The World Health Organisation (WHO) has given the Indian vaccine regulatory structure the highest possible rating of 4 on a majority of parameters. The rating, awarded this month, is higher than the one the organisation gave India in 2012, the last time it assessed the systems and processes of the country’s vaccine regulatory mechanism.
What does this rating mean, and why is it important? What impact can the improved rating have on the Indian pharmaceutical sector, and on Indian industry in general?
So, what did the WHO assess, and how?
For several days last week, a team of experts in multiple disciplines drawn from the WHO’s Geneva headquarters, its India Country Office, and national regulators of the US, Italy, Germany, the Netherlands, Indonesia, Thailand and Egypt, assessed the National Regulatory Authorities (NRA) of India. NRAs are defined by the WHO as “national regulatory agencies responsible for ensuring that products released for public distribution (normally pharmaceuticals and biological products, such as vaccines) are evaluated properly and meet international standards of quality and safety”. In India’s case, the NRA, as defined by the WHO, comprises the Central Drugs Standard Control Organisation (CDSCO), which has regulatory control over the import of drugs, approval of new drugs and clinical trials; the State Drug Regulatory Authorities; the Pharmacovigilance Programme of India (PvPI), the country’s national drug safety programme; and the Adverse Events Following Immunization (AEFI) structures at the central and state levels.
On what parameters was the assessment carried out?
According to the WHO, while all countries need to have a functional NRA, it is absolutely critical for those that produce vaccines, either for their national populations or for export. These countries need to have 6 clear control functions, and the wherewithal to enforce them. These are:
# published set of requirements for licensing
# surveillance of vaccine field performance
# system of lot release
# use of laboratory when needed
# regular inspections for GMP (good manufacturing practices), and
# evaluation of clinical performance.”
The Indian NRA was assessed on nine functions. These were,
# quality of the national regulatory system
# registration and marketing authorisation
# laboratory access and testing
# regulatory inspection
# clinical trial oversight
# NRA lot release
# licensing premises, and
#market surveillance and control.
An official release said, “The assessment has been done in respect of 9 different functionalities and Indian NRA has been declared ‘functional’ with a maturity level of 4, i.e. the highest level as per currently evolved definitions in respect of 5 functions, and maturity level 3 in respect of 4 functions.”
The release said that while “maturity level 4 indicates good results and sustained improvement trends, maturity level 3 reflects systematic process-based approach, early stage of systematic improvements, data availability regarding conformance to objectives, and existence of improvement trends.”
But what does a rating of 4 really mean?
In simple terms, it means that India has been classified as a stringent regulator of vaccines alongside developed countries such as the US, Japan and EU member states. A fully functional NRA is a prerequisite for WHO prequalification of vaccines. One of the requirements to become eligible and retain prequalification status is to have the National Regulatory Authority (NRA) assessed as functional against WHO-published NRA indicators.
The WHO Prequalification Programme facilitates access to vaccines that meet unified standards of quality, safety and efficacy, as well as programme needs. Vaccine manufacturers can only apply for WHO vaccine prequalification if the NRA meets the standards of the WHO-published NRA indicators, i.e., the WHO Global Benchmarking Tool on the functional regulatory system for vaccines.
Besides, as was done during the last such inspection as well, the exercise that happened from February 13-17 updated the Institutional Development Plan of the CDSCO and other involved affiliated institutions to address existing and/or potential gaps, and to build upon the strengths of the existing vaccine regulatory system. The WHO had carried out pharmacovigilance field visits to West Bengal and Madhya Pradesh in December last year.
What is the size of India’s vaccine exports?
The total value of vaccines manufactured by Indian companies is estimated to be in the range of $ 900 million. About 65%-70% is exported — India is a major player in the vaccine supply chain to agencies such as UNICEF, the WHO and the Pan American Health Organisation (PAHO). An article on the Indian vaccine industry in the online forum Biotech Articles a few years ago said:
“India is the major supplier of vaccines to UNICEF which in turn supplies 40% of the total vaccine demand for childhood vaccination in more than 100 countries. The share of the private sector in the total volume of vaccines exported is roughly around 40%. The once neglected vaccine market is now considered a source of steady income. The evidence for this being the takeover of Shantha Biotech by Sanofi Aventis and the possible takeover of Biological Evans by GSK. The reasons which make Indian companies very attractive for takeover are opportunity and assured income from exports, and facilities on par with global standards…”
What impact can the WHO’s rating have on India’s pharma sector and beyond?
It will make it easier for pharmaceutical companies to enter international markets, especially after the setbacks of the last year when vaccines made by several Indian firms lost the WHO prequalification status. As the WHO itself pointed out in a congratulatory letter earlier this week to Health Minister J P Nadda, this will “give an impetus to the “Make in India” mantra of the Hon’ble Prime Minister of India”.