Drug companies move Delhi HC seeking interim relief against FDC ban

A clutch of pharmaceutical companies approached the Delhi High Court on Thursday seeking interim relief against the central government’s decision to ban 156 fixed drug combination (FDC) medicines, so that they could clear the stocks lying in the market.

The Union Ministry of Health and Family Welfare had on August 22 issued notification banning the 156 FDC medicines saying they had no therapeutic benefits.

The high court, after admitting the petition, sought the government’s response by September 2.

FDCs are drugs that contain a combination of two or more active pharmaceutical ingredients (APIs) in a single form, usually manufactured and distributed in a fixed ratio.

The businesses have contended that the prohibition, which was put in place to allay worries about the lack of efficacy and safety data of certain combination medicines, may have a substantial impact on the supply chain of such medicines which have been in the market for decades, an industry source said.

“Due to the immediate disruptions this could cause, these companies are requesting additional time to address regulatory concerns, provide more evidence and ensure a more orderly withdrawal of these medicines from the market,” the source said.

Speaking on the amount of time it may take for the pharmaceutical companies to exhaust the market supplies of the FDCs, an official from one of the affected firms said that it may vary greatly depending on a number of factors, such as the amount of stock currently in circulation, the rate at which these drugs are distributed, and the reach of the distribution network. 

“Usually, it takes a few weeks to many months for the businesses to deplete their present stocks,” the source added. 

The firms have sought an interim relief so that no coercive action is taken against stockists and retailers until the current stock of prohibited FDCs is exhausted. 

According to the government notification, the decision was taken after the Drug Technical Advisory Board (DTAB) and an expert committee formed by the central government recommended that there was no therapeutic justification for the ingredients contained in the said FDCs.  

An expert added that the firms may also have talks with regulatory bodies to develop a gradual withdrawal schedule that lessens the effects on patients. “A fair amount of time to handle this shift efficiently and without sacrificing patient care is probably part of the firms’ court motion for relief,” he added. 

While there is no data available on the market impact as of now, the brands likely to be affected by the ban include those marketed by several pharma giants such as Sun Pharmaceuticals, Cipla, Dr Reddy’s Labs (DRL), Emcure, Alkem, and Torrent, among others.

According to experts, FDCs have become a contentious issue from a safety and regulatory point of view after a parliamentary standing committee report in 2012 observed that some state licensing authorities had issued manufacturing licences for several FDCs without prior clearance from the Central Drug Standard Control Organisation (CDSCO).

“This led to the market being flooded by FDCs that could potentially put patients at risk, as these were not tested for safety and efficacy,” a senior official had told Business Standard.