Pharma Giants Challenge Delhi HC Ban On 156 FDC Drugs

Pharmaceutical companies including Alkem Laboratories and Entod Pharmaceuticals Pvt Ltd have petitioned the Delhi High Court to overturn the recent government notification that prohibits 156 fixed-dose combination (FDC) drugs. In a brief hearing on Wednesday before the division bench of Acting Chief Justice Manmohan and Justice Tushar Rao Gedela, the companies requested interim relief. They are asking for permission to deplete existing inventories of the banned drugs that were manufactured before the notification was enacted and are currently held by stockists and retailers. Additionally, the companies are seeking protection from any coercive measures against stockists and retailers until the existing stock is fully sold.

During the hearing, senior advocate Rajsekhar Rao, representing the pharmaceutical companies, emphasized that the drugs now banned had previously received approval and had been on the market for some time. In response, Acting Chief Justice Manmohan noted that the existing stock should be allowed to be used up. The bench has given the government until Monday, September 2, to provide further instructions. ACJ Manmohan also commented, “Experts will make the final decision... The issue is that we are being asked to act as experts, which is not ideal.”

Earlier this month, the Central government enacted a sweeping ban on 156 fixed-dose combination (FDC) drugs, which combine two or more drugs into a single dosage form. This prohibition, enforced under section 26A of the Drugs and Cosmetics Act, 1940, halted their manufacture, sale, and distribution for human use with immediate effect. This directive mandates an immediate halt to the sale, distribution, and supply of these drugs, as well as the recall of all existing market stocks. The government has criticized these fixed-dose combination (FDC) drugs as being irrational, claiming they offer no therapeutic advantages. The ban includes medications for migraines, anti-allergic drugs like levocetirizine, decongestant syrups, and paracetamol.