Pregnant woman finds foreign particle in vitamin tab in Thrissur, MP-based pharma company blacklisted

The state government has blacklisted a Madhya Pradesh-based pharmaceutical company after a pregnant woman in Thrissur complained of a foreign particle in the tablet supplied by the firm. The decision follows a year-long procedure and legal battle. Kerala Medical Services Corporation Limited (KMSCL) blacklisted the firm following a complaint from a patient of the Community Health Centre, Kadappuram, Thrissur, in 2024.

She complained that when she took the tablet for intake, she noticed a tiny piece of metal fragment embedded in it. KMSCL verified the complaint and found the presence of an unwanted foreign particle in the evidence, and it was directed to stop the distribution of the batch supplied by the company.

The company was blacklisted, following which the firm moved to the High Court. Considering the petition, the HC directed the state government to take appropriate action. In the appeal, the company representatives said that it maintained all quality standards and there was no possibility of getting a foreign particle, especially a metal piece, in the tablet. It also said that the KMSCL did not provide the company a sample of the capsule, and they only received a photograph of the broken tablet. It also alleged that the complaint was fake and intended to sabotage the goodwill.

KMSCL reported to the government that the complaint was forwarded by the Superintendent of the CHC Kadappuram, Thrissur, from a 4-month pregnant woman. "The presence of foreign particles in a tablet is certainly a serious flaw in the manufacturing process. Such a flaw by a GMP-certified manufacturer is not only intolerable but is potentially life-threatening," KMSCL cited in the report.

KMSCL also submitted that the complainant had assumed that the foreign particle embedded inside the tablet may be a metal fragment. As part of the detailed investigation, insisted by the Drugs Controller of the State, the KMSCL conducted X-ray imaging of the evidence submitted by the complainant. The X-ray image proved that the foreign particle embedded within the tablet is transparent to X-rays, meaning that it is not a metal.

A detailed examination of the way the foreign particle is embedded within the tablet revealed that it was embedded inside the tablet at some point in the manufacturing process. "It is quite natural for the complainant, who had already consumed three strips of the same medicine (one tablet each day for 30 days), to notice the visible difference in the tablets she takes daily and to break the tablet to see what was the offending item," the report said.

The company supplied 9,80,000 tablets to the District drug warehouse, Thrissur. KMSCL communicated to the government that although one tablet was found to be adulterated, the corporation was required to follow every procedure strictly. The state government accepted the report of the KMSCL and upheld the decision to blacklist the firm for a period of one year.