Drug Import under License or Permit Drug and Cosmetic Act 1940, and Rules 1945, Pharmacy Law and Ethics. Pharmaceutical Jurisprudence.

• Import Licences

The Following Category of drugs can be imported under a license or permit issued by authorized authorities

• 1. Import of drugs excluding Schedule X

• 2. Import of drugs specified in Schedule X

• 3. Import of drugs by a Government Hospital or Autonomous Medical Institution to treat patients

• 4. Import of drugs for examination, test, or analysis

• 5. Imports of drugs for personal use

• 6. Import of new drugs

General Rules for Import Licence:

The following can apply for an import license

• 1. Persons have a valid wholesale license for the sale or distribution of drugs,

• 2. The manufacturer’s agent in India has a valid license to manufacture drugs for sale,

They apply for an import license with a license fee of Rs 1000/- for a single drug and an additional fee of Rs 100/- for each additional drug. One undertaking shall also be submitted in Form 9 by the manufacturer or any authorized person on behalf of the manufacturer. The applicant shall also submit a registration certificate.

The licensing authority issues an import license after satisfying itself that the applicant is suitable for an import license. Import license remains valid for three years from the date of issue. However, it can be canceled if the licensee does not observe the conditions submitted by him in the undertaking and conditions of the license. Licensing authority allows the licensee to explain his position in writing. If the reply is not satisfactory then the license is cancelled. The license is canceled for such a period as the licensing authority thinks fit. License may be canceled for a particular drug or all drugs. In a similar manner, registration certificates can also be canceled. The licensee can appeal in a court of law against the decision of the licensing authority within 3 months from the date of cancellation.

• A single application shall be submitted for a license to import more than one drug or class of drugs from one manufacturer.

• If the single manufacturer has more than one premise to manufacture drugs then a separate application shall be required for each premise.

• The renewal application should be submitted at least three months in advance from the expiry date of the import license. Renewal for the registration certificate should be allowed at least nine months in advance from the date of its expiry. A current registration certificate shall remain valid until an order is issued regarding the renewal of the registration certificate. Renewal certificates also remain valid for three years.

Other general conditions to be observed by the Import licensee

• 1. The licensee shall observe all conditions mentioned in the undertaking submitted by him that is form 9 in Drugs and Cosmetics Rule 1945

• 2. The licensee shall allow an authorized drug inspector to inspect premises where imported drugs have been stored. Drug inspectors can enter into premises with or without prior notice to the licensee.

• 3. Licensee authority may demand a specific amount of sample of any batch for examination and analysis. The licensee shall furnish samples of imported drugs to the licensee authority.

• 4. Licensing authority may direct the licensee not to sell drugs of a particular batch whose sample has been sent for testing and analysis.

• 5. If a sample of any batch fails to comply parameters of a standard drug, then the licensee shall have to recall all drugs of that batch from the Market.

• 6. The licensee shall maintain a record of all sales. This record shall have all information regarding the drug and the name and address of the person to whom the drug has been sold. A drug inspector is authorized to inspect these records.

• 7. The licensee stores imported drugs in proper storage conditions to preserve the therapeutic effectiveness of imported drugs.

• 8. Patent and proprietary medicines can be imported into India only in containers intended for retail sale.

• 9. A person with a license to manufacture a drug can import patent and proprietary medicine in bulk containers. But he has to get permission from the licensing authority in writing at least three months in advance from the date of import.

The additional requirements to be observed by the licensee have a license to import drugs other than schedule X.

• The application shall be submitted in Form 8 under Drugs and Cosmetics Rule 1945 for a license to import drugs other than Schedule X. Applicant shall also submit an undertaking in Form 9 under Drugs and Cosmetics Rules 1945 and a registration certificate in Form 41 under Drugs and Cosmetics Rules 1945.

• Licensing authority with approval from the central government shall issue import licences in form 10 under Drugs and Cosmetics Rules 1945. In emergency conditions, the licensing authority can issue a license in Form 10 without a registration certificate. But the licensing authority shall have this emergency condition in writing.

Additional requirements observed by the licensee with a license to import drugs mentioned in Schedule X.

• Schedule X includes a list of habit-forming and narcotic drugs. Applicant submits an application in form 8-A under Drugs and Cosmetics Rules 1945 for an import license to import drugs specified in Schedule X along with a prescribed fee, a registration certificate issued in form 41, and an undertaking in form 9 under Drugs and Cosmetics Rules 1945. Licensing authority issued licence in form 10-A under Drugs and Cosmetics Rules 1945. The licensing authority may refuse to issue a license in form 10-A under the following conditions

• 1. Applicant has been convicted under the Narcotic Drugs and Psychotropic Substance Act 1985.

