In India, the manufacturing, Import, distribution and sale of drugs are regulated by the Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945. License is provided for the Import of new drugs & cosmetics subject to those specified in Rule 10 & 10A. No new drug is allowed to import into India without the sanction of the Licensing Authority in writing. Each drug whose composition is not recognized as safe for use by the experts and that has not been used to any extent or for any appreciable period are to be regarded as a new drug. This blog will discuss how to Import New Drugs into India.
Application for Import License
An application for import license is made in Forms 8 & 9, respectively, for obtaining an import license in Form 10. The CDSCO Portal should make each application. Rule 24 of the Drugs & Cosmetics Rules with procedural requirements for getting a license.
Following are the procedural requirements for obtaining a license to Import new drugs in India:
- The application file by the manufacturer himself having a valid wholesale drug license for sale or distribution of drugs & cosmetics rules 1945.
- In a Power of Attorney, the agreement from the manufacturer to his Indian Agent has to be documented & verified either in India before a first-class magistrate or in the origin country.
- The importer (manufacturer’s Agent) in India either has a valid license by the Drug & Cosmetics rules to manufacture a new drug or a valid wholesale license for distribution/sale of new drugs under these Rules.
- The import license application must be followed by a copy of the registration certification grant in Form 42 issued under Rule 27A.
Requirements for Grant of License for Import New Drugs
- Imported substances shall be sorted properly to maintain the properties of the Drugs applied for a license.
- Where any charge in the constitution of the manufacturer address takes place, the current registration certificate is valid for three months. In the meantime, a fresh registration certificate shall be issued Form the licensing authority with the charged information.
Documents for Obtaining License for Import New Drugs in India
Following are the Documents for getting a License to Import New Drugs in India:
- Cover Letter;
- Form-8 and Form-8A are duly Stamped & Signed by the applicant;
- Notarized copy of manufacturing drug license or wholesale;
- Permission under Rule 122A (Application for permission to import new drugs) if a new drug is in the name of the importer;
- Form-9 (Undertaking given from the manufacturer or on behalf of the manufacturer);
- Copy of valid registration certificate (RC) on Form-41 duly attested from the importer or Indian Agent;
Prohibition on Import new drugs into India
Section 10 of the Drugs & Cosmetics Act, 1940 has made the restriction on the Import of the following:
- Drugs of substandard quality.
- Any misbranded and spurious drugs.
- Any adulterated drugs.
- Any drug that needs to cure or mitigate any disease.
- Any drugs include an ingredient that may be harmful or unsafe for consumption.
- Any proprietary or patent medicine with no description of the true formula or list of active ingredients is included.
- Drugs are prohibited from imports under section 10 of the Drug & Cosmetics Act, 1940.
Note: section 10 has an exception related to any drugs in small quantities for the aim of testing, examination or analysis for personal use and subject to prescribed conditions.
Central Government of India Power of Prohibition
The Central Government will prohibit the Import of new drugs if the government is satisfied that:
- The use of such drugs involves risks to humans or any animal.
- The drug lacks its therapeutic value.
- The drugs include ingredients in such quantity, for there is no therapeutic justification.
Following penal provisions are applicable for non-compliance with the provision for Import new drugs:
- The Import of adulterated drugs that involves the risk of human life has imprisonment for the team of three years or a fine that can be a maximum up to Rs.5000, or both. And for the subsequent conviction, imprisonment for five years.
- The Import of drugs against the provisions given in any notification issued under section 10A shall be liable for imprisonment for three years or a fine up to Rs.5000 or both.
- The Import of any drugs prohibited under any section of the Act has imprisonment for six months or fine of Rs.5000 or both. And for the subsequent conviction, imprisonment for one year.
To obtain a licence to import new drugs in India, the licensee must have a sufficient storage facility, and the applicant must be well-known in their field. The license granted must not be suspended or cancelled unless the licensee has not been convicted of any offence under the Drugs & Cosmetics Act 1940 or the Drugs & Cosmetics Act 1945.
Read our Article:Import License of Drugs and Cosmetics in India