The Union ministry of Ayush is actively considering to constitute a new inspecting and certifying body for the grant of Certificate of Pharmaceutical Products (CoPP) as per WHO GMP certification to Ayurveda, Siddha and Unani (ASU) drug manufacturers.
Recently, the secretary, ministry of Ayush had convened a meeting with the Ayurvedic Drug Manufacturers Association (ADMA) to get the association's view on the issue of appointment of new inspecting and certifying body for the grant of CoPP WHO GMP certificate. The Ayush ministry intends to change the inspecting and certifying body for the grant of CoPP WHO GMP certificate for ASU products from the DCGI office to some other agency.
An official from ADMA says, “We had met with the secretary on February 04, 2015. The purpose of the meeting was to have the view of the industry related to the appointment of new inspecting and certifying body for the WHO GMP certificate. The ministry is keen to know whether the new inspecting and certifying body will be welcomed and accepted by the industry.”
He further said that the association doesn't have any problem if the ministry changes the inspecting and certifying body until the inspection and certification are strictly as per the checklist of herbal medicine.
At present the CoPP as per WHO GMP certification are granted by Central Drug Standard Control Organisation (CDSCO). One of the major roles of CDSCO's zonal office is to participate in the joint inspection for issuance/revalidation of CoPPs as per WHO certification scheme after receiving the application of the manufacturing firm.
The GMP certificate to manufacturers of Ayurveda, Siddha and Unani medicines are issued only after complying with the requirements of GMP of Ayurveda, Siddha and Unani drug with regard to the location and surroundings, buildings, water supplies, disposal of waste, container cleaning, stores for raw material, packing materials, finished goods, working space, sanitation and hygiene of workers, machinery and equipments, manufacturing record, distributions record and facility with regard to quality controls, etc. as laid down in Schedule T of Drugs and Cosmetics Act, 1940.