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Ayush ministry to constitute new inspecting & certifying body for grant of CoPP to ASU companies
Swati Rana, Mumbai | Thursday, February 11, 2016, 08:00 Hrs  [IST]

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.

Comments

DEEPAK KUMAR Aug 6, 2016 11:52 AM
Kindly updates us for certifying body for grant of CoPP under WHO GMP to Homeopathic companies in india

Regard's,
Deepak
DR JAGPOORAN DASS Feb 11, 2016 9:36 AM
Ayush ministry to constitute new inspecting & certifying body for grant of CoPP to ASU companies, AYUSH Ministry first define about the Ayurvedic Medicines because ancient formulations described in texts do not have any preservatives/coloring agent or any other chemicals.Ministry should ensure the availability of pure and genuine ASU Medicines in the country.Patent/Proprietary ASU Drugs available in the country should be certified by a Committee at National level.Every ASU Drug dispensed to sufferer must bear a manufacturing Licence number. Number of ASU practitioners are using steroids but there is no check due to the provisions of Drugs & Cosmetics Act.

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