CDSCOCentral Drugs Standard Control Organization (India)
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All stakeholders, public and officers shall take cognizance of the fact that CDSCO has the policy of zero tolerance towards corruption," it said.
A CDSCO spokeswoman did not respond to a request for comment.
The CDSCO's data on near-universal good drug quality in India are also suspect, as will be discussed below.
The draft surveillance guidance issued by CDSCO categorizes pharmaceutical products under four broad groups: New drugs, subsequent drugs approved after 4-years; biologics; radiopharmaceuticals and phytopharmaceuticals.
Ask industry insiders and the general opinion is that instead of moving the CDSCO to the chemicals and fertilisers ministry, it will make more sense to shift the Department of Pharmaceuticals and the NPPA to the health ministry, which should continue to retain the CDSCO (See Table The Web of Governing Structures).
CDSCO has suggested more stringent laws and rules for e- pharmacy in India as we have received several complaints on fake drugs being sold," said Darswal.
After NDA approval from CDSCO, the sponsor can market this new phytopharmaceutical as a new chemical entity-based drug.
The CDSCO was mandated to approve new drug formulations, following which manufacturing licenses were obtainable from state-level authorities.
In notices posted on its website in February and April, India`s Central Drugs Standard Control Organisation (CDSCO) said that it had found some batches of Combiflam to be "not of standard quality" as they failed disintegration tests.
Since the medical equipments and devices industry in India has not been given any separate legal status and coronary stents have been classified as drugs under the provisions of the Drugs & Cosmetics Act, 1940, the Central Drugs Standard Control Organization (CDSCO) is responsible for the regulation of stents in the country.
Department-related parliamentary standing committee on health and family welfare: fifty-ninth report on the functioning of the central drugs standard control organisation (cdsco).
The number of regulatory inspectors at the Central Drugs Standard Control Organization (CDSCO) will double to 1,000, while the number of officials at state regulatory departments will increase from 800 to 3,000.