New Delhi: A week after the capital city hosted the Delhi End TB Summit from March 13 to 15, 2018, a notification from India’s health ministry announced that medical practitioners and pharmacists could face a jail term if they fail to notify the government about tuberculosis (TB) patients.

TB has been a notifiable disease since 2012, one that private doctors and laboratories must report to the government’s reporting system for TB called Nikshay. However, there was no punitive provision, and pharmacists or chemists were not included.

Now, doctors, laboratories and chemists--including those in the public sector--can face a jail term of between six months and two years under Section 269 (negligent act likely to spread infection of disease dangerous to life) and Section 270 (malignant act likely to spread infection of disease dangerous to life) of the Indian Penal Code.

Many activists and doctors that IndiaSpend spoke to ahead of World TB Day on March 24 were unhappy with the new rule, and some called it objectionable, harsh and even unnecessary, saying it creates antagonism instead of working with private doctors and chemists.

With an estimated 2.7 million new TB cases reported in 2016--the highest in the world--every fourth new TB patient was from India, according to data from the World Health Organization. Of these, at least half are treated in the private sector and their diagnosis and treatment is not noted in government records.

As a result, India’s national TB programme, the Revised National Tuberculosis Control Programme (RNTCP), does not have accurate numbers on TB detection, treatment and cure rates in the private sector. This hinders the government’s efforts to prevent and treat the disease, efforts that have been stepped up to meet the professed goal of eliminating the disease by 2025.

This has severe public health implications: certain kinds of TB, if left untreated, are infectious. TB treated incorrectly or incompletely results in the TB bacterium, mycobacterium tuberculosis, developing resistance to existing drugs. Drug resistant TB is more difficult and expensive to treat than regular TB.

While India has managed to reduce the number of new cases of regular TB (by 3.5% from 2015 to 2016) and deaths due to TB (by 12% to 423,000 during the same period), the number of patients with drug resistant TB has increased (13% to 147,000), as IndiaSpend reported in November 2017.

Several new programmes, but activists say more collaboration needed

“India is determined to address the challenge of TB in mission mode. I am confident that India can be free of TB by 2025,” Prime Minister Narendra Modi said at the inauguration of the Delhi End TB Summit, which was attended by the director general of the World Health Organization and the health ministers of 20 countries.

The Indian government announced a number of measures at the summit: a scheme for monthly nutritional support for patients, broader public-private partnership models for treatment and diagnosis, and use of information technology for monitoring the programme and treatment adherence. For the first time, the government spoke of community engagement as a tool to end TB in India.

Most of these schemes, including one to directly transfer benefits to TB patients and increase funding for the national TB programme, are already part of the National Strategic Plan For TB Elimination drafted in 2017, on which IndiaSpend had reported in March, 2017.

Usually, all new proposals have to be presented before a mission steering group that includes health and other allied ministries, state health ministers and 10 health professionals. The last group was disbanded in 2017, and a new group has not been formed.

As a result, the “decisions of penalising doctors should have been discussed and questioned but were not”, said Yogesh Jain, founding member of Chhattisgarh-based non-profit Jan Swasthya Sahyog (JSS), who was a member of the last steering group.

Finding the missing 1 million TB cases

Based on the sale of drugs containing Rifampicin, the main anti-TB drug, this 2016 study estimated that India’s private sector treated between 1.19 and 5.24 million patients in 2014.

However, just 395,691 cases were registered with Nikshay from the private sector during 2017--more than a fifth, or 21.2%, of the 1.86 million TB cases registered with the RNTCP, but nowhere near the figures estimated.

By penalising failure to report TB patients, more patients seeking care in the unregulated private health sector could be brought into the government’s ambit or could be provided more government support while continuing to receive care in the private sector.

However, many experts do not support criminal punishment including a jail term for doctors who do not notify patients. “Private doctors are not denying treatment to TB patients but they may after this notification,” Lalit Anande, chief medical officer of Sewri TB Hospital in Mumbai, said. There are very few good private chest disease specialists who work on TB, and this could disincentive them further, he added.

The penalty is “a little exaggerated and harsh”, said Jayesh Lele, national secretary of the Indian Medical Association, but said there is good reason for it. Doctors have been failing to comply with the 2012 mandate on reporting TB patients, which has led to an increase in drug resistant TB cases and increased the cost of treating patients, he said.

