The Drugs Act, 1976 is a law which controls the manufacturing and import of drug (including veterinary medicine) in Pakistan. Under power conferred by the said Act, the Government has also made the Drugs (Licensing, Registration and Advertising) Rules, 1976 and the Drugs (Import and Export) Rules, 1976 to control the import of drugs into Pakistan.
Under the said Act and the rules a person requiring to import drugs (including veterinary medicine) have to fulfill certain requirements and follow the procedure given in the rules
Registration of Drugs in Pakistan
The Act requires that all finished drugs should be registered with the Drug Registration Board before their sale in the market. Finished drug means a drug that has undergone all stages of production and is ready for use.
An application for registration of a drug shall be made in Form 5-A in duplicate to the Drug Registration Board addressed to its Secretary. It is pertinent to mention that a separate application is required to be made for each drug.
The application for registration shall be accompanies by a fee of:
- Rupees one thousand for the registration of new drug
- Rupees five hundred for the registration of any other drug
Before registering a new drug for which the research work has been conducted in other countries and its efficacy, safety and quality has been established therein, the Registration Board requires the investigation on such pharmaceutical, pharmacological and other aspects, to be conducted and clinical trials to be made as are necessary to establish its quality and, where applicable, the biological, availability, and its safety and efficacy to be established under the local conditions.
Certificate of Drug Registration
Import of Drugs in Pakistan
According to the Drugs (Import and Export) Rules, 1976, there are four different modes to import drugs into Pakistan:
- Import of finished drugs
- Import of drugs other than the finished drugs
- Import of small quantities of drugs for the purpose of clinical trial, examination, test or analysis.
- Import of drugs for personal use
There are different requirements to import of drugs for all above modes which requirements are provided below one by one.
Procedure to Import Finished Drugs in Pakistan
Import license is not required to import finished drugs, however, as per the Drugs (Import and Export) Rules, 1976, the following requirements have to be fulfilled by the importer to import finished drugs:
- The importer must possesses a license to sell by way of retail, wholesale, the drug he wants to import and has adequate facilities for proper storage to preserve its properties. The license to sell is issued by the provincial government.
- Within fifteen days of establishing the letter of credit, the importer must intimate about such import on Form I to an officer authorized by the Federal Government in this behalf.
- The drug should be imported in containers intended for retail sale or supply to hospitals, dispensaries or such other institutions.
- The drugs should be imported against indents issued by the authorized indentors or local agents of the manufacturers.
- To import finished drugs in bulk containers the importer is required to possesses a license for re-packing and obtain permission in writing to such import from an officer authorized by the Federal Government in this behalf. As per rule 4 of the said rules an application in Form 1 is required to be submitted to the Central Licensing Board addressed to its Secretary to obtain license to manufacture drugs by way of repacking.
Procedure to Import other than Finished Drugs in Pakistan
An import license is required to import drugs other than the finished drugs. To obtain import license, an application in Form 2 is required to be submitted to the licensing authority. The said application should be accompanied by a fee of fifty rupees and by an undertaking in Form 3, signed by or on behalf of the manufacturer from whom the drugs are to be imported.
A single application shall be made, and a single licence shall be required, in respect of the import of more than one drug or class of drugs manufactured by the same manufacturer: Provided that if a manufacturer from whom the drugs are to be imported has two or more premises manufacturing the same or different drugs a separate application shall be made, and a separate licence shall be required, in respect of the drugs manufactured in each such premises.
Issuance of Drug Import License in Pakistan
Upon receipt of the said application, the licensing authority, after confirmation of meeting all the requirements, shall issue license in Form 5 to import drugs other than the finished drugs which license shall be valid for two years unless earlier suspended or cancelled. To obtain the said license importer is required to comply with the following conditions:
- The manufacturer shall at all times observe the under-taking given by him or on his behalf in Form 3
- The licensee shall allow the licensing authority or any person authorized by it in this behalf to enter, with or without prior notice, any premises where the imported drug is stocked to inspect the means, if any, employed for testing the drug and to take samples
- The licensee shall on request furnish to the licensing authority from every batch of each drug or from such batch or batches as the licensing authority may from time to time specify as sample in such quantity as the licensing authority may consider adequate for any examination, test or analysis required to be made, and the license shall, if so required furnish full protocols of the tests, if any which have been applied
- The licensee shall ensure proper storage facilities for preserving the properties of the imported drug
- The licensee shall maintain a complete record of utilization of the imported drug, showing particulars of the substance manufactured from it and such further particulars, if any as the licensing authority may specify and such record shall be open to the inspection of licensing authority or any person authorized in this behalf by the licensing authority
- The licensee shall comply with such further requirements, if any applicable to the holders of import licences, as may be specified in any rules that may be made afterwards under the Act in this behalf and of which the licensing authority has given to him not less than three months notice.
