The proposed Central Drug Authority (CDA), though with diluted powers as compared to the original proposal and recommendations, will centralise the licensing in respect of 17 categories of very critical drugs, as per the Drugs and Cosmetics (amendment) Bill, 2013 recently introduced in Parliament.
The categories of drugs which the central licensing authority is empowered to issue licenses will be sera, solutions serum proteins intended for injection vaccines; and includes DNA vaccines and vaccines containing living genetically engineered organisms, toxins, antigens and anti-toxins, antibiotics (betalactums and cephalosporins), parenteral preparations meant for parenteral administration, and hormones and preparations containing hormones among the 17 categories.
The other drugs included in the list are r-DNA derived drugs, RNA interference based products, monoclonal anti-bodies, cellular products and stem cells, gene therapeutic products, xenografts, cytotoxic substances (anti-Cancer drugs), blood products and modified living organisms, as per the bill.
The powers of the CDA, basically going to be renaming of the Central Drugs Standard Control Organisation (CDSCO), will include specification by regulations, the guidelines, norms, structures and requirements for effective functioning of the Central Licensing Authority and the State Licensing Authorities. It will assess periodically the functioning of the Central Licensing Authority and the State Licensing Authorities.
“The Drugs Controller General of India shall act as the Central Licensing Authority and shall have powers to–– (a) issue, renew, suspend or cancel licenses or certificates or permission, as the case may be, for import, export or manufacture of drugs, cosmetics or medical devices or permission for conducting clinical trials; (b) recall or direct to recall any drug, cosmetic or medical device; (c) collect the fees or charges for issue or renewal of licenses, certificates, approvals and permissions issued by the Central Licensing Authority under this Act,” the bill said.
The CDA will be headed by the Secretary of Health and Family Welfare and will have DCGI as the member secretary. The authority will have Ayush secretary, secretary of the Department of AIDS Control, Commerce Secretary, Secretary of the Health Research Department, Secretary of the DBT, DGHS, Joint Secretary from the Legislative Department, and Additional secretary in charge of drugs quality control division in the Health Ministry as ex officio members. Four experts having such qualifications and experience and four State Licensing Authorities will also be the members of the CDA.