Counterfeit drugs creating a challenge for the regulators in India

According to Government-sponsored studies around 3% of medicines in the Indian market are of poor quality or are counterfeit. However, a report published by ASSOCHAM said that 25 percent of medicines sold in India re either counterfeit or of poor quality. Generic drugs like Crocin and Betadine have earned a bad name due to the menace of counterfeiting.

According to former International Pharmaceutical Federation vice president Prafull D. Shah, “Any study showing a higher percentage of Indian drugs as substandard or fake serves the interest of foreign pharma companies since Indian companies have always posed them a threat.” He also said that he had asked ASSOCHAM for the data based on which they provided the 25% figure however they never provided it to me.

The BJP government in 2003 had appointed an expert committee to assess the regulatory infrastructure and the scope of the problem of fake and cheap drugs in India. The panel admitted that there was an absence of scientific and detailed investigation to reveal the exact estimate.

The committee also said, “The Central government should provide assistance to undertake such scientific and statistically-significant study for a clear picture about the exact extent of spurious drugs in the country.”

In 2006-07 with the support of WHO around 7500 samples were collected and tested from across the country out of which 3.12% were of poor quality but the presence of spurious drugs was negligible.

In the second survey, conducted by the Central Drug Standards Control Organisation (CDSCO), a total of 24,780 samples were tested from around 40,000 pharmacies, of which 644 were “SALA (sound-alike and look-alike)”.

Going by raids conducted in the past few years, prominent places where counterfeit drugs are manufactured and sold in wholesale include Baddi in Himachal Pradesh, Agra, Aligarh, Bulandshahr and Muradnagar in Uttar Pradesh, Patna in Bihar and several places in West Bengal.

Source: OutlookIndia.com

Barcoding to become mandatory for drugs in India

The Union Health Ministry in India is going to make barcoding necessary for drugs after an alarming report by US Trade Representative (USTR) which revealed that India was one of the largest producers of fake medicines in the world.

The Drug and Technical Advisory Board (DTAB) had earlier recommended that an Indian law should be made that makes barcoding mandatory for all medicines. This would allow pharmacists, customers and the government to trace medicines across the supply chain and identify where a drug was manufactured

The barcoding would help pharmacist, consumers and government bodies to track and trace medicines across a supply chain. The Indian government is taking the measure after a USTR report which mentioned that up to 20% drugs sold in India are fake and could pose a serious risk to the health and safety of the patient.

As of now barcoding is mandatory for medical devices and exported medicines but for drugs sold domestically, it is voluntary. Raja Selvam, Managing Attorney, Selvam and Selvam said that barcoding would help in preventing the infiltration of fake drugs in the supply chain which will ensure the safety of patients.

DTAB said that mandatory barcoding would help in preventing the problem of false labelling and thus will help the manufacturer in identifying the falsely labelled product. Vikrant Rana, Managing Partner at SS Rana & Co in New Delhi, said that the change was timely, but it will be challenging in the village areas where there is hardly any internet connectivity and electricity making it tough for scanning to be possible.

How counterfeiting affects pharmaceutical industry?

Medicines are boon for human life. Be it a life-saving drug or something as simple as a cold pill, the importance of each of the medicines can only be understood by the patient, and his or her loving ones.

Healthcare industry is being pumped due to the increasing number of diseases and people’s shift towards health care. In this fast-moving world, nobody can afford to stay ill for a long period of time. With the easy availability of medicines and advanced health care facilities, today’s generation is far more safe and secure against chronic diseases.

No wonder, the pharmaceutical industry is booming worldwide bolstered by constant innovations and research. However, on the flip side, the pharmaceutical industry is facing the wrath of counterfeit drugs. Lately, the manufacturing of fake drugs has become a thriving business in third world countries-India being one of them.

According to the World Health Organization (WHO), 10 to 15% of the global drug supply is counterfeit and Africa accounts for up to 30% of the counterfeit medicine in circulation. A per another statistic it is estimated that 1 in 10 drugs sold worldwide is counterfeit.

One of the worrisome situations created by counterfeit medicines is their threat to human lives. According to a news published in The Guardian, “A surge in counterfeit and poor-quality medicines means that 2,50,000 children a year are thought to die after receiving shoddy or outright fake drugs intended to treat malaria and pneumonia alone.”

In order to fight the menace of counterfeiting the Indian government is taking various measures. The Union health ministry will make barcode compulsory for all pharmaceutical ingredient packages so that it may help to track spurious drugs and also monitor imported and domestically produced raw materials. Besides the use of digital authentication, physical anti-counterfeiting technologies can play an important role by adding an extra layer of security to the product.

‘Fake drugs cause death of 2,50,000 children every year’ warn US doctors

Doctors have asked for an urgent international effort to combat the harmful effect of bad drugs that are thought to kill hundreds of thousands of people around the world everywhere.

The doctors cautioned that an increase in counterfeit and cheap grade medicines means that 2,50,000 children are thought to die because of them.

A large number of children are thought to die due to cheap grade vaccines and antibiotics which are meant to treat acute infections and diseases such as hepatitis, yellow fever and meningitis.

“The penalties are a slap on the hand, but we are talking about murder by fake medicine here,” said Joel Breman, a senior scientist emeritus at the US National Institutes of Health in Maryland.

Writing in the American Journal of Tropical Medicine and Hygiene, doctors from the US government, universities, hospitals and the pharmaceutical firm Pfizer warn that the rise in “falsified and substandard medicines” has become a “public health emergency”. On top of the direct harm they cause, bad drugs are a major driver of antimicrobial resistance, which fuels the rise of superbugs. “This is an urgent public health issue and we need to take action,” Breman said.

