Kerala Ayurveda firms back new drug rules, but regulatory worries persist

The Ayurvedic medicine manufacturing industry in Kerala has welcomed the recent amendments to the Drugs and Cosmetics Rules, 1945, describing them as a significant step towards aligning with global herbal medicine standards. Industry leaders believe the changes will reduce bureaucratic hurdles and improve export opportunities.

One of the major amendments relates to Rules 154 and 154A, under which licences issued to manufacturers will now be permanently valid. Earlier, these licences had to be renewed every five years. The manufacturers argue that this move reduces administrative burden and matches international practices of lifetime licences. Rules 156 and 156A, which contained provisions for renewal and the conditions required, have been deleted.

Another key change is the amendment to Rule 160B (2)(ii), which now mandates the appointment of microbiologists with undergraduate and postgraduate degrees and quality control experience. This is expected to strengthen product safety and quality control, bringing the industry closer to the World Health Organization's Good Manufacturing Practices (GMP) norms.

The amendments also allow manufacturers to determine the shelf life of products through accelerated stability studies, which expose products to high stress conditions like heat, humidity, and light over three to six months. Earlier, shelf life was based only on real-time studies. Under the new Rule 161A(2A), real-time validation must be submitted with an expiry period of one year. Additionally, Ayush autonomous labs can now function as central drug labs under Rules 163BB and 163C, addressing the shortage of testing facilities.

D. Ramanathan, general secretary of the Ayurvedic Medicine Manufacturers Organisation of India (AMMOI), called the amendments “a progressive leap” for the sector. “They balance the ease of business with stringent quality assurance. These amendments will help enhance product quality and export business chances as well,” he said.

However, not everyone shares the optimism. A former official of the State Drugs Control department expressed concern that doing away with periodic licence renewal could weaken the regulatory system. “We already have a poor regulatory system as the department is facing a severe shortage of drug inspectors who examine the quality of the products manufactured here. Along with this, drugs made in other States are now coming to Kerala in large numbers. With the scrapping of the periodic checking, the regulatory system will get further weakened,” he added.

The amendments also pose challenges for smaller manufacturers. Meeting upgraded GMP norms and digital traceability requirements may require significant financial and technical investment. Under Schedule M-1, manufacturers must now implement disinfecting steps, backflow prevention, dedicated facilities, controlled environment, filtered air, and quality control clearance. Additionally, integrating QR codes or barcodes listing ingredients on labels and adopting microbiological quality standards will necessitate infrastructure changes and capital expenditure, according to AMMOI functionaries.

While the industry sees the amendments as a forward-looking reform that could boost competitiveness, the concerns raised by regulatory veterans highlight the need for adequate enforcement. The success of these changes will depend on whether the drug control department is strengthened to monitor compliance effectively, especially for smaller players.