The pack of Calcium Sandoz tablets purchased by Dr Shah. The circled portion shows the alleged hair or wire like substance in the tablet
A pack of Calcium Sandoz, the flagship brand of Novartis, purchased recently from Palanpur, Gujarat, has been allegedly found to be contaminated with hair or wire like substances and other foreign particles.
The pack of pills with batch no. 41011 EA was purchased by Dr. Darshan Shah from Jalaram medical stores, Palanpur. Himself a practicing physician, Dr Shah took it immediately to the Indian Medical Association, Palanpur for further investigation.
"The matter came to my notice when my 6 year-old son complained about a bitter taste of Calcium Sandoz pills which he was taking. He also complained of throat pain and fever. I neglected it because it was only a low-grade fever. But as soon as he developed high fever, I examined the medicines carefully and was terribly shocked to see hair or wire strands in the Calcium Sandoz pills,'' said Dr Shah.
The IMA official, who examined the pills samples, also expressed shock and awe on seeing foreign particles. "Calcium Sandoz is one of the highly reputed brands among patients and doctors. This is the first time in my decades of medical practice, I came across to such an incident. It is really shocking. I feel companies should be more responsible while dealing with medicines meant for children,'' he said.
As suggested by Novartis' local distributor DPA Agency and local North Gujarat Chemists Association, Dr Shah contacted Novartis head office in Mumbai. "On receiving my mail, two officials from Novartis India visited my place. They examined the sample and said the impurities might have entered into the pills during manufacturing process. They insisted for the pack of pills to conduct further investigations to ascertain the problem,'' Dr Shah revealed.
However, Dr Shah refused to give the entire pack but only a portion of it as he wanted to keep the rest with him to carry out his own tests. "My son has been consuming Calcium Sandoz for the last couple of years. Now that he's suffering from an upper respiratory tract infection, I just want to ensure that the ailment [infection] is not because of the contaminated pills. So, I'm keeping the tablets with me as my counsel advised,'' explained Dr Shah.
Novartis officials maintained that they could not find any instance of contamination on retesting Batch#41011EA. They cannot ascertain the alleged pack of pills is contaminated nor can they say it was manufactured by Novartis itself or contract manufacturer without receiving the pack.
"We did not receive a sample of the alleged contaminated pack, but started an internal investigation to this subject matter, as per Novartis policy. During the investigation, Batch #41011EA was retested and all results including Micro, Assay and loss on drying results were satisfactory and passed our specifications, as it did at the time of our original testing prior to release to the marketplace," Novartis said reacting to a Pharmabiz query.
The analysis of the retained sample of the said batch demonstrated compliance with the initial release results and the release specifications, "therefore there is no indication of any quality problem with the batch and the matter is closed at our end,'' they added.
Calcium Sandoz, which is currently promoted through OTC route as supplement, enjoys a market share of 9.1 per cent. The OTC sales of Novartis India registered Rs 52 crore last year with a growth of 9.7 %.