The Union ministry of health has decided to convert the three vaccines and sera manufacturing units in the public sector, whose production licenses were suspended in January this year, into testing and training laboratories, it is learnt.
The Ministry has already constituted a Committee of Experts including two from private firms for working on the conversion project. The Committee has to submit its recommendations and action plan within three months to the ministry of health.
Finding non-compliance of GMP norms, health ministry had suspended the manufacturing licenses of CRI, Kasuli, PII, Coonoor and BCG Vaccine Lab, Chennai on January 15, this year.
Dr Surinder Sing, DCGI will act as the chairman of the committee. The other members are Dr C. Sokhey, advisor- CDSCO, New Delhi, Dr J Deshpande- director-Enterovirus, Research Centre-ICMR, Mumbai, Dr. Sunil Gupta, Joint Director, NICD, New Delhi, Arvind Kukrety, ADC, New Delhi, Dr Anil Chawla, vice president R&D, Panacea Biotech Pvt Ltd, Delhi and Dr Sunil Gairola, director, quality control, Serum Institute, Pune. Dr V G Sornani, ADC will associate with the Committee during its inspection in the south zone instead of Arvind Kukrety who is in charge of the north zone only.
The Committee has to study the infrastructure facilities that are available at the three institutes and should explore the feasibility of conversion of the existing laboratories into testing and training laboratories.
The staff of the production units of the institutes will be re-deployed in the proposed testing units after providing necessary training for the new jobs. The Ministry also desires to expand the activities of the Central Drug Laboratory at CRI, Kasauli by using its infrastructure and manpower.
The Committee may explore the possibility of utilizing the existing facilities for setting up a residential training facility and assessment of any additional requirement that may be necessary to make it viable. The committee has also been advised to explore the possibility of having some of the vaccines or anti-sera production at these institutes complying with current GMP norms.