Schedule DII (Import of Drugs)

Schedule
DII (Import of Drugs)

Information required to be submitted by the manufacturer or
his authorized agent with the Application Form for the registration of a
bulk drug/formulation/special product for its import into India. The format
shall be properly filled in and, may be furnished on a Computer Floppy.

General requirement

1.1 Name of the drug/formulation/special product, a brief
description and the therapeutic class to which it belongs.

 1.2 Regulatory status
of the drug. Free Sale Certificate and/ or Certificate of Pharmaceutical
Products (CPP) issued by the Regulatory Authority of the country of origin.

1.3 Drugs Mater File (DMF) for the drug to be registered
(duly notarized).

1.4 GMP by National Regulatory Authority of the country of
origin (duly notarised). 1.5 List of countries where marketing authorization or
import permission for the said drug is granted with date

1.6 List of countries where marketing authorization or
import permission for the said drug is cancelled/withdrawn with date.

 1.7 List of countries
where marketing authorization or import permission for the said drug is pending
since (date).

1.8 Domestic price of the drug in the currency
following in the country of origin.

1.9 List of countries where the said drug is patented.

Requirements of Schedule D II

     Chemical & Pharmaceutical Information
of the drugs-

     i) chemical name,
generic name ii) dosage form, composition, source, specifications & tests
for identification iii) documentation on pack size, storage condition, safety
documents on containers & closures, iv) manner of labeling & package
v)three samples of drug/product & outer packing with batch certificate to
be submitted, vi) batch test reports of five consecutive production batches to
submitted for every site of manufacturing.

     Biological &
Biopharmaceutical information of drugs-

     i) biological
control tests applied on starting material/intermediate products/finished
products, ii) stability of finished product, iii) sterility & pyrogen test
specification & protocol designs, iv) acute & sub acute toxicity test
& specification & protocol, v) date relating to bioavailability studies
& bio equivalence, vi) any other relevant information

    Labeling & packaging information of
drugs-

i) labels should as per specification under the acts &
rules, ii) package inserts ‘d be in English & include following therapeutic
indications: posology & method of administration, contraindications,
special warnings & special precautions, interactions, whether pregnancy
& lactation contraindicated, undesirable effects, antidote for over
poisoning, effects on ability to drive & use machines, iii) package insert
‘d include information on list of exepients, incompatibilities, shelf life,
special precautions for storage, name & specification of the container
& instruction for use/handling.

Specific information for special products- to be supplied
separately in annexures A,B & C.

Import of Drugs

-Classes of drugs prohibited to import

-Import of drug under license

                1) Specified
in Schedule-C/C₁

                2) Specified
in Schedule-X

                3) Imported
for Test/Analysis

                4) Imported
for personal use

                5) Any
new drugs

-Offences and Penalties

Import & Registration of Drug & Cosmetics

-Drugs/cosmetics may be imported to India under the
authority of a license excepting those whose import is prohibited.

-Some drugs/cosmetics can be imported without any permit,
providing they are of standard quality & statement that they comply with
the provisions relating to import has been given to the Customs Collector by
manufacturer or importer.

Registration:

Requirement of registration of premises & drugs
manufactured & meant for the import to India was introduced with effect
from 1.1.2003

– Registration Certificate means a certificate
issued by the LA for the registration of premises & drugs manufactured by
the manufacturer meant for import into & use in India.

– An application for the issue of a registration certificate
should be made to LA along with the information & undertaking specified in
Schedule DI & DII. Registration certificate remains valid for a period of 3
years.

-Requirements of Schedule D I are as follows

          
I.           
Particulars of manufacturer & manufacturing
premises- i) name & address of manufacturing premises to be registered. Ii)
name & address of partners/directors iii) name & address of authorized
agents in India. Iv) brief profile of manufacturer’s business & research
activity v) copy of plant master file. vi) copy of plant registration/approval
issued by authority of concerned foreign country.

