The Andhra Pradesh Drugs Control Administration (APDCA) has ordered Human Biologicals Institute, a division of Indian Immunologicals Ltd (IIL), to stop all manufacturing activities of the measles vaccine with immediate effect, following inspections jointly carried out by a team of officers from APDCA and Central Drugs Standard Control Organization (CDSCO). It has also issued a show cause notice to the company.
The inspections were carried out following the reports of the deaths of four children in Gujarat in March 2011 after the administration of measles vaccine manufactured by the company. It has also received a letter from the Food and Drugs Administration, Gujarat in this regard. According to the sources with state drugs control administration, the department has noticed violations of Schedule M and Schedule L norms of the Drugs and Cosmetics Act, 1940, during the inspection.
Sources added that the critical excipients, including gelatin and sorbitol, that are used in the manufacturing of the freeze dried measles vaccine are not tested for all the pharmacopoeial parameters. The inspection showed that the company has failed to assess the minimum quantity of Neomycin required for the production of measles vaccine as required under the provisions of the Indian Pharmacopoeia and not conducted the tests for the content of Neomycin after washing of cells and also in the finished product of measles vaccine.
The inspecting team also found that the company has failed to conduct the test for neurovirulence and extraneous agents on working seed lots as required under Indian Pharmacopoeia. Even though the expiry date of the vaccine was April 30, 2012, the shelf life of gelatin and Neomycin used in the production of the measles vaccine was expired.
The department added that the company failed to conduct internal audits of the manufacturing premises for compliance with the provisions of the Drugs and Cosmetics Act, 1940 when deaths were reported in the past.
However, the administration is yet to ascertain whether the deaths were caused because of these reasons. It is learnt that the state drugs control administration is planning to seek assistance from the Indian Institute of Chemical Technology (IICT) and Centre for Cellular and Molecular Biology, both located in Hyderabad, to check whether the deaths were caused due to the manufacturing defects.