Registration Certificate for biologicals means a certificate issued under Rule 27A by the licensing authority (Form 41) for registration of premises and biologicals manufactured by the manufacturer meant for import into and use in India. The Registration certificate is granted in form 41 for biologicals.
Any substance falling within the definition of drug, Section 3b of the Drugs and Cosmetic Act (1940) and Rules (1945), as amended, has to be registered for import into the country. The drug along with the manufacturing site needs to be registered for import. The licensing authority shall issue the Registration Certificate for biological after being satisfied that the company fulfils the conditions as laid by the licensing authority.
The biologics are regulated as per the Drugs and Cosmetics Act and Rules for the use, manufacture, export, import and storage of dangerous microorganisms/genetically engineered organisms or cells, 1989 (Rules, 1989) as notified under the Environment (Protection) Act, 1986.
To obtain the Registration Certificate for Biologicals, Form 41 has to be submitted to the Central Drug Standard Control Organization, Directorate General of Health Services, Office of Drugs Controller General of India, Biological Division, along with the documents listed by the regulatory authority from time to time