PART 2

1. Prohibition of Import of Certain Drugs or Cosmetics

2. Import of Drugs under License
3. Import of New Drugs
4. Import of Drugs for Examination, Test or Analysis
5. Import of Drugs or Cosmetics for Personal use
 IMPORT

Import Means to bring into India from any of the

Geographical Borders of our Country.
1. Following Drugs and Cosmetics Prohibited to be
Imported:
1. Any drug or cosmetic which is not of standard quality
2. Any misbranded or spurious or adulterated drug or cosmetics
3. Any drug or cosmetic without import license.
4. Any patent or proprietary medicine, which has not displayed the true formula or
list of active ingredients with their quantities as per the label.
5. Any drug which claims to cure or prevent any disease or ailments specified in
Schedule J.
6. Any cosmetic or drug which is unsafe or harmful.
7. Any drug or cosmetic whose manufacture, sale, distribution and import of which
is prohibited by rule made under this act.
8. Drugs not labelled in the prescribed manner.
9. Drugs after the expiry
10. Those which does not meet the standards, quality and purity specified in the
schedule-F.
 2. Import of Drugs under License:
The following classes of drugs can be imported under the license or permit granted
by the licensing authority:

1. Drugs specified in schedule C and C1 .

2. Drugs specified in schedule X.
3. Minor quantities of drugs imported for the examination, test or analysis.
4. Drugs for personal use covered by a prescription of RMP.
5. Any new drug.
6. An application for an import License shall be made to the licensing authority by
the manufacturer or by the manufacturer’s agent in India and shall be accompanied
by a License fee .
7. Any application for import license shall be accompanied by a copy
of Registration Certificate .
8. The importer should have proper storage facilities for preserving imported drugs
and properties.
9. A fee of `Rs. 250 shall be paid for a duplicate copy of license, if the original is
defaced, damaged or lost.
3. Import of New Drugs

1. A written permission of the licensing authority is required

for the import of new drugs.
2. For obtaining permission, all documentary and other
evidence related to the standards of quality, purity and
strength etc. should be supplied to the licensing authority.
3. An application for an import License for small quantities of
a new drug.
4. Every application shall be accompanied by a fee for a
single drug and an additional fee for each additional drug.
4. Import of Drugs for Examination, Test or Analysis
1. The drug is imported under a license in Form-11.
2. The drug must be exclusively examined in the place specified in the
license by the licensing authority.
3. An authorized inspector must be allowed to investigate the manner in
which imported substances are used.
4. The record of the imported substances along with their quantities,
the date of importation and the name of manufacturer should be
maintained and reported to the authority.
5. The licensee must comply with any further requirements as may be
specified by the authority.
6. In case if the license is cancelled, the licensee may appeal to the
Central Government within three months of the date of the order of
cancellation.
5. Import of Drugs or Cosmetics for Personal use

Import of drugs which are otherwise prohibited under section 10 of

the act can be imported on following conditions:

1. Drugs or cosmetics must be a part of a passenger’s bonafide

baggage and must be intended for the exclusive personal use of the
passenger.
2. They must be declared to the custom collector, if so directed.
3. The quantity of any single drug so imported must not exceed
hundred average doses.
4. Any drug or cosmetic not forming the part of passenger’s baggage,
may be allowed to import to an application made to the licensing
authority in Form 12-A.
5. If the licensing authority is satisfied, a permit is granted in Form
12-B.
1. Prohibition of Manufacture and Sale of Certain Drugs
2. Conditions for Grant of License
3. Manufacture of Drugs for Test, Examination and Analysis
4. Manufacture of New Drugs
MANUFACTURING
Manufacturing
Includes any process for making, altering, ornamenting,
finishing, packing, labelling of a drug or cosmetic with a
view to its sale or distribution
1. Prohibition of Manufacture and Sale of Certain Drugs

The following drugs are prohibited to manufacture for sale.

1. Any drug or cosmetic which is not of a standard quality or

is misbranded, adulterated or spurious;
2. Any patent or proprietary medicine, whose formula with
the quantities, is not disclosed on the label or container
3. Any drug which purports or claims to prevent, cure or
mitigate any such disease specified in schedule J
4. Any cosmetic containing any ingredient which may render
it unsafe or harmful for use
5. Any drug or cosmetic in contravention of this act or rules
made there under.
2. Conditions for Grant of License for Manufacture of Drugs

The license is granted, if applicant complies with the following:

1. The manufacture must be conducted under active direction and

personal supervision of competent technical staff
2. The licensee and factory premises should comply with the
conditions and requirements under Schedule ‘M’ respectively.
3. The applicant must provide for various operations, adequate space,
plant and equipment, 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.
6. For patent and proprietary medicines, the applicant must furnish
the documents and data related to claims, safety, stability,
therapeutic justifications etc.
Types of Licence for Manufacture of Drugs
3. Manufacture of Drugs for Test, Examination and Analysis:

A license is required to manufacture any drug in small quantity for the purpose of
examination, test or analysis purpose.

