Answers awaited as India plans large-scale tests of domestic drug quality

Will it get the results it wants? India's drug regulator plans to test 42,000 domestic-made drugs throughout the rest of this year to prove their quality and shake the notion that the nation's drugs are not safe or are of low quality.

G.N. Singh

Drugs Controller General of India (DCGI) G.N. Singh said his agency already has begun the testing, which he said would prove he is right and "tell the world that our drugs are of quality."

Just in case, though, and for additional reasons, the DCGI plans to hire 200 more drug inspectors and assistants over the next two months to check on quality and other issues involved in the production process. That would give him 550.

In April, India's Commerce Ministry invited stakeholders to discuss the idea of joining the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme, together known as PIC/S with Switzerland headquarters. Forty-five nations are members of the organization.

Also, the agency has deployed a mobile drug-testing lab in one state and plans at least 20 more in other states. The overall effort is intended to force drug makers to follow Good Laboratory Practices, Singh said, according to The Hindu.

The added inspection capability, mobile labs and ensuring GLP would be just what the doctor ordered, the main doctor being the U.S. FDA. The drug-quality survey, however, would not seem to matter too much to that agency or others.

The gold standard theory in developed nations is Good Manufacturing Practices based on the fact that not all drugs can be tested by regulatory authorities, but they can be at least assured the drugs they are asked to review and approve are safe and of efficacy if they follow the rules of quality production.

That too often India drug makers have not followed GMP is the reason their plants have been banned from exporting to the U.S. and other countries, not that an individual drug may have met the quality standard despite that failure. That is why India drug makers have to file all that "accurate" paperwork.

On the other hand, according to a report in the Financial Express, the DCGI plans not only to "show the world" the survey results, assuming they are supportive, it plans to use the results to select areas of the country to monitor for spurious drugs.

- here are stories from The Hindu and the Financial Express