The state health department has directed the Kerala Medical Services Corporation Ltd (KMSCL) to lift the order blacklisting a UP-based firm that faced a complaint of supplying a Paracetamol tablet embedded with a metal piece.

The sanction was imposed on the company in June 2025 for two years, following a complaint by a patient at the Community Health Centre at Narikkuni, Kozhikode. The health department confirmed the complaint based on an internal inquiry. 

The firm, Healer’s Lab, then moved the High Court against the blacklist order. The HC disposed of the petition, directing the government to pass appropriate orders within three months and allowing the firm to bid for tenders floated by other authorities, subject to further orders.

In October, the government held a personal hearing with the company’s representatives. The firm contended that a warehouse manager was deputed to assess the alleged quality issue of the tablets. According to the company, it was illegal and the government failed to prove that the alleged tablet was manufactured by the company since it was not placed in its original intact blister pack.  

The firm supplied more than 20 crore tablets after winning the bid in 2023-24, and no quality issues were reported, it was cited.

The KMSCL, however, stated that the official was deputed to cross-verify the authenticity of the complaint submitted by the Medical Officer, and the assigned officer confirmed its veracity. “The authenticity of the complaint has been verified, and it has been confirmed that such an object cannot be inserted into a fully formulated tablet by humans at any cost, and the impression of the object was clearly seen on the inner side of the broken tablet, the corporation noted in the report.

The detailed investigation, directed by the State Drugs Controller, also showed that the foreign particle found within the tablet was radiopaque to X-rays, suggesting it may be metal. Further, it was reported that several complaints from various healthcare institutions across the state were reported for Paracetamol Tab IP 500mg manufactured and supplied by the firm during the tender year 2023-24 and 15 batches of Paracetamol tab 500mg were declared as Not of Standard Quality (NSQ) as per the statutory analysis conducted by the Drugs Control Department.

The government, however, noted that the tab with the metal piece was verified solely by physical examination and X-ray imaging, and that the batch samples were not drawn for further quality analysis. Further, the Medical Officer, CHC, Narikkuni, handed over the evidence sample to KMSCL only after one month from the filing of the complaint. 

“These actions hinder in establishing the fact beyond doubt that the alleged tablet was manufactured by the firm and entitle the firm to the benefit of doubt. Further, the impact of blacklisting on the firm, which is operating on a PAN India basis for various drugs, resulting in the denial of the opportunity to participate in tenders invited in other states, also needs to be taken into account,” an order issued by the Health and Family Welfare department said.

The government has allowed the petition submitted by Healer’s Lab and has directed the KMSCL to take the necessary action to lift the blacklisting.