Govt banned drugs without considering clinical data: Firms to Delhi HC

The government's decision to ban 344 fixed-drug combinations (FDCs) was taken without considering any clinical data, pharmaceutical companies told the Delhi high court on Tuesday.

"The FDCs were banned in one go without considering any clinical data. The argument of a safer alternative or safer option is absurd. It is a non-starter. What dosage or combination is safe differs from patient to patient," said advocate Kapil Sibal, appearing for Pfizer.

The court has decided to continue the stay on this ban as the hearings will continue on Wednesday. According to IMS Health, only six brands of Pfizer have been banned - their sales were as much as Rs 424 crore between February 2015 and February 2016. "The sector as a whole would not want to make or sell unsafe drugs," said Sibal, adding that many of the affected drugs, like Pfizer's Corex cough syrup, have been in the market for 20-30 years.

The government on March 10 banned these 344 drugs as it found no therapeutic reason for their consumption. Moreover, it was found that many of these FDCs posed health hazard to patients. Consequently, more than 100 pharmaceutical companies went to the Delhi High Court against this ban - which decided to stay this ban until it heard all the arguments.

"If state licensing authorities were illegally issuing licences, the government would not have kept quiet till now," Sibal said, responding to the government's argument on Monday that there were no valid licences for making any of the banned FDCs and it was difficult to implement any action at the state level.

After hearing argumentson behalf of the drug companies for about 90 minutes, the court listed thematter for hearing tomorrow.

The high court had yesterday said the government's decision to ban the 344 FDCswas apparently taken as it could not control the state drug licensingauthorities - which granted approval in to various companies for these FDCs.

"It appears thatsince you do not have power to control your state licensing authorities, youare taking this action. It all boils down to this that you have exercised thispower as you do not have power to take action against those operating withoutvalid license from the Drugs Controller General of India (central druglicensing authority). That is what I feel,\" the high court said on Monday.

The court added that there was a \"lacunae\" in the system if stateauthorities were not under the control of DCGI.