*Phensedyl: When medicine becomes malady: smuggling of cough syrup Phensedyl rampant, even fakes join the fray – The Economic Times

Clipped from: https://economictimes.indiatimes.com/prime/pharma-and-healthcare/when-medicine-becomes-malady-smuggling-of-cough-syrup-phensedyl-rampant-even-fakes-join-the-fray/primearticleshow/92836381.cms

SynopsisOver the decades, smuggling of the popular medicine near the Bangladesh and Myanmar borders has acquired monstrous proportions. Manufacturer Abbott and law-enforcement agencies are fighting the menace, but the impact has been minimal. What’s worse, fly-by-night counterfeiters have joined the illicit trade, supplying spurious products. How is such a racket flourishing when regulations restrict the use and sale of Phensedyl?

That July morning in 1997, Sikkim Police head constable RB Tiwari was manning a checkpost at Rangpo, a hilly town in Sikkim bordering Kalimpong in West Bengal.

While checking a truck, Tiwari found a trunk stashed with medicines hidden behind the driver’s seat. He seized 22 bottles of the popular cough syrup brand Phensedyl and 300 tablets of nitrazepam, a drug used to treat insomnia and sleep disorders. A chargesheet was issued against the driver under the Narcotic Drugs and Psychotropic Substances Act (NDPS).

Later, he was acquitted for lack of evidence.

That could be dismissed as just another incident 25 years ago. But today, smuggling of addictive and habit-forming drugs to neighbouring Bangladesh and Myanmar has acquired monstrous proportions, with scores of such cases routinely filed against such trade.

Abbott, the company that manufactures Phensedyl, and law-enforcement agencies continue to make attempts to curb the menace, but their impact has been minimal. In 2015, Indian regulatory agencies even recommended to entirely ban the sale of such drugs that were rampantly misused and exported illegally to neighbouring countries. The plan was dropped considering the therapeutic benefits of those drugs.

What’s worse, riding on the popularity of the brand, fly-by-night counterfeiters are supplying spurious products across the border, aggravating the problem.

How is such a racket flourishing when regulations restrict the use of Phensedyl and stipulates its sale only under medical prescription? ET Prime investigates.

Tight seal on addictive pills@2x

In recent months, incidents of smuggling of Phensedyl have shot up, particularly from West Bengal and the north-eastern states that share a long and porous border with Bangladesh and Myanmar.

Just last month, an ambush party of the Border Security Force nabbed six Bangladeshi citizens while they were trying to smuggle out 221 bottles of Phensedyl syrup along with fish seeds from West Bengal.

On a closer check, security officials found those caught were to receive 3,000 Bangladeshi taka (currency) from their operators. Last year, security officials from West Bengal reportedly seized 164,000 bottles of Phensedyl cough syrup. The seizures during 2019 were of a similar volume.

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The INCB has some warning signals specific to India. “Available data on the prevalence of opiate use indicate that the region, primarily India, has the largest number of opiate users worldwide, estimated at 12 million people, far more than in any other region. Significant quantities of opiates for domestic consumption in south Asia are likely trafficked from south-west Asia,” the report adds.

A source ET Prime reached out to says Phensedyl smuggling is a big, lucrative business. Each bottle of Phensedyl that moves across the border fetches at least twice, sometimes even thrice, its retail price in India. One of the reasons for Phensedyl’s popularity in Bangladesh is the nation’s strict prohibition laws on liquor consumption. “This leads to clandestine operations,” he says. “Even if it is sold at double of India price, its demand remains high,” this person tells ET Prime.

The supply chain
Since codeine is a byproduct of opium, its supply chain — from cultivation and processing as a raw material to the final stages when it is used as a key ingredient for the cough syrups — is strictly controlled.

Produced mostly in Madhya Pradesh and Rajasthan, raw codeine extract is allocated to each listed producer based on a fixed quota. This material is then shipped in armoured trucks to the manufacturing sites under government security.

Even at the stage when the product is processed in the manufacturing facilities, the possession of the codeine raw material stays with Excise Department officials. After being processed into formulations, it is moved to certified and licensed distributors, or to hubs or company warehouses.

Till it reaches the distributors, an industry official says, the product is tracked closely. But beyond this point, when it gets to retail chemists, it could get into unscrupulous channels. Since there are hundreds of thousands of retail chemists handling the product, it is virtually impossible to keep track of the stocks.

