[ad_1]
New Delhi: The drug regulator has asked state governments for data on vaccine manufacturing and sales, according to officials aware of the matter, to ensure the standards set by the World Health Organization (WHO) are met amid increasing global scrutiny of the Indian pharma industry.
The Central Drugs Standard Control Organisation (CDSCO) is conducting a major exercise for improving the quality, safety and efficacy of biological products, after the deaths of dozens of children in Gambia and Uzbekistan from consuming Indian-made cough syrups.
To be sure, there have been no reports of injuries or fatalities connected with Indian-made vaccines.
In February, the apex drug regulator issued guidelines on biological products such as vaccines, and biological and recombinant DNA products to ensure they are in tune with international guidelines and standards set by regulators in other countries.
“In order to comply with the demands of the anticipated global benchmarking of vaccines by the WHO, the Drugs Consultative Committee (DCC) has once again called on the state’s drugs controllers to provide the information related to vaccine manufacturing and sales to the CDSCO. The committee had earlier also asked the states to provide data; while some did in January, many haven’t submitted,” said an official aware of the matter.
The WHO uses the Global Benchmarking Tool (GBT) to compare or evaluate nations based on a range of regulatory functions. This is a requirement for United Nations agencies to purchase vaccines globally. The WHO also evaluates CDSCO and its affiliated institutions, including the Central Drugs Laboratory, and surveillance systems for Adverse Events Following Immunisation (AEFI).
Among information sought by the drug regulator is a list of officials in the respective department with details of qualification, experience before joining, current regulatory experience, training the number of inspections conducted in vaccine facilities, sampling of vaccines with reports of vaccines storage facilities, etc.
“The committee (DCC) was informed that the data submission is a continuous activity and updated data needs to be provided regularly as per checklist and SOP (Standard Operating Procedure) shared by CDSCO for manufacturing as well as sales premises for following the common practice on inspection process and preparation of uniform inspection reports among the States,” observed the Committee in a letter written to state drug control departments.
“Accordingly, all the State/UT Drugs Controllers were once again requested to provide the information at the earliest,” it added.
According to the WHO, the standard evaluation of vaccines includes review of the manufacturing process, verification of compliance with relevant standards, sample lot testing and a site audit. Procedures are also in place to ensure a standardized approach for streamlined and expedited assessment, including reliance on the responsible National Regulatory Agencies (NRA).
WHO vaccines prequalification works with NRAs that have been recognized as having a sufficient level of “maturity”, according to the WHO’s GBT.
An email sent to the healthe ministry and the DCGI remained unanswered.
Unlock a world of Benefits! From insightful newsletters to real-time stock tracking, breaking news and a personalized newsfeed – it’s all here, just a click away! Login Now!
Download The Mint News App to get Daily Market Updates.
Published: 07 Apr 2024, 03:44 PM IST
[ad_2]
Source link