Drug regulators, pharma firms step up action on fake and substandard drugs | Business Standard News**

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Detection of spurious and substandard drugs was up by 47% from 2020 to 2021, according to an ASPA Report


Government data shows that in 2019-20, of the 81,329 drug samples tested, 2,497 were found to be of non-standard quality (NSQ), and 199 were declared spurious in nature. In 2020-21, this number rose to 2,652 NSQ samples and 263 spurious samples out of 84,874 tested. Between 2019 and 2021, as many as 384 people were arrested in connection with counterfeit or NSQ drugs.

For starters, the state drug controller of Himachal Pradesh has set up an internal team of 3-4 people from the department who are working on generating intelligence on spurious activities happening in the state. Baddi, which is a major pharma manufacturing hub in India, is located in the state.

Speaking to Business Standard, Himachal Pradesh state drug controller Navneet Marwaha said, “None of the spurious drug making units would be anything like a regular one with a manufacturing license. The operations of such units are clandestine. So we have set up a team of officers who are constantly working on generating intelligence about such ‘underground’ activities. It has yielded results-–we have cracked three rackets in the past three months.”

Marwaha’s team recently nabbed four people, including ‘mastermind’ Mohit Bansal, who were making spurious versions of popular drug brands like Montair, Atorva, Zerodol and Urispas. “These people would come from Agra at night, manufacture these drugs here, and then carry them with them in the car back to Agra,” Marwaha says. He estimates that the value of drugs seized from Trizal Formulation (Bansal’s outfit) is about Rs 1.5 crore. Marwaha’s team has busted two more rackets in recent months – Arya Pharma, and Aclime Formulations.

Marwaha says these counterfeiting units often have a food manufacturing license. “The machines used to make nutraceuticals and several drugs are the same. These units don’t usually go for drug manufacturing licences, so it becomes difficult for state drug regulators to nab them,” he explains.

Companies too are taking action to ensure the consumer can detect a spurious drug from a genuine one. It is becoming all the more critical as fake-medicine makers are also counterfeiting life-saving drugs, such as those for cancer.

Last month, the Delhi police crime branch nabbed seven people, including a doctor, for allegedly making cancer medicines and supplying them not only in India but also in Nepal, Bangladesh and China.

Zydus Lifesciences spokesperson tells Business Standard that the firm has introduced a new feature called ZyVerify on its packaging of critical drugs, to help patients identify the product as genuine.

“We have incorporated a new IT-enabled scratch code taht will be printed under a scratchable surface. Patients can check to see if the product bought by them is genuine or not by scratching the surface and verifying the code through the app or the website.

This security feature developed by Hyperlink Infosystem enables patients and institutions to detect counterfeits. All that one needs to do is scratch the code and immediately verify this on an app or website, in no time,” the spokesperson explains.

The company says with the surge in counterfeit products in the market, it was necessary to ensure that a 100 per cent genuine product of its brand was available. “We have already implemented this technology in some products and it is also being extended to other products as well,” the Zydus spokesperson said, adding that the firm is also in the process of implementing a holographic solution for select products that are particularly prone to counterfeiting.

“It will have hidden features that can be detected through a special film and will help in immediate confirmation of an authentic product. The QR code, a great initiative by the government, is being adopted for all products mandated by the government. We will continue to expand the scope of the QR code printing,” the Zydus spokesperson said.

Marwaha says it is important for companies to come down hard on every individual caught counterfeiting.

Darren Punnen, Leader, Pharma & Life Sciences Practice at Nishith Desai Associates elaborates, “Action can be taken by companies from two angles – one is from an IP (primarily trademark) infringement perspective, where the brand owner typically investigates the source of the counterfeiting and initiates criminal or civil action against the offender, the other is from a quality or regulatory perspective, where the brand owner informs the drug regulator (CDSCO and/or state drug controller) about the counterfeits and seeks its intervention.”

“Once the regulator is informed, an investigation (typically with the assistance of the police) is conducted and criminal prosecution for the import, manufacture or sale of spurious drugs is initiated before the relevant court by the regulator itself,” Punnen says.

How do these drugs land up in the market?

Nakul Pasricha, President, Authentication Solution Providers’ Association (ASPA), says that in markets known for large-scale pharma distribution, such as Agra for instance, some distributors do this mixing of genuine and fake medicines and pass it on to chemists. “The chemists are at times unwitting partners in crime, and sometimes they are also actively involved,” he says.

Pasricha adds that according to a worldwide study by the World Health Organisation (WHO) one in 10 drugs distributed worldwide are either spurious or substandard. “In India, the CDSCO has done studies in 2009 and in 2016 in which it found the rate of substandard drugs was somewhere around 4 per cent. Of this, spurious drugs were around 0.3 per cent,” he says.

The ASPA has done a study in which it looked at the incidents being reported by the media across the country. “During Covid-19, we found there was a 47 per cent increase in the number of incidents reported,” he said.

Whatever be the exact number, the menace of counterfeits and substandard medicines cannot be ignored.

In August, Union Health Minister Mansukh Mandaviya asked the pharma industry to act against firms making substandard and fake drugs in the country.

The Centre has decided to introduce QR codes for the authenticity and traceability of 300 common drug brands, including analgesics, vitamins, diabetic drugs, and hypertension medicines. The draft notification was finalised in November. Popular brands like Dolo, Allegra, Asthalin, Augmentin, Saridon, Limcee, Calpol, Corex, Thyronorm, and Unwanted-72 were identified. These high selling brands have been shortlisted based on their moving annual turnover (MAT) value.

While the pharma industry starts work on QR codes, the state drug regulators are getting tech savvy as well.

H G Koshia, commissioner, Food and Drug Controller Administration (FDCA), Gujarat, says they have got machines that can scan and check if any consignment is spurious without breaking the seal. The Gujarat FDCA has already initiated mobile drug testing labs to reduce response time.

Some recent incidents in India:

  • February 2021: A firm engaged in buying expired drugs cheap and reselling them at market prices after repackaging them, was raided in Agra and the drugs seized
  • June 2021: Post Covid-19, as soon as black fungus cases started getting reported in Hospitals, criminals began taking advantage. More than 3,500 vials of black fungus injections were found in a raid in New Delhi.
  • June 2021: Gujarat FDA busted a racket selling fake antiviral drugs Favimax400 and Favimax-200
  • June 2021: Mumbai police arrested a factory owner in Meerut, Uttar Pradesh for allegedly supplying counterfeit Paracetamol and Diclofenac formulations
  • July 2021: Kanpur crime branch arrested a gang and seized fake medicine worth Rs 4 crore. The criminals admitted they were producing medicines and using UP State Transport buses to distribute them. The code words Parle-G and Cadbury were used for order bookings

Source: ASPA Report of March 2022

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