Some Highlights of details covered under Schedule D is:
1. Substances not intended for medicinal use
All provisions of Chapter III of the Act and rules thereunder subject to the condition that if the substance is imported in bulk, the importer shall certify that the substance is imported for non-medicinal uses, and if imported otherwise than in bulk, each container shall bear a label indicating that the substance is not intended for medicinal use or or is of commercial quality.
Entry 2,3,4 has been omitted
5. The following substances, which are used both as articles of food as well as drugs:-
All provisions of Chapter III of the Act and rules thereunder.
- All condensed or powdered milk whether pure, skimmed or malted, fortified with vitamins and minerals.
- Farex, Oats, Lactose and all other similar cereal preparations whether fortified with vitamins or otherwise excepting those for parenteral use.
- Virol, Bovril, Chicken essence and all other similar predigested foods.
- Ginger, Pepper, Cumin, Cinnamon and all other similar spices and condiments unless they are specifically labelled as conforming to the standards in the Indian Pharmacopoeia or the official pharmacopoeias and the official compendia of the drug standards prescribed under the Act and rules made there under.
6. Drugs and cosmetics imported for manufacture and export by units situated in “Special Economic Zones” as notified by the Government of India from time to time.
The provisions of Chapter III of the Act and rules thereunder which required them to be covered by an import licence, import registration and import through notified port of entry, subject to the conditions that these drugs and cosmetics shall not be diverted for sale in the country:
Provided that such imported drugs and cosmetics may be permitted to the domestic area if they meet the requirements of standard procedure for import and registration as required under Chapter III of the Act and rules thereuder.]
Schedule D(I) covers the information and undertaking required to be submitted by the manufacturer or his authorized agent with the Application Form for a Registration Certificate. The format shall be properly filled in for each application in Form 40. The detailed information, secret in nature, may be furnished on a Computer Floppy.
- Particulars of the manufacturer and manufacturing premises
- Particulars of the manufactured drugs to be registered under Registration Certificate.
- Undertaking to declaration
Schedule D (II)
Schedule D (II) covers Information required to be submitted by the manufacturer or his authorized agent with the Application Form for the registration of a bulk drug/formulation/special product for its import into India. The format shall be properly filled in and the detailed information, secret in nature, may be furnished on a Computer Floppy
- Chemical and Pharmaceutical Information of Drugs
- Biological and Biopharmaceutical information of Drugs
- Pharmacological and Toxicological information of Drugs
- Clinical Documentation
- Labelling and Packaging information of Drugs
- Specific information required for the special products
Information to be submitted in Schedule D-II:
Covers Specific information required for the blood products
Covers Specific information required for the diagnostic Kits
Covers Specific information required for vaccines
For Detail Drug and Cosmetic Act and rule download in pdf at http://www.cdsco.nic.in/ by clicking here