CRI sets up India's first GMP-compliant vaccine facility at Kasauli, Himachal Pradesh
25 April 2016
The Central Research Institute (CRI) has set up the country's first Current Good Manufacturing Practice (cGMP) compliant facility for the production of vaccines for universal immunisation programme.
Union minister for health and family welfare J P Nadda inaugurated the first-of-its kind cGMP-compliant facility in the government-sector for the manufacture of DPT and TT vaccines at CRI, Kasauli, in Himachal Pradesh.
CRI is the first central government institute to have cGMP compliant infrastructure for vaccine production. CRI also announced the commercialisation of TT vaccine from this facility for universal immunisation programme and initiated bulk production of DPT.
Nanda said CRI is exploring the feasibility of establishing WHO prequalified cGMP compliant manufacturing facility for yellow fever vaccine as well. This will enable the institute to supply yellow fever vaccine to African and Latin American countries, he said.
Nanda also announced the functioning of the zonal office of the Central Drugs Standard Control Organisation (CDSCO) from the Container Corporation of India building, Baddi, to facilitate pharma companies and exporters from Himachal Pradesh, Punjab and Haryana to get clearances and `no objection certificates'. This office will start working within a week, he informed.
He said the CDSCO office will be shifted to its own premises as and when the HP government provides suitable land at Baddi.
The minister also announced that three to four comprehensive workshops on GMP and Good Laboratory Practices will be organised in May this year in to ensure production of quality medicines in the country, Experts from national and international regulators will brief industry on related issues.
Nadda noted that it was the recent developments in regulatory requirements and introduction of cGMP concept in vaccine manufacturing that have led to the creation of cGMP compliant infrastructure and processes.
CRI has been among a few pioneering institutions in the field of vaccine manufacturing, Nadda noted.
The institute plans to introduce the eGMP concept in the manufacture all vaccines, viz, Japanese encephalitis vaccine, Rabies vaccine and Typhoid vaccine, after establishing cGMP compliant facilities incorporating recent technological advancements, he said. Besides, he said, the 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 will also 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.
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, which will help it increase the production capacity of lifesaving anti-sera and also generate employment opportunities.
Manufacture of immunobiologicals and animal care is an important and highly technical field which requires trained manpower. 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. The course will cover areas like health, research and pharmaceutical and provide a plethora of opportunities for the youth, he added.
CRI has also 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.
CRI, 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 anti-sera for snake bites, rabies and diphtheria, and supplies yellow fever vaccine to different parts of the country.
It also manufactures diagnostic antigens for typhoid, typhus fever and brucellosis and diagnostic anti-sera for cholera and salmonella that are supplied to various Institutions throughout the country.