To ensure that Indian vaccine manufacturers have global quality standards, the government is exploring the feasibility of establishing WHO-approved Current Good Manufacturing Practice (CGMP) facility for yellow fever drugs.
Such a facility will help in supplying yellow fever vaccine to African and Latin American countries as well, Union Health Minister J P Nadda said today after inaugurating the first government facility for CGMP compliance for DPT and TT vaccines at the Central Research Institute (CRI) in Kasauli in Himachal Pradesh.
He also announced the Zonal Office of Central Drugs Standard Control Organization (CDSCO) will start functioning within a week from the Container Corporation of India building in Baddi near hear to facilitate pharma companies and exporters from Himachal Pradesh, Punjab and Haryana to get their clearances and no objection certificates.
Noting recent advancements in regulatory requirement and introduction of CGMP concept in vaccine manufacturing led to the need for creation of CGMP-compliant infrastructure and processes, Nadda said CRI has been able to create this CGMP-compliant facility with the support of the ministry.
"This makes CRI the first central government institute to have CGMP-compliant infrastructure for vaccine production. TT vaccine has been commercialised from this facility for universal immunisation programme use and production of DPT bulk has been initiated.
"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," he said.
He said the Himachal Pradesh government has agreed to provide land for the Zonal Office of CDSCO at Baddi.
Nadda also announced that to ensure production of quality medicines, three to four comprehensive workshops will be organised in May in Baddi on 'Good Manufacturing Practices and Good Laboratory Practices' where top experts from national and international regulators will brief the industry on related issues.
The Health Minister said as part of its expansion plans,
CRI is in process of acquiring 128 bighas of land from the Himachal Pradesh government for creation of CGMP compliant facility for manufacturing of therapeutic anti-serums.
"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," Nadda said.
"CRI has been working as one of the few pioneer institutions in the field of vaccine manufacturing. The institute has plans to manufacture all vaccines like Japanese encephalitis vaccine, Rabies vaccine and Typhoid vaccine.
"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," he said.
He said manufacture of immunobiologicals and animal care were "important and highly technical" field which required trained manpower at every level and that 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 said, adding that CRI has started apprenticeship training for maintenance of high end machinery and equipment that have been installed with creation of a new CGMP facility for production of DPT vaccine.
The Health Minister also launched the website of CRI on the occasion.
CRI is involved in manufacture and supply of various life-saving therapeutic anti-sera for snake bites, rabies and diphtheria and yellow fever vaccine.
