REGULATORY SYSTEM FOR MANUFACTURING, IMPORT AND NEW VETERINARY DRUG APPROVAL IN INDIA
Manufacturing a Veterinary Drug in India
Under the Drugs Act “Manufacturing” includes any process (or part) for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug with a view to its sale or distribution. However, “manufacturing” does not include dispensing or the packing of any drug at the retail sale level. All manufacturing of drugs in India requires a license. The license shall be valid for a period of five years on and from the date on which it is granted .It is also possible to obtain a license to manufacture a product in the factory premises owned by another party, through a practice called “loan licensing”. The good manufacturing practices (GMP) and requirements of premises, plant & machinery are provided in the Schedule M. The items covered are: locations and surroundings, buildings, water supply, disposal of waste, working space and storage areas, health, clothing and sanitation of workers, medical services and equipment standards. The Drug & Cosmetics Act also specifies other conditions for grant of license, competent technical staff and qualification with experience in drug manufacture.
Registration for Importing a Drug into India
All drugs to be imported require import registration. An application for issue of a Registration Certificate shall be made to the licensing authority either by the manufacturer himself, having a valid license or valid wholesale license for sale or distribution of drugs specified under the Drugs & Cosmetics Rules, 1945 and information and undertakings specified in Schedule D (I) and D (II) should duly signed by the manufacturer. Schedule D(I) and D(II) should comprise actual plant and drug data, such as the plant master file ; the manufacturing license in country of origin; a GMP Certificate; a Certificate of Pharmaceutical Products(CPP); drug substance information; finished formulation information; clinical documentation and packaging and labelling information.
License for Importing a Drug into India
An application for import license shall be made to the licensing authority for drugs excluding those specified in Schedule X either by the manufacturer himself or by the manufacturer’s agent in India having a valid wholesale license for sale or distribution of drugs under these rules A license is valid for a year, up to December 31st of the year following the year in which the license was granted and has to renewed thereafter.
License for Importing a Drug into India
An application for import license shall be made to the licensing authority for drugs excluding those specified in Schedule X either by the manufacturer himself or by the manufacturer’s agent in India having a valid wholesale license for sale or distribution of drugs under these rules A license is valid for a year, up to December 31st of the year following the year in which the license was granted and has to renewed thereafter.
New Drugs
No new drug can be imported without the permission of the Licensing Authority. Approval to manufacture a new drug should be obtained from the Licensing Authority. Permission should be obtained from the Licensing Authority to conduct clinical trials for New Drug. “New Drugs” shall mean and include – Ø Drugs not previously available in Indian market.Ø Drugs with new therapeutic indications or dosages that have not been marketed in India. Ø New fixed -dose combinations of two or more drugs. Ø Any drug which was first approved in India less than four years ago, unless it is included in the Indian pharmacopoeia. Ø All vaccines are treated as new drug, unless notified otherwise by DCGI.
REGULATORY SYSTEM FOR MANUFACTURING, IMPORT AND NEW VETERINARY DRUG APPROVAL IN INDIA
