S. Harachand, Contributing Editor04.03.17
The World Health Organization (WHO) has rated India as one of the most stringent regulators of vaccines in the world. In the latest grading, WHOs team of experts assessed India’s National Regulatory Authority (NRA) across nine different functionalities, which include quality of the regulatory system, marketing authorization, regulatory inspection, clinical trial oversight and licensing premises.
NRA for vaccines, as defined by WHO, in India is a multi-level system comprising the Pharmacovigilance Programme of India (PvPI) and the Adverse Events Following Immunization (AEFI)—the country’s drug safety watchdogs—as well as the central and state regulators responsible for approvals and licensing of vaccines and clinical trials.
Following an audit in February, the UN agency found India’s NRA ‘functional’ with a maturity level rating of 4 for five functions, and a maturity level of 3 for the rest. Four is the highest maturity level under WHO’s Global Benchmarking Tool for measuring the maturity of a country’s regulatory systems.
The maturity level 4 indicates good results and sustained improvement trends, whereas maturity level 3 reflects systematic process-based approach, early stage of systematic improvements, data availability regarding conformance to objectives, and existence of improvement trends, according to WHO’s official release.
Meeting the standards of the WHO-published NRA indicators is critical for those countries that manufacture and export vaccines. It is also an essential criterion for obtaining and maintaining WHO prequalification status. Manufacturers can seek pre-qualification only if the respective NRA fulfills the norms set by the WHO Global Benchmarking Tool. Since India is a major supplier of vaccines to UNICEF, the endorsement is expected to give more impetus to the local vaccine manufacturers.
The new WHO rating, which is higher than the one the global agency performed last time in 2012, will also help India to position itself in the league of regulators noted for their tougher standards on the quality and safety of vaccines such as in the U.S., Japan and EU countries.
Indian firms supply as much as 60% of vaccines for the Global Alliance for Vaccines and Immunization (GAVI). The non-profit organization, in turn, makes it available to 73 low and middle-income nations across the world.
Many firsts?
Largely known for low-cost, basic vaccines, manufacturers from India are rapidly getting into more complex, technologically advanced vaccines business. Recent launches and the active research pipelines of some leading Indian vaccine makers indicate this trend.
Serum Institute of India (SII), which commercialized an intra-nasal version of H1N1 influenza vaccine, is currently working with international agencies including WHO, PATH, NIH,CBER/FDA to develop vaccines against diseases like meningococcal A, flu and rotavirus infection. The privately owned SII is presently the world’s largest vaccine maker by the number of doses produced, according to the company website.
Bharat Bio, which claims to be the first to seek a global patent for a Zika vaccine candidate, is having a pipeline of chikungunya, MSRA, HPV vaccines at early stages of development.
Panacea Biotec announced a long-term supply agreement with UNICEF for its pentavalent (DTwP+Hep B+Hib) vaccine early this year. Panacea’s fully liquid vaccine requires no reconstitution and therefore is easier to administer. Panacea Biotec has also introduced inactivated polio vaccine in association with the Institute for Translational Vaccinology, the Netherlands.
Meanwhile, a few others are pursuing direct collaborations with global leaders in the vaccine field for securing technologies they are lacking.
Cadila Pharma of Ahmedabad, Gujarat is a case in point. The company started a joint venture CPL Biologicals Pvt. Ltd. with Novavax Inc., way back in 2009 for exploring the latter’s virus like particle (VLP) technology for producing vaccines.
According to Cadila, utilization of the VLP know-how considerably speeds up the overall production process. The technology cuts short the development time for the new strain-specific vaccine by more than half, compared to the conventional vaccines development methods. In November last year, CPL Bio launched VLP-based seasonal influenza vaccine Cadiflu S in India.
Cadiflu S is the world’s first VLP vaccine against seasonal flu, claimed CPL. The company has the capacity to produce up to 25 million doses of the vaccine every year. Working on a robust pipeline of vaccine candidates against pancreatic cancer, human papilloma virus, varicella zoster virus, hepatitis E, CPL is now planning to build another factory near Ahmedabad for vaccines.
Biological E joined hands with GSK and Novartis for developing combo vaccines and typhoid vaccines. This privately-held vaccine firm is setting up an additional vaccine facility as part of its $150 million investment plan at Genome Valley near Hyderabad. Production of vaccines in the new plant is expected to start by December 2019.
