New Delhi, 24th April, 2016.. Shri J P Nadda, Union Minister for Health and Family Welfare inaugurated the first of its kind Current Good Manufacturing Practise (CGMP) compliant facility within the Central Government for manufacture of DPT and TT vaccine at the Central Research Institute (CRI), Kasauli in Himachal Pradesh today.
The Union Health Minister also announced the functioning of the Zonal Office of CDSCO from the Container Corporation of India building, Baddi to facilitate Pharma companies and exporters from Himachal Pradesh, Punjab and Haryana to get their clearances and No Objection certificates. This office will start working within a week, he informed. He also said that the HP government has agreed to provide land for the Zonal Office of CDSCO at Baddi. The Minister also announced that in order to ensure production of quality medicines, 3 to 4 comprehensive workshops will be organized in the month of May in Baddi on Good Manufacturing Practices and Good Laboratory Practices. Best experts from national and international regulators will be there to brief the industry on related issues.
Expressing happiness at this singular achievement of CRI, the Health Minister congratulated the Institute and stated that this is a milestone in the vaccine production capacity of the country, and. CRI as it gets ready to celebrate its 111th foundation day the coming month.
Shri Nadda noted that recent advancements in regulatory requirements and introduction of cGMP concept in vaccine manufacturing led to the need for creation of cGMP compliant infrastructure and processes. Considering this, CRI has been able to create this cGMP compliant facility for production of DPT group of vaccines with the guidance and support of the Ministry of Health and Family Welfare, he added. This makes CRI the first Central Government Institute to have cGMP compliant infrastructure for vaccine production. TT vaccine has been commercialized from this facility for Universal Immunization Programme use and production of DPT bulk has been initiated, Shri Nadda said. He further stated that as it is essential for vaccine manufacturers to have global quality standards, CRI is exploring the feasibility of establishing WHO prequalified cGMP compliant manufacturing facility for yellow fever vaccine. This will enable the institute to supply yellow fever vaccine to African and Latin American countries.
CRI has been working as one of the few pioneer institutions in the field of vaccine manufacturing, Shri Nadda mentioned. The institute has plans to manufacture all vaccines viz., Japanese encephalitis vaccine, Rabies vaccine and Typhoid vaccine, which were earlier manufactured in the Institute, after establishing cGMP compliant facilities and application of recent technological advancements, he informed. He also said that CRI plans to create state of the art, fully dedicated cGMP compliant laboratory for research on vaccine development and various other public health related issues. The institute plans to undertake research on newer vaccine candidates for existing and emerging diseases and to manufacture more efficacious and safer vaccines as also to contribute to the prevention of spread of novel antigenic variants.
In addition to the these, the Health Minister said that as part of its expansion plans, CRI is in process of acquiring 128 bighas of land from Himachal Pradesh Government for creation of cGMP compliant facility for manufacturing of therapeutic anti-sera. This initiative will increase the production capacity of the institute to cater to the ever increasing demand of these lifesaving anti-sera and also generate significant amount of employment opportunities for country’s youth. Manufacture of immunobiologicals and animal care is an important and highly technical field which requires trained manpower at every level. For Skill development in this area, CRI is initiating a certificate course in ‘Production of Immunobiologicals and Animal Care’, affiliated to the State Council of Vocational Training, Himachal Pradesh. This course will play a significant role in developing trained manpower to work in various health, research and pharmaceutical setups and provide plethora of opportunities for youth of the country, he added. Shri Nadda also stated that CRI has started apprenticeship training for maintenance of high end machinery and equipment that have been installed with creation of new cGMP facility for production of DPT vaccine in the institute.
The Health Minister also launched the website of CRI at the occasion.
Central Research Institute, Kasauli is one of the most important suppliers of vaccines for the Government’s Universal immunization programme (UIP)especially for DPT and TT vaccines. The Institute is involved in manufacture and supply of various lifesaving therapeutic antisera for snake bites, Rabies and Diphtheria, and supplies Yellow Fever Vaccine to different parts of the country. Diagnostic reagents such as diagnostic antigens for typhoid, typhus fever and brucellosis and diagnostic antisera for cholera and salmonella are also manufactured and supplied to various Institutions throughout the country.