State approvals / Delhi / Drugs Control Department
Grant of Drug Manufacturing Licence
Drug Manufacturing Licence are granted after verification of site of manufacturing and documents submitted by the firm as per the requirements under Drugs and Cosmetics Act 1940 and Rules framed thereunder, for manufacturing drugs in the NCT of Delhi
DepartmentDrugs Control Department
TypeNew
StagePre-Establishment
FeeNo fee
Applied—
Documents to submit
| # | Document | Condition | Required |
|---|---|---|---|
| 1 | Each application should be accompanied with a cash deposit receipt as proof that the fees specified under the rules has been deposited in the proper Head of Account | — | Required |
| 2 | A Site-plan giving the layout of the manufacturing premises with dimensions in meters and detail like position of doors, windows etc | — | Required |
| 3 | Key-plan, showing the location of the manufacturing unit giving important land marks so that officers of the Department are able to locate the premises | — | Required |
| 4 | Documentary evidence of the constitution of the firm: Memorandum and articles of association in case of company partnership deed, duly attested by Notary Public, in case of partnership firm, an affidavit of the proprietor, attested by a Notary Public | In case of a proprietorship firm | If applicable |
| 5 | Power of Attorney in the name of one or more than one partner / director/ manager /Secretary or any person who is competent to correspond with the Drugs Control Authorities with regard to grant/Renewal etc. of licence(s) | — | Required |
| 6 | Detailed list of machinery and equipments installed for manufacture of drugs. The list should give full details of each machine, its make, capacity, material of which it is made, whether it is automatic or manual etc. duly signed by an authorized person of the firm | — | Required |
| 7 | Photo copies of certificates of qualification experience latter or approval (in case where persons are already approved) Biodata, consent affidavit and joining report of the whole time technical staff employed for the manufacturing and testing of drugs/cosmetics | — | Required |
| 8 | List of equipment, apparatus and reference books etc. with full details provided for quality control and testing of drugs signed by an authorized person of the firm | — | Required |
| 9 | List of items, with detailed formula, intended to be manufactured | — | Required |
| 10 | An affidavit / undertaking to the effect that neither the owner nor the firm had been convicted under the Drugs & Cosmetics Act 1940 | — | Required |
| 11 | Proof of ownership and proof of possession in respect of the premises | — | Required |
| 12 | All the photocopies of documents should be self attested | — | Required |
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