Govt banned FDCs without considering clinical data: Pharma cos to Delhi HC

Pfizer stops production of Corex cough syrupPharmaceutical companies on Tuesday told the Delhi High Court that the government’s decision to ban 344 fixed drug combinations (FDCs) was taken without considering any clinical data.


The submission was made in the court of Justice Rajiv Sahai Endlaw, before whom over 150 petitions have been filed by pharma and healthcare majors, including Pfizer, Glenmark, Procter and Gamble (P&G) and Cipla, challenging the government’s March 10 decision.


The decision was stayed in each individual case by the court as an interim measure which still continues.

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The companies termed as “absurd” the government’s claim that it took the decision to ban the FDCs on the ground that safer alternatives were available.


“344 FDCs were banned in one go without considering any clinical data. Argument of safer alternative or safer option is absurd. It is a non-starter,” senior advocate Kapil Sibal, appearing for Pfizer, said and added that what dosage or combination was safe would differ from patient to patient.


He also said the industry as a whole would not want to make or sell unsafe drugs and added that many of the affected drugs, like Pfizer’s Corex cough syrup, have been in the market for 20-30 years.


Sibal said that if state licensing authorities were illegally issuing licences, the government would not have kept quiet till now.


He also said that even if licences were to be taken away, then it has to be done by following proper procedure and not the way the government has done it.


After hearing arguments on behalf of the drug companies for about 90 minutes, the court listed the matter for hearing on Wednesday.


The government will advance arguments after the pharma companies make their submissions.


During arguments, the companies also contended that the expert panel, which had observed these 344 FDC had no therapeutic justification, was not a statutory body and cited several judgements to show that only a panel as provided under the Drugs and Cosmetics Act could have been set up.


The high court had yesterday said the government’s decision to ban the 344 FDCs was apparently taken as it could not take action against 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,” the judge had said, adding there was a “lacunae” in the system if state authorities were not under the control of DCGI.


Additional Solicitor General (ASG) Sanjay Jain, appearing for the Centre, had yesterday said there were no valid licences for making any of the banned FDCs and added that it was difficult to implement any action at state level.


The ASG had also said the lack of approval for these FDCs was a secondary issue, with the primary focus being that it “lacked safety and efficacy” and thus, “ban was the only answer”.


Opposing the arguments of the government, the drug companies had said no reason was given for banning the FDCs, other than saying that these combinations were not rational and lacked therapeutic justification.


They also said when the government was saying that these combinations in their current quantities are not safe, then it should have said what combinations in what quantity were safe.


Pursuant to the court’s interim stay order, some well- known medicines on which the ban on sale was lifted were Pfizer’s Corex cough syrup, P&G’s Vicks Action 500 extra, Reckitt Benckiser’s D’Cold, Piramal’s Saridon and Glenmark’s Ascoril and Alex cough syrups.


According to the March 10 notification, “On the basis of recommendations of an expert committee, the central government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use of said drugs in the country.”

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