August 2011

A routine monthly inspection carried out by the Food and Drugs Administration (FDA) authorities in the state of Maharashtra, India, last month noted an increase in the number of sub-standard drug samples raising apprehensions about the availability of safe and genuine drugs in the state.

Officials pointed out that 26 drug samples were found to be spurious, compared with the 16 samples that were not-of-standard quality detected in May and 20 in April. Reportedly, some Ampicillin and Amoxycillin formulations did not have any active ingredients, while others had 6% to 30%. Thiamine tablets with Vitamin B1 and diclofenac sodium, Paracetamol and Magnesium Trisilicate tablets were also found to be sub-standard, officials said.

Sub-standard drugs from India has been a major issue for some time now, though the FDA says its crackdown has ensured a significant drop in the number over the past six months.* In a bid to further counter the spurious drug menace, as of next month, India has also made it mandatory for all pharmaceutical exporters to send their shipments under a trace-and-track surveillance system.

The move will not only pose a hurdle to domestic spurious drug manufacturers , but will also counter drug manufacturers in countries like China who pass off their fake medicines as Indian products. A sizeable number of fake drugs seized in other countries carry a ‘Made in India’ label, though there is ample evidence that they could be actually made in other countries.

In its continued effort, the government has appointed Karnataka drugs controller B.R. Jagashetty to spearhead a sub-group on spurious and adulterated drugs. The group will support the Task Force constituted to formulate a long-term policy and strategy for strengthening the drug sector in the country. The government also plans to provide financial assistance to small drugmakers to upgrade their manufacturing plants to World Health Organization standards, effectively tackling the root of the problem.

• Through a special congressional appropriation in the 2008-2009 federal budget, the FDA was given funds to open a series of permanent liaison offices abroad. These include two in India, located in Mumbai and New Delhi. The others are in China [Beijing, Shanghai, and Guangzou] Latin America [Santiago, Mexico City and San Jose, Costa Rica], Africa [Pretoria], the Middle-East [Amman] and Europe [Brussels].

SOURCE: Pharma Executive