However, most online pharmacies and medical-care websites such as Practo outline specific conditions for use of Phensedyl. Besides that, industry officials say, they keep batch sizes for such cough syrups small. While generally such batches consist of 150,000 bottles, cough-syrup batches are kept at nearly half of that to enable closer tracking.

But industry experts say the problem isn’t limited to smuggling of addictive medical products. The malaise goes deeper. There is a flourishing trade in spurious and counterfeit medicines. This network is so deeply entrenched in the border states that even tip-offs to enforcement agencies like local police, directorate of revenue intelligence, customs, or the Narcotics Control Bureau get leaked, helping fly-by-night operators flee before any surprise raids are conducted. “Even their factories are so mobile that they are dismantled,” a source tells ET Prime.

An industry expert agrees that fly-by-night operators may be making spurious concoctions and smuggling them into Bangladesh. If such products result in deaths, the smuggling issue could snowball into an episode that will seriously damage India’s reputation as a pharmacy of the world.

The life of a brand
Among the high quantum of drugs sneaked into Bangladesh from India, industry experts say, the name Phensedyl comes up in most cases. Perhaps the brand is a victim of its own success, they add.

In the 1990s, then under its French owner Rhône-Poulenc, Phensedyl saw a spectacular rise, making its place among the highest-selling brands in India. Old-timers recall that the cough syrup’s sales were rivalled closely by Pfizer’s Corex, another codeine-based product, and Voveran, a painkiller from Novartis.

That led takeover tycoon Ajay Piramal to buy a portfolio of brands from Rhône-Poulenc in 2000. In 2010, Phensedyl found a new owner in US drug maker Abbott as part of a landmark deal for a portfolio of drugs for USD3.7 billion.

How the brands stacked up in 2013@2x

Phensedyl is the topper in sales among cough syrups that contain codeine. Industry data shows its sales were at INR168 crore in May 2022 for the 12-month period, but some believe it could be closer to INR200 crore.

Phensedyl variants that do not contain codeine may add up to another INR50 crore annually. Phensedyl T is the combination of codeine and triprolidine that falls under the category of narcotic cough suppressant.

Leading codeine-based cough brands@2x

But even as Phensedyl succeeded in consistently staying ahead of competing brands and winning doctors’ prescriptions, controversies have trailed it all through. A senior industry source says the name Phensedyl is synonymous with the entire category of codeine-based cough syrups, similar to what “Xerox” is for photocopiers. “Any seizure of cough brands with codeine, is inadvertently linked to Phensedyl,” he adds.

Companies close ranks
In response to ET Prime’s questions on how Abbott views the increasing cases of smuggling of the drug to neighbouring countries such as Bangladesh, a company spokesperson says, “Abbott has stringent and comprehensive initiatives in place to address the misuse and diversion of our codeine-based formulations, such as Phensedyl. We ensure that the product is only sold to licensed distributors through written, confirmed orders, with a cap on the batch sizes and on the quantity invoiced to each distributor.” This enables precise and detailed tracking of the products by Abbott and the regulatory authorities, spokesperson added.

According to the company, its global product-protection team conducts frequent audits and alerts authorities on diversions of stocks and suspected counterfeit products. “We actively support law-enforcement agencies in the process of investigations,” it says.

Separately, ET Prime learned that a few makers of codeine-based cough syrups, including Abbott, have voluntarily stopped supplying their drugs to Punjab, Bihar, and north-eastern states as a deterrent to smuggling.

But considering the scale of the problem, even all the current measures taken together can at best help temporarily gain an upper hand in the fight.

For a bigger and permanent impact, the assault needs to be stepped up by several notches.

(Graphics by Sadhana Saxena)
(Originally published on Jul 13, 2022, 12:01 AM IST)

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All this points to a well-oiled network that backs illegal movement of addictive drugs. The alarming trend is documented by the International Narcotics Control Board (INCB), a United Nations agency, in a report released last year. The report says that among seized contraband, the most frequently encountered ones are pharmaceutical opioids, which include codeine and codeine-based cough syrups; tramadol, an opioid not under international control; fentanyl; and methadone. “The largest quantities of pharmaceutical opioids seized in 2019 in the region were reported by Bangladesh and India,” it adds.

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