New Delhi : The Central Drugs Standard Control Organisation (CDSCO) has switched to online the procedure for submission of form for test license for veterinary vaccines and drugs, stopping the facility of offline submission of applications in hard copy.
The Drugs Controller General of India (DCGI) has said that the submission of applications for issuance for Form 11, which is for test licence, for veterinary vaccines and drugs is now functional on the online system of Sugam portal and the applicants seeking for such certificate or license shall apply through the online portal as per the checklist in the developed modules. This is part of the CDSCO’s efforts to streamline the regulatory submission procedure.
“The facility of offline submission of applications in hard copy may not be available for processing,” he said in a circular.
Test licence or Form 11 licence is given for the small quantities of veterinary biological product, the import of which is otherwise prohibited under Section 10 of the Drugs and Cosmetics Act and Rules, 1945, may be imported for the purpose of examination, test or analysis subject to conditions including that the licensee shall use the substances imported under the licence exclusively for purposes of examination, test or analysis and shall carry on such tests in the place specified in the license, or in such other places as the licensing authority may from time to time authorise, according to the CDSCO’s guidance for industry document for veterinary biologicals in India.
A draft amendment in the guidelines for conducting clinical trial or field trial of biologicals and drugs for veterinary use, released by the Department of Animal Husbandry and Dairying (DAHD) in May 9, 2023, says that for import of vaccines for the purpose of test and analysis as well as conduct of clinical trials, the applicant may apply in Form 12 along with requisite fee and documents as prescribed in the Drugs Rules, 1945 to the CDSCO. After satisfying the requirements, the CDSCO may consider the application for grant of test licence in Form 11 for the purpose of testing/study.
After obtaining the permission from the DCGI, the applicant shall conduct the field trial and submit the results to CDSCO for further deliberation by the Subject Expert Committee (SEC) or the standing Empowered Committee for Animal Health (ECAH) sub-committee for veterinary biologicals, DAHD. The trial results may be submitted to CDSCO as per the format provided in the Schedule Y of the Drugs Rules, 1945, it says.
According to the Indian Federation of Animal Health Companies (INFAH), the Indian animal healthcare market is estimated at around Rs. 7,000 crore in 2021-22 and the species share in this market includes 55 per cent of livestock, 33 per cent poultry, eight per cent of companion animals and three per cent of aqua while the rest of one per cent is for other remaining animals.
“Though there are no published data, INFAH anticipates the contribution of various categories of animal health products as 39% nutritional, 20% parasiticides, 17% antibacterials, 13% biologicals, and 11% from other categories. There are nearly >50 major companies operating in the animal health market in India though the market is dominated by top 10 players,” says the Association website.
