MANUFACTURING OF DRUGS AND COSMETICS LICENSES REPACKNG LICENSE AND LOAN LICENSE MANUFACTURE OF NEW DRUGS

1. DRUGS AND COSMETICS ACT,
1940 AND RULES, 1945
PART III
L1 Manufacture of drugs – Prohibition of manufacture and sale of
certain drugs, Conditions for grant of license and conditions of license
for manufacture of drugs
PART IV
L1 Manufacture of drugs for test, examination and analysis, manufacture
of new drug, Loan license and repacking license
NABEELA MOOSAKUTTY
ASST.PROFESSOR
DEPT OF PHARMACEUTICS
KTN COLLEGE OF PHARMACY

2. Prohibition of manufacture of certain drugs
and cosmetics

3. Prohibition of sale of certain drugs and
cosmetics

4. The license is granted, if applicant complies with the following conditions:
1. The manufacture must be conducted under active direction and personal
supervision of competent technical staff (approved manufacturing
chemist), as per the rules
2. The licensee and factory premises should comply with the conditions and
requirements prescribed under Schedule M in respect of medical devices
3. The applicant must provide for various operations, adequate space, plant
and equipment for all the manufacturing operations prescribed as per
Schedule M
4. The applicant must provide separate testing unit or quality control section
with an, independent head, with adequate facilities, for the test and
standardization of drugs and raw materials
5. The applicant should make adequate arrangements for the storage of
drugs manufactured by him
6. For patent and proprietary medicines, the applicant must furnish the
documents and data related to claims, safety, stability, therapeutic
justifications etc., as per the rules
7. The licensee shall comply with the requirements of Good Manufacturing
Practices laid down in Schedule M
Conditions for Grant of License

5. After completion of inspection, Drug Inspector forwards detailed report
and his recommendations to the Central Licensing Authority
1. On receipt of application in the prescribed form along with fees for
grant or renewal of license by the applicant, the authority verifies
the statement, post performance of the licensee and the above
requirements. Thereafter, the Licensing authority on necessary
enquiries and satisfaction, grants the license to the applicant in the
prescribed form
2. If Licensing authority is of the opinion that applicant is incapable to
fulfill the requirements, it may refuse to grant or renew the license
Forms - Types of licenses for Manufacture of
drugs

6. Kinds of License and Conditions for Grant of License Following are the types of
licenses under which the drugs can be manufactured:
1) Loan license
2) Repacking license
3) License for manufacture of Schedule C and C1 drugs
4) License for manufacture of Schedule X drugs
5) License for manufacture of drugs other than those specified in Schedules C
and C1 and X
These licenses for the manufacture of drugs are issued by the Licensing
Authorities appointed for their respective territories by the State Governments
The authorities issue the licenses within 3 months of the application
An issued license is valid for one set of premises only
When the drugs are manufactured at more than one place, a separate license is
needed
If there are any changes in the constitution of a licensed firm, the licensee
should inform the Licensing Authority. Licenses of such firms are considered
current for 3 months maximum period from the date of change until a fresh
license has been obtained
Conditions of License for Manufacture of Drugs

7. Procedure:
Manufacture
of
Drugs
other than
Schedule
C/C1 Drugs

8. Manufacture
of
Schedule
C/C1 Drugs
(Biological)

9. Manufacture
of Schedule X
Drugs

10. IV
A license is required to manufacture any drug in small quantity for the purpose of
examination, test or analysis – Conditions of License
1. If a person proposing to manufacture does not hold a license to manufacture drugs
specified in Schedule C and C1 or other than Schedule C, C1 and X, shall obtain a
license Form 29 before manufacturing such drugs
2. The licensee shall carry the manufacture and examination of drugs at the place
specified in the license
3. In case of drugs which are unsafe for use, a license in Form 29 can be granted only on
producing NOC (no objection certificate) from the licensing authority
4. Application must be countersigned by the Head of the Institution, which proposes to
undertake the manufacture
5. License remains valid for a period of 1 year, unless cancelled or suspended
6. Any drug for the purpose of examination, shall be placed in the containers, labelled for
the purpose of manufacturing it, name and address of the manufacturer. Thereafter
supplied to the any other manufacturer, when necessary
7. The licensee shall allow Inspector to inspect the premises and satisfy himself that only
examination, test or analysis is being conducted
8. The licensee shall keep a record the quantity of drugs supplied for analysis also
maintain ‘Inspection Book’
9. The licensee shall comply with such requirements specified and of which the authority
has given him not less than 1 month’s notice
Manufacture of Drugs for Test, Examination and Analysis

11. As per the Rule 122 E of the Drug and Cosmetic Rules 1945, a New Drug can
be:
1. 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 has not been used in the country and has
not been recognized as effective and safe by the LA for the purposed
claims- Local clinical trials
2. A drug already approved by the licensing authority for the proposed
claims, which is now proposed to be marketed with modified or new
claims; or 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, like: (i) New Indications (ii) New Dosage form (including sustained
release dosage form) (iii) New Route of Administration
3. All vaccines shall be new drugs unless certified otherwise by the Licensing
Authority
4. 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.
Manufacture of New Drugs

12. Conditions of License:
1. No ‘new drug’ can be manufactured, prior to the approval from the licensing authority
2. 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 accompanied by prescribed fee
3. The applicant, shall submit data as given in Appendix-1 to Schedule Y, including the
results of clinical trials as per the format of Appendix-2 to Schedule Y
4. While applying for the license, applicant shall furnish the evidence certificate that the drug
has already been approved
5. The LA after being satisfied that the drug if approved to be manufactured as raw material
or as finished formulation shall be effective and safe for use in the country, shall issue
approval in Form 46 and Form 46 A
Subsequent New Drug Application
A Subsequent New Drug application is an application for approval of an already approved new drug by the
Central Drugs Standard Control Organization (CDSCO). It can be made for the following cases:
1. Bulk Drug already approved in the country (approved within 4 years).
2. New drug (Formulation) already approved in the country.
3. A drug already approved and proposed to be marketed with new indication.
4. A drug already approved and proposed to be marketed as a ‘New Dosage Form / New Route of
Administration’.
5. A drug already approved and proposed to be marketed as a ‘Modified release dosage form’.
6. A drug already approved and proposed to be marketed with Additional Strength.
All the applications for approval of New Drug, Fixed Dose Combination and Subsequent New Drug are made
under Form 44 (Application for grant of permission to import or manufacture a New Drug or to undertake
clinical trial).