The Union health ministry's much-hyped nation-wide survey to officially assess the extent of spurious drugs amid conflicting reports by different agencies is likely to take off soon. The ministry is giving its final touches to the proposal before authorising the DCGI office to conduct the study.
However, unlike the earlier announcement by health minister Anbumani Ramadoss, the official study would now cover only 50,000 samples in a realistic manner and would be completed in six months time. The minister had earlier announced that around six lakh samples would be collected from different parts of the country for testing.
The detailed proposal and design of the study had been finalized by the Indian Institute of Statistics and was sent to the ministry for approval. The study would cost around Rs 50 lakh. ``This is one of the most priority cases and now the design looks so realistic. We cannot imagine testing six lakh samples anyway, given the facilities in the country,'' DCGI Dr Surinder Singh told Pharmabiz.
The study assumes significance as there are conflicting views on the extent of spurious drugs prevalent in the country. While a recent WHO study put the extent of spurious drugs at a meagre 0.3 per cent, a survey carried out by Associated Chambers of Commerce and Industry of India (Assocham) said fake and counterfeit drugs were widely disbursed to the extent of Rs 15,000 crore per annum, registering 20-25 per cent growth every year. It constituted up to 25 per cent total medicines sold in certain markets.
In the country, only less than one per cent of drugs manufactured are tested mainly due to lack of facilities and shortage of manpower. Each of the 26 labs already had backlogs of 6-9 months. One lab on an average tests around 25,000 drug samples. So, it would have been nearly impossible to test six lakh samples during six months as announced by the minister. Later, he said about 3 lakh samples used to treat specific medical conditions including cardiovascular diseases, diabetics and cancer would be tested in three months.
However, the proposal has been pending since then without much headway. After the new DCGI took over in February, he made it one of his first priorities to make it possible. Thus, the institute was asked to come up with the design. After several rounds of presentations and discussions, the final design was accepted and was sent for clearance and fund allocation.