Pharma: the good, the bad and the ugly

This week in health: the growing clout of the pharma sector, a potential new dengue vaccine, why Indian students are facing a mental health crisis and all about the HbA1C test for diabetes.

Updated - March 19, 2024 11:00 pm IST

Published - March 19, 2024 03:27 pm IST

Image for representational purpose only.

Image for representational purpose only. | Photo Credit: Getty Images/iStockphoto

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It has turned out to be a pharma week of sorts, in some ways unexpectedly so. In a completely non-medical sense, pharma companies were among those named in the purchase of electoral bonds, over the week. While the details on who gave whom exactly what amount when will be clear in a couple of days, it is a clear indication of the growing clout of the pharma sector in the country. But in core health news, Bindu Shajan Perapaddan records a very important development: the Pharmaceuticals Department formed a panel to reform the prices of drugs and medical devices. With the aim of reforming the pricing framework for drugs and medical devices, the Department of Pharmaceuticals (Pricing Division) has constituted a committee, which is expected to submit its report within the next three months. The committee is mandated to give inputs regarding institutional reforms within the National Pharmaceutical Pricing Authority (NPPA) as well as balancing price and availability of essential medicines, while providing incentives to the industry to sustain growth and exports. Periodic, if not frequent reassessments of pricing and availability are very important for the government to ensure that life-saving drugs continue to be affordable and accessible for the public. 

In a related development, she also reports of the government’s marketing code for pharmaceutical firms. The Department of Pharmaceuticals issued the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024 on March 13, specifying the rules of the use of the words “safe’’ and “new’’ for drugs, and stated that medical representatives must not employ any inducement or subterfuge to gain an interview, and that they must not pay, under any guise, for access to a healthcare professional. It lays out rules for sponsoring continuing medical education programmes, paying health care professionals and their family cash, and gifting is also prohibited. Additionally, no pecuniary advantage or benefit in kind may be offered, supplied or promised to any person qualified to prescribe or supply drugs by any pharmaceutical company or its agent. More importantly, the government declared: “Claims for the usefulness of a drug must be based on up-to-date evaluation of all available evidence. The word ‘safe’ must not be used without qualification, and it must not be stated categorically that a medicine has no side effects, toxic hazards, or risk of addiction. The word ‘new’ must not be used to describe any drug which has been generally available or any therapeutic intervention which has been generally promoted in India for more than a year,” the latest rules state. That has left a lot of industry watchers wondering if the government will take any action on major violators of these provisions, including the Supreme court-declared offender Patanjali. 

But in the good kind of pharma news, we seem on the cusp of some really fast-paced developments and innovations. Investments in R&D seem to be bearing fruit as announcements of drug discoveries or vaccinations dominate headlines these day. Did you know, for instance, that an indigenous drug for sickle cell disease has been developed? Delhi-based Akmus Drugs and Pharmaceutical Limited announced the development of a new drug for sickle cell disease on March 16. The drug would be the country’s first indigenous, room temperature stable drug for sickle cell disease to be available at only 1% of the global price, it said. The pharma company is expected to provide the government the medicine for less than ₹600. The important thing to be noted is the caste and local advantage an indigenous product conveys - the current import price of the global brand of hydroxyurea solution (which necessitates storage at 2-8 degrees Celsius) is approximately ₹77,000.

Indian Immunologicals, incorporated under the National Dairy Development Board, has, meanwhile been working double shift. In an interview to R. Sujatha, K. Anand Kumar, managing director of the company said the dengue vaccine is likely to be available by mid-2026. “We have completed phase 1 trial, [which is] to determine safety. It was very successful. There have been no adverse reports. We will start phase 2 and 3 trials soon,” he said. Apparently, the company is also working on a Zika virus vaccine and another vaccine for the Kyasanur Forest Disease that recently went on a localised epidemic in the Malnad area of Karnataka. He also said that the company’s Hepatitis A vaccine Havisure is doing well in the market, and that a tie-up with the Railways to use in their hospitals has helped in promoting the vaccine. 

Meanwhile, an Indian team has declared it has used a repurposed drug to treat oral cancer subtype in mice using a re-purposed FDA approved deworming drug, R. Prasad reports. 