S. Harachand
Contributing Editor
S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com.
NRA for vaccines, as defined by WHO, in India is a multi-level system comprising the Pharmacovigilance Programme of India (PvPI) and the Adverse Events Following Immunization (AEFI)—the country’s drug safety watchdogs—as well as the central and state regulators responsible for approvals and licensing of vaccines and clinical trials.
Following an audit in February, the UN agency found India’s NRA ‘functional’ with a maturity level rating of 4 for five functions, and a maturity level of 3 for the rest. Four is the highest maturity level under WHO’s Global Benchmarking Tool for measuring the maturity of a country’s regulatory systems.
The maturity level 4 indicates good results and sustained improvement trends, whereas maturity level 3 reflects systematic process-based approach, early stage of systematic improvements, data availability regarding conformance to objectives, and existence of improvement trends, according to WHO’s official release.
Meeting the standards of the WHO-published NRA indicators is critical for those countries that manufacture and export vaccines. It is also an essential criterion for obtaining and maintaining WHO prequalification status. Manufacturers can seek pre-qualification only if the respective NRA fulfills the norms set by the WHO Global Benchmarking Tool. Since India is a major supplier of vaccines to UNICEF, the endorsement is expected to give more impetus to the local vaccine manufacturers.
The new WHO rating, which is higher than the one the global agency performed last time in 2012, will also help India to position itself in the league of regulators noted for their tougher standards on the quality and safety of vaccines such as in the U.S., Japan and EU countries.
Indian firms supply as much as 60% of vaccines for the Global Alliance for Vaccines and Immunization (GAVI). The non-profit organization, in turn, makes it available to 73 low and middle-income nations across the world.
Many firsts?
Largely known for low-cost, basic vaccines, manufacturers from India are rapidly getting into more complex, technologically advanced vaccines business. Recent launches and the active research pipelines of some leading Indian vaccine makers indicate this trend.
Serum Institute of India (SII), which commercialized an intra-nasal version of H1N1 influenza vaccine, is currently working with international agencies including WHO, PATH, NIH,CBER/FDA to develop vaccines against diseases like meningococcal A, flu and rotavirus infection. The privately owned SII is presently the world’s largest vaccine maker by the number of doses produced, according to the company website.
Bharat Bio, which claims to be the first to seek a global patent for a Zika vaccine candidate, is having a pipeline of chikungunya, MSRA, HPV vaccines at early stages of development.
Panacea Biotec announced a long-term supply agreement with UNICEF for its pentavalent (DTwP+Hep B+Hib) vaccine early this year. Panacea’s fully liquid vaccine requires no reconstitution and therefore is easier to administer. Panacea Biotec has also introduced inactivated polio vaccine in association with the Institute for Translational Vaccinology, the Netherlands.
Meanwhile, a few others are pursuing direct collaborations with global leaders in the vaccine field for securing technologies they are lacking.
Cadila Pharma of Ahmedabad, Gujarat is a case in point. The company started a joint venture CPL Biologicals Pvt. Ltd. with Novavax Inc., way back in 2009 for exploring the latter’s virus like particle (VLP) technology for producing vaccines.
According to Cadila, utilization of the VLP know-how considerably speeds up the overall production process. The technology cuts short the development time for the new strain-specific vaccine by more than half, compared to the conventional vaccines development methods. In November last year, CPL Bio launched VLP-based seasonal influenza vaccine Cadiflu S in India.
Cadiflu S is the world’s first VLP vaccine against seasonal flu, claimed CPL. The company has the capacity to produce up to 25 million doses of the vaccine every year. Working on a robust pipeline of vaccine candidates against pancreatic cancer, human papilloma virus, varicella zoster virus, hepatitis E, CPL is now planning to build another factory near Ahmedabad for vaccines.
Biological E joined hands with GSK and Novartis for developing combo vaccines and typhoid vaccines. This privately-held vaccine firm is setting up an additional vaccine facility as part of its $150 million investment plan at Genome Valley near Hyderabad. Production of vaccines in the new plant is expected to start by December 2019.
S. Harachand
Contributing Editor
S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com.