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 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 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.
7. The licensee shall allow Inspector to inspect the premises and satisfy himself that only
examination is conducted.
8. The licensee shall keep a record of the quantity of drugs supplied for analysis also
maintain ‘Inspection Book’.
9. The licensee shall comply with such other requirements as above.
4. Manufacture of New Drugs:
A New Drug is 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.

 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 .

(i) Indications.
(ii) Dosage form
(iii) Route of Administration.

 All vaccines shall be new drugs unless certified otherwise by the Licensing Authority.

 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
Distribution &
1.Wholesale
2.Retail
3.Restricted Sale License
DISTRIBUTION OF MEDICINES

WHOLESALER
 Wholesale & Retail Sale

1. Wholesale: From Distributor / Stockists to Pharmacy.

2. Retail sale: From Pharmacy to Patients.

Drug control Department issues two type of license:

Retail Drug License (RDL) to run a Pharmacy, chemist shop, and

it is issued to only those persons who possess degree or
diploma in pharmacy from a recognized university on the
payment of the requisite fees.

Wholesale Drug License (WDL) which is issued to a person who

is engaged in the business of wholesale of drugs and medicines.
 Conditions of Wholesale License:
1. Area: Shall not be less than 10 sq. m.

2. Storage: It is necessary to have a refrigerator and air conditioner

on the premises because certain drugs such as vaccines, insulin
injections etc. are needed to be stored in the fridge.

3. Competent Staff: The sale can be made either by a registered

pharmacist or another competent person who must be a graduate
with one year experience in drugs or in the presence of any one who
has passed S.S.L.C having experience of four years in drugs, specially
approved by drug control department.

4. License shall be displayed in a prominent place.

5. The drugs shall be purchased from a duly licensed dealer or a

manufacturer.

6. Supply of drugs shall be made against a cash memo. Carbon copies

of the same shall be preserved for 3 years from the date of last entry.
 7. He/She Shall maintain the records of purchase, and
produce all the registers and records during inspection.
Records must be preserved for 2 years from the last entry.

8. An Inspection book shall be maintained .

9. The drugs after expiry, Physician’s sample and the drugs

meant for Government supply, shall not be stocked or sold.

10. A separate record shall be maintained for the supply of

Schedule X drugs, the copies of invoices of sale of such
drugs to the retailer, shall be forwarded to the Licensing
authority.

11. No sale of any drug should be made for the purpose of

resale to a person not holding the license to sell or distribute
the drugs.
Retail sale
• For retail sale, two types of licenses are issued:
i) General licenses
ii) Restricted licenses

Restricted license:
Granted to those dealers who do not engage
the services of a qualified person and only deal
with such classes of drugs whose sales can be
effected without qualified person and vendors who
do not have fixed premises.
Retail sale from Pharmacy

• Facilities as per Schedule - N

• Purchase only from licenced wholesalers
• NO sale of specified drugs (Schedule -H and Schedule -X
without prescription)
• Separate licences for Schedule -C, C1, and X Drugs.
• Sale under Qualified Supervision.
• Maintain Records.
• Prepare for Periodic Inspection.
• Sale of specified household drugs from drug stores.
Conditions of Restricted License:
These are issued for retail sale of drugs. Restricted licences in Forms 20A and 21A.
(a)Dealers or persons in respect of drugs whose sale does not require the supervision
of a qualified person.
(b)Licenses to vendors shall be issued only in exceptional cases for bonafide travelling
agents of firms dealing in drugs.
(c)The licensing authority may issue a license in Form 21A to a travelling agent of a
firm but to no other class of vendors for the specific purpose of distribution to medical
practitioners or dealers samples of biological and other special products specified in
Schedule C.
(d)The licensee must have adequate premises equipped with facilities for the proper
storage of which the license applies, provided that, this condition does not apply to
the vendors.
(e)License should be displayed in a prominent place in a part of the premises open to
the public or must be kept on the person of vendor who shall produce the same on
demand by authorized government officers.
(f)Licensee must comply with the provisions of D and C act.
(g)Drugs should be purchased only from a duly licensed dealer or manufacturer.
(h)The licensee can deal only with such drugs, which can be sold without the
supervision of a qualified person.
(i)Drugs must be sold in their original container.
Required Documents for Obtaining Drug License:

