Delhi HC seeks Centre's stand on challenge to ban on fixed dose combination drugs
New Delhi, Jun 19: The Delhi High Court has sought the stand of the Centre on a petition by a pharmaceutical company challenging the government's decision to ban manufacture, sale and distribution for human use certain Fixed Dose Combination (FDC) drugs.
FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.
While issuing notice on three petitions by Glenmark Pharmaceuticals Ltd against the ban, the court directed the FDC drugs produced by the petitioners that are already in the distribution channel shall not be withdrawn and no coercive steps will be taken against them.
The petitioner was producing FDC drugs under the brand names Glencoff Q, Ascodex Dx Syrup, Ascoril-C Syrup and others, the court noted.
The government had announced a ban on 14 FDC drugs on June 2 this year on the recommendations of an expert committee, saying there was "no therapeutic justification" for these medicines and they may involve "risk" to people.
The court clarified no fresh manufacture of the drugs would take place till July 3, the next date of hearing, and asked the petitioner to file the details of their stock as well as the medicines in circulation.
"It is directed that the drugs which are already in the distribution channel shall not be withdrawn.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".
It granted two weeks to the central government counsel to file a response to the petitions.
The petitioner said it was manufacturing the FDC drugs in question for the last over 30 years.
It claimed the notification banning the FDCs only stated they may involve risk to human beings without specifying the reasons, extent and the nature.
The banned drugs included those used for treating common infections, cough and fever -- combinations such as 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.
In 2016, the government had announced a ban on manufacture, sale and distribution of 344 drug combinations after an expert panel, set up at the behest of the Supreme Court had stated they were being sold to patients without scientific data. The order was challenged by the manufacturers in court.
The currently banned 14 FDCs are part of those 344 drug combinations.
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Ordinance issued to increase number of Supreme Court judges from 34 to 38
New Delhi (PTI): The government has promulgated an ordinance to increase the strength of the Supreme Court from the present 34 judges to 38, including the Chief Justice of India.
The law ministry notified the ordinance on Saturday, which amended the Supreme Court (Number of Judges) Act, 1956, to increase the sanctioned strength of the top court.
So far, the sanctioned strength of the top court was 34, including the Chief Justice of India (CJI). Now, the number of judges has been increased by four, taking the sanctioned strength to 38.
The top court will now have 37 judges, other than the CJI.
With the apex court having two vacancies at present, and the ordinance coming into force immediately, the Supreme Court Collegium will now have to recommend six names for appointment as judges in the top court.
A bill will be brought in the Monsoon Session of Parliament to convert the ordinance – an executive order – into a law passed by Parliament.
The Union Cabinet had cleared a draft bill on May 5 to increase the number of apex court judges.
The strength of the Supreme Court was last increased from 30 to 33 (excluding the CJI) in 2019.
The Supreme Court (Number of Judges) Act, as originally enacted in 1956, put the maximum number of judges (excluding the CJI) at 10.
This number was increased to 13 by the Supreme Court (Number of Judges), Amendment Act, 1960, and to 17 by another amendment to the law.
The Supreme Court (Number of Judges) Amendment Act, 1986, augmented the strength of judges from 17 to 25, excluding the CJI.
A fresh amendment in 2009 further increased the strength from 25 to 30.
Article 124(3) of the Constitution lists the qualifications required to become a Supreme Court judge.
An Indian citizen who has either served as a high court judge for at least five years, or as an advocate for 10 years, or is a distinguished jurist, can be appointed to the top court.
The strength of the Supreme Court is increased based on the recommendations of the CJI, who writes to the Union law minister. After consulting the finance ministry, the Department of Justice under the law ministry moves the Cabinet with a draft bill.
