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Showing posts with label generic. Show all posts
Showing posts with label generic. Show all posts

Thursday 6 April 2023

How dangerous are India’s generic drugs? Very

 

India relies on the weak oversight of developing countries that make up the bulk of its exports – that’s how it can continue to push substandard and often deadly medicines there. — Bloomberg

 

FOR a nation that seeks to claim the mantle of “pharmacy to the world,” India is scandalously short on regulatory oversight.

In the last six months, its generic cough syrups have killed dozens of children, its eye drops have caused blindness and its chemotherapy drugs have been contaminated.

The children who died – mostly under the age of five years – were given Indian-made over-the-counter products contaminated with industrial solvents and antifreeze agents that are fatal in even small amounts.

The eye drops that contained extensively drug-resistant bacteria? So far 68 patients across 16 US states have been affected. Three people died, several had to have their eyeballs removed, some went blind, the Centres for Disease Control and Prevention reported on March 21.

The Indian company, Global Pharma Healthcare, issued a voluntary nationwide recall for the drops. India is the largest provider of generic medicines, producing 20% of the world’s supply, according to the government’s Economic Survey.

Its US$50bil (RM220bil) drug-manufacturing industry exports medicines to over 200 nations and makes 60% of all vaccines. It boasts “the highest number” of US Food and Drug Administration or FDA-compliant plants outside America, and indeed, some of its generic pharmaceutical companies produce high-quality medicines.

That may well provide consumers with a level of comfort, but history suggests it is unwise to trust that feeling.

The latest drug recalls just add to a long line of scandals that have tainted the sector.

In 2013, a US subsidiary of major Indian drug manufacturer Ranbaxy Laboratories Ltd pleaded guilty to US federal criminal charges and agreed to pay US$500mil (RM2.2bil) lion for selling adulterated generic drugs, fabricating data, and committing fraud. Serious flaws in the FDA compliance regime allowed these breaches to go undiscovered, until a years-long investigation laid bare the endemic corruption.

A generic drug made in India and modelled on Lipitor sold in the US to treat high cholesterol, for example, was contaminated with shards of blue glass, as journalist Katherine Eban documented in her book, Bottle of Lies: The Inside Story of the Generic Drug Boom. Her book draws in part on the experience of whistleblower Dinesh Thakur, who worked at Ranbaxy.

You would think such a damning indictment would prompt India to develop a safer, better pharmaceutical oversight regime. Think again.

The systemic fraud exposed by the investigation – where data was routinely falsified to fool inspectors, increase production and maximise profit – did not result in a regulatory overhaul.

Still, a two-day “brainstorming session” held in February appeared to acknowledge the system’s inherent weaknesses, with Health Minister Mansukh Mandaviya telling participants India needed to “move from generic to quality-generic drugs.”

Discussions involved “how to make the country’s drugs regulatory systems transparent, predictable and verifiable,” according to a health ministry media release.

Consumers shouldn’t hold their breath, though. A national law on drug recalls has been under discussion since 1976 without resolution, and the government – at least publicly –remains in denial: Since the Ranbaxy scandal, Thakur has campaigned for the reform of India’s main regulator, the Central Drugs Standard Control Organisation, and, with lawyer T. Prashant Reddy, has written his own book, The Truth Pill: The Myth of Drug Regulation in India, which was published in October.

They note that adulterated Indian drugs aren’t just killing children in developing-world export markets like Gambia and Uzbekistan. They’re also killing children at home: In 2019, at least 11 infants died in the state of Jammu because of cough syrup containing diethylene glycol. 

The World Health Organisation (WHO) sent alerts in October and January, asking for the cough medicine to be removed from the shelves. (It also issued a warning last year for cough syrups made by four Indonesian manufacturers sold in that country, where 203 children died in similar circumstances.)

Maiden Pharmaceuticals, whose medicines were sold in Gambia and linked by the WHO to the deaths of at least 70 children, has denied wrongdoing. And India’s regulator rejected the WHO’s findings, saying no toxic substances had been found in samples taken from Maiden’s plant. 

It shouldn’t have taken more deaths for Prime Minister Narendra Modi’s administration to act. The red flags have been there for years. What’s lacking is political will, and transparency. The FDA publishes different reviews of new drug applications on its website, along with detailed notes. 

So why does contamination with such deadly substances occur so regularly?

“The simple answer is that Indian pharmaceutical companies quite often fail to test either the raw materials or the final formulation before shipping it to market,” Thakur said.

India relies on the weak oversight of developing countries that make up the bulk of its exports – that’s how it can continue to push substandard and often deadly medicines there.

In the absence of a global framework for pharmaceutical safety, what can be done to make the generic drugs that consumers around the world have come to rely on safer and effective?

For a start, the WHO’s prequalification programme, which facilitates the purchase of billions of dollars’ worth of medicines through international agencies such as Unicef, must be overhauled. Then there’s the question of holding these companies to account for the harm they cause inside and outside India via legal avenues and victims’ compensation. — Bloomberg 

- Ruth Pollard is a Bloomberg Opinion columnist. The views expressed here are the writer’s own.

