Falsified and substandard medicines can be ineffective, promote drug resistance and even cause severe illness and death, said panel chairman Lawrence Gostin, Georgetown University Law Center professor and director of the WHO Collaborating Center on Public Health Law and Human Rights. The report [“Countering the Problem of Falsified and Substandard Drugs” available at www.nap.edu] urged regulators to adopt international practices on surveillance, regulation and enforcement, including technical quality standards developed by the International Conference on Harmonization.

Most important to pharma companies, the panel backed a mandatory U.S. electronic drug track-and-trace system able to identify products at the unit level through unique serial numbers. This approach is supported by the Food and Drug Administration – which requested the report — but considered too costly and complex by manufacturers, pharmacists and wholesalers.

The expert panel also proposed to strengthen supply chain tracking through tighter state regulation of drug wholesalers, including creation of a public database of distribution firms that have had licenses suspended or revoked. And the federal government would help low- and middle-income countries detect substandard products by identifying new sampling and analytical technologies through a central repository at the National Institute of Standards and  Technology (NIST).

Counterfeits separate

One strategy for building support for all these activities is the panel’s decision to drop the term “counterfeit” in describing substandard drugs that pose a public health risk. The aim is to narrow the use of “counterfeit” to refer to products that infringe on trademarks and intellectual property protections, but are not necessarily substandard or adulterated. Calling all poor quality drugs “counterfeit,” the report notes, is seen by advocates for generic and low-cost medicines as a way to use the campaign against “bad drugs” as a guise to enforce patent and trademark regulations.

Similarly, the report  defines more clearly “substandard,” “falsified” and “unregistered” drugs to provide a basis for regulatory agencies to target their legal and regulatory efforts.

The panel also calls for international development and financing agencies to support drug manufacturers in low-income countries that seek to upgrade facilities to meet good manufacturing practices. Such investment efforts would counter fake drug marketing by boosting local capacity for producing quality medicines.

Although an international treaty enforcing drug quality standards is the ultimate goal, publication of guidance on best practices as an interim step “is more realistic,” noted panel member Hans Hogerzeil, professor of global health at Groningen University in the Netherlands. The IOM panel also is asking the World Health Assembly to support its basic recommendations at its May 2013 annual meeting.

There’s some optimism that this report may spur FDA, manufacturers, distributors and pharmacists to reach agreement on an effective drug track-and-track system, an issue that has generated heated debate for more than a decade. Congressional action is needed to authorize mandatory tracking, as well as to require states to support a database on licensed drug wholesalers. Added resources for FDA to take on these tasks also is a real challenge.

While cost is an issue everywhere in implementing new regulatory and oversight programs, Gostin noted that limiting the use of substandard drugs would bring notable benefits in terms of lower hospital costs and fewer drug-resistant medicines. Adopting the panel’s recommendations, he said, is “a very good investment.”

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.

While some of the offenders are well-known drug manufacturers (like Alkem Laboratories for omeprazole capsules and Venus Biosciences for Odicin-200), many are small drugmakers, such as Affy Pharma for levocetirizine tablets, Medipol Pharmaceuticals India for clauvmentin dry syrup, Endolabs for paracetamol tablets, Softsule for DIAX OD, Therachem Laboratories for Metflox, Medopharm for Miliclav dry syrup/ amoxycilin and potassium CLA.S, Biocin Healthcare for Thyomin tablets and Nuclotec Remedies for Digizyme syrup.

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 the other countries carry a ‘Made in India’ label, though there is ample evidence that they could be actually made in other countries.

The European Union has also decided to not seize Indian drug dispatches that use Europe as a transit point. According to a new understanding between India and the EU, none of the customs authorities in the 27-nation EU bloc will confiscate any drug dispatches meant for third country destinations like Latin America or Africa. Earlier, some of the EU customs authorities, mainly the Netherlands and France, had confiscated several Indian off-patent generic drug consignments going to Brazil via European ports over alleged infringement of EU intellectual property rights (IPR). Protesting the action, India and Brazil filed a case against the EU in the World Trade Organization. Though this case is related to alleged infringement of IPR, it brought to the fore the issue of sub-standard drugs. Indian pharmaceutical exports total about $10 billion per annum, comprising mainly generic drugs. The government wants to raise these exports to $25 billion over the next three years. Actions like the seizure of drug consignments in the EU ports or charges of sub-standard drugs imported from India can well derail the whole process.

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].