Last Updated on December 31, 2023 by The Health Master
applications for Veterinary Vaccine and Drug Test
The Central Drugs Standard Control Organisation (CDSCO) in India has taken a significant step towards digitalization and streamlining regulatory procedures by switching to an online submission system for test licenses for veterinary vaccines and drugs.
This move, announced by the Drugs Controller General of India (DCGI), replaces the traditional offline submission of applications in hard copy.
In this article, we will delve into the details of this new process and understand its implications for the veterinary healthcare industry in India.
The Transition to Online Submission
The Drugs Controller General of India (DCGI) has announced that the submission of applications for Form 11, which is the test license for veterinary vaccines and drugs, will now be facilitated through the online system of Sugam portal.
Applicants seeking this certificate or license must adhere to the checklist provided in the developed modules during the online application process.
This transition is part of CDSCO’s efforts to enhance efficiency and streamline the regulatory submission procedure for veterinary vaccines and drugs.
The Discontinuation of Offline Submission
As part of the transition to the online system, the facility for offline submission of applications in hard copy will no longer be available for processing.
Hence, all applicants must now utilize the Sugam portal for their submissions.
Understanding the Test License (Form 11 License)
The test license, also known as Form 11 license, is granted for small quantities of veterinary biological products that are otherwise prohibited for import under Section 10 of the Drugs and Cosmetics Act and Rules, 1945.
However, these restricted products may be imported for examination, test, or analysis purposes under certain conditions.
The licensee must use the imported substances exclusively for examination, test, or analysis and conduct these activities at the specified location or any other authorized place, as per the CDSCO’s guidance for the industry document for veterinary biologicals in India.
Draft Amendment for Conducting Clinical Trials
The Department of Animal Husbandry and Dairying (DAHD) released a draft amendment in the guidelines for conducting clinical trials or field trials of biologicals and drugs for veterinary use on May 9, 2023.
As per the amendment, applicants seeking to import vaccines for test and analysis or to conduct clinical trials must apply in Form 12.
The applicant needs to submit the required fee and documents prescribed in the Drugs Rules, 1945, to the CDSCO.
Once all requirements are met, the CDSCO may consider granting the test license in Form 11 for the purpose of testing and study.
Field Trial and Results Submission
After obtaining permission from the DCGI, the applicant must conduct the field trial and submit the results to CDSCO.
The Subject Expert Committee (SEC) or the standing Empowered Committee for Animal Health (ECAH) sub-committee for veterinary biologicals at DAHD will further deliberate on the trial results.
The submission format for the trial results follows the guidelines provided in the Schedule Y of the Drugs Rules, 1945.
Insights into the Indian Animal Healthcare Market
According to the Indian Federation of Animal Health Companies (INFAH), the Indian animal healthcare market was estimated to be around Rs. 7,000 crore in the fiscal year 2021-22.
This market comprises various species, with livestock accounting for 55%, poultry for 33%, companion animals for 8%, aqua animals for 3%, and the remaining 1% for other animals.
INFAH anticipates the contribution of different categories of animal health products in this market.
Their estimates indicate that:
- 39% of the market consists of nutritional products,
- 20% of parasiticides,
- 17% of antibacterials,
- 13% of biologicals, and
- 11% from other categories.
Although there are over 50 major companies operating in the Indian animal health market, the top 10 players dominate the industry.
Conclusion
The transition to online submission for test license applications for veterinary vaccines and drugs by CDSCO marks a significant step towards modernization and streamlining of regulatory procedures.
This shift will undoubtedly enhance the efficiency and convenience for applicants, leading to smoother and faster regulatory processes for veterinary healthcare products in India.
As the Indian animal healthcare market continues to grow, such initiatives will play a crucial role in fostering innovation and promoting the health and well-being of animals nationwide.
Disclaimer: This article contains information derived from Pharmabiz. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.
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