2. 2.
   Particulars of manufactured drugs to be registered under registration
   certificate- i) name of drug to be registered for import into & use in
   India. ii) a copy of approval list of above drugs showing permission for
   manufacturing/marketing in the country of origin. iii) a copy of GMP
   certificates as per WHO guidelines. iv) domestic prices of drugs to be
   imported in the currency of country of origin, v) names of drugs which are
   original products of the manufacturer.
3. 3.
   Undertaking to declare that- i) that applicant shall comply with the
   conditions imposed under acts & rules, ii) applicant report from time
   to time any changes pertaining registration certificate or any
   administrative action taken due to ADR, iii) applicant shall allow LA to
   enter & inspect manufacturing premises & to examine process or
   procedures & allow to take samples of drugs concerned for test,
   analysis or examination, in respect to any drug manufactured for which
   application for registration certificate has been made.

Classes of Drugs Prohibited to Import

·        
Any Misbranded drugs

·        
Any drug of substandard quality

·        
Drugs claiming to cure diseases specified in
Schedule-J

·        
Adulterated drugs

·        
Spurious drugs

·        
Drugs whose manufacture, sale/distribution are
prohibited in original country, except for the purpose of   test, examination and analysis.

·        
Patent/Proprietary medicines whose true
formula is not disclosed.

Import of the biological drugs(C/C₁)

·        
Separate import licenses are granted for the
import of biologicals and other special products and for drugs specified in
Schedule X.

·        
Conditions to be fulfillled:

·        
Licensee must have adequate and proper facility
for the storage.

·        
Licensee must maintain a record of the sale.

·        
Licensee must allow an inspector to inspect premises
and to check the records.

·        
Licensee must furnish the sample to the
authority.

·        
Licensee must not sell drugs from which sample
is withdrawn and he is advised not to sale, and recall the batch from
the market.

Import of the Schedule-X drugs (Narcotic &
Psychotropic drugs)

·        
Conditions to be fulfilled:

·        
Licensee must have adequate storage facility.

·        
Applicant must be reputable in the
occupation, trade or business.

·        
The license granted even before should not
be suspended or cancelled.

·        
The licensee has not been convicted any
offence under the Drugs and Cosmetics Act or Narcotic and Psychotropic
Substances Act.

Drugs Imported for examination, test or analysis

·        
Small quantities of drugs whose import is
otherwise prohibited can be imported for the purpose of examination, test or
analysis

·        
Conditions to be fulfilled:

·        
License is necessary under form-11 from
the licensing authority

·        
Must use imported only for said purpose
and at the place specified in the license.

·        
Must keep the record with respect to
quantities, name of the manufacturer and date of import.

·        
Must allow an inspector to inspect the
premises and check the records.

Drugs imported for personal use

·        
Conditions to be fulfilled:

·        
Up to 100 average doses may be imported without
any permit, provided it is part of passenger’s luggage.

·        
More than 100 doses imported with license. Apply
on form no.-12-A,12-B

·        
Drugs must be bonafide personal use.

·        
Drugs must be declared to the custom
officers if so directed.

Import of drugs without license

• Substances
  not used for medicinal purpose
• Drugs
  in Sch-C₁ required for manufacturing and not for medicinal use.
• Substances
  which are both drugs and foods such as:

                                Condensed/Powdered
Milk

                                Malt

                                Lactose

                                Farex/Cereal

                                Oats

• Predigested
  foods
• Ginger,
  Pepper, Cumin, Cinnamon

Penalties related to Import

Cosmetics prohibited to import

·        
Misbranded cosmetics

·        
Spurious cosmetics

·        
Cosmetic containing harmful ingredients

·        
Cosmetics not of standard quality

·        
which contains more than-2 ppm  Arsenic, 20 ppm lead, 100 ppm heavy
metals

Places through which drugs may be imported in India

Application of laws relating to Sea & customs

The Customs Collector & other Officers authorized in
this behalf by the Central Government may detain any imported packages which he
suspects to contain any drug or cosmetic the import of which is prohibited
under this act, and report such detention to the drugs Controller, India &
if necessary forward any package or sample to Central Drugs Laboratory for analysis.