Drugs Import Policy and Procedure in India | Import of Pharmaceuticals

Import of Pharmaceuticals Drugs in india

Drugs Import Policy and Procedure in India


India is the third-largest manufacturer in the field of Pharmaceutical industry. This industry is governed by the Ministry of Health & Family Welfare and Ministry of Chemical & Fertilizers. Although India produces many drugs itself but a large portion is imported mainly from the European Union, followed by North America and Asia.

Drugs Export and import is regulated by the Central Drugs Standard Control Organisation (CDSCO), through 11 Port offices located in different parts of the country. CDSCO regulates the drug import and export of drugs in India by the following rules and Acts.

1. Drugs and Cosmetics Act, 1940 and Rules, 1945. 

2. Pharmacy Act, 1948. 

3. Drugs and Magic Remedies Act, 1954. 

4. Medicinal and Toilet Preparation Act, 1956. 

5. Narcotic and Psychotropic Substances Act, 1985.

6. The Drugs (Prices Control) order, 1995.

 

The bulk drug (Active Pharmaceutical Ingredients) and finished formulations are regulated under the Drugs and Cosmetics Act, 1940 and Rules, 1945. The application for registration and import has to be made to the Drugs Controller General at CDSCO.

 

Guidelines for permission to import or manufacture of new drugs for sale or to undertake clinical trials

No Drug is allowed to be imported in India without the sanction of the licensing authority in writing. All drugs that are not recognized as safe for the use by experts or are not consumed to a large extent are known as new drugs.

Permission for importing new drugs may be acquired from the licensing authority after furnishing the necessary documentary evidence of the drug's standards of quality. The application for importing new drugs should be accompanied as specified in schedule Y.

 

l  Form 44 -Application for grant of permission to import or manufacture a new drug or to undertake Clinical trail 

 

l  Form 12 -Application for license to import drugs for examination, test, or analysis 

 

l   Form 11 -License to import drugs for examination, test, or analysis (1yr validity) 

 

l  Form 4 -Issue of import certificate (6 months validity) 

 

l  Form 1 -Application for the issue of import certificate for import of narcotic drugs and psychotropic substances (6-month validity) 

   

Application for Permission: An application is made in FORM 44 accompanied with the following data-


· Chemical and pharmaceutical information

· Animal Pharmacology data

· Animal toxicology data

· Human Clinical Pharmacology data

· Regulatory status in other countries

· Prescribing information

· Complete testing protocol for quality testing

Clinical Trial: Concerning new drug, clinical trial means the study of such new drug in human subjects to generate data for discovering or verifying its, 

· clinical or; 

· pharmacological, including pharmacodynamics.

· adverse effects.


Stages of Drug importation


Phase 1

1. Application for the issue of a Registration Certificate shall be made in form 40 by the manufacturer or authorized agent to the licensing authority.

2. A power of attorney shall document the authorization by a manufacturer to his agent. Such power of attorney shall be executed and authenticated either in India before a First Class Magistrate, or in the country of origin before such an equivalent authority. 

3. (i) A fee of one thousand and five hundred US dollars 2[or its equivalent in Indian rupees] shall be paid along with the application in Form 40 as registration fee for his premises meant for manufacturing of drugs intended for import into and use in India.

4. (ii) A fee of one thousand US dollars 2[or its equivalent in Indian rupees] shall be paid along with the application in Form 40 for the registration of a single drug meant for import into and use in India and an additional fee at the rate of one thousand US dollars for each additional drug: Provided that in the case of any subsequent application for registration of additional drugs by the same manufacturer, the fee for accompanying shall be one thousand US dollars 2[or its equivalent in Indian rupees] for each drug.

5. The applicant shall be liable for the payment of a fee of five thousand US dollars for expenditure as may be required for inspection or visit of the manufacturing premises or drugs, by the licensing authority or by any other persons to whom powers have been delegated in this behalf by the licensing authority under rule 22.

6. The applicant shall be liable for the payment of testing fee directly to a testing laboratory approved by the Central Government in India or abroad, as may be required for examination, tests and analysis of the drug.

7. A fee of three hundred US dollars shall be paid for a duplicate copy of the Registration Certificate if the original is defaced, damaged.

8. No Registration Certificate shall be required under these rules in respect of an inactive bulk substance to be used for a drug formulation, with or without Pharmacopoeia conformity.


Phase 2:

1. An application for an import License shall be made to the licensing authority in Form 8 for drugs excluding Schedule X, and in Form 8-A for Schedule X drugs; either by the manufacturer or by the manufacturer's agent in India who is having the wholesale license for sale or distribution of drugs and shall be accompanied by a License fee of one thousand rupees for a single drug and one hundred rupees for each additional drug and by an undertaking in Form 9 duly signed by or on behalf of the manufacturer.

2. Any application for import licence in Form 8 or 8-A, which shall be accompanied by a copy of Registration Certificate issued in Form 41 under Rule 27-A; in the case of emergencies the issue of Import License by the central government in Form 10 or 10-A without the issuance of Registration Certificate under Rule 27-A, for reasons to be recorded in writing.

3. A fee of two hundred and fifty rupees shall be paid for a duplicate copy of the licence if the original is defaced, damaged or lost.