Regulator flags 49 out of 1,336 drug samples as ‘not of standard quality’ and one spurious

Defects arising out of minor variations in quality but injurious to health, it says

Image for representation purpose only.

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 (for December-2019), has flagged 49 samples including eye drops, painkillers, vitamin and even antibiotics as “not of standard quality”.

Of the 1,336 samples tested, 1,286 were declared of standard quality, 49 “not of standard quality’’ and one spurious.

Of the drugs that ‘failed’, samples were tested in labs in Kolkata, Chennai, Chandigarh, Guwahati and Mumbai. The samples were drawn by CDSCO in Chennai, Ghazaibad, Kolkata, Himachal Pradesh, Arunachal Pradesh and Assam.

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.

“Drugs manufactured by the licensed manufacturers found not of standard quality because of defects arising out of minor variations in quality. 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,’’ noted a senior health official.

According to CDSCO, 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.

The CDSCO has noted that spurious or imitation drug products are formulations manufactured concealing the true identity of the product and made to resemble another drug, especially any popular brand, to deceive the buyer and cash in on the popularity of the original. The product may or may not contain the active ingredients. “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,’’ it added.