Instead of imprisonment, the government should have implemented the three levels of penalty followed by the USA, said Yatin Dholakia, secretary and technical advisor of the Maharashtra State Anti-TB Association. The USA’s medical council imposes a fine on first offence, followed by a larger fine and eventually suspension of registration for repeated violation. “The Maharashtra government is planning to have a similar bill with three-level penalty which may be tabled in the next winter session,” he said.

The harsh penalties, by criminalizing pharmacies, could create a new underground market for TB drugs, Blessina Kumar, CEO of the Global Coalition of TB Activists and coordinator of Touched by TB, a national coalition, told IndiaSpend. The move may work to increase reporting but will depend on how the government monitors the exercise and finds out who is not reporting TB cases, she said.

Public health officials can also be penalised for failure to report. After a patient is registered with the government system, public health officials must visit them at home, counsel them and their families, ensure adherence to the treatment protocol and follow up until treatment is complete. They must also trace contacts of TB patients for possible infections and offer preventive therapy to eligible cases. If a public health official does not take appropriate public health action after being informed about a TB patient, they can be fined or imprisoned or both.

Privacy concerns

At the Delhi End TB Summit, the government announced an incentive of Rs 1,000 for private doctors for reporting new TB cases. The incentive would apply to health workers, neighbours, chemists and patients, too.

“We are opposed to anyone [not a doctor or chemist] notifying TB cases for an incentive,” said Kumar of the Global Coalition of TB Activists. “Imagine a situation in which your neighbour hears you coughing for over two weeks and reports your case, and people show up at your house? It will criminalize patients, not empower them,” she said.

“Doctors do not need an incentive to notify or treat patients,” said Anande from Sewri TB Hospital, adding that patients’ privacy must be preserved.

Aadhaar a roadblock

From April 1, 2018, the government will provide every TB patient nutritional support of Rs 500 through a direct benefit transfer to their bank account.

More than a million TB patients lack adequate nutrition, IndiaSpend reported in May 2017. Prevalence of TB was 3.7 times more among those with a low standard of living than in those with a medium or high standard of living.

To receive nutritional support, patients need to provide details of their Aadhaar and Aadhaar-linked bank account, according to this November 2017 government circular.

In a meeting with health secretaries of various states during the Delhi End TB Summit, additional secretary and mission director Manoj Jhalani said RNTCP has little data on Aadhaar-linked bank accounts. For instance, only 20% of TB patients in Rajasthan and 40% in Uttar Pradesh have provided details of an Aadhaar-linked bank account, according to the health secretaries of both states.

Jhalani added states would decide how they provide nutritional support. Chhattisgarh, for example, has decided to distribute food rations instead of a cash transfer.

“Denying someone’s social right based on the fact whether they have Aadhaar number or seeded account or if their biometric matches is horrifying,” said Jain of Jan Swasthya Sahyog. He added JSS was one of the few organisations that persuaded the government to provide nutritional support to TB patients but they never imagined that would be become “a mechanism to deny support to patients”.

“The scheme will require effective implementation to ensure it reaches the recipients. We also need to ensure the money is used for nutritional purposes and keep the amount inflation adjusted,” said Chapal Mehra, convenor of the Indian non-profit Survivors Against TB.

Slew of changes since 2017, and many teething issues

Since 2017, the government has doubled its spending on the RNTCP, switched to a more successful treatment regimen, made machines available in each district for testing drug resistance, and partnered with the private sector to expand access to treatment and counseling.

When IndiaSpend visited some DOTS (Directly Observed Therapy (Short Course)) centres in Delhi, where patients registered with RNTCP take TB medicines, many DOTS providers said they had been noting down patients’ Aadhaar numbers and IFSC codes, as directed by their supervisors. But not all agreed direct transfers were a good idea.

“It would have been better if the government continued the scheme of providing the patients with protein powder like they did a few years back which helped many patients gain weight,” one DOTS provider told IndiaSpend, not wanting to be named.

Recently the RNTCP shifted to a daily fixed-dose combination regimen from earlier alternate-day course. DOTS providers said there is shortage of drugs, and patients’ prescriptions do not come packaged individually as before. “We are breaking packets to ensure there are enough daily doses for all the patients that visit every day,” said another DOTS provider.

(Yadavar is a principal correspondent and Khaitan is a writer/editor with IndiaSpend.)

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