In other news, the Central Drugs Standard Control Organisation (CDSCO) has cautioned against the manufacture and sale of unapproved drugs, specifically warning against drugs falling under the category of “New Drugs”. The organisation citing the example of drugs – Meropenem (antibacterial agent) and Disodium EDTA (to treat calcium overload) – noted that they have got information that some manufacturers are involved in manufacturing/marketing of unapproved drugs which CDSCO does not yet approve. In its communication to all zonal/sub-zonal offices of CDSCO and the Indian Drugs/Pharmaceutical Association forum, it said that no new drug shall be manufactured for sale unless the licensing authority approves it and additionally a person who intends to manufacture a new drug in the form of Active pharmaceutical ingredients (API) or Pharmaceutical formulation – as the case may be for sale or distribution – shall make an application for grant of permission to the central licensing authority as per the specifications.

Following up on COVID-19, long-term studies which are now being made available, an IIT-Madras study finds that Tamil Nadu recorded no casualties among pregnant women in T.N. during the COVID-19 pandemic. An Indian Institute of Technology Madras study of antenatal care and emergency delivery services for pregnant women in the State across the three COVID-19 pandemic waves from 2020 to 2022 found that there were no casualties among pregnant women. The researchers said the expansion of ambulance service and increased awareness during the pandemic, especially during the second wave, contributed to enhanced emergency care delivery for all, including obstetric and neonatal cases. While in the United States maternal deaths rose during the pandemic years of 2020 and 2021 as compared to the preceding years, 2018 and 2019. Around 25% of all maternal deaths in 2020 and 2021 were caused by COVID-19. Countries such as Lesotho, Haiti, Mexico and Sierra Leone also suffered during the pandemic and a considerable decline in the number of first antenatal visits were recorded in these countries. Lack of transportation facilities and pharmaceutical supplies hindered routine healthcare services, according to healthcare providers. 

A Lancet study showed that life expectancy dropped by 1.6 years during the pandemic, reversing past progress. Global life expectancy dropped by 1.6 years between 2019 and 2021, a sharp reversal from past improvements, according to a research published in The Lancet journal. The study found that life expectancy declined in 84% of countries and territories during this time. This demonstrated the “devastating potential impacts of novel pathogens”, the researchers said. Mexico City, Peru and Bolivia experienced some of the largest drops, the study found.

Here, we move on to one of the biggest attacks on the demography today, one that comes from non communicable diseases.

Serena Josephine M. writes this long-form story — In Tamil Nadu, a calling card to strike at cancer — about how attempts to screen and detect cancer early have shown clear benefits. An experiment in rural Tamil Nadu, the experiment reaches out to the population, including door-to-door visits and actively campaigning among women to attend the screening programme. While it has been scaled up to more centres, the State also robustly supports it with the Makkalai Thedi Maruthuvam campaign, roughly translated as healthcare at the doorsteps. 

Here is some crucial information for diabetologists and endocrinologists. The International Diabetes Foundation last week recommended a more sensitive test to indicate the risk of developing diabetes. The Oral Glucose Tolerance Test used to be the gold standard a few decades ago. Diabetologists set their standards with the blood glucose level measured before and after consuming a 75 gm sugar solution, standard for measuring intermediate hypoglycaemia, a condition known as pre-diabetes. These results are even more accurate than a Fasting Plasma Glucose reading or even a HbA1C count, they said. The recent statement from the IDF says that a one-hour post glucose tolerance test value is crucial - if it is over 155 mg/dL, then that person has a high risk of developing diabetes, whether or not his or her fasting and two-hour values are normal. As the world wrestles with this non communicable disease, it fine tunes and refines standards that will make it easier to identify those at risk of type 2 diabetes and prevent onset of a disease, that requires a strict diet and lifestyle modification, but possibly also drugs to keep sugar levels down, and avoid slipping into complications. 

In this context, if you ask, what HbA1C, here’s a primer on the HbA1C test and why is it used to check for diabetes. Do hit the link. 

