Although the new government at the centre is seriously pursuing the decision of the previous government to enact laws strengthening penal provisions for spurious drug manufacture, it is not so keen on scientifically analysing the extent of the spurious drug problem in the country, it is learnt.
The government's response to the recommendations of the report of the Mashelker Committee on Drug Regulatory Reforms about a year on the need for such a survey is not at all encouraging. While the previous government had announced its willingness to release immediate funds for the purpose, Delhi Pharmaceutical Trust (DPT), the organization that was given the task of conducting the survey, is yet to hear anything encouraging from the present government.
Various pharmaceutical industry associations and apex industry chambers / organizations are also not bothering the government on conducting such a survey. Interestingly, the entire spurious drug problem was brought to light by these organizations.
It should be noted that according to drugs control department statistics, there is no proven instance of spurious drug detection in 15 states of the country during the last three years. Spurious medicine was found just once in other three states during the period.
The DPT was supposed to come out with a scientific evaluation of the extent (number of units/brands/amount) and nature (content lower than claimed or missing or content okay but misusing some other fast selling brand) of counterfeiting in India. It was also to prepare a distribution table covering Metros, Suburbs, Rural Areas and Micro Interior Areas.
As per DPT plans, the samples collected in the survey will be checked by the designated lab for physical signs of counterfeiting. The lab will analyze 100 per cent of suspected samples, 50 per cent of probable suspects and 25 per cent of not suspected specimens. The samples will be analyzed for: Identification of active ingredients, Content of active ingredients and Sterility (if applicable).
The samples will be double blinded through a coding system before they are sent for analysis. Data obtained will be collated and extrapolated over each particular product's total sale across respective territory as well as across the entire country. For obtaining a larger picture the data will be pooled and extrapolated over country's overall volume of pharmaceutical products. Data may be stratified to obtain desirable information perspective.