The drug controller general of India (DCGI) will flag off his nationwide survey to map the extent of fake drugs by mid-November and intends to wrap up the exercise by mid-January.
The drug regulator will hire people who would pose as customers in the chemist shops and collect up to 300,000 samples for the proposed survey.
On a mission: Drug controller M. Venkateswarlu hopes the survey will give a true picture of the menace.
“Data analysis should take another couple of months” from mid-January, said drug controller M. Venkateswarlu. He said he has received inputs from statistical institutes on how to ensure that the spread and the sampling are statistically significant. “We could be looking at 50,000 samples each of 5-6 large volume brands. This could mean 2.5-3 lakh samples being collected,” said Venkateswarlu, who says he is ready to restrict the number of brands but doesn’t want to compromise on the sample size.
Mint reported on 18 July that the controller was going to undertake a national survey to get some understanding of the extent and incidence of fake drugs. “The survey will give us a statistical and realistic estimate of the problem. Even if there is as much wrong with the sector as is made out to be, we need a true picture of the menace first,” Venkateswarlu said at that time.
Some estimates have put the problem at as low as 0.3% of the Rs34,000 crore domestic drug market, though much higher figures have also been cited as well. The global average is around 7%.
Prafull D. Sheth, vice-president of industry think tank International Pharmaceutical Federation, did a study using so-called mystery shoppers for the World Health Organization recently but disagrees with the methodology being employed by the controller.
“Large volumes of specific brands can be picked up only if you are tracking counterfeits in a specific therapeutic category. But if you are doing a national study, it is appropriate to expand the number of brands in the survey,” he said.
Sheth’s own study involved more than 10,000 samples of 56 top selling brands, picked up from chemist shops across the country. The results: about 3% of the samples were suspected to be counterfeit.
“South Asian countries, particularly the Thai-Cambodia border, face rampant counterfeiting of anti-malarial drugs,” notes Sheth. “In such cases, one can focus on specific brands. In a national survey, how do you pick on those few brands that are most likely to be counterfeit? Moreover, if those brands go out of market in a few years and new ones come in, what will become of the survey estimate?”
According to the controller’s plans, 500 people will be hired to pick up samples from medical shops—hospitals are being kept out of the purview of the study—and these will then be sent to respective drug makers to identify counterfeits.
Though their associations have agreed to support the DCGI’s initiative, the success of the survey will depend on the cooperation extended and quick response from the pharmaceutical companies.