The Mashelkar Committee for Review of Drugs Regulatory System is likely to call for a centralized system for approval of drug manufacturing facilities in the country. The panel is known to be of the opinion that "centralization" is the only solution to ensure uniform standards for manufacturing units across the country.
While the changes in rules would be applicable to all new drug-manufacturing facilities with immediate effect, the panel may prefer to give some breathing time to the existing units to go for central clearance.
According to sources, the committee may recommend for central registration of existing drug manufacturing facilities at the time of renewing the licenses issued for their facilities. Currently, the licenses for manufacturing facilities are renewed every five years by the state drugs control authorities.
The recommendations, if taken up seriously, can ensure phased upgradation of all existing manufacturing units within a given period of time. It may also give the much needed time for the SSI sector to comply with the WHO GMP norms that are to come in force by the end of the current year.
The final report of the committee to be ready by the month end is expected to come out with the recommendations in this regard.
The interim report of the committee had emphasized the need for a uniform and competent enforcement infrastructure as well as uniform procedure in all States. "This is important because a drug manufactured in one State moves freely in inter-state commerce as well as in export market. However, the infrastructure facilities, the number and quality of drug inspectors, testing facilities, support systems, etc. continues to vary significantly from State to State. Thus, while in some States the organization is headed by a full time technical person, the others have administrators, police or medical persons as heads of office," the report had noted.
The conclusions of the interim report said that the Central Government should initiate steps to strengthen the Central infrastructure. The committee wanted the centre to continue to provide assistance to States for testing of drug samples specially the smaller States where it is technically and economically not viable to have a full fledged laboratory of their own.
"The Committee will submit the full proposal on convening CDSO into a Central Drug Administration (CDA) in its final report," it said.