Deepanshu Singh is teaching live on Unacademy Plus
EDITORIAL ANALYSIS OF NEWSPAPERS IN LESSTHAN 10 MINUTES Presented B 26th February,2017 chrome
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EDITORIALS COVERED IN TODAY'S LESSON INDIAN EXPRESS CAN EVEN SAFER JAB, SAYS WHO
o India's vaccine regulatory system has just been marked higher than the score it obtained in the last assessment 5 years ago. o What does this rati Indian pharmaceutical sector, and on Indian industry in general? Indian pharmaceutical sector, and on Indian industry in genera? WHO
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. o What did the WHO assess, and how? 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" Indian bodies 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. Events Following Immunization (AEFD) structures at the central and state levels.
o On what parameters was the assessment carried out? 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 o But what does a rating of 4 really mean? e In simple terms, it means that India has been classified as a stringent regulator of vaccines alongside developed o Vaccine manufacturers can only apply for WHO vaccine prequalification if the NRA meets the standards of the d as a stringent regulator of vaccines longside developed countries such as the US, Japan and EU member states. WHO-published NRA indicators, i.e., the WHO Global Benchmarking Tool on the functional regulatory system for vaccines. o What impact can the WHO's rating have on India's pharma sector and beyond? o 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. o 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) o Boost to 'Make in India'