The office of the Drug Controller General of India (DCGI) will be shortly launching the much-delayed official study to ascertain the quantum of spurious and substandard drugs in the country, it is learnt.
The study would now be launched anytime now as the Centre has approved the required Rs 50 lakh for the purpose. Once the fund is transferred, the study would begin the sources said.
The study will be spearheaded by the office of the DCGI with as many as 31,000 drug samples picked up by drug inspectors, posing as patients across the country. The study is expected to be over in six months and come out with a report.
The proposed study has identified 61 popular drug brands from nine therapeutic categories that will be tested. They include anti-tuberculosis medications, anti-allergics, drugs to counter diabetes and cardiovascular diseases, anti-infective steroids, anti-malarials, NSAIDs, anti-histaminic and multi-vitamin preparations.
Though first Union health minister Ambumani Ramadoss went public in September last promising a massive study of six lakh samples from December, the unrealistic ambition never took off. Later the Indian Institute of Statistics made a realistic project report as requested by DCGI Dr Surinder Singh and same was now approved by the health ministry to get an official view on the extent of counterfeit market in the country.
Some reports had suggested huge prevalence of fake drugs while the government, quoting a WHO-sponsored study and based on the tests in its own labs, claimed it as much lower. The WHO study said only 0.3 per cent of samples were found to be spurious.
However, 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 upto 25 per cent total medicines sold in certain markets, the trade body claimed.
Meanwhile, the small scale pharma players have been demanding for an official survey as the entire SME sector was accused of spreading fake drugs, tarnishing its image. In the country, only less than one per cent of drugs manufactured are tested due to lack of facilities and staff, it is pointed out.