Test Licenses
REQUIREMENTS/DOCUMENTS TO BE SUBMITED FOR APPROVAL/ GRANT OF LICENCE TO MANUFACTURE ADDITIONAL PRODUCTS UNDER DRUG LICENSES GRANTED
1. Aplication for grant of additional products with the following information.
2. Consolidated list of Formulations with packing particulars under each licence(Form 25/28) separately category wise viz. Tablets, Capsules, Injectables etc.
3. Challan in original remitting the fee of Rs.300/- for each product applied in the Head of Account
0210 – Medical and Public Health
04 –Public Health,
104 – Fees, Fines etc
Product Information in Respect Bulk Drugs:
i) Manufacturing procedure of each product
ii). Flow Chart with structural Formula of reactions as per Master Formula record and analytical procedure of each applied product with mode of procurement of official reference standards or working standards.
iii).Consumption coefficients of Raw Materials.(as per Format)
iv). Official Monographs copies
v). Details of effluents generated and their treatment followed.
vi). Specimen labels of all applied products
vii). List of Manufacturing & Analytical equipment in the format
viii).Consent letters of Technical staff in the Format.
ix). Photocopy of valid G.M.P. Certificate or reference of compliance of revised Schedule “M”,if any, available
x) New drug status of the product or otherwise with documentary proof.
Product Information in Respect Formulations:
i). Consolidated list of Formulations with packing particulars separately Category wise Viz.Tablets, Capsules, Injectables etc.
ii).Manufacturing & Analytical procedure of each product.
iii).Specimen label
iv).Labels of the similar products moving in the market for formulations not include in IP
v).Declaration regarding the Brand Names of the Product.
vi).Copies of monographs of drugs which are not included in IP
vii). List of Manufacturing & Analytical equipment in the format
viii). Consent letters of Technical staff in the Format.
ix). Photocopy of valid G.M.P. Certificate or reference of compliance of revised Schedule “M”,if any, available
x) New drug status of the product or otherwise with documentary proof.
Points to be considered while applying for grant/ approval of API Drugs / Formulation Products
1. The name of drug (Formulation) shall be shown with proper name of the drug followed by trade Name.
2. The Specification of the Product and the ingredients in the Formula shall be written as IP or other Pharmacopial Specifications followed by its name ( as the case may be ) if the drug is in IP it should be used for domestic Sale and if it is not in IP any other Pharmacopial or in house (IH) specifications can be used for domestic sale. For Export any specification can be approved as per the customer requirement
3. If the applied API or Formulation is a new drug as per the definition under Rule 122 E of Drugs and Cosmetics Rules 1945, the permission from Drugs Controller General of India is required for approval.
4.New Drug status remains for 4 years from the date of approval by DCG (I) .
5.For approval of Formulations with combination of drugs, the list approved by DCG (I) will be taken on the bases for approval.
6.New drugs shall not be permitted without the approval of DCG (I) even for Test Licence for Chemical and Instrumental Analysis only ) Provided in case of FDC’s in which individual APIs are not New Drug, they can be permitted for Chemical and Instrumental analysis.
7.Joint inspection with CDSCO official is required for grant of Licences / additional products in case of Blood Banks, LVPS, Vaccines, Sera Products and r-DNA Products and approved Laboratories.
8. When there is no specific approval by DCG (I) regarding strength and route of administration of API all the dosage forms are not to be approved except oral dosage forms viz. Tablets, Capsules, Liquid Orals, Oral Powders, When single API ( Bulk Drug ) is approved by DCG (I).
9. FDCs of Veterinary Products may be permitted basing on the evidence of similar market label if individual APIs in FDC are not new Drugs. ( This procedure is adopted until a consolidated list of approved FDC drugs of Veterinary products is communicated by DCG (I).