Readers’ comments: Shifting goalposts in article about quality of India’s generic medicines

A few points regarding the article on generic drugs (“Hard questions remain about the quality of generic drugs in India”)

​1. The authors claim the results are “too good to be true” compared to historical data.

Historical data, like the 2017 survey, often focused on smaller, unregulated manufacturers. Dr Abby Philips’s study focused heavily on centralised procurement – Jan Aushadhi. Centralised systems have strict pre-dispatch testing. The 100% success rate suggests that when the government acts as a bulk buyer, the quality control at the source is more rigorous than at the local, unorganised retail level.

2. Private labs might have been biased or intimidated by the government’s “flagship scheme”.

Professional NABL-accredited labs risk their licences and international reputation if they falsify data. Furthermore, Philips’s study was crowdfunded and public; any discrepancy discovered later would destroy his own credibility as a public health advocate. The transparency of the Twitter thread acts as a safeguard against “under-the-table” bias.

3. A drug can pass a lab test for purity but fail to work in the human body (bioequivalence).

This may be technically correct, but the authors are moving the goalposts. Pharmacopeial testing (purity, dissolution, disintegration) is the legal legal standard for quality in India. While Bioequivalence is the “gold standard” for efficacy, a drug that passes pharmacopeia standards is legally and scientifically considered “Standard Quality”. Demanding bioequivalence for every single common generic (like Paracetamol) would exponentially increase medicine prices, defeating the purpose of affordable healthcare.

​4. Generics for sensitive issues (like transplant or thyroid) are risky without bioequivalence studies.

There is a consensus here. Most doctors agree that for narrow therapeutic index drugs (example, levothyroxine, cyclosporine), patients should ideally stick to the same brand to avoid minor fluctuations. However, using this specific “high-risk” category to cast doubt on all generics (like common antibiotics or painkillers) is a logical fallacy that creates unnecessary “medicine hesitancy” among the poor.

​5. One-off testing doesn’t prove the factory produces good medicine every day.

It may be true, but this is why we have the Revised Schedule M (India’s updated Good Manufacturing Practices). The government has recently made international-grade manufacturing standards mandatory for all MSME pharma units. Testing market samples is the only way a third party can verify the system. If market samples consistently pass, it is a strong indicator that the underlying manufacturing process is stabilising.

6. ​The study results would be worse if samples came from small, local private pharmacies.

This argument actually supports the case for Jan Aushadhi. If the “centralised bulk strategy” produces 100% quality results, the solution isn’t to doubt generics but to expand the Jan Aushadhi model and centralised procurement to all states to eliminate the “smaller, poor-quality manufacturers” the authors are worried about. – Suraj Anandan

Sinhala Buddhism ‘tarnished’

A little knowledge is a dangerous thing, it is said. That captures The Robe and the Sword: How Buddhist Extremism Is Shaping Modern Asia by Sonia Faleiro (“Militant Buddhism: A long history of how Sri Lankan Buddhist monks treated non-practitioners”). The author has twisted Hindu ideologies with compassionate philosophy of Buddhism to tarnish the spiritual elements of the great religion of Buddhism. The excerpt is made up of mudslinging towards Buddhism and its followers in Sri Lanka.

To better understand Buddhism, one needs to study Buddhist doctrines and the fundamentals of Buddha’s teachings by the monks who are monastically educated, especially elderly monks who have reached the higher levels of spiritual attainment. The clergy of all religions are fallible and one cannot randomly interview novice monks or monks who were not educated about Buddha’s teachings.

The Mahavamsa is not the Buddha’s teachings. Mahavamsa, or the Great Chronicle, is considered the world’s longest and unbroken historical record of Sri Lanka since 543 BCE. Mahavamsa is also updated as a modern continuation in volumes under the ministry of cultural affairs of Sri Lanka. In a nutshell this book is nothing but a potboiler. – Asela Unantenne

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Every country in the world has their own culture and religion. There is no such thing as a multi-cultural country. There are many examples of countries who tried to experiment with multiculturalism and failed.

Sri Lanka is the only country the Sinhalese have. If they lose it, they will become like the Jews before the creation of the State of Israel, orphans travelling the world with no purpose, freedom, identity or dignity. The Hindus mentioned in the article were responsible for the death, mutilation and sacking of Sinhalese cities. They stole the wealth of the Sinhalese, turning them into paupers while destroying Buddhist temples.

The Mahavamsa has also been falsely interpreted to portray King Dutugamunu as some sort of Sinhalese Buddhist supremacist. It is a pity that this article is favoured towards the minorities but does not paint the Sinhalese as people who have their own identity to maintain and protect.

When people talk about Sinhalese Buddhist supremacists, they never shift their focus towards minorities who are not satisfied with whatever they have been given. If the minorities are subjected to intimidation due to a “sinhala buddhist supremacist” attitudes, where do they get the freedom of speech, religion and access to basic human rights and have coexisted alongside us for 78 years of independence? – Wathsara Halangoda