Bloomberg: India May Send Officials to Inspect China Drug Units

In a story written by Thomas Abraham for Bloomberg News, India may be sending health officials to China to inspect manufacturing units of bulk drug suppliers to the South Asian nation.

The Press Trust of India is citing an un-named government official, that this action may be necessary to prevent cheap imports.

According to the Press Trust of India, “Indian Health officials want to verify drugs supplied to India are made at units certified by government agencies.”

To read the entire story, visit: http://www.bloomberg.com/apps/news?pid=20601091&sid=aC4k5.Pgfv.g.

This is an ironic twist given that both India and China’s pharmaceutical industries and supply chains have a notorious reputation around the globe.

Secure Pharma Chain Blog endorses any amount of increased regulatory scrutiny within either country to protect health care consumers around the globe.

To learn more about solutions that protects the pharmaceutical supply chain, visit: http://www.xstreamsystems.net/.

Fake Drugs are a Real Menace

Quality and safety concerns hurt India’s pharmaceutical promise. A new report studies the extent of such worries.

Nick Schulz, Editor of American.com and a fellow at the American Enterprise Institute writes an interesting piece which was posted June 3rd on Livemint.com regarding the Indian Pharmaceutical industry and its largest obstacle in its rise to become a true pharmaceutical power-“concern over the quality and safety of its pharmaceutical supply chain.”

Mr. Schulz states, “if India can overcome these concerns—something a report published on 18 May indicates is possible—the sky is the limit for Indian firms to push the technological frontier in this critical industry.”

Some of the highlights from Mr. Schulz:

· Concerns about fake and substandard drugs have led to multiple actions by governments around the world to hinder trade in Indian medicines. In 2008, the European Union detained Indian drugs citing concerns over counterfeiting and fakes. Governments from Sri Lanka to Nigeria have also blocked some Indian drugs from entering the market. Drug industry officials from Japan to the US have also fingered fakes as a chief obstacle to a more robust Indian drug industry.

· The Indian government has pushed back against this common perception, releasing a report late last year claiming that the vast majority of drugs produced in India were of high quality. But that government-sponsored report was likely far too optimistic. Its underlying data and methodology have not been made available to the public, and its findings flew in the face of anecdotal and other evidence that India’s problem with quality is genuine.

The article also reports on a recent study co-sponsored by the London-based Legatum Institute and the New Delhi-based Liberty Institute, A Safe Medicines Chest for the World: Preventing Substandard Products from Tainting India’s Pharmaceuticals.

· In Delhi, 80% of the sampled pharmacies were providing at least some substandard medicines (ranging from drugs with zero-active ingredient to those with chalk or talcum powder substituting for active ingredient). In Chennai, almost 40% of the surveyed pharmacies were found to have sold some below-standard products.

· Meanwhile, 7% of the samples from wholesale traders that the researchers investigated were found to be of poor quality. This is encouraging, in that it is a small enough percentage that one can imagine a concerted effort tackling this problem. But since wholesalers sell across the market, it means just a few bad actors can have widespread impact.

· Almost three quarters of the pharmacists surveyed admitted there was a problem with substandard medicines and said they knew of pharmacists who were complicit in the sale of substandard drugs. Perhaps most worrisome, over 90% of respondents said they had been approached by a wholesale trader offering to sell them substandard pharmaceuticals at a discount. Most of the pharmacists claimed that government corruption and bribery were problems in maintaining high standards. And almost 25% of the pharmacists reported that government officials had demanded bribes of them.

Mr. Schulz explores some of the necessary measures that the Indian Government and the Indian Pharmaceutical Industry need to do to improve their quality, protect the pharmaceutical supply chain, improve their commercial reputation and protect consumer’s world wide.

Secure Pharma Chain Blog encourages all members of the pharmaceutical supply chain world wide to protect themselves from fraudulent, adulterated and counterfeit medications by deploying solutions that authenticate and verify the inventories.

To learn more about pharmaceutical supply chain solutions, visit: http://www.xstreamsystems.net/.

To view the report on livemint.com, visit: http://www.livemint.com/2010/06/03210904/Fake-drugs-are-a-real-menace.html.

India's Fake Drugs Are a Real Problem

India’s Food and Drug Administration recently conducted a series of raids to combat counterfeit drugs. Large amounts of counterfeits were seized in these raids and several individuals were arrested.

Roger Bate, a leading authority on counterfeit drugs recently wrote an article for the Wall Street Journal on these raids and the prevalence of counterfeit drugs in this region.

