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Compliance Requirements under the Rules

1. Form 41: Registration Certificate (Rule 25B)

Form 41 is the Registration Certificate issued by CDSCO to certify manufacturing entity or importing entity that the products intended for manufacture or import met baseline standards for safety and efficacy. Each factory / unit requires a separate Registration Certificate.

A single application may be made, and a single Registration Certificate in Form 41 may be issued in respect of the import of more than one drug or class of drugs, manufactured by the same manufacturer. Provided that the drug or classes of drugs, are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit. Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs, separate Registration Certificates shall be required in respect of the drugs manufactured by each such factory.

Renewal Period: Valid for a period of three years from the date of its issue. Provided that if application for a fresh registration certificate is made 9 months before the expiry of the existing certificate the current certificate shall be deemed to continue in force until orders are passed on the application.

2. Form 10: Import licences for drugs not specified in Sch X (Section 10 (c), Rule 23 & 24)

An import licence in Form 10 is required for the import of drugs, except for those listed in Schedule X. An application for an import licence must be submitted to the licensing authority in Form 8 for drugs excluding those listed in Schedule X.

Application for an import licence must be submitted to the licensing authority in Form 8 for drugs excluding those listed in Schedule X. Every application in Form 8 or Form 8A must include a copy of the Registration Certificate issued in Form 41 under rule 27A.

Renewal Period: Valid for a period of three years from the date of its issue. Provided that if application for a fresh licence is made three months before the expiry of the existing licence the current licence shall be deemed to continue in force until orders are passed on the application.

3. Form 10A: Import licences for drugs specified in Sch X (Section 10 (c), Rule 23 & 24)

An import licence in Form 10A is required for the import of drugs, except for those listed in Schedule X. An application for an import licence must be submitted to the licensing authority in Form 8A for drugs excluding those listed in Schedule X.

Application for an import licence must be submitted to the licensing authority in Form 8A for drugs excluding those listed in Schedule X. Every application in Form 8 or Form 8A must include a copy of the Registration Certificate issued in Form 41 under rule 27A.

Renewal Period: Valid for a period of three years from the date of its issue. Provided that if application for a fresh licence is made three months before the expiry of the existing licence the current licence shall be deemed to continue in force until orders are passed on the application.

4. Appeal against suspension or cancellation of Import Licence (Rule 29)

A person aggrieved by the order for suspension or cancellation of registration certificate may appeal to the Central Government within 30 days of receipt of the order.

5. Appeal against suspension or cancellation of Registration Certificate (Rule 29A)

A person aggrieved by the order for suspension or cancellation of registration certificate may appeal to the Central Government within 30 days of receipt of the order.

6. Prohibition of import after expiry of potency (Rule 30)

No biological or other special product specified in Schedule C or C(l) shall be imported after the date shown on the label, wrapper or container of the drug as the date up to which the drug may be expected to retain a potency not less than, or not to acquire a toxicity greater than, that required, or as the case may be, permitted by the prescribed test.

7. Prohibition of Import of Certain Drugs (Rule 30B)

No drug, the manufacture, sale or distribution of which is prohibited in the country of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis

8. Ensure compliance with Standards of Drugs (Rule 31)

This provision states that imported drugs must meet prescribed standards of strength, quality, and purity. If specific standards are provided in the rules, the drug must comply with them. Additionally, the licensing authority will not permit the import of any drug if it has less than 60% of its shelf life remaining at the time of import

9. Packing and labelling of Imported Drugs (Rule 32)

No drug shall be imported unless it is packed and labelled in conformity with the rules in Parts IX and X and conforms the standards laid down in Part XII provided that in the case of drugs intended for veterinary use, the packing and labelling shall conform the rules in Parts IX and X and Sch F(l).

10. Packing and labelling of Homoeopathic medicine (Rule 32A)

No Homoeopathic medicine shall be imported unless it is packed and labelled in conformity with the rules in Part IXA

11. Form 11: Licence to Import Drugs for the purposes of Examination, Test or Analysis (Rule 33)

Small quantities of drugs the import of which is otherwise prohibited under section 10 of the Act may be imported for the purpose of examination, test or analysis subject to the some conditions as prescribed in Rule 33. The application for such licence shall be made in Form 12.

Under Section 10 of the Act, small quantities of otherwise prohibited drugs may be imported for examination, testing, or analysis, subject to the following conditions:

1. 1. Import is permitted only with a Form 11 licence.
   2. Imported substances must be used exclusively for testing at the location specified in the licence, unless otherwise approved by the licensing authority.
   3. Authorized inspectors may visit the premises at any time, with or without prior notice, to inspect, verify usage, and collect samples.
   4. The licensee must maintain and report import details to the licensing authority, including quantity, date of import, and manufacturer information.
   5. The licensee must adhere to any new requirements introduced under Chapter III of the Act, with at least one month’s notice from the licensing authority.
   6. The application for such licence shall be made in Form 12 accompanied by a fees of Rs. 5000 for a single drug and Rs. 2000 for each additional drug.

12. Appeal against cancellation of licence for examination, test or analysis (Rule 35)

A person aggrieved by the order for cancellation of licence for examination, test or analysis may appeal to the Central Government within 3 months of the date of the order.

13. Import of patent or proprietary medicines in Retail Containers (Rule 37)

Patent or proprietary medicine shall be imported in containers intended for retail sale

14. Permission to import Patent or Proprietary medicines (Rule 37)

Patent or proprietary medicine may be imported in bulk containers by any person who holds a licence to manufacture, if such person has obtained permission in writing to import such medicines from the licensing authority at least three months prior to the date of import and the imports are made within a period of twelve months from the date of issue of such permission.

15. Details accompanied by Imported Drugs (Rule 38)

All consignments of drugs sought to be imported shall be accompanied by an invoice or other statement showing the name and address of the manufacturer and the names and quantities of the drugs.