Ayurvedic Products whose Certificate of Pharmaceutical Product (CoPP) granted as per WHO-GMP* Certification Scheme by Central Drugs Standard Control Organization as on 02.03.2020.
Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
The WHO Certification Scheme for finished pharmaceutical products is an international voluntary agreement to provide assurance to countries participating in the Scheme, about the quality of pharmaceutical products moving in international commerce (World Health Assembly resolution WHA22.50 (1969), World Health Assembly resolution WHA28.65 (1975), World Health Assembly resolution WHA41.18 (1988), World Health Assembly resolution WHA45.29 (1992), World Health Assembly resolution WHA50.3 (1997). The primary document of the Scheme was the Certificate of Pharmaceutical Product (CPP). The WHO Expert Committee on Specifications for Pharmaceutical Preparations, during its forty-third meeting, recommended that the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce should be reviewed in light of the changing environment, including the rapid globalization of the pharmaceutical manufacturing sector coupled with changes in the make-up of both the regulators and the groups involved in procurement.
Good Manufacturing Practices (GMP)
Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines. GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements.
*The Good Manufacturing Practice (GMP)