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1.6 List of countries where marketing authorization or import permission for the said drug is cancelled/withdrawn with date.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

OFFENCES	PENALTIES
Import of spurious OR adulterated drug OR drug which involves risk to human beings or animals OR drug not having therapeutic values	a)      3 years imprisonment and 5000 Rs.  fine on first conviction b)      5 years imprisonment OR 10000 Rs. fine OR both for subsequent conviction
Any drug other than referred above, the import of which is prohibited	a)      6 months imprisonment OR 500 Rs. fine OR both for first conviction b)      1 year imprisonment OR 1000 Rs. fine for subsequent offence

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

Ferozpur cantonment & Amritsar Railway station	In respect to drugs imported by rail across the frontier with Pakistan
Ranaghat, Bongaon & Mohiassan Railway Stations	In respect to drugs imported by rail across the frontier with Bangladesh
Raxaul	In respect to drugs imported by road & rail connecting India & Nepal
Chennai, Kolkata, Mumbai, Cochin & Kandla	In respect to drugs imported by sea into India
Chennai, Kolkata, Mumbai, Delhi, Ahmedabad & Hyderabad	In respect to drugs imported by air into 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.