Pharmaceutical companies are moving court to challenge DCGI directive issued to state drug authorities to withdraw licences issued for irrational combinations in the past. Some of the state drug controllers have already issued orders to the companies to withdraw these irrational combinations from the market.
Industry sources said that the affected companies will put the onus of proving a drug rational or irrational on the drug control department of the state government which had given license to the pharma companies to manufacture them. "The individual companies will move court", a senior industry association leader said adding, "The association will not interfere as this is a case between a company and the licensing authority."
The affected companies will challenge the decision of the DCGI in the court where the definition of irrational combination will stand the scrutiny of law. The companies will challenge the ground under which their products have been branded as irrational by the DCGI. The drug control department will be under pressure to prove them irrational as the same department which had issued manufacturing and marketing licenses to these products.
Interestingly, against the earlier list of more than 1100 combinations, the state drug controllers have named only eight irrational combinations which should be withdrawn from the market. "We have received a list of 7 or 8 irrational combinations from the DCGI. We have issued the same to the joint commissioners, who are the licensing authority, to withdraw these combinations from the market," a senior FDA official in Maharashtra said.
The crucial decision to withdraw licenses to more than a thousand irrational combination drugs was taken at a meeting of state drug controllers convened by the DCGI on June four in Delhi. As per the decision, thousands of licences for the combination drugs sanctioned by state drug controllers during the last over a decade were to come under the DCGI scanner for review.