The Delhi High Court Thursday quashed a central government order banning 344 fixed dose combinations (FDC) of drugs after hearing more than 400 petitions from pharmaceutical companies.
Judge Rajiv Sahai Endlaw noted that the the drugs in question were in the market for decades and the notification did not make for a case for the urgency.
The Union health ministry banned the 344 drugs with a gazette notification on 10 March.
So what are FDCs?
FDCs combine two or more drugs in a single pill. For example, a pill that includes a pain killer and an antibiotic would be a 'combination drug' that, in some cases, could help fight lethal viruses. But they may be harmful or have side effects.
Why the ban?
The ban on popular brands such as Phensedyl, Corex and Vicks Action 500 was a result of a view held and corroborated by health experts. According to them combination drugs could potentially have dangerous side-effects and increase chances of drug resistance.
Many FDCs also do not have any advantage over the individual drugs. A drug like Zimnic AZ, a popular FDC, is simply a combination of paracetamol, aceclofenac and nimesulide.
The court took cognizance of Kokate Committee, set up to examine these drugs, and recommended the ban. According to it, the banned drugs could have serious health concerns and there were better alternatives.
Combination drugs have also been known to have other drawbacks, such as increase in antibiotic resistance. The concern has been growing in the last one year, with even the United Nations acknowledging it. Drugs for common diseases like E.Coli have started to fail. Some experts are calling this an 'antibiotic apocalypse'.
While health experts lauded the move, industry experts had said that the move could impact sales to the tune of Rs 1,500 crore.
What was the reason behind the ban?
The high court's decision was based on observations and claims from pharma companies that the government did not consult the Drugs Technical Advisory Board or the Drugs Consultative Committee, a violation of the Drugs and Cosmetics Act. Around 454 petitions were moved by various big pharma companies including Cipla, Pfizer and Glenmark.
The other reason the high court stated was the violation of Section 26A of the Drugs Act which states that the license holder of the drug must receive a three-month notice.
The court also noted that these drugs were available in the market for years and there was no reason for an abrupt ban.
"The manner in which the proceedings till the issuance of the notification have gone, does not suggest any such grave urgency (to ban the drugs)."
The government had defended that the ban was not sudden, and that it has been researching and testing the efficacy of more than 6,200 combinations of drugs for the past one year. Of this, it identified 344 that needed to be banned because they posed a risk to humans and better alternatives were available.
The pharma companies also argued that the ban order was passed without considering the clinical data available to prove that the drugs were not harmful and termed the government's argument as "absurd". They also argued that the Kokate Committee report could not substitute the functions of the Drugs Controller.
DG Shah, secretary general, Indian Pharmaceutical Alliance, which represents about 20 of India's largest pharmaceutical companies, said due process of law in the banning of the drugs was not followed. Individual companies were not notified and it is time to reassess the ban, added Shah.
Pharma companies have called this move a knee-jerk reaction. Public Health experts are calling this a bane on healthcare with powerful pharma companies, many of which based in the United States, using their clout to challenge the Ministry of Health's decision to ban FDCs from the market which would also help fight antibiotic resistance.
A source from the ministry of health however stated that they will go ahead with their plans to ban more drugs if the committee comes out with adequate justification to ban them.
The Centre will now have to challenge the high court's order and take the matter to the Supreme Court. The Centre has also has to plead for a transfer all cases regarding the ban from state high courts to the SC. The decision now rests with the apex court.
Edited by Jhinuk Sen