Does every biological drugs in India understand new drug ?
Please note that according to the New Drugs and Clinical Trials Rules 2019, of The Drug & cosmetic Act 1940 and Rules thereunder 1945.
“New drug” means,―
(i) a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not
been used in the country to any significant extent, except in accordance with the provisions of the
Act and the Rules made thereunder, as per conditions specified in the labelling thereof and has not
been approved as safe and efficacious by the Central Licencing Authority with respect to its
(ii) a drug approved by the Central Licencing Authority for certain claims and proposed to be
marketed with modified or new claims including indication, route of administration, dosage and
dosage form; or
(iii) a fixed-dose combination of two or more drugs approved separately for certain claims and
proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an
the approved combination is proposed to be changed with certain claims including indication, route
of administration, dosage and dosage form; or
(iv) a modified or sustained-release form of a drug or novel drug delivery system of any drug
approved by the Central Licencing Authority; or
(v) a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified
organism, monoclonal anti-body, stem cell-derived product, gene therapeutic product or
xenografts intended to be used as a drug;
Explanation.― The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licencing
Authority and the drugs referred to in sub-clauses (iv) and (v) shall always be deemed to be new
Therefore, according to the above definition of the “New drug”, if any Biological drug which is covered under clause (v) as above will be always considered as a “New drug” in India.