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Experts applaud fee rationalization and mandatory GMP compliance in amended ASSU Drug Rules
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Shardul Nautiyal, Mumbai
November 26 , 2024
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Experts have applauded fee rationalization and mandatory GMP compliance in the recently amended Ayurvedic, Siddha, Sowa-Rigpa, and Unani (ASSU) Drug Rules. The rationalization of fees for ASSU drug licenses has substantially reduced the financial burden on manufacturers seeking licensing and retention for proprietary ASSU products.
Mandatory adherence to Good Manufacturing Practices (GMP) and GMP certification has been widely welcomed by industry experts and stakeholders.
“Earlier, acquiring an Ayurvedic Manufacturing Licence in Form 24D required a base fee of Rs. 3,000 for 10 products, with an additional Rs. 2,000 per product. This has been reduced to a uniform fee of Rs. 200 per product. For licence retention, the earlier fee of Rs. 1,000 for 10 products, along with Rs. 1,000 per additional product, has been revised to Rs. 100 per product," informed Nilesh Gandhi, Former Assistant Commissioner (Drugs), FDA, Maharashtra.
“The rationalization of fees is a progressive step that reduces the financial strain on small and medium-scale manufacturers. It will encourage wider participation in the traditional medicine sector and promote the growth of ayurvedic and other ASSU drugs," Gandhi added.
The amendments also underline the importance of GMP certification and compliance. This measure aims to improve the quality of ASSU products, ensuring they meet global standards and fostering greater consumer trust in traditional medicine systems.
“By making GMP compliance mandatory, the Ayush Ministry is not just enhancing product quality but also paving the way for increased acceptance of Indian traditional medicines in international markets,” Gandhi added.
“The fee rationalization and emphasis on GMP compliance are expected to benefit the traditional medicine sector. Reduced costs will lower entry barriers for new businesses, promoting innovation and competition. Stringent adherence to GMP will elevate the credibility and effectiveness of ASSU products and improved product quality can bolster India's position in the global market for traditional medicines,” experts concluded.
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