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Rule - 122E D

The document defines a new drug as: 1) A substance of chemical, biological, or biotechnological origin that has not been significantly used in the country for prevention, diagnosis, or treatment of disease and has not been recognized as effective and safe for proposed claims. 2) A drug already approved for certain claims that is now proposed to be marketed with modified or new claims such as new indications, dosage, dosage form, or administration route. 3) A fixed dose combination of two or more drugs individually approved earlier that are now proposed to be combined for the first time or with a changed ratio of ingredients, with certain claims.

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58 views1 page

Rule - 122E D

The document defines a new drug as: 1) A substance of chemical, biological, or biotechnological origin that has not been significantly used in the country for prevention, diagnosis, or treatment of disease and has not been recognized as effective and safe for proposed claims. 2) A drug already approved for certain claims that is now proposed to be marketed with modified or new claims such as new indications, dosage, dosage form, or administration route. 3) A fixed dose combination of two or more drugs individually approved earlier that are now proposed to be combined for the first time or with a changed ratio of ingredients, with certain claims.

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Chintan Makadia
Copyright
© Attribution Non-Commercial (BY-NC)
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122E. Definition of new drug.

- For the purpose of this Part, new drug shall mean and include: (a) A new substance of chemical, biological or biotechnological origin; in bulk or prepared dosage form; used for prevention, diagnosis or treatment of disease in man or animal; which, except during local clinical trials, has not been used in the country to any significant extent; and which, except during local clinical trials, has not been recognized in the country as effective and safe for the proposed claims. (b) A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration. (c) A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration. (See items (b) and (c) of Appendix VI to Schedule Y). Explanation. For the purpose of this rule(i) (ii) All vaccines shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21; A new drug shall continue to be considered as new drug for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia whichever is earlier.

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