Bitter pill: why has Delhi HC made drugs costlier for diabetics?

14 November is World Diabetes Day. Here are some facts to mark the occasion.

India is the planet's diabetes capital with 50.7 million people affected by the disease. China follows with 42.3 million diabetics and the US with 26.8 million.

Diabetes kills about a million people in India every year, more than any other country, according to the International Diabetes Federation.

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By 2035, an estimated 592 million Indians will be diabetic. That is about one in every 10 people.

By 2035, an Indian will die from diabetes every six seconds, taking the annual toll to about 5.1 million people.

Given this, one would expect the government to go all out to tackle the health crisis, particularly ensuring affordable life-saving drugs.

To its credit, the National Pharmaceutical Pricing Authority has sought to do just that. On 11 November, the NPPA capped the prices of 18 medicines used to treat various diseases, including diabetes. These include drugs made by leading pharma companies such as Cipla, Merck, Franco Indian, Alembic Pharma and Unichem.

It's, in fact, the judiciary that has dealt a blow to efforts to provide cheaper drugs to diabetes patients.

What did the court do?

Early last month, the Delhi High Court barred Mumbai's Glenmark Pharma from selling, distributing, marketing or exporting its anti-diabetic drugs Zita and Zita-Met. Reason? They infringe the patent of US-based Merck Sharp and Dohme Corp.

Glenmark's drugs, launched in 2013, are cheaper, generic alternatives to Merck's Januvia.

Zita and Zita-Met, the court observed, use Sitgliptin Phosphate Monohydrate, a compound based on the molecule Sitagliptin "invented and patented" by Merck.

And since Glenmark can't manufacture the compound without first producing Sitagliptin, the court ruled, it can't produce generic versions of Merck's drugs. The company has, however, been allowed to sell the drugs it has already produced.

Glenmark had contended that it was using Sitagliptin in combination with phosphate, which is a different salt and makes its medicines sufficiently distinct in chemical and physical properties from the patented drug.

By 2035, an Indian will die from diabetes every six seconds. About 5.1 million will die every year

Merck, on the other hand, relied on Section 48 of the Indian Patents Act, 1970, which gives the company with a patent "exclusive rights to prevent any third party from the acts of making, using, offering for sale, selling or importing into India." Patents can, however, be revoked in case of a national health emergency.

A spokesperson for Merck said the company was pleased with the decision of the court.

Glenmark has not been fined for the patent infringement but will have to pay Merck's litigation costs.

What does this mean for patients?

The most visible effect of the court's verdict would be on the price. A 50gm Zita tablet costs Rs 14 compared to Rs 43 for Merck's drug. Indian diabetes patients would now be forced to buy the costlier medicine.

This concern was raised in the court, but the bench ruled that this wasn't a ground to allow the manufacture of the cheaper generic variant.

How will this affect the patients? Many doctors contend that anti-diabetic drugs, generic or not, are anyway unaffordable for most patients.

"The monthly cost per patient is Rs 900-1,600, depending on the dose," according to Dr Anoop Mishra, who heads the C-DOC Centre of Excellence for Diabetes at Fortis. "This puts it out of the reach of most Indians."

"Since most diabetics have to take the drugs throughout their life, cheaper medicines would be of immense help," he added.

Dr Anirban Biswas, a diabetologist, echoed this view. "The average monthly expenditure is unaffordable for the poor. NPPA should cap the prices of more medicines and include them into the national list of essential medicines."

Sumit Sobti, 35, a cab driver who has been diagnosed with Type-2 diabetes, spends more than Rs 300 on drugs a week. "My expenses have soared since I was diagnosed, that includes drugs and regular check-ups. And sometimes, the doctor prescribes a combination of drugs that cost even more."

Kalpana Sonar, 45, a mother of two from Mumbai, spends Rs 500 a week on medicines and a similar amount on check-ups. If that wasn't worrying enough, Sonar fears her young children will get the disease as well. And she is worried she won't be able to afford the treatment if the drugs become more expensive.

What does this mean for IP rights?

The Intellectual Property lobby is elated at the verdict.

Shamnad Basheer, founder of the IP Chair at the National University of Juridical Sciences, Kolkata, said, "Patent decisions should not be the vehicle for price regulation. If the government finds the prices high, it can control those through the price regulator."

IP lawyers hailed the verdict arguing that it would assure multinational pharma companies that India's IP regime is strict enough to avoid patent infringement. The US and the EU have long been pressuring India to change its patent laws for the benefit of their pharma giants.

"The court's decision would enable the government and the IPA to tell the US and other critics of India's IP regime that the country does not compromise on protection and enforcement of IP rights," said DG Shah, Secretary General, Indian Pharmaceutical Alliance.

Drugs for a diabetic cost Rs 900-1,600 a month. That is unaffordable for most Indians: Dr Anoop Mishra

The alliance had recently written to Commerce Minister Nirmala Sitharaman, urging the government not to buckle under the American pressure to tighten the IP regime.

"This case will also reassure companies that civil suits can be disposed of expeditiously. It took the high court only two years from the filing of the suit to settle it," said Abhishek Malhotra, a managing partner at the law firm TMT which handles IP cases.

This is all well for Big Pharma, but what good does it do the patients?

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