- Tous > Quality and Safety: Medicines > Counterfeit Medicines
- Tous > Quality and Safety: Medicines > Quality Assurance
(2009; 164 pages)
Circulation of spurious drug can lead to grave, adverse consequences on both consumers (patients) and genuine manufacturers. According to State Drug Controller, the extent of circulation of spurious drug is about 0.3%.
However, media often magnifies it, in a sensational manner, between 10%-25% which is mostly unverified. Due to dire consequences on public health in view of circulation of spurious drug, a systematic study was necessary to assess actual extent of spurious drug circulation in the community at large.
Samples of popular brands of oral solid dosage (OSD) formulations, belonging to 9 therapeutic categories (anti-infective, anti-malarial, anti-T.B. Drugs, steroids, antihistaminic, cardiovascular drugs, anti-diabetics, NSAIDs, and multivitamin preparations), were collected between November & December 2008. Samples of 61 popular brands of the above mentioned class were collected. Collection of samples of each brand were made from retail pharmacy outlet (25 each from metros, big cities, district headquarters, towns and villages) in each zone of CDSCO (East, West, North and South) with the help of NGOs and consumer associations, who in turn, collected drug without prescription from retail shop by acting as surrogate patients. Details of the sample (name of drug, brand name, expiry date, batch number, address of retail pharmacy outlet, etc.) were recorded as per preset format and samples were stored as per required storage conditions.
Samples collected were handed over to authorized quality assurance person of the respective manufacturer for identification by physical examination so as to establish the authenticity and were asked to return the samples with comments for undertaking further chemical analysis.
From the samples which were accepted by the manufacturers as genuine product (24,125), five drug samples of each brand were randomly selected and were subjected to further chemical analysis in Government testing laboratory (Indian Pharmacopoeia Commission) and Private Testing laboratory (M/s Arbro Laboratory, New Delhi).
Later, on the direction of Ministry of Health & FW, an additional 2,671 samples were also sent for chemical analysis (11.072 % of the collected samples which were accepted by the manufacturer as genuine i.e. 24,125).
Most of the pharmacy retail shops in metro cities refused to sale the scheduled drug without prescription and in towns and district headquarters there was tendency to replace one brand with other brand. Though most of the drugs were not available in retail pharmacy outlets, located in villages, availability of all selected brands was uniform throughout the country. Most of the retail shop did not provide cash memo without request and at times even with request. A total of 24,780 samples were collected by visiting around 40,000 pharmacy outlets, of which 644 samples were of SALA (Sound Alike and Look Alike). Of remaining 24,136 samples, only 11 samples were not accepted by manufacturers as their genuine product by physical examination. These unaccepted samples were mainly from Bihar, West Bengal, UP and Gujarat states accounting five, three, two and one sample respectively. However, none of these samples failed in identification test.
Of 305 samples subjected to chemical analysis, only 3 were found to be substandard with respect to the content of the active ingredient mentioned on the label (reported results are 86.0, 89.3 and 84.8%). Additional 2,671 samples, which were subjected to testing on the direction of Ministry of Health & FW, showed 100% conformity with respect to identification and assay as reported by the government analyst at various central government testing laboratories.
The extent of spurious drug in retail pharmacy is much below the projections made by various media, WHO, SEARO, and other studies i.e. only 0.046 % (11 samples out of 24,136 samples).