• 2. Applicant has been convicted under the Drugs and Cosmetics Act 1940 and Rules 1945.

• 3. Applicant's previous license has been suspended or canceled.

Applicant can appeal to the central government against the decision of the licensing authority not to grant an import license. An appeal should be made within 30 days from the date of receipt to refuse the grant of import license. The central government issues orders after enquiring about all matters.

The licensee to import Schedule X drugs shall maintain a separate record of the sale and distribution of Schedule X drugs. This separate register should have the following information

• 1. Name of the drug,

• 2. Batch Number,

• 3. Name and address of the manufacturer,

• 4. Date of transaction,

• 5. Opening stock on the business day,

• 6. Quantity of drug received, if any,

• 7. The source of drug from which drugs are received,

• 8. Name of the purchaser, his address and license number,

• 9. Balance the quantity of drugs at the end of the business day,

• 10. Signature of the person under whose supervision the drugs have been supplied.

Import of Small Quantities of Drugs for Examination, Test or Analysis

• Any head of the institution can import drugs in small quantities for examination, test, or analysis. Then can apply for an import license even for those drugs that have been prohibited from being imported under section 10 of the Drugs and Cosmetics Act 1940.

• An application for a license for examination, test, or analysis shall be made in Form 12. The application must be countersigned by the head of the institution or by the proprietor or by the director of the company or firm that wishes to import drugs for examination, test, or analysis. Application in form 12 with license fee Rs10/- (Rs one hundred only) for single drug and additional fee Rs 50/- (Rs fifty only) for each additional drug. The license fee shall be deposited through challan in the Bank of Baroda or any other bank notified by the central government. Licensing authority issued import licenses in form 11 under the Drugs and Cosmetics Rules 1945. The licensee (Head of the institution) has to follow the following conditions

• 1. The licensee shall use imported drugs exclusively for examination, test, or analysis.

• 2. It shall be used in the institute premise for which the license has been issued.

• 3. It can be used in other institutions as per guidelines issued by the licensing authority from time to time.

• 4. The licensee shall allow the drug inspector authorized by the licensing authority to enter into premises where drugs are kept. An authorized drug inspector can enter into said premises with or without prior permission from the head of the institution. He can inspect premises and investigate the manner of using imported drugs.

• 5. Authorised drug inspector can take samples of drugs.

• 6. The licensee shall keep a record of all imported drugs showing the name of the drugs, date of import, quantity of drug imported, and name of manufacturer

• 7. The licensee shall comply with all rules and regulations informed by the licensing authority in one month advance.

• 8. If the licensee fails to comply with any provisions of drugs and cosmetics rules and any other compliance from the licensing authority then the import license may be canceled. The licensee may appeal to the central government against this cancelation of the license. However, an appeal should be made within 3 months from the date of the license cancellation order.

Import of small amounts of new drugs by a Government Hospital or Autonomous Medical Institution to treat patients

Import of new drugs is prohibited under section 10 of the Drug and Cosmetic Act 1940. These drugs can be imported to treat patients suffering from life-threatening diseases, to treat diseases causing serious disability, or require as disease therapy in urgency. This drug has been recommended by a government medical officer or by an Autonomous Medical Institution providing tertiary care. This recommendation must be duly certified by the medical superintendent of the government hospital or the head of the autonomous medical officer. Application is submitted in form 12-AA by the medical officer of a Government hospital or autonomous medical institution with a license fee of Rs 100/- (Rs One hundred only) for a single drug and Rs 50/- (Rs Fifty Only) for each additional drug. Licensing authority grants license to import new drugs in form 11-A. Licence is granted under the following conditions

• 1. New drug to be imported must be approved for marketing in the country of its origin

• 2. The licensee shall use imported drugs exclusively to treat patients suffering from life-threatening diseases or to treat diseases causing serious disability or require disease therapy in medical urgency. Imported new drugs must be used under the supervision of a medical practitioner at the place specified in the import license. Licensing authority can authorise to use of this drug in places other than those specified in the import license.

• 3. Licensing authority can depute drug inspectors to perform the following purposes

  • a. Inspect imported drugs in premises specified to store imported drugs

  • b. Inspect relevant records maintained for imported drug

  • c. Inspect the manner of drug used and its investigation

  • d. take a sample of imported drug

• Drug inspectors can enter into licensed premises with or without prior notice to the hospital.

• 4. The licensee shall keep a record of all imported drugs and submit it to the licensing authority every 6 months. This record has information such as the name of the imported drug, the quantity of the new drug imported, the name and address of the patient to whom the drug has been prescribed, the quantity of the new drug issued to the patient, the date of import, name of the manufacturer, and name of the disease.

