India's drug watchdog calls all hands on deck in largest ever inspection effort

Print 30 June 2015
EJ Lane / FeircePharmaAsia

India's Central Drugs and Standards Control Organisation (CDSCO) has told staff to forget holidays and weekends as it undertakes a massive drug inspection exercise it intends to complete by the end of the year.

G.N. Singh

The unprecedented plans in India to test at least 42,000 domestic-made drugs to prove their quality was put forth by G.N. Singh Drugs Controller General of India (DCGI) in May which he said would "tell the world that our drugs are of quality."

But a hitch has come up in the ambitious plans in the works for a year, the Indian Express newspaper said, leading to a memo to CDSCO staff that the size of the job at hand means all work and no play.

"Due to this, 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," a June 17 memo seen by the Indian Express read.

"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."

Singh told the newspaper that nothing less than the country's reputation as a drugmaker was on the line.

"There are reports in both the domestic and international media about 25% to 40% of Indian drugs being sub-standard," Singh said. "This survey will conclusively put an end to such speculation."

The CDSCO said as well that it has deputized 75 drug inspectors and advertised for contractual help, primarily retired government officers, to assist senior officials in their day-to-day jobs.

In an earlier interview, Singh said the CDSCO staff was a fraction of the U.S. FDA and noted that broader plans were afoot to streamline the regulatory oversight of the entire sector.

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