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Business News/ Opinion / Views/  Opinion | The menace of counterfeit drugs that India must fight

Opinion | The menace of counterfeit drugs that India must fight

We need a regulatory mechanism that is geared for quality and armed against fake drugs

Photo: MintPremium
Photo: Mint

India imports around 70% of its raw materials, like active pharmaceutical ingredients and key excipients, for the manufacture of essential drugs from China, the fraying of ties with which has transformed the course of the country’s pharmaceutical business. Even as we promise to “Make in India", we will have to take tough decisions as far as our drug dependence and domestic market are concerned. While the government is working towards making India self-reliant, a potential shortage of drugs and an inward-looking approach could pose another challenge—the perils of counterfeit drugs. Domestically-produced generics have often come under the scanner for failing quality tests. A World Health Organization (WHO) report in 2017 said, “About 10.5% of medicines sold in low and middle-income countries, including India, are substandard and falsified." This is especially alarming at a time when the world is anxious about the adequacy of basic medicine supplies, given the reduced production and increased demand mostly everywhere.

India has been battling the challenge of substandard drugs for a while. The problem was in the spotlight when the government launched its Jan Aushadhi initiative, in which five medicines were reportedly recalled in a span of 20 days because of quality lapses. There were also reports of this number rising to 11 in four months.

Estimates for 2019-20 reveal that during this period, India had four drugs and 27 batches that were recalled. In fact, for many of these drugs, the shelf-life was only three months. The government must tighten its noose on quality and ensure that patient safety takes precedence over geography for medicines. The idea is to give patients the safest option available, whether it comes from the domestic market or overseas.

As per 2019 statistics, India had only 47 drug testing facilities under the National Good Laboratory Practice programme. To make matters worse, we had only six central labs, testing just 8,000 samples per year.

In 2018, the Central Drug Standard Control Organization identified about 4.5% of all generic drugs in the Indian market to be substandard. Additionally, just one-fourth of the 12,000 manufacturing units in India have been found to comply with the WHO’s good manufacturing practices, the mandatory quality regulations that drug makers must adhere to. Not just locally, India’s reputation in the global pharmaceutical market is at stake.

A parallel world of fake medicines can have a severe impact on overall healthcare, causing adverse side effects or worsening the spread of diseases. India has just 20-30 test laboratories that can tell good or relatively poor-quality products apart from counterfeits. We need a lot more, not least because of the rising demand for quality healthcare in India.

The Drugs Controller General of India (DCGI) should work closely with local drug control authorities and pharmaceutical companies to get to the root of the problem. A joint effort is needed so that well-defined protocols are followed to help combat the crisis of counterfeit drugs and ensure the safety of patients.

If a particular drug produced by a pharmaceutical company is sent for a quality check after a complaint is raised by a doctor or patient, the current procedure is that the drug controller raids the medicine shop and takes samples of the drug in question to laboratories for testing. Once the DCGI receives the result of a test, it releases a memorandum that states the quality of the drug to be “Not of standard quality", without informing the drug controller of the state or the pharmaceutical company whose name the drug’s packaging bears. It is important for the DCGI to clearly state whether the drug tested falls under the category of a poor quality or counterfeit drug. This will help us plug a big gap in addressing the issue of fake drugs. It could guide the appropriate course of action to be taken. Pharmaceutical companies should only be held responsible for producing poor-quality drugs, not for pills that are imitations of what they make.

It is counterfeit drug sellers at the retail level that should be held responsible for fakes after such an investigation, because they procure these from dubious suppliers. Fraudulent agents sell fake drugs illegally under the name of a certain pharmaceutical company that is almost always unaware of it. Fighting this menace is beyond the purview of individual pharmaceutical companies, though it is in their interest to see it stopped for the damage it causes their reputation, and calls for intervention from authorities like the drug controller and even law enforcement agencies. If the ministry of commerce and industry wants to enhance the image of Indian pharmaceuticals, then solving this problem is imperative.

As of now, many well-reputed drug firms unfairly find themselves at the receiving end of anger over scandals involving fake drugs being recalled that they had nothing to do with. What’s worse is the lack in clarity of filing a criminal case against the counterfeit drug seller or medicine shop.

At a time when we are talking about making India self-reliant, we must not forget that we have also had feedback from drug regulators around the world for discrepancies in our manufacturing quality. What India needs is a regulatory mechanism that not only promises an influx of innovative drugs from around the world, but also ensures that our patients have access to superior quality products. Combating counterfeit drugs should be a key objective of the exercise.

Gajendra Singh is a public health expert.

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Published: 09 Aug 2020, 07:45 PM IST
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