FDA cancels licences of 10 Ayurvedic drug firms
MUMBAI, Aug. 12 -- The state Food and Drug Administration (FDA) has permanently cancelled the licences of ten companies manufacturing ayurvedic products after serious violations of the Drugs and Cosmetics Act, 1940, were found in their operations. The companies, based in Pune, Baramati, Nashik and other places (see graphic), were found defaulting during the FDA's comprehensive inspection drive of 434 licenced Ayurvedic drug-manufacturing establishments across the state.
During the inspections, various aspects were scrutinised and show-cause notices seeking explanation were issued to 135 Ayurvedic manufacturing establishments.
The FDA press note said that manufacturing in the ten firms whose licence was cancelled was being carried out in the absence of qualified and approved technical personnel. The quality control department was not functioning, the necessary machinery and equipment required for manufacturing and testing were not available and the manufacturing premises were unhygienic and did not comply with prescribed standards. Apart from this, there was an absence of batch manufacturing records and raw material records, as well as discrepancies in such records and incorrect manufacturing dates on product labels. Testing of raw materials and finished products was not being carried out and records of raw materials were not available.
FDA commissioner Tukaram Mundhe said, "Ayurvedic medicines are widely used by the public. The manufacture of classical medicines must be carried out as prescribed in recognised authoritative reference texts. Strict action will be taken against manufacturers who fail to comply."...
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