Substances specified in Schedule C(1)

Section 122 of the Drugs and Cosmetics Act and Rules deals with substances specified in Schedule C(1). The following provisions shall apply in the case of a substance specified in Schedule C (1): - "(a) The container shall comply with the requirements, if any, specified in Schedule F or Schedule F (1) [or as specified], as the case may be.

The following provisions shall apply in the case of a substance specified in Schedule C (1): - "(a) The container shall comply with the requirements, if any, specified in Schedule F or Schedule F (1) 4[or as specified], as the case may be. * 5 * * * * (c) The substance shall conform to the standards of strength, quality and purity specified in Schedule F or Schedule F (1) 4[or as specified], as the case may be and the tests for determining the strength, quality and purity of the substance shall be those specified in Schedule F or Schedule F (1) 4[or as specified,] as the case may be. 6(d) The tests for determining the strength, quality and purity of a substance specified in Schedule F or Schedule F (1) 3[or as specified] as the case may be shall be applied to samples taken from the final product after each manufacturing process has been completed.

(e) The substance should be stored in a cool place and away from light. 1. Subs. by G.S.R. 753 (E), dt. 4-11-1999. 2. Added by F.1-27/56-D, dt. 18-12-1956 3. Amended by F.1-6/62-D, dt. 2-7-1969 4. Subs. by G.S.R. 663 (E), dt. 3-7-1992 5. Omitted by G.S.R. 19, dt. 7.1.1978. 6. Amended by G.S.R. 19, dt. 7.1.1978. . [PART XA. IMPORT OF MANUFACTURE OFNEW DRUG FOR CLINICAL TRIALS OR MARKETING 122-A. Application for permission to import new drug .- 2[(1) (a) No new drug shall be imported, except under, and in accordance with, the permission granted by the Licensing Authority as defined in clause (b) of rule 21.

(b) An application for the grant of permission to import a new drug shall be made in Form 44 to the Licensing Authority, accompanied by a fee of fifty thousand rupees:

Provided that where a subsequent application by the same applicant for that drug, whether in modified dosage form or with new claims, is made, the fee to accompany such application shall be fifteen thousand rupees.

Provided further that any application received after one year of the grant of approval for the import and sale of new drug, shall be accompanied by a fee of fifteen thousand rupees and such information and data as required by Appendix I or Appendix IA of Schedule Y, as the case may be]. de® (2) The importer of a new drug when applying for permission under sub-rule (1), shall submit data as given in Appendix I to Schedule Y including the results of local clinical trials carried out in accordance with the guidelines specified in that Schedule and submit the report of such clinical trials in the format given in appendix II to the said Schedule:

Provided that the requirement of submitting the results of local clinical trials may not be necessary if the drug is of such a nature that the Licensing Authority may, in public interest, decide to grant such permission on the basis of data available from other countries:

Provided further that the submission of requirements relating to Animal Toxicology, Reproduction studies, Teratogenic c studies, Perinatal studies, Mutagenicity and Carcinogenicity may be modified or relaxed in case of new drugs approved and marketed for several years in other countries if he is satisfied that there is adequate published evidence regarding the safety of the drug, subject to the other provisions of these rules. 2[(3) The Licensing Authority, after being satisfied that the drug if permitted to be imported as raw material (bulk drug substance) or as finished formulation shall be effective and safe for use in the country, may issue an import permission in Form 45 and/or Form 45- A, subject to the conditions stated therein:

Provided that the Licensing Authority shall, where the data provided or generated on the drug is inadequate, intimate the applicant in writing, and the conditions, which shall be satisfied before permission could be considered.] 122-B. Application for approval to manufacture new drug other than the drugs classifiable under Schedules C and C(1) .- 2[(1)(a) No new drug shall be manufactured for sale unless it is approved by the Licensing Authority as defined in clause (b) of rule 21. 1. Ins. by G.S.R. 944 (E), dt. 21-9-1988. 2. Subs. by G.S.R. 900 (E), dt. 12.12.2001.

(b) An application for the grant of approval to manufacture the new drug and its formulations shall be made in Form 44 to the Licensing Authority as defined in clause (b) of Rule 21 and shall be accompanied by a fee of fifty thousand rupees:

Provided that where the application is for permission to import a new drug (bulk drug substance) and grant of approval to manufacture its formulation/s, the fee to accompany such application shall be fifty thousand rupees only.

Provided further that where a subsequent application by the same applicant for that drug, whether in modified dosage form or with the new claims, is made, the fee to accompany such subsequent application shall be fifteen thousand rupees:

Provided also that any application received after one year of the grant of approval for the manufacture for sale of the new drug, shall be accompanied by a fee of fifteen thousand rupees and such information and data as required by Appendix 1 or Appendix 1-A of Schedule Y, as the case may be.] (2) The manufacturer of a new drug under sub-rule (1) when applying for approval to the Licensing Authority mentioned in the said sub-rule, shall submit data as given in Appendix 1 to Schedule Y including the results of clinical trials carried out in the country in accordance with the guideline specified in Schedule Y and submit the report of such clinical trials in the same format given in Appendix II to the said Schedule. 1[(2A) The Licensing authority as defined in clause (b) of rule 21 after being satisfied that the drug if approved to be manufactured as raw material (bulk drug substance) or as finished formulation shall be effective and safe for use in the country, shall issue approval in Form 46 and/or Form 46A, as the case may be, subject to the conditions stated therein:

Provided that the Licensing Authority shall, where the data provided or generated on the drug is inadequate, intimate the applicant in writing, and the conditions, which shall be satisfied before permission could be considered.] (3) When applying for approval to manufacture a new drug under sub-rule (1) or its preparations, to the State Licensing Authority, an applicant shall produce along with his application, evidence that the drug for the manufacture of which application is made has already been approved by the Licensing Authority mentioned in Rule 21:

Provided that the requirement of submitting the results of local clinical trials may not be necessary if the drug is of such nature that the Licensing Authority may, in public interest, decide to grant such permission on the basis of data available from other countries:

Provided further that the submission of requirements relating to Animal Toxicology, Reproduction studies, Teratogenic studies, Perinatal studies, Mutagenicity and Carnicogenicity may be modified or relaxed in case of new drugs approved and marketed for several years in other countries if he is satisfied that there is adequate published evidence regarding the safety of the drug, subject to the other provisions of these rules. * 2 * * * * 3[122D. Permission to import or manufacture fixed dose combination .- (1) An application for permission to import or manufacture fixed dose combination of two or more drugs as defined in clause (c) of rule 122-E shall be made to the Licensing Authority as defined in clause (b) of Rule 21 in Form 44, accompanied by a fee of fifteen thousand rupees and shall be accompanied by such information and data as is required in Appendix VI of Schedule Y. 1. Ins. by G.S.R. 900(E), dt. 12-12-2001. 2. Rules 122-C omitted, ibid. 3. Subs. by G.S.R. 900(E), dt. 12-12-2001.

(2) The Licensing Authority after being satisfied that the fixed dose combination if approved to be imported or manufactured as finished formulation shall be effective and safe for use in the country, shall issue permission in Form 45 or Form 46, as the case may be, subject to the conditions stated therein:

Provided that the Licensing Authority shall, where the data provided or generated on the fixed dose combination is inadequate, intimate the applicant in writing, and the conditions which shall be satisfied before grant of approval/permission could be considered.

Section 122, The Drugs and Cosmetics Act and Rules (Act 23 of 1940).