IMPORT OF DRUGS
Prohibition of Import of Certain Drugs or Cosmetics:
Following Drugs and cosmetics cannot be imported:
1. which is not of standard quality;
2. Any misbranded or spurious or adulterated drug or cosmetics;
3. without import license, for the import, for which an import license is prescribed.
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 containing any ingredient, 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, except for the purpose of examination, test or analysis.
8. Drugs not labelled in the prescribed manner.
9. Drugs after the expiry, and those which does not meet the standards, quality and purity specified in the schedule-F.
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 excluding those specified in schedule X.
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 of ` 1,000 for a single drug and ` 1,000 for each additional drug, duly signed by or on behalf of the manufacturer.
7. Any application for import license in Form 8 or 8-A, shall be accompanied by a copy
of Registration Certificate issued in Form 41; in the case of emergencies, the issue of Import License by the central government in Form 10 or 10-A without issuance of Registration Certificate under Rule 27-A, for reasons to be recorded in writing.
8. The License remains valid upto 31st Dec of the year following the year in which its granted unless cancelled or suspended earlier.
9. The importer should have proper storage facilities for preserving imported drugs and properties.
10. A fee of ` 250 shall be paid for a duplicate copy of license, if the original is defaced, damaged or lost.
Conditions of Import License:
An Import License is subject to the following conditions:
1. The licensee must observe at all the times the undertaking given by him or on his behalf in Form 9:
2. The licensee must allow any authorized Inspector to:
(i) Enter the licensed premises where imported drugs are stored.
(ii) Inspect the substances employed for testing.
(iii) Take samples.
3. The licensee must furnish the adequate quantity of sample from the required batches to the licensing authority for examination along with complete protocols of the test
applied.
4. If licensing authority so directs, until receipt of Certificate of Authorization, the licensee must not sell any batch products to which samples are submitted to the
licensing authority.
5. The licensee must maintain the record of all sales of imported substances as prescribed under the rules, and should furnish the same during the inspection.
6. The licensee must maintain separate records for the sale or distribution of Schedule-X drugs.
7. Licensee must also comply with such further requirements, prescribed by the authority and of which he has been given not less then four months of notice.
MANUFACTURE OF DRUGS
Prohibition of Manufacture and Sale of Certain Drugs
The following drugs are prohibited to manufacture for sale under section 18 of the act:
1. 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 lable 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 thereunder;
Conditions for Grant of License
The license is granted, if applicant complies with the following conditions:
1. The manufacture must be conducted under active direction and personal supervision of competent technical staff , as per the rules.
2. The licensee and factory premises should comply with the conditions and requirements prescribed 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., as per the rules.
After completion of inspection, Drug Inspector forwards detailed report and his recommendations to the Central Licensing Authority.
1. On receipt of application in the prescribed form along with fees for grant or renewal of license by the applicant, the authority verifies the statement, post performance of
the licensee and the above requirements. Thereafter, the Licensing authority on necessary enquiries and satisfaction, grants the license to the applicant in the
prescribed form.
2. If Licensing authority is of the opinion that applicant is incapable to fulfill the requirements, it may refuse to grant or renew the license.
LOAN LICENSE
It is issued by the licensing authority, to a person who does not own, arrangements for manufacture but intends to avail the manufacturing facilities owned by another licensee.
1. In the case of pharmacy business is operating its business in more than two states then it is required to obtain a drug license in each state where the business is carried on. A separate license shall be issued in case drugs are sold at more than one place.
2. 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. In the case of any changes or modification in business activity authority must be informed and all
the registers, records, and forms must be maintained in a specified manner.
3. 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.
4. Application for manufacture of more than ten items for each category of drug on a loan licence shall be accompanied by an additional fee of rupees three hundred per additional item specified in Schedule M and Schedule M3.
5. The licensee shall allow Inspector to inspect the premises and satisfy himself that only examination is conducted.
6. The licensee shall mainatain ‘Inspection Book’ in Form 35.
7. The licensee shall comply with further requirements specified by the authority.
8. 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.
9. Shall maintain the reference samples from each batch for the period of 3 years.
10. Report to the licensing authority, regarding the changes in expert staff or change in the manufacture or testing units.
11. For Schedule C and C1 drugs, the licensee shall furnish the data of stability and date
of expiry to the licensing authority.
12. 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 of rupees one thousand, issue a duplicate licence.
REPACKING LICENSE
1. It is granted for the purpose of breaking up any drug than those specified in Schedule C and C1.
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 mainatain ‘Inspection Book’ in Form 35.
7. Shall maintain the reference samples from each batch of repacked drugs, for thenspecified period.
8. Licences remain valid for a period of 5 years from the date its granted or renewed, unless suspended or cancelled.