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

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

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-

1. 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.
2. 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.
3. 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.