1. Application Form.
2. Cover letter with the name and designation of the applicant.
3. Copy of challan achieved by depositing fees for obtaining
drug license.
4. Declaration in a prescribed manner.
5. Site plan for the premises.
6. The basis of possession of premises.
7. In the case of rented property, ownership proof.
8. Document related to the constitution of business such as
Incorporation certificate/ MOA (Memorandum of
Association)/AOA (Articles of Association)/Partnership Deed.
9. Affidavit related to non-conviction of
director/partner/proprietor.
10. Testimony of registered pharmacist or competent person
and their appointment letter in case of an employed person.
SALE
1. General Labelling Requirements
2. Special Labelling Requirements
3. Specimen Labelling
 LABELLING & PACKAGING

Labelling & Packing of drugs

A. General labelling requirements
B. Specimen labels for drugs and cosmetics
C. List of permitted colors.
D. Offences and penalties.
 Labelling & Packaging

All the general and specific labeling and

packaging specified to all classes of drugs and
cosmetics should be as per the provisions made

under the act.

 Labelling

• Name of drug
• Brand or Generic Name
• Net content
• Content of API
• Mfg. Name & address
• Batch no.
• License no.
• Date of Mfg
• Date of Expiry
• Schedule
Unused coded, spotted label and packaging material
shall be destroyed
SPECIMEN LABELS
LOAN LICENSE

Loan License approval is issued by the licensing authority, to a person

who does not own or have any arrangements for manufacture but
intends to avail the manufacturing facilities owned by another licensee.
1. The licensing authority shall, before the grant of a loan licence, satisfy himself
that the manufacturing unit has adequate equipment, staff, capacity for
manufacture, and facilities for testing, to undertake the manufacture on behalf of
the applicant for a loan licence.
2. In the case of pharmacy business ,operating its business in more than two states
then it is required to obtain a drug license in each state .
3. After the license is granted to the business, the licensee must ensure that all the
conditions of the drug license must be complied with during business.
4. The licensee shall allow Inspector to inspect the premises and satisfy himself .
5. The licensee shall maintain ‘Inspection Book’ .
6. The licensee shall test each batch of raw materials used and each batch of the
final product and also maintain the records of manufacture and testing of each
batch as per schedule U.
7. Shall maintain the reference samples from each batch for the period of 3 years.
8. Report to the licensing authority, regarding the changes in expert staff or change
in the manufacture or testing units
9. For Schedule C and C1 drugs, the licensee shall furnish the data of stability and
date of expiry to the licensing authority.
10. If the licensing authority is satisfied that a loan licence is defaced damaged or lost
or otherwise rendered useless, he may, on payment of a fee issue a duplicate
licence.
REPACKING LICENSE

Repacking Medicines simply means a medication is taken

from its original packaging and placed into a smaller and
simpler type of packaging.
Repackaging medicines often separates it into individual
doses, making it easy for the patient to keep on track with
their medication schedule.
REPACKING LICENSE
It is granted for the purpose of breaking up to smaller units of any drug .

1. Repacking of drugs should be conducted under hygienic conditions under personal

supervision of competent person, approved by the licensing authority.
2. The licensee must provide and maintain adequate arrangements for carrying out
tests of drugs repacked, in the specified place by the authority.
3. The licensee shall allow Inspector to inspect the premises and to take samples of
repacked drugs.
4. The licensee shall test each batch of raw materials used and each batch of the
final product and also maintain the records of manufacture and testing of each batch
as per schedule U. Records must be retained for 5 years from the date of repacking.
5. Licensee must allow the Inspector to inspect all the registers and records
maintained.
6. The licensee shall maintain ‘Inspection Book’ in Form 35.
7. Shall maintain the reference samples from each batch of repacked drugs, for the
specified period.
8. Licences remain valid for a period of 5 years from the date its granted or
renewed,unless suspended or cancelled.
LIST OF PERMITTED COLOURS

No drug shall contain a colour other than that specified below:

(1) Natural Colours: Annatto, Carotene, Chlorophyll, Cochineal,

Curcumin, Red oxide of iron, Yellow oxide of iron, Titanium dioxide,
Black oxide of iron.

(2) Artificial Colours: Caramel, Riboflavin.

(3) Coal Tar Colours: Quinazarine Green SS, Alizarin Cyanine Green F,
Fast Green FCF, Tartrazine, Erythrosine, Eosin YS or Eosine G, Toney
Red or Sudan III, Indigo Carmine, Brilliant Blue FCF, Orange G, Resorcin
Brown, Naphthol Blue-Black.

(4) Lakes Colour the aluminium or calcium salts of any of the water-
soluble colours listed above.