A modified notification under schedule T of the Drugs & Cosmetics Act for the units under the Indian System of Medicine will be issued by the end of this year. Hence, the deadline for implementation of the GMP for the existing Ayurvedic/Siddha and Unani drug manufacturing units is likely to be postponed beyond January 2003.
In the first week of September, the Department of ISM had asked the state Drug Control (DC) offices to come with fresh suggestions and recommendations for a further revision in the already notified provisions for GMP in the area of Indian System of Medicine manufacturing. The previous deadline for the compliance for existing units has already expired in last June.
However, L Prasad, joint secretary, Department of ISM, while speaking to Pharmabiz.com said that the fresh notification would specify few standards to be followed in selection of machineries and equipments in the manufacturing facilities and also some changes in the quality testing norms. "Otherwise, there is no change in the GMP announced by the government," he said.
Though, there were few modifications suggested by some state enforcement authorities in the Schedule T soon after the GMP guideline was released for the industry views and recommendations, the Central Department had notified the same in 2000 and had been insisting on the enforcement of the provisions with no significant revisions in it.
Although the Union government has extended the time for the existing units to another six months to December 31, 2002, the official circular to this effect is yet to reach most of the state FDAs. Hence, going by the standing Rule of the Department of ISM to disallow the manufacturing units to continue production in the non-GMP complied facilities after June 23, many of the State authorities have issued the pre-closure notice to the manufacturers who are not found complied with the norms.