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Ensuring quality, safety and efficacy of drugs

Strengthening the quality of drug development, manufacturing and review are key factors for ensuring patient safety and improving clinical research conditions in India.

It is crucial to note the fact that healthcare access is not a slave to pricing.

This year’s annual Budget clearly underlined the importance of the health sector, with a huge outlay and an emphasis on developing the public healthcare system and launching several public private partnerships. The Union government has been taking several steps towards improving healthcare accessibility. The relaunch of the Jan Aushadhi campaign to promote generics is one such instance. The intent behind this is to promote medicines at a nominal rate to the vulnerable sections of the society. The draft pharmaceutical policy is yet another step to consolidate these efforts.

Unfortunately, despite these measures that reduce prices, healthcare access to safe and quality drugs is far from reality in India. It’s time the real issues are recognised and addressed. It is crucial to note the fact that healthcare access is not a slave to pricing. The need of the hour for the government is to be cognisant of the real issues and take steps to implement solutions to these issues. The government and people must realise that only focusing on prices will actually impede access and increase the risk of unsafe and substandard drugs.

At first glance, promoting generics may seem like a good approach, but it is often treated very simplistically. Implementation in the long term is questionable, simply because it offers no incentives to the healthcare system. Focusing on pricing priorities, or more particularly on pushing for a ‘generics-only approach,’ will not really benefit patients; rather, I believe, the government should focus on bringing value by enforcing stringent quality and surgical protocols, apart from investing in better healthcare infrastructure and training of healthcare professionals.

Let’s look at the real picture. Nine years after the Jan Aushadhi campaign was launched by the then UPA government in 2008, and relaunched in 2016 by the NDA government, it is still difficult to say whether it’s a successful model. The intention of the campaign was to provide quality medicines at affordable prices to the masses, through special centres. However, patients often complain that these centres are ill-stocked, and many critical drugs are not available.

In a recent article in The Print, five medicines have been recalled from Jan Aushadhi stores in the past three weeks, due to quality lapses. There were six other recalls between January and March, taking the total to 11, in the first four months of 2018, while there were a total of 11 recalls in 2017.

It was also stated that the Bureau of Pharma PSUs of India, responsible for the implementation of the campaign, currently doesn’t have anyone heading its quality control, regulatory affairs or medicine procurement departments. So, who is in charge to ensure safety and efficacy of these medicines?

A lot has been spoken about the price of branded generics in comparison to pure generics, on various social platforms. However, what is often missed is a dialogue or conversation with respect to quality. In developed countries, the key difference between a branded medicine and its generic version is the price. This is because a generic drug is approved only after it has met rigorous standards established by the respective federal agencies (such as the US Food and Drug Administration, or FDA) with respect to identity, strength, quality, purity and potency. Nevertheless, the scenario in India is mostly converse.

Had there been no concern for quality and safety of medicines, the idea of introducing free generics in public health facilities would had been a splendid one. However, the consequences of allowing medicines of doubtful efficacy will lead to ill-health and will directly wreak havoc to the country’s mortality statistics. Therefore, the concept of public health ethics comes under scrutiny.

Till date, no extensive study has been conducted on the state of poor quality or spurious or substandard medicines, nor are they well defined. Hence, due to the absence of a standard drug regulatory mechanism, Indian doctors rely on the reputation of companies who have demonstrated their commitment to quality, over time. Quality of drugs is said to be compromised by adding less active pharmaceutical ingredients (APIs), but this can’t only be attributed to purity and potency.

Even if the drugs manufactured are of a certain quality, poor storage and creaky supply chains also result in patients getting products whose active ingredients may have lost efficacy. In fact, the absence of regular inspections at the drug manufacturing sites and ill-equipped drug testing laboratories make things worse. Many manufacturing units are reportedly not compliant with the World Health Organisation’s good manufacturing practices (GMP) or good laboratory practices. While there are 12,000 manufacturing units in India, only 25% of them comply with GMP standards. There are few nationally accredited laboratories in India.

Furthermore, strengthening the quality of drug development, manufacturing and review are key factors for ensuring patient safety and improving clinical research conditions in India. Thereby, a boost in investment of drug regulatory and testing infrastructure is the need of the hour.

Branded generics manufactured by research-based companies are backed by high-quality standards, reliable and sophisticated supply chain infrastructure, and clinical science and innovation. Everyone deserves to be benefited by the value that branded generics bring to the patients in the form of assured quality standards, proven safety and efficacy, better absorption, and reduced side-effects. Generating awareness around the value of branded generics and differences between branded and generics versions is key to aid patients in taking informed decisions, and reinstall the trust in the overall Indian healthcare system.

Companies, universities and governments spend a fortune every year, leading the way with breakthrough innovation, saving and improving lives of millions. However, continued research and medical innovation is reliant upon a sustainable business environment that recognises and rewards innovation. We should not allow this innovation to be dampened and continue to put science and evidence at the forefront of all healthcare decisions. That is how we will tackle neglected diseases that plague large parts of rural India.

By Amir Ullah Khan, Economist, and Director of Research at Aequitas.

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