Import of Drugs and Excipients in India

[malay pota]

Import of Drugs and Excipients in India

• Import of Drug

The import, manufacture, distribution and sale of drugs, cosmetics and medical devices in the country is regulated under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 made there under. The Central Government exercises regulatory control over these articles imported into the country through the Central Drugs Standard Control Organization (CDSCO) headed by the Drugs Controller General India DCG(I). The manufacture, sale and distribution of drugs are primarily regulated by the State Drug Control Authorities appointed by the State Governments.  The objective of the drug regulatory system in the country is to ensure availability of safe, effective and quality drugs, cosmetics and medical devices based on scientific excellence and best possible regulatory practices.

Drug is defined in the Section 3 of the Drugs and Cosmetics Act 1940.The Central Government has the power to declare any item or medical devices as Drug by Notification in the Official Gazette. By virtue of the said power the Central Government has Notified Disposable Hypodermic Syringe, Disposable Hypodermic Needle, Orthopedic Implant, Catheter; IV Cannula as drugs in 1989.

Drugs manufactured outside India can be registered or unregistered.

1. Registered Drugs.
2. Unregistered Drugs.

Registered Drug

Registered drug means the Drug which is registered in India

Unregistered Drug

Unregistered drug means the drug which is not registered in India.

For the safety of the Indian public only Registered Drugs is allowed to be imported and Sold or used domestically in  India  either directly or  as an input for manufacturing the final products which will be used domestically  in India.

 Where to Import the registered Drugs

The import of the drugs is permitted through the designated ports specified under the Drugs and Cosmetics Rules, 1945.The said ports are called as Nominated Port for entry. The Ports are Mumbai (Sea and Airport), Nava Sheva (Sea Port), Kolkata (Sea and Airport), Chennai (Sea and Airport), Hyderabad (Airport), Delhi (Airport), Kochi (Sea Port) and Ahmadabad (Air Port), Bangaluru (Air Port), Goa (Sea and Air Port).

At every Nominated Port CDSCO has Office headed by the Assistant or Deputy Drug Controller of India.

Import of the registered Drugs

 When any drug is registered in India a certificate of Registration in the prescribed Form 41 is issued by the appropriate authority of the Central Government. When any person wants to import the registered drug he/it is required to have import licence issued by the appropriate authorities of the Central Government. As per rules 23 and 27 of the Drugs and Cosmetic Rules, 1945 the import licence to import drugs which are not specified in Schedule X to the said Rules will be issued in the prescribed Form 10 and for Import of Drugs specified in the Schedule X to the Drugs and Cosmetic Rules, 1945 the import licence will be issued in the prescribed Form 10A.

For better understanding, in India the drugs which are specified in Schedule X to the Drugs and Cosmetics Rules cannot be purchased over the counter without the prescription of a qualified doctor. Not only that the retailer also has to preserve the prescription for a period of two years.

Labeling on the imported consignment

On every import consignment of the registered drugs a label should be affixed showing the name and address of the manufacturer, date of manufacturing ,batch number, date of expiry of the drug, name and address of the importer ,import licence number and date(Form 10 or 10A).

Testing

As a safeguard to the Indian public, the Drug Controller office at the Nominated Port where the import consignment  arrive draws sample from the imported drug for testing to verify that the drug which is being imported in India as a registered drug is the same drug which is actually registered in India or not. The samples are sent for testing at the Central Drug Testing Laboratory of the Government of India. If the result of the testing comes to the satisfaction of the Drug Controller office the import consignment of drug is allowed to be cleared from the Customs and delivery of the imported consignment is give to the importer.

Sometimes it may happen that there is a delay in arrival of the testing result or the consignment of Drug is in a large quantity say 1000 kg or more imported by Air or the import consignment of drugs requires cooling temperature say below 2 degree or sometime may be in minus say -2 to -3 degree temperature to keep preserved the drugs. For keeping the imported drug in cooling storage there is very high storage charge has to be paid by the importer. In such cases the importer may request, for saving the storage cost of the imported cargo, to the Drug Controller office at the Port of Discharge by submitting Legal Guarantee in the prescribed format on the Non Judicial stamp paper of the appropriate amount stating that they will not use or dispose off the imported drugs until the result of the testing comes. The Drug Controller office at the Nominated port will release the consignment after taking sample.

Import of Unregistered drugs

Unregistered drug means the drug which is not registered in India hence, no import licence is issued consequently; import of such drug in India is not possible. Considering representation of various Drug Manufacturers Associations for granting exemption from registration requirement under the Drugs and Cosmetics Act., if the import of unregistered drug made under Advance Authorization (Advance Licence).The  Government of India Ministry of Commerce & Industries has by Policy Circulars made a provision that no registration is required if unregistered drug imported under Advance Authorization subject to the following conditions:

1. The Advance Authorization will be issued against valid export order and to the extent raw material (Imported Drug) required to manufacture the final product which has to be exported.
2. The final product which is to be exported should be manufactured from the unregistered drug so imported under the advance authorization.
3. The export has to be made within 12 months from the date of the First import made under the advance authorization.
4. The export of the final products made out of the drug so imported under the authorization to the same buyer against whose export order the advance authorization is issued if due to certain reason it is not possible to export to the same buyer the final products should be exported to other buyer.
5. If the raw material is not possible to be utilized for manufacturing the final products which is to be exported the imported material can be used in any other products which is /are to be exported.
6. If it is not possible to manufacture the final product from the imported materials the imported material should be re-exported.
7. If re export of imported material is not possible the same should be destroyed in presence of the Jurisdictional Excise Authority.
8. If the final products manufactured out of the imported material the final product should be destroyed in presence of the Jurisdictional Excise Authority.
9. The advance authorization holder is required to submit documentary evidence regarding such destruction of the imported raw material or the final product manufactured from the imported material.
10. The advance authorization holder has to pay applicable Customs duty on the imported material against which Export Obligation is not fulfilled along with applicable interest.

For availability of safe, effective and quality drugs, medical devices based on scientific excellence and best possible regulatory practices the imported material under the advance authorization which is unregistered in India is not allowed to be diverted for the domestic consumption within India

Import of Drug for Testing

Import of any drug for the purpose of examination, test or analysis in India is allowed subject to the import should be made against Test Licence issued by the appropriate authorities in the prescribed form No.11.  

• Import of Excipient

For manufacturing of a drug some substance is used for coloring or as preservative or as filler or diluter. The substance is not active in the drug in which it is used but works as vehicle or medium for the drug or other active substance. The substance which is so used it is called ‘excipient`.

Excipient can be imported in India without any Import licence issued under the Drug and Cosmetics Act 1940.However, No Objection Certificate (NOC) issued by the Drug Controller Office of India is required for import of such excipient. The NOC issuing authority will mention in the NOC name and address of the manufacturer,  name and quantity of the item to be imported and an instruction that ‘Not for Medicinal use.’ Should be mentioned on the packing of the excipient  so imported.

A copy of the NOC is sent to the Assistant/Dy. Drug Controller office at the port where the imported cargo is to be arrived. No testing is required of the material imported as an excipient.   

Discussions to this article

[YAGAY AND SUN]

Thanks Malay for sharing of such a beautiful Article.

[Prijesh J]

Thanks Malay for the good article, need to understand is there any ready reckoner where we can check if there is any sale ban on chemicals or drugs in particular state in India. Where in Importation is free.

[raghunandhaanan r vi]

Dear Malay

Good Article .............. Very informative too.

Thanks