Frequently Asked Questions (FAQ) on Conducting Clinical Trial/Field Trial of Biologicals and Drugs for Veterinary use in India
Q-1. When is NOC from the Department of Animal Husbandry & Dairying (DAHD) required?
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.
Q-2. What is a “new drug” ?
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..
Q-3. What are the documents required for grant of No Objection Certificate (NOC) for import and manufacturing of veterinary vaccines/biologicals/drugs from DAHD?
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.
Q-4. For strains already in the market, would the requirement of local / bridging trials be waived off?
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.
Q-5. For strains approved in country of origin/other countries, would the requirement of local/bridging trials be waived off?
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.
Q-6. Whether Approval / Marketing Authorization, issued by the competent Authorities in the country of origin/other parts of the world, can be considered for exemption of Clinical Trials/Bridging Trials for new veterinary products ?
Ans. No. Local data must be generated in India for approval of new veterinary products, irrespective of its regulatory status in other countries.
Q-7. Regarding the importation of exotic pathogens/vaccine strains in (please refer OM: K-11053/47/2021-LH-Part I dated 28th March, 2022 and 8th June, 2022) ?
Ans. ●Is the importation of exotic pathogens/vaccine strains permitted in India?
To support both the domestic and export industry, the importation of exotic pathogens/vaccine strains is conditionally permitted subject to risk assessment on a case-by-case basis, good containment system, along with necessary regulatory requirements and supervision. The procedure needs an application to the Department through CDSCO with all details and information along with the purpose for examination by the Department on a case-to-case basis.
●Whether the case will be examined after importation of pathogen?
No, following pre-import conditions should be fulfilled before any import is allowed, which would be examined by the Department to take appropriate decision: Suitable provisions are in place to ensure no cross-contamination with domestic strains. Ensuring that the supply of vaccines for priority national programs is not hampered as a result of export needs. Ensuring appropriate bio-containment measures to prevent any leakage of exotic strains.
●Whether the No Objection Certificate will be required before import from DAHD for each and every case.
Yes, each and every case received for importation of exotic pathogen/vaccine strain for manufacture of livestock or poultry vaccine will be examined in the Department with due procedure.
Q-8. Can the firms submit the request for grant of licence to import IVD kits and reagents to ECAH ?
Ans. The firms are advised to refer Medical Device Rules 2017 of Drugs & Cosmetics Rules, 1940 and submit application to Central Drugs Standard Control Organization (CDSCO).
Q-9. Can the firms submit the request for grant of licence to import veterinary equipment to ECAH ?
Ans. The firms are advised to refer Medical Device Rules 2017 of Drugs & Cosmetics Rules, 1940 and submit application to Central Drugs Standard Control Organization (CDSCO).
Q-10. What is the policy for vaccination against Low Pathogenic Avian Influenza (H9N2) ?
Ans. Please refer to the following notification –K-11053/70/2021-LH dated 08.08.2022
IMPORTATION OF EXOTIC PATHOGEN STRAINS FOR MANUFACTURE OF LIVESTOCK & POULTRY VACCINE PERMISSION
K-11053_47_2021-LH-Part I dated 28th March, 2022
Q-11. What is the procedure for expanding/ modifying the currently registered indications?
Ans. Expanding or modifying the indications/ intended use are considered as a major change. This shall require prior approval by CDSCO and subsequently by DAHD, only if requested by CDSCO by way of a formal letter to examine the amendment.
Q-12. What is “Clinical Trial”?
Ans. A study which aims to examine under field conditions the safety or efficacy of a Veterinary drug under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a marketing authorisation or a change thereof. The firms are advised to refer to Clinical Trial Document.
Q-13. Where do we conduct clinical trial for Veterinary drugs?
Ans. In case of New Drugs for veterinary use, the applicant shall conduct the field trial or clinical trial only after obtaining permission from DCG(I)/NOC from DAHD. Animal ethical approval and owner’s consent are also important before starting the trial. Please refer clinical trial document.
Q-14. Do we need any approval for conducting clinical/field trials?
Ans. In case of New Drugs for veterinary use, the applicant shall conduct the field trial or clinical trial only after obtaining permission from DCG(I)/NOC from DAHD. Animal ethical approval and owner’s consent are also important before starting the trial. Please refer clinical trial document.
Q-15. Is there any specific requirement for the manufacturing of batches for clinical trial / field trial?
Ans. Three test batches shall be manufactured at a facility after obtaining licence in Form 29 to manufacture the veterinary drugs for purposes of examination, test or analysis issued by the concerned State Licensing Authority. Clinical trial batches shall be manufactured following the cGMP guidelines. Please refer clinical trial document.
Q-16. Do we need to conduct clinical trials / field trials in all indicated species of animals?
Ans. If the drug is to be used for several species of animals (for eg. FMDV, Rabies vaccine), the clinical trial must be conducted for all target species for which the drug is to be used. Animal study results, generated during the developmental stage shall be used to determine the dose requirement, safety and potency for other indicated species. Please refer clinical trial document.
Q-17. What is Severe Adverse Event (SAE) during veterinary drug trials?
Ans. A Serious Adverse Event (SAE) is actually a special case of an adverse event where adverse outcomes are severe. It includes the following events:
●Death of any of the animals associated with a clinical trial.
●An event that can lead to life-threatening complications or put the lives of animals at risk as a result of participation in a clinical trial.
●Events that result in such a condition where the animals may require immediate hospitalisation or increase the duration of hospitalisation.
●Any events that lead to a permanent or temporary physical disability in the body of the animals. Any sort of incapacity is also regarded as SAE.
●Any events where an investigator or team of investigators feel that it can lead to significant hazards.
Q-18. How many geographical locations are to be selected for conducting the clinical trial/ field trial?
Ans. The clinical/ field trial shall usually be conducted at least in two different geographical locations in India. For vaccine trials, the locations can be selected based on disease prevalence (study shall be conducted where the disease is highly prevalent) wherever the primary/ secondary efficacy criteria are assessed. Disease prevalence criteria is not applicable wherever immunological parameters such as protective titre are assessed as correlate of protection. However, drug protocol (including place) should be vetted from the Department before conduct.
Q-19. What are the safety parameters to be assessed during the trial?
Ans. Parameters used to determine systemic effects of the drug may include allergic reactions, shock syndromes, abnormal clinical signs, mortality, anorexia, pyrexia, changes in behaviour (such as depression), weight gain, feed conversion, carcass quality, milk/wool/fur production, egg production and hatchability of breeding eggs and male and female fertility. Additional or alternative parameters relevant for a specific drug may be used, where appropriate and justified. Please refer clinical trial document.
Source- https://nandi.gov.in/dahd/login-page
Compiled & Shared by- This paper is a compilation of groupwork provided by the
Team, LITD (Livestock Institute of Training & Development)
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