PRESS RELEASE

FDA MAHARASHTRA clears unconditionally, Vitamin A solution manufactured by Nicholas Piramal

Mumbai, January 2007:  The Joint Commissioner, Food and Drugs Administration, Maharashtra State has declared on 30.12.06 that Batch no MH0102 of Standard Quality as defined in the Drugs and Cosmetic Act 1940. The sample complies with IP 85 requirements for Concentrated Vitamin A Solution. The sample also complied with Test for Toxicity.

All the drug samples of Vitamin A manufactured for UNICEF including batch (MH0102), collected at the time of inspection are declared as Standard quality based on the report by the Government Analyst, FDA, Maharashtra State, Mumbai

The plant in Raigad, Maharashtra was inspected on 9th December after receiving the news of the death of two children in Lucknow and the production of concentrated Vitamin A solution was suspended till the results of the quality and toxicity tests were declared. After all drug samples were declared of Standard quality and non toxic by the Government Analyst the FDA has given permission to restart the production from 1st January 06.

Dr Swati Piramal, Director of Nicholas Piramal said “The FDA Maharashtra had done a commendably thorough job to recheck the quality of control samples vindicating our stand that the Vitamin A coming from our GMP manufacturing facility in Raigad was not toxic, and complies with IP quality standards.”

Nicholas Piramal had submitted quality control data, methods of GMP production, release data, bulk drug storage, sterile tanks, toxicity report of independent toxicology lab as well as compliance reports from global regulatory agencies to the FDA, Maharashtra.

Vita A is formulated in a dedicated facility for UNICEF and it is audited by international agencies. The company does not sell this product for general distribution in chemist’s shops.
Random samples supplied to UNICEF are tested by TGA Australia and all the samples tested were found to have world-class quality by the Australian regulatory agency. In addition, over 10 lakh children have already consumed Vitamin A from batch 102 in June/July without any adverse event showing that any contamination could not have occurred during the production of this batch. Since it is not possible for a batch to be partially contaminated the cause of the incident at the user’s end should be investigated and the death cannot be attributed to the concentrated Vitamin A solution.

The company reiterates that its Vitamin A was manufactured using world class GMP manufacturing and is of standard quality. The company co-operated with all investigating and regulatory agencies.