Ans.No Objection Certificate can be issued by DAHD, at the behest of CDSCO, for grant of permission to import or manufacture a new Veterinary vaccine/biological/drugs or to undertake Field Trial if no vaccine containing the same strain of the same source is already approved in India.

Ans.As per definition of “New Drug” under Rule 122 E of Drugs Rules 1945 of Drugs & Cosmetics Act, 1940,
A new drug means:
● A drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent has not been approved as safe and efficacious by Central Licencing Authority (CLA) i.e. DCG(I) with respect to its claims; or
● A drug approved by the CLA for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or
● A fixed dose combination of two or more drugs, approved by CLA separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or
● A modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; or
● A vaccine, r-DNA derived product, living modified organism, monoclonal antibody, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug unless certified otherwise by CLA..

Ans. ●Letter from CDSCO to examine the proposal from the angle of essentiality and desirability of the product.
●Duly filled DAHD Checklist.
●Detailed Dossier along with supporting documents as specified in the DAHD Checklist and other documents as necessary.
Note: Submit soft copies via E-mail to DAHD while keeping CDSCO in the E-mail.
Soft Copies: They must be well labelled with document number, name of the firm, date of submission etc. Scanned copies of only signed documents like test reports will be acceptable as soft copies. The table of content under each head should be linked to the files (s) or relevant documents for easy reference. Firms should preserve/maintain the soft copy of submitted documents in safe custody for any future reference if required.

Ans. Since in biologicals, the process and scale adopted during manufacturing determines the product and its critical quality attributes, and small changes can alter the biosimilar attributes, this aspect would also be examined based on the the microorganism (bacteria/virus etc) and cell characterization, and process comparability data (with originator or similar product in market) on critical quality attributes, which is to be supplied by the applicant. Therefore, the existence of strains already in the market doesn’t waive off the requirement for the need to generate local data or conduct bridging trials.

Ans. Since in biologicals, the process and scale adopted during manufacturing determines the product and its critical quality attributes, and small changes can alter the biosimilar attributes, this aspect would also be examined based on the microorganism (bacteria/virus etc) and cell characterization, and process comparability data (with originator or similar product in market) on critical quality attributes, which is to be supplied by the applicant. Therefore, the approval of strains in country of origin/other countries doesn’t waive off the requirement for the need to generate local data or conduct bridging trials.

Ans. No. Local data must be generated in India for approval of new veterinary products, irrespective of its regulatory status in other countries.