How to Import Small Quantities of Drugs in Pakistan
Similarly the import of drugs other than the finished drugs, import license is also required to import of small quantities of drugs for the purpose of clinical trial, examination, test or analysis. To obtain the said license an application in Form 4 is required to be submitted. Upon receiving the said application, the licensing authority may require from the applicant such other particulars to be supplied as it may consider necessary. License is be issued by the licensing authority in Form 6 for the period of two years subject to the following conditions:
- The licensee will use the drug exclusively for the purpose for which it has been imported and at the place specified in the licence, or at such other place as the licensing authority may from time to time authorize
- The licensee shall allow the licensing authority or any person authorized by it in this behalf to enter, with or without prior notice, the premises where the drugs are kept and to inspect the premises and investigate the manner in which the drugs are being used and to take samples thereof
- The licensee shall keep record of, and shall report to the licensing authority, the drugs imported under the licence, together with the quantities imported, the date of importation and the name of the manufacturer
- The licensee shall comply with such further requirements if any, applicable to the holders of licences for clinical trial, examination, test or analysis as may be specified in any rule made afterwards under the Act and of which the licensing authority has given to him not less than one month’s notice.
Requirements to Import Drugs in Pakistan
Apart from specific requirements as describe above there are some other general requirements which have to be comply with to import all types of drugs. Following are these general requirements:
- Every drug shall be produced in sufficient quantity so as to ensure its regular and adequate supply in the market. In case of an imported drug, the importer in Pakistan shall ensure regular and adequate supply of the drug in Pakistan.
- The importer shall maintain a record of all sales by way of wholesale made by him of the imported drugs, and such record shall be open to the inspection by any person authorized in this behalf.
- The importer shall maintain an inspection book on which a member of the Registration Board or of the licensing authority or an Inspector shall record proceedings of each of his visits, his impressions and the defects notified by him and such inspection book shall be signed by him as well as the licensee or his authorized agent
- The importer shall ensure that the import of each batch of a drug is accompanied by a batch certificate in Form 7 from the competent health authority or any other such agency of the country of export or from the manufacturer and a copy of the test report of the drug from the competent health authority or any other such agency of the country of export or from the manufacturer
- The importer shall allow any person authorized in this behalf to enter, with or without prior notice, any premises where the imported drugs are stocked, to inspect the storage facilities and to take samples for testing
Clearance Certificate from Customs
No drug is released from the customs unless a clearance certificates has been obtained by the importer from an officer authorized in this behalf by the Federal Government. To obtain clearance certificate, the importer, shall on receipt of information of arrival of the consignment of drugs at the port of importation report in Form 8 along with three copies of the invoice to the officer authorized by the Federal Government to grant clearance.
Sampling by the Customs Authority
If the Collector of Customs or an officer authorized by him has reason to suspect that any drug does not comply with the provisions of the Act or the rules made there under, he may, or if requested by as officer authorized in this behalf by the Federal Government shall, take samples of any drugs from the consignment and forward them to the officer-in charge of the laboratory appointed for the purpose by the Federal Government and may detain the drugs from the consignment of which samples have been taken until the report of the officer-in charge of the said laboratory on such samples is received.
Provided that if the importer gives an undertaking in writing not to dispose of the drugs without the consent of the Collector of Customs and to return the consignment or such portion thereof as may be required, the Collector of Customs shall make over the consignment to the importer. If an importer who has given an undertaking is required by the Collector of Customs to return the consignment or any portion thereof, he shall return the consignment or portion thereof within ten days of receipt of the notice.
Procedure in Case of Non-remediable Contravention
If the officer-in-charge of the laboratory appointed for the purpose by the Federal Government reports to the Collector of Customs that the samples of any drug in a consignment do not conform to the specification or that the drug contravenes in any other respect the provisions of the Act or the rules made there under and that the contravention is such it cannot be remedied by the importer, the Collector of Customs shall communicate the report forthwith to the importer who shall within two months of his receiving the communication, either export all the drugs of that description in the consignment to the country from which they were imported or surrender them to the Federal Government for disposal in such manner as it may deem fit.
Provided that the importer may, within fifteen days of the receipt of the report make a representation against the report to the Collector of Customs who shall forward the representation with a further sample to the licensing authority or, as the case may be, the Registration Board which after obtaining, if necessary, the report of the .officer-in-charge of the Federal Drugs Laboratory, shall pass orders thereon which shall be final.
Procedure in Case of Remediable Contravention
If he officer-in- charge of the laboratory appointed for the purpose by the Federal Government reports to the Collector of Customs that the samples of any drug contravene in any respect the provisions of the Act or the rules made there under and that the contravention is such that it can be remedied by the importer, the Collector of Customs shall communicate the report forthwith to the importer and permit him to import the drug on his giving an undertaking in writing not to dispose of that drug without remedying the said contravention.
Inspection by the Inspector
A Federal Inspector or a person authorized in this behalf by the Federal Government may physically inspect the consignment and draw samples from each batch for test and analysis as may be necessary and, if the consignment has been released by the customs, may order the importer not to sell or offer for sale or dispose of the drug for a reasonable period not exceeding one month with a view to obtain a test report.
Provided that the Federal Inspector or such authorized officer may prohibit the disposal of a drug for a longer period if he has sufficient reason to believe that the import, in any way, is in contravention of any or the provision of the Act or the rules made under the Act, in which case the importer shall not dispose of that drug until a certificate authorizing the sale of the batch has been issued to him.