Industry experts have expressed their approval of the revised fee structure and the enforcement of mandatory Good Manufacturing Practices (GMP) compliance in the newly updated regulations for Ayurvedic, Siddha, Sowa-Rigpa, and Unani (ASSU) medicines. The new fee adaptation for ASSU drug licenses significantly alleviates the financial pressure on manufacturers aiming to obtain and maintain licenses for proprietary ASSU products.
The requisite commitment to GMP protocols and the necessity of certification have been broadly welcomed by industry specialists.
“Previously, to obtain an Ayurvedic Manufacturing Licence in Form 24D, manufacturers faced a base fee of Rs. 3,000 for ten products, with an added Rs. 2,000 charge for each product thereafter. This has now been amended to a flat fee of Rs. 200 per product. Furthermore, the former retention fee of Rs. 1,000 for ten products, supplemented by Rs. 1,000 per additional item, has been adjusted to Rs. 100 per product,” shared Nilesh Gandhi, a Former Assistant Commissioner (Drugs) at FDA, Maharashtra.
Gandhi remarked that “the fee modification is a forward-thinking action alleviating financial constraints for smaller and medium-sized producers. It encourages greater participation in the sphere of traditional medicine and supports the expansion of ayurvedic and additional ASSU remedies.”
These amendments also emphasize the critical role of GMP certification and adherence. This initiative is designed to enhance the quality of ASSU products, ensuring alignment with global benchmarks and fostering stronger trust from consumers in traditional medicinal frameworks.
“By enforcing GMP compliance, the Ayush Ministry is not only improving the quality of products but also opening avenues for broader acceptance of Indian traditional medicines in international arenas,” Gandhi commented further.
“The revision of fees and focus on GMP adherence is projected to advance the traditional medicine industry. Lower costs help reduce entry obstacles for startups, fostering innovation and market rivalry. Strict GMP compliance will enhance the trustworthiness and efficacy of ASSU products, and improved product standards are likely to strengthen India’s stature in the global traditional medicine marketplace,” experts unanimously agreed.