Import of drug

Drug and Cosmetic Act 1940 and Rules 1945.

Compiled by: Alok bains

IMPORT OF DRUGS

An import licence will be required to import drugs into India. While certain classes of drugs and cosmetics are prohibited to be imported into India. Chapter III of the drug and cosmetic act 1945 and Part IV Rule number 21 to Rule Number 43 deal with provisions of drugs and cosmetics to be imported under the Drugs and Cosmetics Rules 1945 (amendment 2013).

Classes of Drugs or Cosmetics Prohibited to be imported into India: (Section 10 of Drugs and Cosmetics act 1940).

The central government prohibits the import of certain categories of drugs and cosmetics by notification in official Gazettes. No person can import the following category of drugs and cosmetics. However, the central government may allow the import of any one category of drug for special purposes after consultation with Drug Technical Advisory Board (DTAB).

1. Substandard drugs or cosmetics.

2. Adulterated Drugs or Adulterated cosmetics

3. Misbranded Drugs or Misbranded Cosmetics.

4. Spurious Drugs or Spurious Cosmetics.

5. Drugs purport or claim to cure or prohibit diseases or disorders mentioned in Schedule J of Drugs and Cosmetics Rules 1945.

6. Patent and proprietary medicines' true formula or name of active ingredients is not disclosed on the label of the container.

7. Drugs that have been prohibited to manufacture, sell and distribute are prohibited in the country of origin.

8. Drugs harmful likely to be harmful or risky for human beings or animals.

9. Drugs that do not claim their therapeutic value.

10. Drugs containing active ingredients with no therapeutic justification,

11. Any cosmetic that has ingredients harmful or unsafe to be used under the direction recommended.

12. Drugs have less than sixty per cent residual shelf-life period as of the date of import:

    However under special conditions licensing authority can allow the import of drugs with a lesser half-life period,

13. No drug shall be allowed to be imported if not labelled as a prescribed condition of labelling in drug and cosmetic rules 1945.

14. No drugs shall be imported after their expiry date

Customs officers have the power to detain any such drugs that have been prohibited to be imported. They shall send a report to the drug controller of India regarding such detention. If necessary, they also send samples of detained drugs to the central drug laboratory in Kolkata for testing and analysis of such drugs.

Compiled by Alok Bains

Drug and Cosmetic Act 1940 and Rules 1945.

Compiled by: Alok bains

IMPORT OF DRUGS

Offences (Section 13 of drugs and cosmetics act 1940)

1. Import of adulterated (under section 9A) or spurious drug (under section 9B) or any spurious cosmetic ( in section 9D) or any substandard cosmetic (in section 10) shall be punishable with imprisonment up to three years and a fine up to five thousand rupees,

2. Import of drugs or cosmetics prohibited to be imported under section 10, shall be punishable with imprisonment up to six months, or with a fine of up to five thousand rupees or both,

3. Import of any special drug or cosmetic prohibited to be imported by central government (section 10A), shall be punishable with up to three years, or with a fine up to five thousand rupees, or both;

4. Subsequent offence to the Import of drugs or cosmetics mentioned in point number 1 and point number 3 shall be liable to imprisonment and a fine of up to 10 years or both.

5. Subsequent offences to the Import of drugs and cosmetics mentioned in point number 2 shall be liable to imprisonment up to 1 year or a fine of up to 5 years or both.

6. Above punishments shall be in addition to punishment awarded by the Sea Customs Act, 1878.

7. Consignment of drugs or cosmetics shall be confiscated

Compiled by Alok Bains

Drug and Cosmetic Act 1940 and Rules 1945.

Compiled by: Alok bains

IMPORT OF DRUGS

Offences (Section 13 of drugs and cosmetics act 1940)

1. Import of adulterated (under section 9A) or spurious drug (under section 9B) or any spurious cosmetic ( in section 9D) or any substandard cosmetic (in section 10) shall be punishable with imprisonment up to three years and a fine up to five thousand rupees,

2. Import of drugs or cosmetics prohibited to be imported under section 10, shall be punishable with imprisonment up to six months, or with a fine of up to five thousand rupees or both,

3. Import of any special drug or cosmetic prohibited to be imported by central government (section 10A), shall be punishable with up to three years, or with a fine up to five thousand rupees, or both;

4. Subsequent offence to the Import of drugs or cosmetics mentioned in point number 1 and point number 3 shall be liable to imprisonment and a fine of up to 10 years or both.

5. Subsequent offences to the Import of drugs and cosmetics mentioned in point number 2 shall be liable to imprisonment up to 1 year or a fine of up to 5 years or both.

6. Above punishments shall be in addition to punishment awarded by the Sea Customs Act, 1878.

7. Consignment of drugs or cosmetics shall be confiscated

Compiled by Alok Bains

Drug and Cosmetic Act 1940 and Rules 1945.

Compiled by: Alok bains

IMPORT OF DRUGS

Import Licences

The following Category of drugs can be imported under a licence or permit issued by authorised 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: Persons wishing to import any drug from outside India must have a registration certificate to import drugs. Persons apply for registration to the licensing authority in form 40. Applicant should have a valid wholesale licence to sell or distribute drugs. An undertaking shall also be submitted from the manufacturer of the drug to be imported or from the authorised person on behalf of the manufacturer. Application for registration shall be submitted with a fee as per the below details.

1. US Dollars 1500/- as registration fee for premises meant for manufacturing of drugs to be imported into India.

2. US Dollars 1000/- as the registration fee for a single drug to be imported into India and an additional US Dollars 1000/- for each additional drug.