Source: theguardian.com

New report on global pharmaceutical anti-counterfeiting technologies

A new report on global pharmaceutical anti-counterfeiting technologies has been released which covers many aspects like forecast, status, market size and trends. The report also mentions the complete information about market players, growth scenarios and the prominent market drivers. The report is segmented according to markets, types, regions and applications.

Anti-duplication technology plays an important role in the identification of counterfeit drugs. Duplicate drugs may include spurious ingredients or adulterants in wrong proportions. Duplication can take place in both generic and branded products. It’s well known that fake drugs pose serious health risks and may lead to imminent or long-term effects. Global pharmaceutical anti-duplication solutions are being used widely as Governments world over have become serious to stop counterfeiting of medicines. Technological advancements in anti-counterfeiting technology will further boost the pharmaceutical market.

The main reasons for the rise of counterfeit drugs are lack of awareness, poor monitoring of supply chains and weak regulations. Developed countries like the USA have implemented RFID (radio-frequency identification) while the European countries believe in the 2D barcodes. The developing nations like India are sensitized about the extent of the problem and have formulated rules mandating barcodes. Even the pharmaceutical companies have got serious and are employing Pharmaceutical Anti-Counterfeiting Technologies in order to eliminate the illegitimate drugs in their supply chain.

While most American companies have implemented RFID (Radio Frequency Identification) their European counterparts still rely on barcodes. Developing countries have assessed the criticality of the situation and have laid down rules related to the same. Pharmaceutical companies in India are implementing different anti-counterfeiting technology to battle duplication.

 

NITI Ayog collaborates with Oracle to stop fake drugs

A WHO (World Health Organisation) report states that 35 % of duplicate drugs sold all over the world comes from India. This means that one out of ten medical products circulating in India are fake or of substandard quality. Approximately 20 % of the drugs sold across the nation are counterfeit or fake. The report further states that the fake drug market in India stands at Rs 4000 crore. The aftermaths of fake medicines are quite worrisome not just for India but for other countries as well. Duplicate medicines can promote antimicrobial resistance due to which the infection can be carried and passed on to people travelling to different countries. The mutated bacteria or virus is impossible to be treated with the same medicines as they become resistant to it.

Witnessing the looming danger, NITI Ayog which is government’s policy think tank has collaborated with Oracle and Apollo hospitals. Oracle will implement its block chain technology and a ledger system in the supply chain of pharmaceutical company. This will lead to creation of records cannot be altered with every transaction.

With the implementation of blockchain technology all kinds of medical and pharmaceutical products will be eliminated form the hospital chain’s inventory. The technology will help in reducing the distribution and sale of fake medicines. The system will also help in real-time monitoring of the production and export. The blocks of blockchain technology are continuous growing list of records that are linked using cryptography. In the pharmaceutical sector, blockchain will help in stopping the entry of fake drugs.

The collaboration of NITI Ayog and Oracle will help hospital chains across India to bring the entire inventory under the blockchain which will effectively check the intrusion of fake drugs. Moreover, government will also be able to keep a tap on the production and supply of the drugs. Besides big companies like Oracle many startups such as LinkLab, LifeCrypter, Chronicled and BlockVerify are also working to find solutions for the pharmaceutical sector through the use of blockchain technology.

AICDF wants anti-counterfeiting technology for essential medicines

The CDSCO (Central Drugs Standard Control Organization) is on the verge of implementing a track and trace mechanism for prominent drug manufacturing companies which are most susceptible to counterfeiting. But, the step can only reap benefits if the move extends to NLEM (National List of Essential Medicines) products as well says, AICDF (All India Chemists & Distributors Federation).

CDSCO has identified top 300 drug companies based on the moving annual data. The organization wants top 300 drug brands to print a 14-digit number on the labels of the product along with their contact number. This will help the consumer to check the authenticity of the drugs by sending a text message on the number provided on the label. One would receive information like batch number or the expiry date of the product with other details verifying the product’s genuineness.

However, the AICDF has disagreed with the current move and has stated that counterfeiters concentrate more on the brands which have been popular for more than a decade- the brands well known to common people. Joydeep Sarkar General Secretary of AICDF stated that any new molecule included in NLEM, post-DPCO-2013, can churn out huge profits. In 1995 the NLEM brands had a profit margin of 100 % which has now grown up to 500 to 800 %.

Sarkar also said that government should take proactive measures to banish counterfeiting from the pharma industry but, production of fake medicines starts with the availability of basic ingredients imported by companies. It’s the negligence of the concerned authorities who are quite liberal in allowing easy import of salts rather clearing them through a stringent check. Moreover, no restriction on proper disposal of expired medicines has also encouraged the sale of counterfeit medicines as manufacturers show reluctance to take back expired medicines from stockists. He also pointed out that instead of taking measures against the real offenders who are the manufacturers, authorities consider traders as the prime culprits.

Expressing his doubt on the efficacy of unique code to be printed on dug packs to counter duplication he said that the use of a code, QR-code or a special mark will not be able to restrict counterfeiting. In the past counterfeiters have been able to replicate labels and with time they would also find ways to replicate special codes thus diminishing the line between fake and real product.

Fake Drugs

42% of the World’s Fake Drugs are Dumped in Africa

As though access to essential drugs and medications was not sufficiently hard to develop nations, another examination uncovers that a portion of the medications that we can get hold of might make us more ailing. As indicated by the World Health Organization (WHO), in a report discharged on November 28, an expected 1 of every 10 medical items flowing in low and middle-income nations are either substandard or misrepresented. Continue reading “42% of the World’s Fake Drugs are Dumped in Africa”