India has a substandard, fake drugs problem. Lack of recall law, scrutiny is making matters worse

New Delhi: The country’s top drug regulator announced in its monthly alert for August that 59 different medicines had been discovered, some of them well-known. and A product sold by a leading pharmaceutical company turns out to be substandard or counterfeit. Understandably, this sparked outrage, with accusations of supplying drugs and cough syrups to other countries with serious adverse events, including deaths.

But advocates for patient rights and improved drug quality say India has major issues to address, including the country’s lack of an effective mechanism to ensure national recalls of such medicines.

For example, in 2022-23, the last financial year for which data on NSQ and placebos are available, as many as 3,477 or 3.5 per cent of the 96,713 samples tested were found to be problematic. In 2018-2019, this number was 3.4%.

In the latest list issued by the Central Drugs Standard Control Organization (CDSCO) in August, 54 drugs were declared NSQ and five more were declared fake.

NSQ medicines are medicines that are ineffective or less effective because they do not meet national or international quality standards. Counterfeit medicines, on the other hand, are medicines manufactured by someone other than an authorized manufacturer and designed to look like the real thing. They are also often unsafe or dangerous.

This list only includes names of manufacturers, not distributors, but includes brands from major pharmaceutical companies such as Sun Pharma, Lupine, Torrent, Glenmark, and Alkem (CDSCO It was pointed out that NSQ or the name of the drug brand where counterfeits were found) were also included. .

On the corporate side, many companies were quick to dissociate themselves from the episode, saying the flagged batches were fake and not their own products.

The Pharmaceutical Alliance of India, a network of 23 of India’s top pharmaceutical companies, also issued a statement in response to the warning, alleging false reporting and deliberate distortion of facts by some media outlets.

IPA Director-General Sudarshan Jain said in a statement on September 29, “Misleading reporting irresponsibly interchanges the terms NSQ and fake drugs, unfairly implicating legitimate manufacturers in the production of fake drugs.” “There is,” he said.

He added that the production of fake drugs is a serious criminal offense that threatens public health, and that the unreasonable link between fake drugs and legitimate manufacturers has serious reputational and financial implications. “Furthermore, this tarnishes India’s reputation as a reliable drug supplier on the world stage. It is important to clearly distinguish between NSQ and fake drugs,” the statement stressed.

Drug Controller General of India (DCGI) CDSCO Director Rajeev Singh Raghuvanshi on Wednesday said the publication of nearly 50 samples found of poor quality was part of the routine process. “Most of these drugs have failed on very small parameters with negligible health risks,” he told reporters on the sidelines of the Biopharmaceutical and Life Sciences Summit organized by the Confederation of Indian Industry. spoke.

Also read: Inside India’s shadowy pharmaceutical industry — a dingy pharma sector, cash payments and inadequate testing

Ineffective drug recall policies

Despite increasing calls for legislation mandating the recall of medicines found to be ineffective or unsafe, CDSCO’s revised standards for drug recall in July this year are in the form of guidelines and lack legal backing. was.

These standards, like the previous standard released seven years ago, impose recall liability on manufacturers and distributors.

The guidelines define two types of recall. One is when a licensee voluntarily initiates a recall as a result of an observed anomaly in product quality during a periodic review or investigation of a market complaint or other defect. It is legal if there is an order from drug enforcement authorities, but it does not explain in detail how a statutory recall will be affected.

“We don’t have any laws or statutes that require a recall. It’s a perfect eyewash. If the failed samples are not recalled and the patients who take these drugs are not informed about the failure, I don’t see the point in testing,” said Dinesh Thakur, a public health expert focused on improving health policy in the United States and India. he told ThePrint.

Mr. Thakur, co-author of this book, The true pill: The myth of drug control in Indiacalled this a complete abdication of the regulator’s responsibility.

Prashant Reddy, a lawyer and co-author of the book, also stressed that the government should first carry out a nationwide recall of all batches of medicines from the market and withhold manufacturing licenses for these companies.

“The government should then conduct and publish a root cause analysis of each failed drug to determine exactly why the drug failed quality tests. “We need to know whether the drug failed because it was improperly formulated by the manufacturer or because it was poorly stored as it passed through the supply chain,” he explained.

Depending on the cause of the failure and the manufacturer’s responsibility, the government should prosecute the manufacturer in accordance with the law, he added.

Reddy also asked what steps are being taken to inform patients who have purchased the drugs that these drugs are ineffective, adding that there is no system in place to address these issues.

However, Raghuvanshi maintained that in the case of NSQ and counterfeit medicines, the regulator will recommend prosecution or administrative action depending on the severity of the violation.

Asked how the regulator was making doctors and the public who prescribe batches of medicines declared NSQ or fake drugs aware, he said the media was doing a “good job”.

“Our drug alerts are posted on our website every month and are in the public domain. And over the past six to eight months, the press has been reporting well on these alerts,” he said. .

But Reddy insisted the government should clarify what steps it is taking to withdraw the drug from the market. “There’s no point in just asking a company to do a recall,” he says. He also said authorities must verify the recall and destroy the recalled batches.

What about FDC drugs?

Another major concern is that despite being responsible for drug recalls, Malini Aisola, chairperson of patients’ rights group All India Anti-Drug Network (AIDAN), said CDSCO’s drug alerts do not meet standards. It was found that the name of the company selling the drug was not listed. I will take a rest at Manufacturers and marketers alike.

In India, as in several other countries, large pharmaceutical companies outsource the manufacturing process to small and medium-sized enterprises, managing only the marketing and distribution of parts. “We don’t know how many big companies marketing these brands are involved. They just don’t have their names on the warning list,” Isola said.

She added that although the proportion of NSQ and counterfeit drugs remains below 4%, it is not significant.

“Furthermore, the statistics may be deceptive as samples tested for quality contain very little FDCs (Fixed Dose Combination Drugs), which constitute over 40% of medicines sold in India. This is because there are no standards in place to check quality,” Isola said.

FDCs contain two or more drugs in a single drug form, and many of these combinations available in India lack approval from the central regulator CDSCO and are subject to safety and efficacy concerns. It has been approved for production by states without proper evidence.

(Edited by Amrutanshu Arora)

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