matter of these writ petitions. The legal term mutandis, according to experts, means that the order will apply to the other cases with necessary changes, but with the main points remaining the same.
The Interim Order on June 28, 2023 based on a petition from Lupin Ltd and another, 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,” said the Order. It also clarified that the direction against taking of coercive action would apply with respect to stocks manufactured on or before June 2, 2023 and that the distribution channel would cover all persons including stockists, wholesalers, retailers etc., with whom the stocks or the drug in question may be present after they have left the premises of the petitioner.
The Court also sought the petitioners to file details of the stock of their respective drugs as on the date of hearing before the next date of hearing and also give an affidavit of stock in circulation.
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