By Praveen Prabhakar
Posted on
AYUSH Ministry mandates appointment of one DI for 30 manufacturing units
Bengaluru: The Union Ministry of Ayush has mandated that all its state regulatory departments should be equipped with adequate number of technical officers including drug inspectors and drug controllers commensurate with the number of manufacturing plants in the state. The appointment of one drug inspector (DI) per 30 manufacturing unit and other drugs control officers could be considered on the basis of the regulatory workload and area of jurisdiction.
The move is to improve effective enforcement as per the legal provisions for the Ayurveda, Siddha, Unani and Homoeopathy drugs with qualified inspectorate personnel.
The state licensing authority, drug inspectors and the government analyst for Ayurveda, Siddha, Unani and Homoeopathy medicines should be appointed and notified in accordance with the ASU qualifications prescribed in the Drugs and Cosmetics Rules 1945. The non-technical officers can be appointed as licensing authority for ASU&H drugs under the state and union territories administration.
The manufacturing license for ASU&H drugs may not be granted without GMP compliance. Non complying units will have the licenses cancelled with immediate effect. The licensing authority can grant or renew licenses only on being satisfied that the references of all ingredients and formulations of ASU drugs are from authoritative books listed in the D&C Act. The quality standards, proof of safety and effectiveness of the intended drugs are in accordance with the pharmacopeia and provisions of Rule 158B of the D&C Act 1945 respectively.
