Delhi High Court scraps central government's ban on 344 FDC drugs

Medicines, such as Vicks Action 500 Extra and Corex cough syrup that had been off chemists' shelves for some time, will now once again become available to the public. Overturning the ban imposed by the Centre on March 10, the Delhi High Court, on Thursday, ensured that 344 fixed dose combination (FDC) medicines can now be sold again.

The overturning of the ban came about when Justice Rajiv Sahai Endlaw allowed 454 petitions moved by various pharmaceutical and healthcare majors, like Pfizer, Glenmark, Procter and Gamble, and Cipla, challenging the government's ban. The petitions claimed the decision had been taken by the Centre without following due procedure prescribed in the Drugs and Cosmetics Act. As a result, the court, had from March 14 onwards, stayed the operation of the Centre's decision.

The order has drawn mixed responses from various sectors. "The Delhi HC decision is really unfortunate. The 344 FDCs that had been banned did not find mention in any standard textbooks of medicine. All these FDCs were the creation of the drug companies along with strong misleading promotions. The gullible public will buy such medicines which are both a huge economic waste and harmful," said Dr Gopal Dabade, Coordinator, All India Drug Action Network.

The HC on Thursday said that proceedings till issuance of the notification did not suggest there was any grave urgency to ban these drugs. The court also said that the government's power under section 26A of Drugs and Cosmetics Act cannot be exercised in the public interest, except when a drug poses a risk to consumers.

This is what the drug and pharmaceutical companies had contended in court. They argued that the Centre had not properly implemented its powers under section 26A. They also argued that the ban order was passed without considering clinical data and had termed as "absurd" the government's claim that it took the decision to ban FDCs on the ground that safer alternatives were available.

Defending its stand, the Centre had argued that the FDC medicines are new drugs and thus require a licence from Drugs Controller General of India for manufacture and sale. The government also argued that there were no valid licences for making any of the banned FDCs and added it was difficult to implement any action against them at the state level.

The Centre contended the lack of approval for these FDCs was a secondary issue; the primary focus for the government was that these drugs lacked safety and efficacy, and thus a ban was the only answer. It also said that the banned FDCs had no therapeutic justification.

"The drugs banned were irrational combinations though they did not pose any immediate threat to life. In fact, the use of some irrational FDCs can at times be harmful," said a senior official involved in drug regulatory consultation for the government.

He added that though the government was not against FDCs "There are clear advantages of rational FDCs being used for treatment for parkinson's disease, hypertension, HIV/AIDS. It would have been better to have a detailed deliberate consultation with the various stakeholders to promote awareness of such drugs amongst the public rather than promoting irrational drugs," the official said.