Table 1.

Substandard medicines

Defect type	Number of medicines	Per cent	Defect details	Number of medicines
Stability defects	205	32	Concern about stability of active ingredients	63
			Levels of impurities in excess of specification at different time points	50
			Dissolution, disintegration and drug release failure	45
			Others	47
Contamination	139	21	Impurities	82
			Lack of sterility assurance	35
			Microbial contamination	22
Minor packaging defects	71	11	Fault involving the external packaging or minor printing errors that do not involve name or strength of a medicine	60
			Missing or incorrect product registration number, batch number, manufacturer's name or expiry date	11
Major packaging defects	65	10	Missing or incorrect name, strength, or active ingredient of a medicine on carton or box	35
			Packing a medicine in the wrong carton or present of a foreign tablet or capsule in the bottle or blister	30
Defects in active ingredient	62	10	Excessive amount of active ingredients	26
			Inadequate amount of active ingredient	20
			Active ingredient is out of specification	16
Delivery defects	35	5	Fault with a device	22
			Leakage or loose/ tight seal, cracks in a vial or broken tablets	9
			Others	4
Other defects	72	11	GMP deficiencies and deviation from preapproved specifications	48
			Inappropriate shipment	14
			Dissolution/disintegration failure	10
Total	649	100		649

GMP, Good Manufacturing Practices.