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Our Bureau, New Delhi December 17 , 2018
The pharmacopoeia standards for drugs and formulations used under Ayurveda, Siddha, Unani and Homoeopathic (ASU&H) systems of medicine will be available online soon. The move is expected to help manufacturers produce quality alternate drugs whose demand is on the rise in domestic and global market.

To start with, Ayurveda Pharmacopoeia, which will give scientific details of over 700 ayurvedic drugs, will be made available online by Pharmacopoeia Commission for Indian Medicine and Homeopathy. It is an autonomous body under the Ayush ministry with the mandate to develop pharmacopoeial standards for drugs.

According to officials, while demand for the herbal drug is on rise, many manufacturers are still unaware that they have to comply with standards and quality control parameters as given in the authoritative books, pharmacopoeias and formularies. So far pharmacopeia of 400 single molecule drugs under Ayurveda category and 300 drugs of double molecules has been prepared.

The government has already made it mandatory for the industry to comply with the Pharmacopoeias and Formularies prescribed in the Drugs and Cosmetics Act, 1940 and Rules 1945 in the manufacturing of ASU and homoeopathic drugs.

Recently, the ministry and the national pharmaceuticals regulator have finalised the timeline and list of mandatory documents for issuing their stamp of approval to all ASU drugs manufactured in the country. The move is expected to help hundreds of firms obtain their GMP certificates in accordance with the World Health Organisation guidelines in a time-bound manner.

According to an official note issued by the Drug Controller General of India (DCGI) Dr S Eswara Reddy, the Ayush ministry will perform the product evaluation from the angle of quality, safety and efficacy while the Central Drugs Standard Control Organisation will look into the tenets of the GMP applied for producing the drug. ASU manufacturers should henceforth apply for the grant or renewal of approvals to the DCGI and the drug control cell of Ayush ministry.

The note states that the initial processing of the application should be done in 30 days, query response application to be processed in 15 days and a joint site inspection by both agencies to be conducted in 90 days. The manufacturer should submit data on finished formulation including product specification, method of analysis, accelerated and real time stability study evaluation for three batches of the drug and a process validation report on the analytical method.

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