3. US Dollars 5000/- shall be paid to inspect the manufacturing facility by licensing authority.

4. The applicant shall also pay a testing fee to the testing laboratory to test and analyse samples of drugs to be imported.

5. US Dollar 300/- for a duplicate copy of the registration certificate if the original registration certificate is damaged or defaced or lost.

6. Import of inactive bulk substances does not require any registration fee.

Licensing authority issued a registration certificate in form 41 of drugs and cosmetics rule 1945 after satisfying itself that applicant is suitable to get a registration certificate.

The fee shall be paid through Chalan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other bank specified by the licensing authority. The fee can also be paid by the manufacturer of the drug to be imported through an electronic clearance system to the bank of Baroda.

The following can apply for an import licence

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

2. Manufacturer’s agent in India having a valid licence to manufacture drugs for sale or having a valid wholesale licence to sell or distribute drugs

They apply for an import licence with a licence 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 authorised person on behalf of the manufacturer. The applicant shall also submit a registration certificate.

Licensing authority issue an import licence after satisfying itself that applicant is suitable for an import licence. Import licence remains valid for three years from the date of issue.

But it can be cancelled if the licensee does not observe the conditions submitted by him in the undertaking and conditions of the licence. Licensing authority gives an opportunity to the licensee to explain his position in writing. If the reply is not satisfactory then the licence is cancelled. Licence is cancelled for such period as licensing authority thinks fit. The licence may be cancelled for a particular drug or for all drugs. In a similar manner, the registration certificates can also be cancelled. Licensee can appeal in a court of law against the decision of licensing authority within 3 months from the date of cancellation.

A single application shall be submitted for a licence 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 licence. 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 authorised 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. The licensee authority may demand a specific amount of sample of any batch for examination and analysis. Licensee shall furnish samples of imported drugs to the licensee authority.

4. The 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 the 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 authorised 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 having a licence to manufacture a drug can import patent and proprietary medicine in a bulk container. But he has to take permission from licensing authority in writing at least three months in advance from the date of import.

Compiled by Alok Bains

Drug and Cosmetic Act 1940 and Rules 1945.

Compiled by: Alok bains

IMPORT OF DRUGS

Import Licences Additional requirements to be observed by the licensee have a licence to import drugs Other than schedule X.

The application shall be submitted in form 8 under drugs and cosmetics rule 1945 for a licence 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 licensing authority can issue a licence in form 10 without a registration certificate. But licensing authority shall have this emergency condition in writing.

The additional requirements to be observed by the licensee have a licence 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 licence 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 a licence in form 10-A under drugs and cosmetics rules 1945.

The licensing authority may refuse to issue a licence in form 10-A under the following conditions.

1. The applicant has been convicted under Narcotic Drugs and Psychotropic Substance Act 1985.

2. The applicant has been convicted under the drug and cosmetic act 1940 and rules 1945.

3. The applicant's previous licence has been suspended or cancelled.

Applicant can appeal to the central government against the decision of licensing authority not to grant an import licence. the appeal should be made within 30 days from the date of receipt to refuse the grant of import licence. 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 licence number,

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

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

Compiled by Alok Bains

Drug and Cosmetic Act 1940 and Rules 1945.

Compiled by: Alok bains

IMPORT OF DRUGS

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 licence even for those drugs that have been prohibited to be imported under section 10 of the drugs and cosmetics act 1940.

An application for a licence 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 the drug for examination, test or analysis. Application in form 12 with licence fee Rs10/- (Rs one hundred only) for single drug and additional fee Rs 50/- (Rs fifty only) for each additional drug. The licence fee shall be deposited through challan in the bank of Baroda or any other bank notified by the central government. Licensing authority issued import licences for this purpose in form 11 under drugs and cosmetics rules 1945. The licensee (Head of the institution) has to follow the following conditions

1. Licensee shall use imported drugs exclusively for examination, test or analysis.

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

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

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

5. An authorised drug inspector can take samples of drugs.

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

7. Licensee shall comply with all rules and regulations informed by licensing authority in one month advance.

If the licensee fails to comply with any provisions of drugs and cosmetics rules and any other compliance from licensing authority then the import licence may be cancelled. Licensee may appeal to the central government against this cancellation of the licence. But an appeal should be made within 3 months from the date of the licence cancellation order.

Compiled by Alok Bains

Drug and Cosmetic Act 1940 and Rules 1945.

Compiled by: Alok bains

IMPORT OF DRUGS

Import of a small amount 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 a life-threatening disease or treat diseases causing serious disability or require 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 a 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 licence fee of Rs 100/- (Rs One hundred only) for a single drug and Rs 50/- (Rs Fifty Only) for each additional drug.

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

3. The 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 drugs

   c. Inspect the manner of drugs used and their investigation

   d. take a sample of imported drug

4. Drug inspectors can enter into licence premises with or without prior notice to the hospital.

5. Licensee shall keep a record of all imported drugs and submit it to licensing authority after 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.

6. 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 import for a single patient by the licensing authority

The licensing authority may cancel the import licence if the hospital or medical institution does not follow the conditions to import the new drugs. 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.

Compiled by Alok Bains

Drug and Cosmetic Act 1940 and Rules 1945.

Compiled by: Alok bains

IMPORT OF DRUGS

Imports of drugs for personal use

Drugs prohibited to be 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 custom authority

4. The quantity of drug imported for personal use is not more than 100 doses

5. The quantity imported is as per the recommendation of a registered medical practitioner

6. 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 grant permit in form 12-B.

Compiled by Alok Bains