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Karnataka Ayush sector upbeat on recent amendment to renew manufacturing & loan licenses to perpetuity

Nandita Vijayasimha, Bengaluru
Monday, November 11, 2024, 08:00 Hrs  [IST]

The recent amendments brought by the Union Ministry of Ayush to the Drugs and Cosmetics Rules, 1945 are significant, as they introduce new regulatory requirements for the manufacturing and sale of traditional medicines.

The amendment to renew manufacturing and loan licenses to perpetuity by depositing a one-time retention fee, regardless of the period for their license renewal, within a period of one year reflects the growing focus on ensuring quality, safety and accountability in the production and distribution of traditional medicines, which are an important part of India's healthcare system.

According to Dr H Y Rathod, state licensing authority, Karnataka Directorate of Ayush, “This change in regulatory amendment is particularly significant. With the one-time fee for license retention, manufacturers can plan long-term without the burden of frequent regulatory interventions. However risk-based inspections across the 225 units in the state will continue.”
 
Dr. DBA Narayana, chief scientific officer, Ayurvidye Trust and a regulatory expert, has highlighted that the amendment, particularly the introduction of a one-time retention fee for license renewal, is a step toward enhancing the ease of doing business, and encourages investment in the Ayush sector.
 
With the new amendment, businesses are required to pay a single retention fee, which streamlines the process. This eliminates the need for multiple renewals, saving time and effort for manufacturers and regulatory authorities alike, he added.

Traditionally, the Ayush sector had to go through the process of renewing their licenses periodically, which involved documentation, submission of forms, and inspections by regulatory authorities. This process could be time-consuming and create uncertainty for manufacturers, said Dr Narayana.

Further Dr Narayana also said, the introduction of a new category for ‘New Homoeopathy Medicines’ within the recent amendments is an exciting development for this sector. It reflects the government's commitment to regulating and promoting innovation in the field of Homoeopathy, while ensuring quality, safety, and efficacy. This move can open new doors for the industry, both domestically and internationally, by providing a clearer framework for the approval and commercialization of novel homeopathic formulations.

Chiming in on a similar note was Dr Niranjan Murthy, president, Karnataka Ayush Drug Manufacturers Association (KADMA) and managing director, Pentacare Ayurpharma who told Pharmabiz that amendment is a positive development. The key features here are licensing fee and the qualifications. The licensing fee has reduced in a rational manner and primarily focused on existing products for which there was slab. Now this is Rs. 100 per product and the licensing fee is Rs 1,000 which is a perpetual with a declaration. This is absolutely affordable for the micro-small and medium enterprises (MSMEs) which forma major chuck of the Ayush sector.

For the qualifications the amended regulations have broadened the umbrella. So long it was BAMS graduates now they have included the B Pharm (Ayush) specialisation qualified candidates. Currently this specialisation is offered by a few universities, he said.

The government's push for real-time stability data submission is a crucial development, especially with the growing importance of product quality and regulatory compliance. This move will accelerate the process of ensuring Ayush medicines, meet the highest standards of safety, efficacy, and quality control throughout their shelf life.

To conclude, these recent amendments are not just positive but realistic and practical for the industry. They address critical needs like simplified processes, improved quality control, stability data submission, while also laying the groundwork for sustainable growth and global competitiveness, said Dr Murthy.

 

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