The Karnataka Directorate of Ayush is expediting the process of going online to accept and disburse manufacturing license applications adhering to Schedule T or good manufacturing practices (GMP). This is in sync with the National Ayush Mission (NAM) framework.
The online mode was adopted to ensure safety due to the COVID-19 pandemic and to bring in efficiency in operations. Currently, the Ayush directorate provides two online services: non-conviction certificate and performance certificate issued via the Seva Sindhu portal.
“Efforts are on to move towards the e-licensing pathway at an investment of Rs. 25 lakh. This is expected to be operational over the next five to six months. However, for sales licensing and audit of outlets, there is no provision for Ayush under the Drugs & Cosmetics Act,” Dr H Y Rathod, deputy drugs controller and drugs licensing authority, Karnataka Directorate of Ayush, told Pharmabiz.
The department approved 98 of the 100 applications for sanitizers during this COVID-19. Two products were rejected for want of stability and anti-microbial studies.
“In the area of immunity booster drugs, we approved products coming under the ambit of Ayush Kwatha which is recommended by the Ministry of Ayush for COVID-19 prevention and promotion of good health. Of the 30 applications received, we approved 15-20 products. Those that were rejected were for want of first schedule reference and not submitting finished goods testing specifications. We approved applications that were in order for new product applications and monitored them as advised by Ministry of Ayush,” he added.
Karnataka accounts for 230 manufacturers and the directorate’s enforcement team conducts biannual inspections. Karnataka has one inspector to audit 25 manufacturing units as mandated by the Mashelkar Committee. "Routine inspections of all manufacturers happen periodically and inspectors are asked to visit production plants to check for any inconsistencies in product quality or market complaints, he said.
“We have been able to ensure efficiency and transparency despite the difficult times of this pandemic lockdown. Applications for license and its approvals have been via e-mail. Considerable attention is given to ensure manufacturers adhere to GMP. Sampling of sanitizers has begun and show cause notices are issued to not-of-standard quality products. Currently, 98 sanitizers approved for production and are in the market. Of these 25 products were picked up at random for testing, of which four are proven to be of standard quality. Test reports of the remaining 21 are awaited,” said Dr Rathod.
The directorate for Ayush has 10 drugs inspectors and one deputy drugs controller (DDC). The DDC is the State Licensing Authority and the Commissioner of Ayush is the Controlling Authority. The enforcement team is the backbone of the Directorate of Ayush. At its training institute in Ramanagaram, this February, a two-day course on inspection, D&C Act and investigation protocol was conducted in association with the local drugs control department, law and forest department.