Even as various industry associations and apex bodies like Confederation of Indian Industry (CII) and Federation of Indian Chambers of Commerce and Industry (FICCI) are competing to announce plans at various forums to eradicate the menace of spurious drugs, the first ever scientific survey on the actual extent of spurious drug problem in the country is yet to take off.
The need for such a survey was highlighted in the interim report of the Mashelker Committee on Drug Regulatory Reforms about six months ago and was duly taken up by the government. Though the centre had announced its willingness to grant immediate funds for the purpose, Delhi Pharmaceutical Trust (DPT), the organization that was given the task of conducting the survey, is yet to receive any amount.
Curiously, Indian pharma seems to be happy with the fear psychosis caused by the conflicting news about the presence of spurious drugs in the country. Indian Pharmaceutical Alliance (IPA), the association representing domestic pharma majors had been in the forefront to propagate the grave nature of spurious drug presence.
It was due to the insistence of IPA the Mashelkar Committee, had taken up spurious drug issue with utmost seriousness, even though the government records suggested the contrary. However, IPA seems to be so convinced of the high percentage of spurious drug presence that the association was not keen on seeing the survey done.
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.
While the survey is yet to commence, CII Spurious Drugs Forum members are part of a national initiative headed by Suresh P Prabhu, former Union Minister, to counter the menace of spurious drugs in the country. The FICCI has also announced their plans for an initiative to form a National Initiative Against Piracy and Counterfeiting (NIAPC).