 "Image courtesy: Fresenius Kabi")
The high court in Delhi quashed on Thursday a central government order banning 344 fixed dose combinations (FDCs) of drugs.
The verdict from judge Rajiv Sahai Endlaw came on multiple petitions from pharmaceutical companies after the Centre's decision to ban the drug combinations earlier in the year.
An FDC is a 'cocktail' drug. It contains two or more therapeutic ingredients, packed into a single dose. The concept is widely accepted in global markets, due to less cost and patient convenience.
The Centre issued the ban notification on March 10, pursuant to the Kokate committee report. Most large pharmaceutical manufacturers, including Pfizer, Abbott, GlaxoSmithKline and Cipla, immediately appealed to the high court in Delhi.
The ban had been issued after the committee's observations that the specified FDCs lacked therapeutic justification. This impacted several high-selling brands such as Corex, Phensedyl and Vicks Action 500 Extra.
The court first heard the petitioners on March 14 and provided the manufacturers interim relief, allowing them to continue production and sale of the notified FDCs. In doing so, it noted the drugs in question had been in the market for decades and the notification itself did not make out a case for urgency.
In the hearings that followed, the petitioners drew the court's attention to relevant provisions of the Drugs and Cosmetics Act requiring prior consultations by the government. And, argued the same conditions applied to notifications under Section 26A,under which the ban was issued. The pharma companies had also highlighted the fact that the central government had targeted FDCs while allowing the same drugs in combination to be prescribed to patients individually.
The government attempted to highlight its authority to conduct periodic testing exercises and also withdraw previously issued approvals under concerns on public interest. It asked the court to interpret the move as a necessary requirement for the betterment of society and for purposive interpretation to the Drugs Act.
Rejecting the Centre's arguments, Thursday's verdict quashing the March 10 notification agreed with the petitioners on the lack of mandatory consultations with the Drug Testing Advisory Board and the Drug Consultative Committee, statutory requirements under Section 26A. As a result, the Centre's decision without such consultations has been held to be void.
"The exercise of power in issuing the impugned notification is held to be not in consonance with the Act. The petitions have to succeed on this ground," says the Endlaw judgment.
It also says the Kokate committee report could not substitute the functions of the Drugs Controller. And, there had been lack of discussion on the panel's report. This further vitiated the breach, though the Centre might have acted for the public good.
Abbott and Pfizer issued statements which welcomed the verdict. Bejon Misra, founder of Consumer Online Foundation, said the law should not be an impediment in the process of ensuring safety in pharmaceutical drugs.
Ahead
While the Rs 5,000-crore pharma industry rejoices, the government still plans on banning the second batch of FDCs, in addition to seeking remedies against Thursday's adjudication. "This verdict will not affect our decision to ban the second batch of FDCs. While we will not hurry with the ban, it has to happen wherever we feel there is a lack of therapeutic justification," a health ministry official told Business Standard.
In the second batch of 500-odd FDCs under examination, the Central Drugs Standard Control Organization says around 200 combinations are irrational. The government is awaiting responses from companies that have been given irrationality notices or been ordered further examination of their FDCs.
To consolidate all the petitions against the March 10 notification, the Centre had earlier moved the Supreme Court for transfer of the matters before the various high courts to a single forum. The apex court is likely to hear the plea on Friday.
