Testing on 42,000 drugs to ‘prove quality to world’

A mega survey involving testing of 42,000 samples of Indian drugs for quality will be completed in the next six to eight months, according to GN Singh, Drugs Controller General of India (DCGI).

Speaking to newspersons on the sidelines of a conference on quality of drugs organised by the US Pharmacopoeia (USP) on Tuesday, Singh said DCGI had already commenced the testing.

“After about six months, we will actually know and tell the world that our drugs are of quality. This will also help negate misnomers as various numbers are being circulated about percentage of spurious/low quality Indian drugs,” he said.

The apex body for drug control is also ramping up its capacity. “We will be recruiting about 200 drug inspectors and assistant inspectors in next two months to strengthen our testing capabilities,” he said. At present its enforcement wing has 350 employees.

A pilot on mobile drug testing labs being run in Gujarat will also be scaled up. This year, DCGI wants to launch at least 20 more labs which will be deployed in states like Jammu & Kashmir, Bihar and UP, the official said.

FDI Visits

There will be more focus on ensuring strict adherence to Good Laboratory Practices (GLP) by the companies, he added.

When asked on measures to deal with increasing number of warning letters and other issues being faced by the Indian drug makers with the US Food and Drug Administration (USFDA), Singh said primarily it was an issue between the buyers and sellers.

“When somebody buys, they want their own rules of the game. But in a meeting with FDI team recently, we have requested it to inform us so that we can also send our inspectors along with its teams,” he said. The USFDA has positively responded.

“Already 35 to 40 per cent of all generic medicines in the US market are from India with an almost similar lead in the Europe.

“This is set to grow with the current focus on ‘Make in India’” he said.

The DCGI is also working on introducing various mechanisms for ease of operations in pharma exports.