The Central drug regulator has started the biggest sampling drive ever in the country — and possibly the world — to conclusively analyse the extent of counterfeit drugs that are available in the market. Following the embarrassing revelations about Maggi, this survey is likely to make or break India’s reputation as one of the leading manufacturers of generic drugs in the world.
A whopping 50,000 samples have been lifted from across the country over the last one and half months. The last such sample survey was conducted in 2008 with about 2500-3000 samples being analysed then.
The Central Drugs and Standard Control Organisation (CDSCO) is working overtime to come out with a report within the next six months.
On Wednesday, it sent out a circular to its staff that they should work beyond office hours and during weekends, if required, to ensure that all deadlines are met.
- Oxytocin: Delhi High Court asks for data, regulator raids at least 3 factories
- Teva Pharmaceutical: Shares rise after FDA approves new migraine drug
- Govt panel findings: ‘Its hip implant recalled in Australia, in same month Johnson & Johnson got registration certificate in India’
- Explained Snippets: Country by country, years of life lost due to air pollution
- Fluoroquinolones drugs: Changes in labelling likely
- Oxytocin: Drug regulator calls for ‘strict vigil’
“This is the biggest drug survey in the country and so far as my information goes, the biggest ever in the world because a survey of this scale has not been done before, anywhere. We conduct small, periodic tests and the available data shows that the level of spurious or sub-standard drugs is well within acceptable limits. However, there are reports in both the domestic and international media about 25-40 per cent Indian drugs being sub-standard. This survey will conclusively put an end to such speculation,” Drug Controller General of India, Dr G N Singh, told The Indian Express.
According to data currently available with the CDSCO, an estimated 4-4.5% of drugs imported, manufactured and marketed in India are spurious or adulterated. In the last largescale survey of 2008 the figure was even lower. The current figure is a mean of periodic surveys done over the last seven years.
Sources in the organisation say that while the Maggi fiasco has reinforced the need for stringent quality control, the actual process was planned much in advance.
“We have been planning this for the last one year. This survey will once and for all clear doubts about Indian drugs in the global arena.
Moreover, if there are some gaps in regulation, we can identify and rectify them. We are aiming for zero tolerance,” Singh added.
The circular issued by CDSCO to its staff reads: “Due to this (sample survey of 50,000) the CDSCO and its field formations may not, obviously, be able to adhere to the timelines prescribed for various items of work with reference to its mandated functions. Since the timelines are to be adhered to without any exception, all officers/staff are hereby called upon to take up their allocated functions on top priority. If required, all concerned may sit late after office hours and attend office on Saturdays/Sundays/holidays to dispose of the pending work.”