CHASING STANDARDS
CDSCO has, inter alia, sought a list of officials in respective departments, and their qualifications following immunization (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, number of inspections conducted in vaccine facilities, and sampling of vaccines, along with reports on vaccines storage facilities.
“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,” said the committee in a letter written to state drug control departments.
“Accordingly, all the state/UT drug 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 site audits. Procedures are also in place to ensure a standardized approach for streamlined and expedited assessment, including reliance on the responsible National Regulatory Agencies (NRAs).
An email sent to the health ministry and the Drugs Controller General of India remained unanswered.
WHO’S evaluation of vaccines includes, as per its standard, a manufacturing process review
The Prime Minister’s Office (PMO) has asked the commerce ministry to examine the model text of bilateral investment treaty (BIT) and suggest modifications to further improve the ease of doing business, according to persons aware of the development.
The exercise assumes significance as only seven countries have accepted the existing model text treaty, and most developed nations have expressed reservations on the text with regard to provisions such as dispute resolution.
BITs help protect and promote investments in either country. These pacts are important as India has earlier lost two international arbitration cases against British telecom giant Vodafone and Cairn Energy plc of the UK over the retrospective levy of taxes.
The persons cited above said an internal discussion will be held on the model text of the treaty on Monday in the commerce ministry with experts and lawyers.
“There will be a presentation in the meeting. We are having an internal discussion on the issue. The PMO is looking into it and has asked the commerce ministry to provide a thirdparty perspective on the model text,” they said.