We must record here of the other bold attempt to reassess the prevalence of risk factors for cardiovascular disease among those living in extreme poverty. It has conventionally been assumed that prevalence of cardiovascular disease (CVD) risk factors among those living in extreme poverty in low and middle-income countries (LMICs) is low. This group has been thought to take in fewer calories and have correspondingly lower body mass index, consume a largely plant-based diet and be in occupations associated with higher physical activity- all known to limit the risk factors that one bears for developing CVD. However, changes in the environment and the availability of cheap food and an increasingly sedentary lifestyle have, over the years, put paid to this assumption. For this, we have to thank the findings of a recent paper in Nature Human Behaviour by Pascal Geldsetzer et al. Studying risk factors across income groups, they found that there was not a substantial difference when it came to smoking hyptertension, and diabetes were concerned. Notably, their access to medication or treatment was also limited, or non existent. 

On the occasion of World Kidney Day (on the second Thursday of March) Shakthirajan Ramanathan writes on advancing equitable access to kidney care in Tamil Nadu, couched in the context of the first department of Nephrology in India being started at the Government General Hospital and the Premier Institute of Madras Medical College in Tamil Nadu in December 1971.  

In our tail piece for the week, a piece from The Hindu’s archives pushes itself through the rich content we have and emerges a winner. Fifty years ago, in March 1974, The Hindu reported a discussion between two parliamentarians. Responding to a question by Jyotimoy Basu of the CPM, A.K. Kisku, Union Deputy Minister for Health, said that Coca Cola “was neither detrimental to human health nor did it impair appetite”. Intervening in the debate on the expansion of the Coca Cola Export Corporation’s activities in India and facilities extended to it by the Government, Mr. Kisku said he was quoting from the latest report of the National Institute of Nutrition. Now, neither politician nor nutritionist will dare to claim something like this, would they?

From the Health page

If you have a few moments, also read: 

No Smoking Day: Government urged to remove designated rooms in hotels, airports.

Serena Josephine M. explains why governments are seeing red with Rhodamine B - the reason to ban pink cotton candy and gobi manchurian.

Zubeda Hamid converses with Dr. Soumitra Pathare to ask if there is a mental health crisis among students in India, in the In Focus podcast.

Bird flu strain raises alarm as virus kills South American wildlife.

For our regular offering from the regional bureaus, see below:

Andhra Pradesh

Nellore Sravani reports: Expert calls for more awareness on organ donation to save lives of kidney patients.

Karnataka

Karnataka tops country in cochlear implant surgeries, says Dinesh Gundu Rao.

Government to focus on dealing with hearing impairment in children, says Karnataka Health Minister.

Contemporary, traditional medicinal systems should find evidence-based solutions to tackle infectious diseases’, says expert.

Activist flays move to privatise Govt. Mother and Child Hospital in Udupi.

Kerala

SOPs for district-level AMR committees released in Kerala.

Suspected case of Lyme disease reported in Ernakulam.

Distributors yet to resume drug supply to Kozhikode MCH.

Kerala health authorities issue alert as Kasaragod sees a rise in mumps cases.

Kerala’s dental health initiatives draw praise at national review.

Sam Paul A. writes: ‘Salad Day’ helps preschoolers beat the summer heat at these Alappuzha anganwadis.

Kerala public health committee discusses monsoon preparedness.

Kerala mental health review boards to start functioning from April.

Code Grey protocol becomes a reality in hospitals in Kerala.

Tamil Nadu

T.N. Public Health department issues advisory for mumps, measles, chicken pox.

Experts emphasise the need to cut salt intake for better health.

T.N.’s doorstep medical care scheme has reached multiple vulnerable groups, finds survey.

New multi-speciality block to improve operational capability of Coimbatore Medical College Hospital.

‘Internal rift’ in GTMCH hits radiological investigations and treatment.

Stanley Hospital marks World Kidney Day by honouring renal transplant recipients.

TVMCH doctors perform rare surgery to save one-day-old baby’s hand with thrombosis.

Telangana

Siddharth Kumar Singh reports on how National Health Mission contract employees are threatening strike over unpaid salaries.

Health department to fill 4,356 vacancies at 26 government medical colleges in Telangana.

Congress government is striving to build a robust healthcare system in Telangana, says Industries Minister.

Lavpreet Kaur and Naveen Kumar write that Telangana is in the grip of intoxication and addiction.

As always, do put us on your radar, as we bring more health content your way. Get more of The Hindu’s health coverage here.

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