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Sunday 7 April 2013

A victory for patients & generic drugmakers vs Novartis in landmark patent case

The Indian Supreme Court’s ruling that only genuinely new inventions should be granted patents means that medicines can still be affordable.

The front office of Novartis in Mumbai, India, Monday, after India's Supreme Court rejected drug maker's attempt to patent a new version of a cancer drug Glivec. 

PATIENTS around the world who look to India for low-cost medicines to treat their ailments heaved a sigh of relief last week when the Indian Supreme Court turned down a claim for a patent for a cancer drug.

This means that drug companies in India can continue to produce generic versions of the same drug, Glivec or Gleevec, at a much lower price, thus making it affordable to thousands more cancer patients.

Glivec, produced by the Swiss-based company Norvartis, can cost a patient up to US$70,000 (RM217,000) for a year of treatment, whereas the generic versions of the same medicine made by Indian companies cost around US$2,500 (RM7,750). The drug is used to treat some forms of leukaemia as well as a rare type of stomach cancer.

The Supreme Court decision also seems to open the road for patents not to be granted for more medicines, since it confirmed that only drugs that are genuinely a new invention can be granted patents.

When a patent is granted to a company for a drug, other companies are not permitted to produce generic versions of the medicine for a period of 20 years or so.

The monopoly given to the patent holder enables it to charge high prices since there is a lack of competition.

Many or even most patients are unable to buy the medicines, giving rise to frustration and despair especially when their lives are at stake.

Some companies whose patents are about to expire apply for a new patent for the same drug after changing the composition slightly or changing the form of the drug.

The “new” drug is often not a new invention, but only a minor modification that is made with the aim of having the patent renewed for another period. This practice is popularly termed “evergreening” of the patent.

An extension of the patent term means that the company continues to enjoy the monopoly and high prices, which continue to be out of reach to many patients.

Although governments are obliged to have laws allowing for patents to be given for inventions under the World Trade Organisation’s TRIPS agreement, each country is allowed to set its own definition and standards for what is an invention.

The Supreme Court decision confirms that the Indian patent authorities exercised their powers lawfully and properly when they rejected the patent application for Gleevec on the ground that the medicine was not a new invention.

Novartis had challenged the interpretation given by the Indian Patent Office to Section 3 (d) of the Indian Patents Act that seeks to prevent the grant of patents for non-inventive new forms of known medicines.

The Novartis application had claimed a patent for a new salt form (imatinib mesylate), a medicine for the treatment of chronic myeloid leukaemia, sold under the brand name Gleevec (or Glivec in other countries).

The Indian patent office had rejected the patent application on the ground that the claimed new form was anticipated in an earlier US patent of 1996 for the compound imatinib and that the new form did not enhance the therapeutic efficacy of the drug. The decision was upheld by the Indian Patents Appellate Board.

The legal challenge from Novartis had caused anxiety among patients groups, governments of developing countries and some international organisations in view of the possible negative implications for access to affordable medicines if the Norvatis petition succeeded.

Most developing countries rely on Indian generic drug companies for the supply of low-priced medicines for many diseases.
A weakening of the interpretation or use of Section 3 (d) would have enabled multinational drug companies to extend their patent monopolies based on “evergreening” or “trivial” incremental improvements which could delay the supply of generic medicines for the treatment of HIV/AIDS, cancer and other diseases.

The decision by the Indian Supreme Court is thus of major significance not only for India but for patients and health authorities in the developing countries.

In interpreting Section 3 (d), the Supreme Court observed that this section was introduced in the 2005 amendment to the Patents Act to ensure that while India allowed product patents on medicines in accordance with its WTO obligations, it did not compromise public health through “evergreening” of pharmaceutical patents.

The court hence took into account the concerns about the impact of the TRIPS agreement on public health and on the development of an indigenous pharmaceutical industry.

Moreover, it considered the implications of the Novartis case for the availability of essential medicines at affordable prices globally.

The court decision reproduced two letters from Dr Jim Yong Kim, the former director of the Department of HIV/AIDS at the World Health Organisation (current president of the World Bank) and from UNAIDS to the Indian health minister expressing their concerns relating to the continuous availability of affordable Indian generic drugs in other developing countries.

Thus, the Supreme Court decision has implications beyond India. It upholds the high standards by which drug patent applications can be processed. While genuinely new inventions are granted patents, drugs that are not really new need not.

The implication is that Indian generic companies can be expected to produce many more medicines in future, and continue their reputation as the “pharmacy of the developing countries”.

It is also heartening that the court decision reaffirms the priority for concerns for the patients’ right to receive treatment at more affordable prices.

The court decision is also likely to spark interest among other developing countries about the Indian patent law and the policies guiding it. Developing countries can learn from the Indian approach of balancing patents and public health.

Global Trends
By MARTIN KHOR

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