With international and national reports alleging that India is home to the biggest fake-drug market, spurious and poor-quality drugs are two major causes of concern. In some reports, more than 25% of medicines available in India have been declared spurious or fake.
But statistics by the Central Drug Standard Control Organisation (CDSCO), an ombudsman under the government of India, show that the percentage of spurious drugs is quite low and substandard drugs are a far bigger cause for worry.
“Spurious drugs in India account for just 0.046% as per the survey of 2009. I don’t know why there has been a lot of emphasis on them. The real challenge is substandard medicines in the country, the percentage of which is around 6%,” said a highly placed source in the ministry.
There has been no nationwide survey since 2009 but the authority conducted smaller inspections from 2009 to 2012. After collecting 1.37 lakh samples from all over the country, it found that 345 samples were spurious; a whopping 6,500 were sub-standard. In 2009-10, CDSCO tested 39,248 medicine samples, of which 1,942 were found to be substandard whereas 117 or 0.29 per cent were found spurious. Similarly, in 2010-11 and 2011-12, 49,682 and 48,082 samples were tested. Out of these, 2,372 and 2,186 were found to be substandard.
In a separate survey conducted between April to July 2012, a total of 18,262 samples were tested, out of which only 25 were found spurious whereas 677 were inferior in quality. “Spuriousness is certainly an issue, but the bigger issue is that of sub-standard medicines. India is one of the largest producers of high-quality yet low-cost medicines and we have been at loggerheads with western countries as they too at some point have declared our high-quality medicines spurious,” said Leena Menghaney, campaign coordinator of Medecins Sans Frontieres (MSF) India.
“In a tropical country like India, even high-quality medicines will become sub-standard if a chemist doesn’t take proper care. Production of substandard medicines in clandestine units can be an issue which needs the attention of the concerned authority. However, the cost of drug production in India is way cheaper than in Europe and other continents, so the number of such units would not be very high. But, yes, sub-standard medicines are a challenge and the government needs to address it,” Leena said.
A few years ago, a national daily reported, on the basis of an allegedly WHO report, that 35% of fake drugs produced in the world come from India. However, WHO denied any such report or a survey. Experts believe that if India had 25% of spurious medicines in the market, deaths would increase as every fifth drug sold by a chemistwould be fake.
However, some experts pointed out that the government might not be able to fathom the right figure of spurious drugs because it doesn’t have an adequate inspection and testing mechanism in place. “India has faced a lot of flak from the international community on the issue of spurious drugs and this might be one of the reasons why the government wants to show the real number.
Another reason could be that CDSCO is still ill-equipped,” said an expert.
The government has spent a hefty amount on CDSCO. “The CDSCO labs need new and sophisticated equipment. Similarly zonal/sub-zonal/port/airport offices of CDSCO need up-gradation. CDSCO also needs to open its offices abroad to monitor imports. All these areas are proposed to be covered during the 12th five year plan for which CDSCO has been allocated an amount of Rs1,800 crore,” reads the answer in form of action taken submitted by government to parliamentary committee recently.