The stay granted on March 21 by High Court of Delhi on banned drugs is extended by one day on Monday.
Justice RS Endlaw, asked the companies to provide a list of the drugs for which the state licensing authorities (SLAs) have issued licenses and those for which Drug Controller General of India (DCGI) had given them approval.
The stay went through around hundred petitions on 21st march.
About 35 pharma companies and government have process of hearing arguments in front of justice Endlaw.
There was argument made by companies that government should also banned FDCs for which they had received DGCI approval, as involvement of companies in proper discussions on safety and efficiency of the FDCs was refused by them.
“There is no reason given why several drugs approved by DCGI have been banned. The expert committee report itself in several cases says that (some of these FDCs) have been approved by the Centre, so (they are) not considering it,” said a lawyer representing one of the petitioning companies.
Some lawyers representing petitioners argued that the government had also not consulted the Drug Technical Advisory Board (DTAB)the statutory committee provided under the Drugs & Cosmetics Act before banning these FDCs.
According to the government, these arguments are secondary to the issue that these drugs have been found to be unsafe for consumption.
“This ban is not related to any specific licence, manufacturer or brand. This exercise was started pursuant to a report by the parliamentary standing committee,” said Sanjay Jain, additional solicitor general (Delhi High Court). “These FDCs are not safe or efficacious for human consumption and there is no justification or rationale for them,” he added.
The banned combinations were never given international approval and have enough single drug alternatives that are even manufactured by some of the petitioners, according to Jain. “No patient is going to die without these FDCs because they are independently available,” he said.
There will now be a day-to-day hearing for these cases, Jain said. The court will also decide whether there is legal justification of granting the stay on Tuesday, he added.
Earlier the government has banned around 300 fixed drug combinations (FDC) included the most common sold cough syrup corex and Vicks action 500 medicine of famous pharmaceutical companies Abott, Pfizer etc.