DGHS, health ministry have conflicting Covid-19 treatment protocols, confusion continues to reign

The Covid-19 treatment protocols to be followed by India put out by three different arms of the health ministry are conflicting. Though quite late in the day, the guidelines published by Directorate General of Health Services on May 27, 2021, are evidence-based, while the protocols put out by the Ministry of Health and Family Welfare on May 24, 2021, continue with irrational medicines. There is a third treatment protocol on the Indian Council of Medical Research.

It is easy to conflate ICMR with ministry of health and family welfare and with DGHS, but these are all not the same entities. Moreover, it is quite irresponsible to put out evidence-based guidelines after India has hit a crisis point.

“In the new guidelines, DGHS has gotten rid of irrational treatments, done away with inordinate number of diagnostics and has given a strong recommendation against continued and frequent use of High Resolution CT scans (HRCTs). It has taken into account many of the concerns that were there. Other than Tociluzumab and Remdesivir, it has not recommended any other experimental drugs,” said Malini Aisola of All India Drug Action Network.

“If these guidelines are implemented effectively, it will save the people a lot of money, irrational therapies and reduce random drugs being administered to the patients,” pointed out Dr SP Kalantri, director-professor of Medicine at Mahatma Gandhi Institute of Medical Sciences and Medical Superintendent of Kasturba Hospital.

DGHS guidelines have correctly classified Covid-19 patients into four categories – Asymptomatic, mild, moderate and severe. Both the ICMR and ministry of health’s guidelines have classified patients into three categories - mild, moderate and severe.

“These DGHS guidelines are as close to science and evidence as much as possible right now. They have correctly classified Covid-19 patients into four categories and they clearly state that asymptomatic patients need no test or drugs. They also state that a patient’s mild illness can be managed with only paracetamol or fever-reducing medicines and cough syrups. They also require no tests here,” said Kalantri.

The DGHS guidelines state that only when a patient gets admitted to the hospital with moderate Covid-19 and develops hypoxia that the patient would need steroids. Here too the guidelines are specific and state that they need to given in a right dose to the right patient at the right time, making sure that there would not be an abuse of steroids like what is happening in the country right now. Hypoxia is when the body is deprived of Oxygen supply.

“They have given specific indications for Tociluzumab. Those patients who have hypoxia are already on steroids and are deteriorating despite been given Oxygen, they may be given a dose of Tociluzumab. It is an expensive drug as one injection costs Rs 50,000. This has been done so that such patients don’t have fungal infections because there are cases where Tociluzumab can flare up fungal infections,” explained Kalantri.

The various irrational medicines, which are making rounds in the country, do not find a place in the DGHS guidelines. “So, you don’t have drugs like Hydroxychloroquine, Ivermectin, Favipiravir, convalescent plasma, antibiotics like azithromycin or Doxycycline and vitamins A, D, C and Zinc in the DGHS guidelines. They have completely deleted all of that. These are clean. The treatment of mild and moderate patients is purely on science,” added Kalantri.

However, both ICMR and the Ministry’s guidelines still show HCQ, so their love affair with the drug is still not over. There is no evidence for Ivermectin, but it is still in guidelines released by the ministry of health and ICMR. ICMR suggests that it could be given patients with mild Covid-19 even though these therapies are based on low evidence.

On Remdesivir, DGHS has stated that it an experimental therapy, which should be used only on patients within 10 days of the onset of the disease. They have stated that it’s still not clear if it works or not, needs to be used with extreme caution and people need to know about the side effects of Remdesivir. They have downplayed Remdesivir in these guidelines.

“This is in line with the World Health Organisation’s guidelines, which state that Remdesivir doesn’t reduce mortality and also doesn’t decrease chances of ICU hospitalisation. While the guidelines do not categorically state that Remdesivir should not be used, it warns and puts the onus on the physician’s dialogue with the patient. Right now we don’t know if it helps or not, as it is still experimental. There might be adverse effects too,” added Kalantri. The health ministry, after the end of the second wave where people were buying the drug in black, released an advisory on June 7, 2021, to stop the irrational use of this experimental and reserve drug.

Right now there is an irrational use of high resolution CT scans all over the country. People are getting even five HRCTs during hospitalisation. The guidelines spell out the dos and don’ts for HRCTs. This is a departure from the earlier guidelines because it is stating that there is no need to do this investigation in certain cases because it amounts to using your resources, money, energy and healthcare system in an unproductive way. It goes on to list the specific instances where HRCTs might be needed.

Lastly, there is a page dedicated to Mucormycosis too, which clearly spell out what investigations are needed, the kind of anti-fungal drugs and for how many days it must be taken, whether it should be intravenous or oral. They are mostly clean, crisp and implementable.

Though DGHS has put out the treatment protocol for mucormycosis, the choice of medicine is Liposomal Amphotericin. “There are existing guidelines by DGHS on management of mucormycosis in COVID-19 that were published on May 17, 2021, which name liposomal amphotericin B as the treatment of choice but also that conventional Amphotericin B (deoxy cholate) may be used if liposomal form is not available and "renal functions and serum electrolytes are within normal limits". However these guidelines were not given wide publicity or circulated to the medical fraternity in spite of the fact that they were issued very late and after India has hit a crisis point in mucormycosis cases. The same guidelines are part of the DGHS guidelines for management of COVID,” explained Aisola.

“Pursuant to directions from the Delhi High Court, ICMR had framed an advisory on treatment for COVID associated mucormycosis dated June 3, 2021, and presented it to the Court. The Court further directed on June 4, 2021, that it should be clarified that the Advisory has been framed in the context of the shortage of Liposomal Amphotericin B by issuing an amended Advisory or an addendum, which would be reviewed every 2 weeks for the next three months. The Advisory is yet to be issued and shared publicly. How is further delay justifiable under the present circumstances of acute scarcity of amphotericin since several weeks and given the time sensitivity for patients?” added Aisola.

Now the advisory from ICMR is expected to provide a new set of treatment recommendations, underscored Aisola, for COVID associated mucormycosis, different from the DGHS guidelines, especially in respect of use of liposomal Amphotericin B.

Another one of the issues of the DGHS document is that there is no version history which is important during Covid, so as to identify the latest version because things are constantly evolving in a pandemic. “The country should have a single treatment protocol. If we have one from the health ministry, another from ICMR, a third from DGHS, a few from scientific groups and task forces, it makes the treatment procedure chaotic,” added Kalantri.