Overview of CDSCO Drugs Import License
Chapter III of the Drugs & Cosmetics Act of 1940 and Part IV of the Drugs and Cosmetics Rules of 1945 govern the import of drugs into India. Drug registration certificates and import license applications are processed in accordance with Rule 24(A) and Rule 24 of the Drugs & Cosmetics Rules 1945. According to CDSCO, the following are considered as drugs:
- All medications intended for internal or external use on humans or animals, as well as all substances intended for use in diagnosis, treatment, mitigation, or prevention of any disease or disorder in humans or animals, including preparations applied to the body to ward off insects like mosquitoes.
- Such substances (other than food) are intended to alter the composition or any function of the human body, as well as all substances intended to be used for the destruction of human tissue.
- Every substance that is intended to be used as a drug component, including empty gelatine capsules.
Under the Drugs & Cosmetics Act 1940 and Rules 1945, the import, manufacturing, sale, and distribution of drugs are all regulated in India. Currently, the Act regulates both finished formulations and bulk drugs (active pharmaceutical ingredients). Before being imported into the country, any substance that meets the definition of “drug” under Section 3(b) of the Act must be registered with CDSCO. The manufacturing facility must also be registered for import in addition to the drug. The local authorised agents of foreign manufacturers with manufacturing or sale licenses or foreign manufacturers with wholesale licences in the country may submit applications for registration certificates and CDSCO drugs import licenses to the licensing authority designated by the Act.
Benefits of CDSCO Drugs Import License
The manufacturer or importer of drugs can benefit greatly from a CDSCO Drugs Import License. The intended population is protected, and the seller is free from any legal repercussions when they sell drugs in India. Some of the benefits of a CDSCO drugs import license are-
- It ensures patients' safety and makes sure that they are not exposed to health risks.
- When CDSCO certifies a drug, it undergoes quality assurance testing at a certified lab, has a quality certificate and produces the best outcomes possible for the patients.
- Indian market depends on foreign suppliers as the demand for drugs is high in India.
- As a result, the regulatory body ensures that the imported drug is of good quality. This is the rationale behind establishment of the regulatory body to address products of average and subpar quality.
- CDSCO Drugs Import License strengthens the brand identity of drugs imported
- With new standards and guidelines in place, each drug manufacturer has the chance to explore the market actively after registering their product under a specific law
- There are varied possibilities for the International manufacturers as the Indian government has decided to permit foreign manufacturers to import drugs due to the country's increased demand for them
- The authority performs on-site audits to make sure that drugs are manufactured and stored in compliance
- The audit helps in locating equipment flaws and assists in reducing risks that could one day harm a patient
- Maintaining compliance must therefore be a top priority for every manufacturer and distributor
Eligibility to Import Registered Drugs in India
- Foreign manufacturers who have obtained a license for sale or distribution of drugs in India are eligible to import registered drugs into India.
- A local representative who is authorised by a foreign manufacturer and who holds a manufacturing or sales license.
Documents Required for CDSCO Drugs Import License
The Central drugs standard control organisation, which operates under Directorate general of health services, Ministry of Health & Family Welfare Government of India, requires the following documents for CDSCO Drugs Import License in India:
- Covering Letter
- Application Form, duly signed and sealed
- The Original power of attorney
- Challan of fees paid along with the application form
- Copy of import permission for new drugs
- Copy of a valid wholesale license
- Authorisation letter of the company
- Duly signed and sealed undertaking
- Notarised copy of Plant Master File
- Notarised copy of Drug Master File
- Original notarized copy of Manufacturing License, FSC, GMP, COPP ( For finished products)
- Attested copy of Product Registration Certificate (CFDA)from china or Certificate of suitability from (EDQM)
- Original label/specimen
CDSCO Drugs Import License
Procedure to Obtain CDSCO Drugs Import License
- The manufacturer or his Agent must first acquire a Registration Certificate before applying for an import license to import registered drugs into India. The applicant must request an import license and registration certificate from CDSCO.
- An application for CDSCO Drugs Import License is made to the Licensing Authority for drugs excluding those specified in Schedule X and in the application form for drugs specified in Schedule X, either by manufacturer himself having a valid Wholesale License for sale or distribution of drugs under these Rules or by manufacturer's Agent (importer in India either having a valid License to manufacture for sale of a drug or having a valid Wholesale License for distribution or sale of drugs under these Rules & an undertaking in the form duly-signed by or on behalf of the manufacture.
- The Licensing Authority shall, on being satisfied, if granted, the conditions of the License will be observed, issue an Import License. A CDSCO Drugs Import License unless it is sooner cancelled/suspended, shall be valid for a period of 3 years from date of its issue.
Prohibition of Import of Certain Drugs
According to Section 10 of the Drugs and Cosmetics Acts, 1940, there are certain drugs that are prohibited from being imported to India. The prohibited drugs are as follows-
- Any drug or cosmetic which is not of standard quality.
- Any misbranded drug
- Any adulterated or spurious drug
- Any drug or cosmetic for the import of which a license is prescribed. And if imported, it must be done in accordance with the License.
- Any patent or proprietary medicine import is prohibited unless the true formula and the list of active ingredients, along with its quantities, are displayed in the container of the product.
- Any drug design or device accompanying it or by any other means that purports or claims to cure or mitigate any disease or ailment or to have any such other effect is prohibited from being imported.
- Any cosmetic containing any ingredient which may be unsafe or harmful for use
- Any drug or cosmetic whose import is prohibited by the rule made under chapter III of the Drugs and cosmetics acts, 1940
Offences Related to Drug Import License
CDSCO allows Imports of Drugs by providing a CDSCO Drugs Import License to the Foreign Manufacturers. However, there are certain drugs that are prohibited and importing them may lead to offences causing imprisonment and penalties. The offences and penalties are as follows-
- Import of adulterated or any kind of spurious cosmetics- Punishment for importing any kind of adulterated drug or any spurious cosmetic may lead to imprisonment for a term which may extend to three years or a fine up to Rs.5000, or both.
- Import of any drug prohibited under Section 10- Import of any drug prohibited under Section 10 of Drugs and Cosmetics Act, 1940 may lead to imprisonment for a term of six months or a fine up to Rs. 5000, or both.
- Import of any drug against the provisions of section 10 A- Importing any drug against the provisions of Section 10 A of The Drugs and Cosmetics Act, 1940 may lead to imprisonment for three years or a fine up to Rs. 5000, or both.
Frequently Asked Questions
The Drugs and Cosmetics Act of 1940's Chapter III and the Drugs and Cosmetics Rules of 1945's Part IV contain the rules for importing registered drugs into India.
Drug registration and import in India are handled by the Import and Registration Division of the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
The Licensing Authority issues a Registration Certificate in accordance with the 1945 Drugs and Cosmetics Rules to register the premises and the drugs produced there that are intended for import into and use in India.
An import license is either a permit to bring in substances other than those listed in Schedule X, or a permit to bring in substances listed in Schedule X.
The prerequisites for re-registering a drug are the same as those for registering it for the first time.
The licencing authority will issue an import license in Form 10 within three months of the date of receipt of an application if the application is valid.