As per new notification by the Indian govt to amend New Drugs & Clinical Trials Rules 2019, a draft has been issued by the Ministry of Health and Family Welfare that suggests to add genetically modified DNA derived products as vaccines. These may contain allogeneic and autologous cells. These Cell-based human medicinal products may have genetically modified cells and cells that are associated with mesh, a scaffold and a device.
The New Drugs & Clinical Trials Rules 2019, rule 2, sub-rule (1), clause (w) and sub clause (v) states that a new drug is a vaccine. It is a r-DNA (recombinant Deoxyribonucleic acid) derived product, monoclonal anti-body, living modified organism, gene therapeutic product, stem cell derived product that is made to use as a drug.
As per the new draft (read below), it has been proposed by the Ministry that the New Drugs & Clinical Trials Rules 2019, in rule 2, in clause (w) and in sub clause (v), the word “cell or stem cell derived product” shall be replaced for the word “stem cell derived products”.
The Central Government proposes to make some amendment to the New Drugs & Clinical Trials Rules 2019 and it has released the draft in consultation with the Drugs Technical Advisory Board.
This draft is published for information of all the affected person. These draft rules are considered on or after the 45 days expiry period from the date on the copies of the Gazette of India having draft rules made public.
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The Gazette notification stated that suggestion or objections that may be received from any person within this specified period shall be considered by the Central Govt.
“Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Nagar, New Delhi – 110011 or emailed at [email protected]” the notification added.
As per the proposed amendment;
“1. (1) These rules may be called the New Drugs and Clinical Trials (……Amendment) Rules, 2021. (2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the New Drugs and Clinical Trials Rules, 2019, in rule 2, under sub-rule (1), in clause (w), in sub-clause (v), for the words “stem cell derived products”, the words “cell or stem cell derived product” shall be substituted.
Meanwhile, according to a shocking new report China created a cookbook of covert Genetic Bioweapons engineered to target races based on specific DNA before COVID-19 officially began.
Read the draft below: