New Delhi: Delhi High Court on Monday said the government's decision to ban around 344 fixed dose combinations (FDCs) was apparently taken as it could not take action those companies making such medicines with licences from state authorities.
"It appears that since you do not have power to control your state licensing authorities, you are taking this action. It all boils down to this that you have exercised this power as you do not have power to take action against those operating without valid license from the Drugs Controller General of India (DCGI). That is what I feel," Justice Rajiv Sahai Endlaw said adding there was a "lacunae" in the system if state authorities were not under control of DCGI.
The observation came after the court heard arguments of Additional Solicitor General (ASG) Sanjay Jain, appearing for the Centre, who said there were no valid licences for making any of the banned FDCs and added it was difficult to implement any action at state level.
However, the ASG also said the lack of approval for these FDCs were a secondary issue and the primary focus was that it "lacked safety and efficacy" and thus, "ban was the only answer".
Opposing the arguments of the government, senior advocate Kapil Sibal, appearing for Pfizer, said no reason was given for banning the FDCs other than saying that these combinations were not rational and lacked therapeutic justification. He also wondered whom the government was promoting and, in a lighter vein, remarked "Patanjali is becoming more famous nowadays".
When the government was saying these combinations in current quantities are not safe, then it should have said what combinations in what quantity were safe, Sibal said.
The ASG, seeking lifting of the stay on the ban, said thousands of FDCs were under scanner but only 344 were banned as "there was no therapeutic justification for them".
He said that in India "general tendency of medical practitioners is to take the easy route. So they prescribe what is already available in a fixed dose."
To this, the court said,” This cannot be an argument. Then why not say they were prohibited from manufacturing" and added that if someone was manufacturing without approval then action has to be taken against them.
"What you have done is you have banned FDCs whether approval exists or not," it added.