Below are some of the highlighted statistics cited in the article:

• In 2009, Bate examined five essential medicines in 52 different pharmacies in Delhi and Chennai. In Dehli, 12% of the pills were substandard, as were 5% in Chennai. About 2% of the pills contained no active ingredient.


• In a more recent investigation of Delhi’s wholesalers, they discovered that 7% of all tested samples were substandard and 3.6% were likely counterfeit.


• Last year alone, counterfeit drugs were seized by authorities in Bangalore, Mumbai, Delhi, Jaipur and many other Indian cities.


• In 2008, about half of the medical products that were confiscated by European Union customs officials originated in India.


• Estimates of substandard drugs reach as high as 30% of all medicines sold in parts of Africa, Asia and Latin America. But the truth is we don't really how bad the problem has become.


• The public-health consequences of the counterfeit drug trade are serious. These products, often adulterated with road paint and chalk, look identical to the antibiotics they pretend to be.


• Thousands of people probably die every year either because they're poisoned by bad ingredients in counterfeits or because the counterfeit doesn't treat the victim's malady.

In the article, Bate discusses the huge profits to be made and the necessity for stricter enforcement and how new technology can be used to combat this deadly menace.

XStream Systems has an anti-counterfeiting solution that allows wholesalers to molecularly verify the quality and authenticity of their inventory. In a world where what you see is not always what you get, our penetrating technology authenticates the medication and not just its packaging.

To learn more about XSteam Systems Solution visit: www.xstreamsystems.net.

For the full article visit: www.wsj.com.

Six Chinese Sentenced to Death for Selling Fake Drugs Labeled “Made in India”

Six Chinese traders who exported fake anti-malaria drugs to Africa Labeled as “Made in India” have been sentenced to death. Chinese officials have offered apologies to India, but no further information on the traders’ identities was given.

The issue became a major controversy last June when Nigeria's National Agency for Food and Drug Administration and Control said it had seized a large consignment of spurious anti-malaria drugs worth $210,000.

Indian officials had received complaints that drugs exported from China but mislabeled as manufactured in India were being exported to South Africa, Ghana, Ivory Coast and other parts of Africa.

To view the entire article visit: timesofindia.indiatimes.com.

India: Blowing the Whistle on Fake Drugs

In the August 30th issue of Telegraph India, the Union health minister, Ghulam Nabi Azad, was reported as announcing a “whistle blower policy”, aimed at encouraging the common man to provide information about the manufacture of fake drugs

• Based on the information gathered by the Central Drugs Standard Control Organization, the office of the Drug Controller General of India raids places suspected of manufacturing or selling such drugs


• The tip-off often comes from a member of the general public


• The government hopes that a cash reward will lead to more people coming forward with such information.

To view the article visit: www.telegraphindia.com.

Business Standard: Validation Check Imposed on Medicine Exports in India

The August 5th edition of the Business Standard reports on Drug Controller General of India (DCGI) requiring all pharmaceutical contracted manufacturing exports will be required to furnish validation certificates of authenticity for importing firms overseas.

• The move, initiated by the office of the Drugs Controller General of India (DCGI), is expected to boost India’s image as a supplier of quality, low cost medicines.


• According to the official directive, all contract manufacturers exporting medicines using neutral code (which do not mention the name of the manufacturing or marketing firm) will have to present certificates from the regulators of the importing country to prove the genuine nature of the importing firm. In other words, the foreign regulator will have to endorse the product name and marketing registration these companies have obtained from the regulator.


• The drug exporters hailed the intention of the DCGI, but expressed concern over the sudden implementation of the circular. “There are hundreds of medicine products that are being exported to all parts of world”, they said adding: “ If DCGI wants the credentials of all the foreign sourcing companies from respected drug regulators, the consignments will not be cleared for the next three months. It will affect our credentials and credit worthiness.”


• The exporters wanted the directive to be confined to less regulated markets, where there is scope for mischief. Indian drug exports had recently come under regulatory scrutiny in several countries due to alleged complaints of spurious and counterfeit medicines.

XStream System applauds the move by DCGI and encourages screening and validation within all points of the supply chain as an important solution to counterfeit, substandard and adulterated pharmaceuticals.

XStream’s XT250 system can be easily deployed within the supply chain to screen, validate and authenticate pharmaceuticals within their sealed, unit-of-sale container without opening, destroying and degrading the product.

To view the entire article visit: www.business-standard.com