Registration of Manufacture Drug License- by Janmejay Singh Rajput, Company Secretary
A.
List of Application Forms
for Various Drugs Manufacturing License
|
1.
|
Form 24/ Form 25A*
|
For manufacture for sale/distribution
of Allopathic drugs
other than those specified
in schedule C, C(I) and X
|
*Other forms as
applicable depending on the drugs to be manufactured.
B.
Information and Documents required
Please
to provide following documents for further process:
(i) Application should be
accompanied with a DD/challan as proof that the fees specified under the Rules
has been deposited in the proper Head of Account.
(ii) A site plan giving
the layout of the manufacturing premises with dimensions in meters and details
like position of doors, windows etc.
(iii) 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.
(iv). 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.
(v) 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 license(s).
(vi) Detailed list of
machinery and equipments installed for manufacture of drugs.
Note:
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.
(vii) Attested photo copies
of certificates of qualifications, experience, letter of approval (in case
where persons are already approved) Bio-data, consent, affidavit and joining
report of the whole time technical staff employed for the manufacturing and
testing of drugs.
(viii) 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.
(xi). List of items, with
detailed formula, (including Pharmaceutical aids, excipients) intended to be
manufactured.
Note:
Each item details are required to be given in the Performa prescribed by the
department each of which should be signed by an authorized person of the firm
and the manufacturing chemist.
(x) An
affidavit/undertaking to the effect that neither the owner nor the firm had
been convicted under the Drugs & Cosmetics Act 1940.
(xi) Certified true copy
of Proof of ownership and proof of possession in respect of the premises.
(xii) All the photocopies
of documents should be self attached/certified as true copy.
TEAM JSRA
