The Food and Drug Administration, Maharashtra, has granted permission to Nicholas Piramal India Ltd. to restart the manufacturing, sales and distribution of concentrated vitamin A solution, after freezing the manufacturing facility for more than three weeks, following the death of two children in Lucknow, Uttar Pradesh, to whom the vitamin solution was administered through a UNICEF project.
The FDA has cleared the concentrated vitamin A solution IP 85 section as free from toxicity and has declared the four drug samples collected at the time of inspection as of standard quality. The FDA has also conducted an inspection in the company's manufacturing facility at Raigad, Maharashtra. The Administration issued a clean chit to the batches including MH0102, administered to the school children at Lucknow, on December 30, 2006 and gave permission to restart production from the beginning of January 2007, informed sources said.
The mishap, after the solution was inducted succeeding the mid-day meal in a public school at Lucknow, has occurred on December 1, 2006 as the part of UNICEF's child nutrition programme aimed at preventing blindness. Following the reports, the FDA ordered the company on December 9, 2006 to stop manufacturing of the product till the results of the quality and toxicity tests are declared and issued a show cause notice to the company later.
The company officials informed that the company's facility for manufacturing vitamin A formulation is dedicated for the requirements of UNICEF and the random samples are got tested with the TGA Australia, ensuring international quality, while many of the testing laboratories under drug control authorities in India lacks technical expertise to test various formulations.
Responding to the issue, Dr Swati A Piramal, director-strategic alliances and communications, Nicholas, said that the company suspects a sabotage behind the mishap, in which the medicines may be mishandled or manipulated by somebody after the company transferred the batch of 20,000 bottles to the UNICEF. She said that there should be a link between the drug control administration and companies to tackle similar issues in future.
"The FDA and industry should work together to create Industry-FDA Connect programmes that can look at complaints quickly and using good equipment," Dr Piramal told Pharmabiz. "The Mashelkar report on FDA reform had highlighted that the FDA labs with exceptions like Maharashtra are poorly equipped, don't have scientists and often don't have the protocol for testing because many companies have proprietary formula. In one case one of our products had zero active ingredient according to the FDA in Delhi we could prove that they did not have the right method or equipment for testing our proprietary product. Therefore before banning a product or suspending production they should ask the company for testing methods etc," she opined in a correspondence to Pharmabiz.
She explained that the batch MH0102 has been administered to over 10 lakh children in June and July without adverse events it is not possible for a batch to be partially contaminated. The death and disease cases reported were of anaphylaxis reactions, which would not happen in case of drug toxicities. The cause of the incident should be investigated at the user's end, as the death cannot be attributed to the concentrated vitamin A solution, maintained Swati.
It is to be noted that there were reports on death of three children after administering the vitamin A solution of Nicholas Piramal, manufactured for the same UNICEF programme by November 2001. The company officials said that both mishaps are different in nature, as the first incident happened due to over consumption of the drug administered in the absence of medical experts.