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Regulator flags drug samples

Date: 19 January 2020 Tags: Reports & Indices

Issue

The Central Drugs Standard Control Organization (CDSCO), in its latest list of drugs/medical devices and cosmetics declared not of standard quality/spurious/adulterated/misbranded, has flagged 49 samples including eye drops, painkillers, vitamin and even antibiotics as not of standard quality.

 

Details

  • The drugs failed the quality test because of the presence of foreign matter, description, particulate matter, extractable volume & assay, sterility, disintegration, dissolution and others parameters.

  • Such defects may arise because of inadequate pre-formulation development studies, lack of in-process controls exercised by the manufacturer or unsuitable conditions under which drugs are stored or transported.

  • Drugs can be found not of standard quality if broken or chipped, have presence of spot/discolouration/uneven coating, cracking of emulsions, clear liquid preparations showing sedimentation, change in colour of the formulation, small variation in net content, weight and formulations failing to respond to the colour test.

  • There can be isolated cases of presences of foreign matter, labelling error including nomenclature mistake, Rx, NRx, XRx, Red Line, Schedule H. Caution, colour etc.

  • Spurious drugs are usually manufactured by unlicensed anti-social elements but sometimes licensed manufacturers may also be involved.

  • The adulterated drugs are those drugs which are found to contain an adulterant/substituted product or contaminated with filth rendering it injurious to health.

Central Drugs Standard Control Organisation

 The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices. Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under the ambit of Ministry of Health and Family Welfare.