Rajeev Singh Raghuvanshi. File

India’s drug regulator Drugs Controller General of India (DCGI) on Wednesday (October 9, 2024) said manufacturers of around 45 medicines have been ordered to recall their products for not meeting quality norms, while action has been initiated to book the makers of five spurious drugs.

In an interaction with reporters on the sidelines of CII Pharma and Life Sciences summit in New Delhi, the DCGI of the Central Drugs Standard Control Organisation (CDSCO) Rajeev Singh Raghuvanshi clarified that the recent reports of “50 fake medicines” being banned were “completely wrong”.

“They are not fake medicines. They were ‘not of standard quality’ medicines. There is a difference between the two. Only five of them were spurious in our terminology, which you can talk as fake,” he asserted.

Every month, he said the CDSCO samples and tests about more than 2,000 samples from the market, and out of that, “some 40-50, of them fail in one or the other parameter, which could be very minor parameters, also not of any health risk and we put that on our portal.”

Referring to the recent reports, Mr. Raghuvanshi said, “So the one picture which is being given is that there were 50 fake medicines which we banned. That was completely wrong. They were not fake medicines and they were not banned. They were just notified as not of standard quality.”

When asked what actions have been taken following the recent notification by the CDSCO, he said, “On our part, what as a process we do is all these are put on recall. So the day, we get the information about the ‘not of standard quality’ or ‘spurious’, immediately the next step is to inform the manufacturers and tell them to recall the drugs and that’s a process.”

As for the five spurious drugs, he said, “We have identified the spurious products, and then action starts from the person who sells, from where we have samples, and then we do the mapping of the whole supply chain.” He acknowledged that it is still a work in progress to bring the culprits to book.

“The Drug and Cosmetics Act, has all the provisions to take care of the issue related to fake medicine and spurious drugs,” he said, adding, “There are set procedures which are followed once we detect them and we take them to logical conclusion, and that’s what is happening currently”.

Mr. Raghuvanshi further said, “We give recommendations for prosecution or recommendation for administrative actions, depending on how serious non-compliance issues are there.”

Last month, more than 50 drugs, including antacids and paracetamol, were listed in CDSCO’s monthly list of substandard or fake medicines sold in India.

Hyderabad:

The Telangana government has warned against the consumption of any and all medicines manufactured by Meg Life Sciences after three – MPOD 200, MEXCLAV 625, and CEFOXIM-CV – were found to have “no active ingredient (medicine)”. All three had only “chalk powder and starch (and) posed significant health risks to consumers”, the state’s Drugs Control Administration said.

The company itself – which claimed to be based in Himachal Pradesh’s Sirmaur district – has been found to be a fictitious/non-existent company, the DCA said in a statement issued on Tuesday.

“In light of these grave findings, the Drugs Control Administration, Telangana, hereby issues a Spurious Drug Alert and Stop Use Notice for all drugs claiming to be manufactured by Meg Life Sciences… healthcare professionals are informed to STOP USE immediately…” the DCA said.

The claimed ingredient in MPOD 200 is Cefpodoxime Proxetil and Lactic Acid Bacillus, while that in MEXCLAV 625 is Amoxicillin and Potassium Clavulanate, and Lactic Acid Bacillus, and in CEFOXIM it is supposed to be Cefpodoxime Proxetil and Potassium Clavulanate, and Lactic Acid Bacillus.

“Retailers and wholesalers are directed to STOP the sale and distribution of any drugs bearing the label of ‘Meg Lifesciences’, and to inform the area Drugs Inspector immediately,” the DCA added, and urged the public to report any information regarding distribution, or sale, of all such drugs.

The DCA provided a toll-free number – 1800-599-6969 – for the public to file reports.

This is, tragically, not the first incident of spurious drugs being sold in the market.

Last week a similar racket in Uttarakhand was busted after a joint operation by the Telangana DCA and Hyderabad Police, in which counterfeit drugs containing chalk powder were passed off as those from reputed pharma manufacturers like Cipla and GlaxoSmithkline.

Five people were arrested in that case.

Last month, drug officials in Maharashtra seized over 21,000 tablets passed off as an antibiotic – ciprofloxacin, used to treat various bacterial infections – from a government hospital in Nagpur.

The fake tablets – worth crores – were supplied to several government hospitals.

READ | Fake Drug Racket In Maharashtra, Over 21,000 Tablets Seized

In this case too ‘Refined Pharma’, the company that made the fake drugs, was fictitious; officials told news agency PTI the registered address of the company, in Gujarat, did not exist. Three men – Vijay Choudhary of Thane, Hemant Mule of Latur, and Mihir Trivedi of Bhiwandi – were arrested.

READ | Fake Cancer Drugs Worth 8 Crore Seized In Delhi, 4 Arrested

In January there were also allegations of fake and/or substandard drugs being dispensed in Delhi government hospitals and mohalla clinics, which are part of the ruling Aam Aadmi Party’s flagship medical care projects. The claims sparked a political row, with the Union Home Ministry ordering a CBI probe and the Delhi government also taking action – seven mohalla clinic doctors were sacked.

READ | CBI To Probe Fraud Allegations In AAP’s Mohalla Clinics In Delhi

A month before that, Delhi Police’s Crime Branch busted a fake medicine factory in the city’s Gulabi Bagh area and arrested its owner. The factory was making an ‘anti-itching gel’ called Betnovate-N.

READ | Factory Making Fake Anti-Itching Gel Busted In Delhi, Owner Arrested

Nearly 60 cartons of empty tubes – each carton had 1,200 tubes – were recovered from.

And, in August last year, drug officials in Kolkata found fake drugs worth a massive Rs 2 crore that were being passed off as manufactured by leading pharma firms, including Cipla and Dr Reddy’s.

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