Battle of FDC drugs gets murkier

New Delhi: The court room of the Delhi High Court heated up immensely with the pharma companies and the government locking horns over the recent FDC drugs ban.

The government has come down very firmly on all pharma companies in the banning of 344 fixed drugs combination case heard in the High Court yesterday. Replying to the pharma companies submission that the ban on the fixed dose combinations had been taken without considering any clinical data, the government's reply stated:

"The fact that a product which falls under the definition of a new drug but is wrongly licenced by any State Licencing Authority without any approval of the licensing authority as defined under Rule 21(b), that is Drugs Controller General (India) cannot be the basis to assume that the product is rational, safe and efficacious."

According to Bar & Bench in its reply to the arguments presented by the opposing pharma groups, the governments justification ran as "

In case, where the composition of the FDCs were found irrational even after second examination including the replies from the manufacturers/applicants, the Government had no option but to prohibit them to safeguard public interest and hence these were prohibited under section 26A in order to safeguard public health from such irrational FDCs irrespective of the manufacturer.”

The major pharma groups that made their submissions in the court of Justice Rajiv Sahai Endlaw, before whom 150 petitions had been filed were :Pfizer, Glenmark, Procter and Gamble (P&G) and Cipla being a few. They were all challenging the government's March 10 decision.

The court as an interim measure has decided to maintain and continue a stay in each of the cases.

Calling the government's ban "absurd" due to availability of alternative safer options, Mr. Kapil Sybil appearing in the Pfizer case termed the ban decision as a 'non starter', justifying that dosage and combination needs would differ in individual cases. Justifying the pharma company's stand further, he added, Pfizer's Corex cough syrup had been in the market for 30 years, and it should be understood that the industry would not want to sell unsafe drugs.Mr. Sybil termed the governments way of going about the ban wrong , expressing the need for proper procedures being implemented.

The pharmaceutical companies in response to a stance taken by the government on imposing the ban in the face of its inability to take action against those companies making such medicines with licences from state authorities, stated , "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)."

The judge in response to the above statement said "That is what I feel," 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, yesterday had also made a point in this regard saying 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. However, the ASG had emphasized on the fact that the lack of approval for these FDCs was a secondary issue, the primary focus being that they "lacked safety and efficacy," thus leaving the government with the option of a ban, as the only solution .

The pharma groups during arguments also contended that the expert panel, which had observed these 344 FDC having 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 should have been set up to decide on the matter. In opposition to the government's arguments, the pharma groups felt no reason had been given for banning the FDCs, other than saying that these combinations were not rational and lacked therapeutic justification. They also said that if the government found the combinations unsafe then they should have come up with what combinations, and 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.

The government meanwhile further clarifying its stand in its reply stated"t he Government has made elaborate attempts to ensure that all facets of the matter get duly examined and no injustice is done to anyone and more importantly the safety of patients is not compromised. In the process sufficient notice and opportunity had been given to all concerned to present their case."

The court has listed the matter for hearing tomorrow.The government will be furthering arguments after the pharma companies make their submissions.