• 5. The quantity of new drugs imported for a single patient should not exceed 100 dosages. In exceptional circumstances, more dosages of drugs may be allowed to be imported for single patient by the licensing authority

• The licensing authority may cancel the import license if the hospital or medical institution does not follow the conditions to import the new drugs. The licensee may appeal to the central government within three months from the date of receipt of the order. The central government may investigate the matter and issue its decision.

Imports of drugs for personal use

Drugs prohibited from being imported into India under section 10 of the Drugs and Cosmetics Act can be imported for personal use under the following conditions

• 1. Application has been submitted in form 12-A under the Drug and Cosmetic Act 1940.

• 2. Drugs are part of bona fide passenger baggage and exclusive personal use of the passenger

• 3. Drugs shall be declared to the customs authority

• 4. Quantity of drug imported for personal use is not more than 100 doses

• 5. Quantity imported is as per the recommendation of the registered medical practitioner

• 6. The licensing authority has an opinion that the quantity of drugs to be imported is reasonable for the personal use of the patient.

• The licensing authority grants a permit in form 12-B.

Procedure for Import of Drug (Control over the import of drug by the customs collector):

If the customs collector has doubts or has been informed by the officer authorized by the licensing authority regarding compliance with the Drug and Cosmetic Act 1945 chapter III rules he can take samples of imported drugs. He sent this sample to any other laboratory assigned by the central government for testing and analysis of imported drugs. He may detain imported drugs whose sample has been taken until a report from the laboratory has been received. The custom collector can hand over the consignment to the importer if the importer submits an undertaking in writing that

• 1. Drugs shall not be disposed of without the consent of the customs collector.

• 2. Drugs shall be returned within 10 days from the date of notice received from the customs collector

• If a report from the director of the laboratory states that the imported drug is of substandard quality and that it cannot be remedied by the importer then it will be conveyed to the importer. The importer shall export all these substandard drugs to the country of their origin within two months from the date of receipt of the report copy from the customs collector. Otherwise whole consignment shall be forfeited by the central government and it will be destroyed.

• The importer can make representation against the custom collector. Under this condition, the customs collector shall send a representation with the sample of the imported drug to the licensing authority. The licensing authority shall further forward the sample to the director of the central drug laboratory, Kolkata. The report of the director of the central Drug Laboratory shall be final.

• If the report indicates that the quality of imported substandard drugs can be rectified by the importer then the customs collector may allow the import of that consignment of drugs. Here importer shall submit an undertaking that the consignment shall not be disposed of without permission of the officer authorized by the central government for this purpose.

Exemption from provisions of drug import:

The following categories of drugs do not require an import license for their import. That is an exemption from provisions of Chapter III of the Drugs and Cosmetics Act 1940.

• 1. Drugs not intended for medicinal purposes. These drugs can be imported without a license. But their container label should indicate that the drug is not intended for medicinal use

• 2. Drugs belong to schedule-C under the Drug and Cosmetic Act if imported for manufacturing purposes and not intended for medicinal use. But persons importing it should have a license to manufacture schedule-C and C1 drugs.

• 3. Substances that come under both drug and food articles such as lactose, oats powdered milk, condensed milk, etc fortified or not but not as injectable can be imported without a drug import license

• 4. Pre-digested food, chicken essence, virol, and Bovril can be imported without an import license

• 5. Spices and condiments like pepper, ginger, cumin, cinnamon, etc can be imported without a drug import license.

Places assigned to import drugs:

Drugs can be imported into India through the following places

• 1. Firozepur Cantonment and Amritsar Railway Stations: drugs imported by rail from Pakistan.

• 2. Ranaghat, Bongaon, and Mohiassan Railway Stations: drugs imported by rail from Bangladesh.

• 3. Petrapole Road in West Bengal, Sutarkandi in Assam, Old Raghna Bazar, and Agartala in Tripura: drugs imported by Road from Bangladesh.

• 4. Raxual: drugs imported by road and railway lines connecting Raxual in India and Birganj in Nepal.

• 5. Chennai, Kolkatta, Mumbai, Cochin, Nhava Sheva, Kandla, and Inland Container Depots at Tuglakabad and Patparganj in Delhi and Tuticorin in Tamil Nadu and Marmugao port in Goa: drugs imported by sea into India.

• 6. Chennai, Kolkata, Mumbai, Delhi, Ahmedabad, Hyderabad, Goa and Bengaluru: drugs imported by air into India.

Alok Bains