The import, manufacture, distribution and sale of drugs, cosmetics and notified 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 thereunder. The Central Government exercises regulatory control over these imported drugs 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 the availability of safe, effective and quality drugs, cosmetics and medical devices based on scientific excellence and best possible regulatory practices.
Drug is defined in 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. And the said devises are called Notified Devises. 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 and thereafter many devises are notified as Notified devises.
Drugs can be of two types
- Registered Drugs.
- Unregistered Drugs.
Registered drug means the Drug which is registered in India.
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 for the Indian public either directly or as an input for manufacturing the final products which will be used 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 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) Mundra (Sea Port).
There is an Office of CDSCO at every Nominated Port 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/she is required to have an 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 license to import drugs that 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 purchase prescription for a period of two years.
Labelling 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 either Form 10 or 10A, whichever is applicable, number and date.
As a safeguard to the Indian public, the Drug Controller office at the Nominated Port where the import consignment arrives draws a 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 then sent for testing to the Central Drug Testing Laboratory (CDTL) of the Government of India. The import consignment is allowed to be cleared from the Customs if the result of the testing comes to the satisfaction of the Drug Controller office.
It may sometimes happen that there is a delay in the 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 temperature below 2 degrees or sometimes maybe in minus say -2 to -18 degree temperature to keep preserved the drugs. Sometimes it may happen that the drugs are of such nature that it is not advisable to open in the port area for taking a sample for testing. In such cases to avoid unnecessary storage charges and the safety of the material the imported material is allowed to be Customs cleared with pending testing formalities and the testing of the imported material is done at the factory or the place mentioned in the import licence instead of at the Port. For that purpose, the importer is required to request the Drug Controller office at the Port 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 material until the result of the testing comes. The Drug Controller office at the Nominated port will release the consignment after taking the sample or the Drugs controller will take visit the factory or the place where the imported material is kept and draw a 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:
- 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.
- The final product which is to be exported should be manufactured from the unregistered drug so imported under advance authorization.
- The export has to be made within 12 months from the date of the First import made under the advance authorization.
- 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 buyers.
- If the raw material is not possible to be utilized for manufacturing the final products which are to be exported the imported material can be used in any other products which is /are to be exported.
- If it is not possible to manufacture the final product from the imported materials the imported material should be re-exported.
- If re-export of imported material is not possible the same should be destroyed and self-declaration and Chartered Accountant certificate in this regard are required to be obtained and submitted to the Advance Authorization issuing authorities at the time of closure of the licence or when the licence issuing authorities demands for the same.
- If the final products manufactured out of the imported material and the same is not possible to export the final product should be destroyed and self-declaration and Chartered Accountant certificate in this regard are required to be obtained and submitted to the Advance Authorization issuing authorities at the time of closure of the likened or when the licence issuing authorities demands for the same.
- 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.
- 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 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 Excipients
There are two main things in the manufacturing of Pharmaceuticals items one is Active Pharmaceuticals Ingredient (API) and other is Excipient. An excipient is an inactive substance in Pharmaceuticals item manufacturing. It is used as a vehicle or medium in the manufacturing of Drugs. An excipient is things like colouring agent, preservatives etc.
In the medicals stores, different colours like red, green, yellow, black, brawn tablets and capsules are available, the colour is not an active ingredient or not a drug in the tablet or capsule the substance which is used to give colour in manufacturing of tablet or capsule is called excipient. Similarly, the substance which is used in the manufacturing of drug with a view to improve and amplify the self-life of the drug is not an active substance in the manufacturing of drug the substance used is called excipient.
Here the excipient is not a drug but it is used in the manufacturing of the drug so, for the purpose of regularizing the import of excipient under the applicable Act and Rules it is required to have a No Objection Certificate (NOC) from the Drugs Authorities of India for import of the excipient.
Unlike drugs, there is no provision for testing of the excipients.