Head of the project Dr S. Raizuddin had all the correspondence with Ministry of Education and Ministry of Health. "We have wrongly been pushed into the scam. We had no role to play in the scam," he maintained. The NAB on the directive of the PAC has started scrutinising the available record to ascertain who sabotaged the local production of low-price Hepatitis B injection "Interferon". Secretary said that the Ministry of Science and Technology has always supported capacity building, R&D and indigenous production of biopharmaceuticals like interferon and had approved the PSDP project of CAMB entitled "Cloning and Expression of Selected Human Genes for the Production of Recombinant Human Pharmaceutical' at a cost of Rs 3 7.00 million in 2004 for the period of 04 years. The said project was completed in 2008 resulting in the production of interferon at the laboratory scale.
However, after the completion of the interferon project in 2008, the Ministry of Science & Technology was not taken on board at all for further work on interferon production for commercialisation, clinical trials, etc, and Dr S. Riazuddin, made all subsequent correspondence relating to these aspects with Ministry of Health at his own from the platform of Center of Excellence in Molecular Biology (CEMB), University of Punjab for registration and licensing to manufacture interferon injections. As a result, Ministry of Health allowed CEMB, University of Punjab for filling 100,000 ampoules of Interferon Alfa 2-a using the facility of Cirin Pharmaceuticals (Pvt) Ltd, Hatter for clinical trials to be jointly conducted by PMRC and CEMB. The permission was valid for one time only and was subjected to compliance of SOPs submitted with the application. Accordingly, 100,000 ampoules of interferon were filled with manufacturing and expiry dates of December, 2008 and December, 2010, respectively.
After the completion of the filling process, Dr S. Riazuddin along with Dr Anwaar A. Khan, Sheikh Zayed Postgraduate Medical Institute, Lahore submitted a project entitled "Trial of Locally Produced Recombinant Interferon Alpha 2a in the Treatment of Chronic Hepatitis C Genotype 2 and 3 on Human Subjects" through Dr Huma Qureshi, Executive Directive, PMRC, Islamabad in February 2009 for Grant-in-Aid from the Central Research Fund (CRF) for conducting clinical trials of the titled drug. However, Dr S. Riazuddin and Dr Anwaar A. Khan both failed to satisfy the experts Committee on Drug Research and the project was returned with following comments:
"The Committee expressed its deep concern that although this was an important project which need priority to encourage indigenous research activity, the safety of the study subjects and public at large was even more important, which had so far not been established in the said case and recommended that as per practice in other countries, safety studies must be conducted on the product before going for any comparative efficacy / phase III studies. The committee advised to Principal Investigator (PI) to conduct the safety studies in the first instance and present the safety data before his instant request could be discussed further". However, the PI has failed to respond to the expert committee's observations and the interferon injections which were produced for clinical trials expired in December, 2010.